Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-27 @ 10:35 AM
Study NCT ID:
NCT05417620
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2022-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Le Kip Kip: A Campaign to Change Social Norms and Build Sustainable Demand for PrEP Among Women in South Africa
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sschwartz@jhu.edu', 'phone': '443-983-2564', 'title': 'Dr. Sheree Schwartz', 'organization': 'Johns Hopkins Bloomberg School of Public Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A limitation is using programmatic data to assess PrEP initiation among those accessing HIV testing through TB HIV Care. Since HIV testing and PrEP initiation programmatic data are not linked, we cannot determine the proportion of eligible women who initiate PrEP. Thus, we rely on PrEP initiation counts for the primary outcome.'}}, 'adverseEventsModule': {'timeFrame': 'up to 1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care', 'description': 'Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.\n\nStandard of Care: Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.', 'otherNumAtRisk': 301, 'deathsNumAtRisk': 301, 'otherNumAffected': 0, 'seriousNumAtRisk': 301, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enhanced Social Media Campaign', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.', 'otherNumAtRisk': 92, 'deathsNumAtRisk': 92, 'otherNumAffected': 0, 'seriousNumAtRisk': 92, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Enhanced Social Media Campaign + PrEP Champions', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nPrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 0, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Enhanced Social Media Campaign + Community Mobilization', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nCommunity Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Enhanced Social Media Campaign + PrEP Champions + Community Mobilization', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nPrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve.\n\nCommunity Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma.', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 0, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17949', 'groupId': 'OG000'}, {'value': '3091', 'groupId': 'OG001'}, {'value': '924', 'groupId': 'OG002'}, {'value': '925', 'groupId': 'OG003'}, {'value': '2279', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.'}, {'id': 'OG001', 'title': 'Enhanced Social Media Campaign', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.'}, {'id': 'OG002', 'title': 'Enhanced Social Media Campaign + PrEP Champions', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nPrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve.'}, {'id': 'OG003', 'title': 'Enhanced Social Media Campaign + Community Mobilization', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nCommunity Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma.'}, {'id': 'OG004', 'title': 'Enhanced Social Media Campaign + PrEP Champions + Community Mobilization', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nPrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve.\n\nCommunity Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma.'}], 'classes': [{'categories': [{'measurements': [{'value': '17949', 'groupId': 'OG000'}, {'value': '3091', 'groupId': 'OG001'}, {'value': '924', 'groupId': 'OG002'}, {'value': '925', 'groupId': 'OG003'}, {'value': '2279', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.707', 'groupIds': ['OG000'], 'paramType': 'Incidence rate ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.21', 'ciLowerLimit': '0.44', 'ciUpperLimit': '3.31', 'pValueComment': 'Threshold for significance: 0.05.', 'groupDescription': 'This statistical analysis is done at the district level where counts of initiations in intervention districts are compared to standard of care districts. In the measure type we report "rate = average counts of PrEP initiations per number of study months".', 'statisticalMethod': 'Regression, Poisson', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'De-identified aggregate counts of female sex workers (FSW) and adolescent girls and young women (AGYW) service-users within the TB HIV Care programme database who initiate PrEP during the intervention period. Number of service users in the program database who initiated prep are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population are de-identified aggregate FSW and AGYW service-users in the TB HIV Care program database that initiated PrEP during the study period.'}, {'type': 'SECONDARY', 'title': 'Proportion of PrEP Persistence at 1-month Within the TB HIV Care Programme', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16769', 'groupId': 'OG000'}, {'value': '6933', 'groupId': 'OG001'}]}, {'units': 'Districts', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.\n\nStandard of Care: Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.'}, {'id': 'OG001', 'title': 'Enhanced Social Media Campaign/PrEP Champions/Community Mobilization', 'description': 'Clusters in this arm will receive the enhanced social media campaign alone or combined with PrEP champions, community mobilization, or both.\n\nSocial Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nPrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve.\n\nCommunity Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.88', 'groupId': 'OG000', 'lowerLimit': '8.88', 'upperLimit': '76.88'}, {'value': '27.60', 'groupId': 'OG001', 'lowerLimit': '-9.92', 'upperLimit': '65.12'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1', 'description': 'Proportion of FSW/AGYW clients within the TB HIV Care programme database who return for 1-month follow-up visit. For each district, the proportion of clients who returned for this visit was calculated. The mean proportion across the standard of care and intervention districts is reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Districts', 'denomUnitsSelected': 'Districts', 'populationDescription': "The analysis population are de-identified aggregate FSW and AGYW service-users in the TB HIV Care programme database who initiated PrEP during the trial period and due for a 1-month follow-up visit. The intervention arms are grouped under the social influence campaign intervention as per the study protocol's analytic approach."}, {'type': 'SECONDARY', 'title': 'Proportion of PrEP Persistence at 4 Months Within the TB HIV Care Programme', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9948', 'groupId': 'OG000'}, {'value': '4461', 'groupId': 'OG001'}]}, {'units': 'Districts', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.\n\nStandard of Care: Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.'}, {'id': 'OG001', 'title': 'Enhanced Social Media Campaign/PrEP Champions/Community Mobilization', 'description': 'Clusters in this arm will receive the enhanced social media campaign alone or combined with PrEP champions, community mobilization, or both.\n\nSocial Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nPrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve.\n\nCommunity Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.48', 'groupId': 'OG000', 'lowerLimit': '7.14', 'upperLimit': '57.85'}, {'value': '15.56', 'groupId': 'OG001', 'lowerLimit': '-3.50', 'upperLimit': '34.47'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 4', 'description': 'Proportion of FSW/AGYW clients within the TB HIV Care programme database who return for 4-month follow-up visit. For each district, the proportion of clients who returned for this visit was calculated. The mean proportion across the standard of care and intervention districts is reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Districts', 'denomUnitsSelected': 'Districts', 'populationDescription': "The analysis population are de-identified aggregate FSW and AGYW service users in the TB HIV Care programme database who initiated PrEP during the trial period and due for a 4-month follow-up visit. The intervention arms are grouped under the social influence campaign intervention as per the study protocol's analytic approach."}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Found Intervention Acceptable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-trial Cross-sectional Survey Respondents', 'description': 'FSW and AGYW service users who were enrolled to complete a post-trial cross-sectional survey from selected standard of care and intervention districts.'}], 'classes': [{'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 12', 'description': 'Acceptability: Respondents who reported intervention acceptability captured in post-trial cross-sectional survey', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As outlined in the protocol, acceptability of the social media campaign was assessed among post-intervention cross-sectional survey respondents who reported exposure to the Le Kip Kip social influence campaign.'}, {'type': 'SECONDARY', 'title': 'Adoption as Assessed by Number of Facebook Page Visits by Unique Users', 'denoms': [{'units': 'Participants', 'counts': [{'value': '631493', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Le Kip Kip Social Media Campaign', 'description': 'This group consists of individuals who were exposed to the Le Kip Kip Facebook page through organic and paid posts, videos, and page visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '52608', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Service user uptake and engagement with campaign measured via the number of Facebook page visits. Facebook users who visited the campaign content is reported.', 'unitOfMeasure': 'visits', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population is the number Facebook users that have seen the content.'}, {'type': 'SECONDARY', 'title': 'Total Cost', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}]}, {'units': 'Social Influence Campaign', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.'}, {'id': 'OG001', 'title': 'Enhanced Social Media Campaign/PrEP Champions/Community Mobilization', 'description': 'Clusters in this arm will receive combinations of the enhanced social media campaign, PrEP champions, and community mobilization.\n\nSocial Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nPrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve.\n\nCommunity Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma.'}], 'classes': [{'categories': [{'measurements': [{'value': '223736', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'Total cost associated with planning, designing, and implementing the social influence campaign will be assessed via review of detailed study budgets. The reported value represents a single point estimate (in USD) of the total cost incurred, based on actual budget expenditures. Because this is a cumulative total cost, non-sampled financial figure, measures of dispersion/precision are not applicable. This outcome measure is based on a review of detailed study budgets related to the planning, design, and implementation of the social influence campaign.The unit analyzed is the campaign itself and analyzed as the overall cost of the Enhanced social media campaign/PrEP champions/Community mobilization arm per protocol.', 'unitOfMeasure': 'Dollars', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Social Influence Campaign', 'denomUnitsSelected': 'Social Influence Campaign', 'populationDescription': 'This analysis does not involve any participants'}, {'type': 'SECONDARY', 'title': 'Penetration as Assessed by Number of Participants Who Report Engagement With Campaign Among Social Support Networks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-trial Cross-sectional Survey Respondents', 'description': 'FSW and AGYW service users who were enrolled to complete a post-trial cross-sectional survey from selected standard of care and intervention districts.'}], 'classes': [{'title': 'Families', 'denoms': [{'units': 'Participants', 'counts': [{'value': '577', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Peers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '576', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}, {'title': 'Partners', 'denoms': [{'units': 'Participants', 'counts': [{'value': '560', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 12', 'description': 'Extent to which the social influence campaign reached FSW/AGYW and their families/peers/partners measured via descriptive statistics from post-trial survey questions on campaign exposure and perceptions of the campaign among FSW/AGYW and their social support networks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As outlined in the protocol, penetration of the social influence campaign is captured by post-intervention cross-sectional survey respondents from selected standard of care and intervention districts who answered questions regarding the reach of the Le Kip Kip campaign to their families, peers, and partners.'}, {'type': 'SECONDARY', 'title': 'Fidelity as Assessed by Percentage of On-Schedule Posts', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}]}, {'units': 'Posts', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Le Kip Kip Social Media Campaign', 'description': 'Social media metrics to determine adherence to posting frequency.'}], 'classes': [{'title': 'Content Posting Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}]}, {'units': 'Posts', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '300', 'groupId': 'OG000'}]}]}, {'title': 'Boosted Post Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}]}, {'units': 'Posts', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Month 12', 'description': 'Extent to which the social influence campaign was carried out according to plan measured via social media metrics to determine whether static and video content were shared across platforms as planned. Fidelity is assessed by tracking adherence to the planned posting schedule. Participants were not included in assessing fidelity of on-schedule posts, rather posts made across social media platforms were analyzed. Adherence was assessed by documenting whether all scheduled posts were successfully and timely published as planned during the campaign period.', 'unitOfMeasure': 'Posts', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Posts', 'denomUnitsSelected': 'Posts', 'populationDescription': 'As outlined in the protocol, participants were not included in assessing fidelity of on-schedule posts, rather posts made across social media platforms were analyzed.'}, {'type': 'SECONDARY', 'title': 'Adoption as Assessed by Number of Views by Unique Users', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}]}, {'units': 'Posts', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Le Kip Kip Social Media Campaign', 'description': 'This group consists of individuals who were exposed to the Le Kip Kip Facebook page through organic and paid posts, videos, and page visits.'}], 'classes': [{'title': 'Number of times each ad was viewed', 'categories': [{'measurements': [{'value': '576384', 'groupId': 'OG000'}]}]}, {'title': 'Number of times a video was viewed', 'categories': [{'measurements': [{'value': '44081', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Service user uptake and engagement with campaign as assessed by number of times each ad was viewed overall and number of video views.', 'unitOfMeasure': 'views', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Posts', 'denomUnitsSelected': 'Posts', 'populationDescription': 'As outlined in the protocol, adoption will be assessed using social media metrics and analytics from the number of unique users who have seen the Le Kip Kip Facebook page content at least once.'}, {'type': 'SECONDARY', 'title': 'Adoption as Assessed by Number of Ad Clicks', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}]}, {'units': 'Posts', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Le Kip Kip Social Media Campaign', 'description': 'This group consists of individuals who were exposed to the Le Kip Kip Facebook page through organic and paid posts, videos, and page visits.'}], 'classes': [{'categories': [{'measurements': [{'value': '35934', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Service user uptake and engagement with campaign measured via the number of times someone clicked on each ad', 'unitOfMeasure': 'clicks', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Posts', 'denomUnitsSelected': 'Posts', 'populationDescription': 'As outlined in the protocol, adoption will be assessed using social media metrics and analytics from the number of unique users who have seen the Le Kip Kip Facebook page content at least once.'}, {'type': 'SECONDARY', 'title': 'Fidelity as Assessed by Programme Logs Completed', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}]}, {'units': 'Campaign implementers', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care', 'description': 'Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.'}, {'id': 'OG001', 'title': 'Enhanced Social Media Campaign/PrEP Champions/Community Mobilization', 'description': 'Clusters in this arm will receive combinations of the enhanced social media campaign, PrEP champions, and community mobilization.\n\nSocial Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nPrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve.\n\nCommunity Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma.'}], 'classes': [{'title': 'Average reporting fidelity among PrEP champions', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}]}, {'units': 'Campaign implementers', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG001'}]}]}, {'title': 'Average reporting fidelity among community mobilizers', 'denoms': [{'units': 'Participants', 'counts': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}]}, {'units': 'Campaign implementers', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Extent to which the social influence campaign was carried out according to plan was measured via trainings, logs of communication with PrEP champions, and community mobilization logs/quality assessments.', 'unitOfMeasure': 'percentage of campaign implementers', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Campaign implementers', 'denomUnitsSelected': 'Campaign implementers', 'populationDescription': 'As outlined in the protocol, the extent to which the social influence campaign was carried out according to plan as assessed via programme logs completed by PrEP champions and community mobilizers.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care', 'description': 'Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.'}, {'id': 'FG001', 'title': 'Enhanced Social Media Campaign', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.'}, {'id': 'FG002', 'title': 'Enhanced Social Media Campaign + PrEP Champions', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nPrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve.'}, {'id': 'FG003', 'title': 'Enhanced Social Media Campaign + Community Mobilization', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nCommunity Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma.'}, {'id': 'FG004', 'title': 'Enhanced Social Media Campaign + PrEP Champions + Community Mobilization', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nPrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve.\n\nCommunity Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '50', 'numSubjects': '301'}, {'groupId': 'FG001', 'numUnits': '27', 'numSubjects': '92'}, {'groupId': 'FG002', 'numUnits': '26', 'numSubjects': '55'}, {'groupId': 'FG003', 'numUnits': '26', 'numSubjects': '48'}, {'groupId': 'FG004', 'numUnits': '26', 'numSubjects': '105'}]}, {'type': 'Service-users in the TB HIV Care Program Database at the Ward-level (Not Enrolled)', 'achievements': [{'groupId': 'FG000', 'numUnits': '50', 'numSubjects': '17949'}, {'groupId': 'FG001', 'numUnits': '27', 'numSubjects': '3091'}, {'groupId': 'FG002', 'numUnits': '26', 'numSubjects': '924'}, {'groupId': 'FG003', 'numUnits': '26', 'numSubjects': '925'}, {'groupId': 'FG004', 'numUnits': '26', 'numSubjects': '2279'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '50', 'numSubjects': '301'}, {'groupId': 'FG001', 'numUnits': '27', 'numSubjects': '92'}, {'groupId': 'FG002', 'numUnits': '26', 'numSubjects': '55'}, {'groupId': 'FG003', 'numUnits': '26', 'numSubjects': '48'}, {'groupId': 'FG004', 'numUnits': '26', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'wards', 'preAssignmentDetails': 'A total of 601 participants were enrolled and engaged in HIV prevention services from the TB HIV Care Program. The TB HIV Care program had a total of 25,168 service-users in their database who initiated prep and were included in the analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '601', 'groupId': 'BG005'}]}, {'units': 'Wards', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care', 'description': 'Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.'}, {'id': 'BG001', 'title': 'Enhanced Social Media Campaign/PrEP Champions/Community Mobilization', 'description': 'PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.'}, {'id': 'BG002', 'title': 'Enhanced Social Media Campaign + PrEP Champions', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nPrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve.'}, {'id': 'BG003', 'title': 'Enhanced Social Media Campaign + Community Mobilization', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nCommunity Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma.'}, {'id': 'BG004', 'title': 'Enhanced Social Media Campaign + PrEP Champions + Community Mobilization', 'description': 'Social Media Campaign: PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.\n\nPrEP Champions: Venue-based PrEP champions will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers that have repeated contact with the women the programme is intended to serve.\n\nCommunity Mobilization: PrEP community mobilization teams will be recruited to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, Learning Support Agent meetings with parents/guardians, local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '601', 'groupId': 'BG005'}]}, {'units': 'Wards', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}], 'classes': [{'categories': [{'measurements': [{'value': '23.8', 'spread': '7.8', 'groupId': 'BG000'}, {'value': '26.4', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '28.2', 'spread': '8.8', 'groupId': 'BG002'}, {'value': '25.2', 'spread': '7.8', 'groupId': 'BG003'}, {'value': '24.7', 'spread': '7.2', 'groupId': 'BG004'}, {'value': '24.9', 'spread': '7.9', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Age, Customized', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '601', 'groupId': 'BG005'}]}, {'units': 'Wards', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}], 'classes': [{'title': 'Age', 'categories': [{'title': '15-17', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '110', 'groupId': 'BG005'}]}, {'title': '18-24', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '244', 'groupId': 'BG005'}]}, {'title': '25-29', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '91', 'groupId': 'BG005'}]}, {'title': '30-34', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}]}, {'title': '35+', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '84', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '601', 'groupId': 'BG005'}]}, {'units': 'Wards', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}], 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '601', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '601', 'groupId': 'BG005'}]}, {'units': 'Wards', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}], 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '297', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}, {'value': '594', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '601', 'groupId': 'BG005'}]}, {'units': 'Wards', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}], 'classes': [{'title': 'South Africa', 'categories': [{'measurements': [{'value': '301', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '601', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Education Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '293', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '569', 'groupId': 'BG005'}]}, {'units': 'Wards', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}], 'classes': [{'categories': [{'title': 'Currently in school', 'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '57', 'groupId': 'BG004'}, {'value': '251', 'groupId': 'BG005'}]}, {'title': 'Did not complete highschool', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '88', 'groupId': 'BG005'}]}, {'title': 'Completed highschool', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '186', 'groupId': 'BG005'}]}, {'title': 'Completed university/trade school or higher', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Row population differs from the overall as participants had the option to skip or decline to answer certain questions.'}, {'title': 'Relationship Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '596', 'groupId': 'BG005'}]}, {'units': 'Wards', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}], 'classes': [{'categories': [{'title': 'Single', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '226', 'groupId': 'BG005'}]}, {'title': 'Steady partner not living together', 'measurements': [{'value': '169', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}, {'value': '300', 'groupId': 'BG005'}]}, {'title': 'Steady partner living together', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '70', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Row population differs from the overall as participants had the option to skip or decline to answer certain questions.'}, {'title': 'Current Housing Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '297', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}, {'value': '595', 'groupId': 'BG005'}]}, {'units': 'Wards', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}], 'classes': [{'categories': [{'title': 'Owns/rents', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '165', 'groupId': 'BG005'}]}, {'title': 'Staying with others (e.g., family, friends)', 'measurements': [{'value': '200', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}, {'value': '378', 'groupId': 'BG005'}]}, {'title': 'Shelter', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}, {'title': 'Student housing', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}, {'title': 'Brothel', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Row population differs from the overall as participants had the option to skip or decline to answer certain questions.'}, {'title': 'Currently Taking PrEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}, {'value': '600', 'groupId': 'BG005'}]}, {'units': 'Wards', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}], 'classes': [{'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '59', 'groupId': 'BG004'}, {'value': '320', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Row population differs from the overall as participants had the option to skip or decline to answer certain questions.'}, {'title': 'Smartphone Ownership', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '105', 'groupId': 'BG004'}, {'value': '601', 'groupId': 'BG005'}]}, {'units': 'Wards', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}], 'classes': [{'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}, {'value': '433', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Participants With Internet Access', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}, {'value': '596', 'groupId': 'BG005'}]}, {'units': 'Wards', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}]}], 'classes': [{'categories': [{'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '78', 'groupId': 'BG004'}, {'value': '431', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Row population differs from the overall as participants had the option to skip or decline to answer certain questions.'}], 'typeUnitsAnalyzed': 'Wards', 'populationDescription': 'Baseline characteristics were analyzed for 601 service-users surveyed pre-intervention from three selected control districts (n=301) and randomized wards within three selected intervention districts (n=300) to assess service-user characteristics before the intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-20', 'size': 407143, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-21T15:09', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 601}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'dispFirstSubmitDate': '2024-09-30', 'completionDateStruct': {'date': '2023-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2022-06-02', 'resultsFirstSubmitDate': '2025-04-21', 'studyFirstSubmitQcDate': '2022-06-08', 'dispFirstPostDateStruct': {'date': '2024-06-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-07-10', 'studyFirstPostDateStruct': {'date': '2022-06-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Service-users Who Initiate PrEP Uptake Within the TB HIV Care Programme', 'timeFrame': '12 months', 'description': 'De-identified aggregate counts of female sex workers (FSW) and adolescent girls and young women (AGYW) service-users within the TB HIV Care programme database who initiate PrEP during the intervention period. Number of service users in the program database who initiated prep are reported.'}], 'secondaryOutcomes': [{'measure': 'Proportion of PrEP Persistence at 1-month Within the TB HIV Care Programme', 'timeFrame': 'Month 1', 'description': 'Proportion of FSW/AGYW clients within the TB HIV Care programme database who return for 1-month follow-up visit. For each district, the proportion of clients who returned for this visit was calculated. The mean proportion across the standard of care and intervention districts is reported.'}, {'measure': 'Proportion of PrEP Persistence at 4 Months Within the TB HIV Care Programme', 'timeFrame': 'Month 4', 'description': 'Proportion of FSW/AGYW clients within the TB HIV Care programme database who return for 4-month follow-up visit. For each district, the proportion of clients who returned for this visit was calculated. The mean proportion across the standard of care and intervention districts is reported.'}, {'measure': 'Number of Participants Who Found Intervention Acceptable', 'timeFrame': 'Month 12', 'description': 'Acceptability: Respondents who reported intervention acceptability captured in post-trial cross-sectional survey'}, {'measure': 'Adoption as Assessed by Number of Facebook Page Visits by Unique Users', 'timeFrame': 'Month 12', 'description': 'Service user uptake and engagement with campaign measured via the number of Facebook page visits. Facebook users who visited the campaign content is reported.'}, {'measure': 'Total Cost', 'timeFrame': 'Month 12', 'description': 'Total cost associated with planning, designing, and implementing the social influence campaign will be assessed via review of detailed study budgets. The reported value represents a single point estimate (in USD) of the total cost incurred, based on actual budget expenditures. Because this is a cumulative total cost, non-sampled financial figure, measures of dispersion/precision are not applicable. This outcome measure is based on a review of detailed study budgets related to the planning, design, and implementation of the social influence campaign.The unit analyzed is the campaign itself and analyzed as the overall cost of the Enhanced social media campaign/PrEP champions/Community mobilization arm per protocol.'}, {'measure': 'Penetration as Assessed by Number of Participants Who Report Engagement With Campaign Among Social Support Networks', 'timeFrame': 'Month 12', 'description': 'Extent to which the social influence campaign reached FSW/AGYW and their families/peers/partners measured via descriptive statistics from post-trial survey questions on campaign exposure and perceptions of the campaign among FSW/AGYW and their social support networks.'}, {'measure': 'Fidelity as Assessed by Percentage of On-Schedule Posts', 'timeFrame': 'Month 12', 'description': 'Extent to which the social influence campaign was carried out according to plan measured via social media metrics to determine whether static and video content were shared across platforms as planned. Fidelity is assessed by tracking adherence to the planned posting schedule. Participants were not included in assessing fidelity of on-schedule posts, rather posts made across social media platforms were analyzed. Adherence was assessed by documenting whether all scheduled posts were successfully and timely published as planned during the campaign period.'}, {'measure': 'Adoption as Assessed by Number of Views by Unique Users', 'timeFrame': '12 months', 'description': 'Service user uptake and engagement with campaign as assessed by number of times each ad was viewed overall and number of video views.'}, {'measure': 'Adoption as Assessed by Number of Ad Clicks', 'timeFrame': '12 months', 'description': 'Service user uptake and engagement with campaign measured via the number of times someone clicked on each ad'}, {'measure': 'Fidelity as Assessed by Programme Logs Completed', 'timeFrame': '12 months', 'description': 'Extent to which the social influence campaign was carried out according to plan was measured via trainings, logs of communication with PrEP champions, and community mobilization logs/quality assessments.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PrEP', 'Pre-exposure Prophylaxis', 'HIV prevention', 'Cluster randomized trial', 'Community-based methods', 'Key populations', 'Female sex workers', 'Adolescent girls and young women', 'South Africa'], 'conditions': ['Pre-exposure Prophylaxis', 'HIV Infections']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the impact of a social media campaign and community engagement activities to promote pre-exposure prophylaxis (PrEP) use among young women and to influence community norms around PrEP in South Africa. To do this, the investigative team will analyze PrEP initiation and retention data from the study's implementing partner, TB HIV Care, a non-profit organization providing PrEP to marginalized young women in South Africa. The effect of the social media campaign and community engagement will be tested using a short duration cluster randomized trial (CRT).", 'detailedDescription': 'The cluster randomized trial (CRT) will not engage in PrEP provision to individuals, but instead employs geographical regions to serve as units of randomization where social media content and community engagement will be targeted. TB HIV Care employs a large team to provide routine service delivery while the CRT tests strategies including a social media campaign and community engagement that may amplify PrEP uptake and persistence among the community, leveraging the programme infrastructure to actually provide services as it is already doing. Embedding strategies within the programme ensures that the existing results come from real world contexts and focuses on implementation of support strategies rather than clinical care provision. The CRT will be implemented across 10 districts, with 5 districts serving as control sites and 5 as intervention sites.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'genderBased': True, 'genderDescription': 'Eligibility to limited to cisgender women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible to take PrEP per TB HIV Care programmatic criteria\n* Engaged in TB HIV Care HIV prevention program\n\nExclusion Criteria:\n\n* Not eligible for PrEP (not at risk for HIV) per TB HIV Care programmatic criteria'}, 'identificationModule': {'nctId': 'NCT05417620', 'briefTitle': 'Le Kip Kip: A Campaign to Change Social Norms and Build Sustainable Demand for PrEP Among Women in South Africa', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Optimizing Pre-exposure Prophylaxis (PrEP) Implementation and Effectiveness Among Women at High Risk for HIV Acquisition in South Africa', 'orgStudyIdInfo': {'id': '90089975'}, 'secondaryIdInfos': [{'id': 'R01MH121161', 'link': 'https://reporter.nih.gov/quickSearch/R01MH121161', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard of Care', 'description': 'Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced social media campaign', 'description': 'Social media campaign which will be disseminated on Facebook, Instagram, and WhatsApp with targeted ads/promotion of materials in intervention districts.', 'interventionNames': ['Behavioral: Social Media Campaign']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced social media campaign + PrEP champions', 'description': 'Venue-based peers who will provide PrEP information, share personal experiences with PrEP, and refer young women to TB HIV Care to receive PrEP if interested in addition to the enhanced social media campaign.', 'interventionNames': ['Behavioral: Social Media Campaign', 'Behavioral: PrEP Champions']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced social media campaign + Community mobilization', 'description': 'Peers will work within wards to organize and attend community meetings to share PrEP information and facilitate discussions with young women, male partners, family members, and other community members in addition to the enhanced social media campaign.', 'interventionNames': ['Behavioral: Social Media Campaign', 'Behavioral: Community Mobilization']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced social media campaign + PrEP champions + Community mobilization', 'description': 'Clusters in this arm will receive both the PrEP champion and community mobilization interventions in addition to the enhanced social media campaign.', 'interventionNames': ['Behavioral: Social Media Campaign', 'Behavioral: PrEP Champions', 'Behavioral: Community Mobilization']}], 'interventions': [{'name': 'Social Media Campaign', 'type': 'BEHAVIORAL', 'description': 'PrEP social influence campaign, which will use online approaches to promote PrEP within communities in addition to the standard of care activities. Messaging crafted with community input will be geographically targeted to women, parents/mentors, and male partners on Facebook, Instagram, and Whatsapp, all with the intention to promote PrEP for women at high risk of HIV infection and change community norms and influence around PrEP. A combination of static imagery and brief videos will be used to engage these groups via social media platforms. A Facebook page will be created and maintained that can be accessed by anyone anywhere, but will only be advertised/promoted in the intervention districts.', 'armGroupLabels': ['Enhanced social media campaign', 'Enhanced social media campaign + Community mobilization', 'Enhanced social media campaign + PrEP champions', 'Enhanced social media campaign + PrEP champions + Community mobilization']}, {'name': 'PrEP Champions', 'type': 'BEHAVIORAL', 'description': 'Within venues served by the FSW and AGYW programs, the team will identify and train 1 venue-based PrEP champion per venue who will receive supplies (e.g. a hat, pin and posters, flyers, IEC material) to wear to promote PrEP, facilitate linkage between women interested in PrEP and the TB HIV Care PrEP programme. PrEP champions will be either peers with experience taking PrEP, venue managers or local influencers (e.g. women running shops next to the mobile serving AGYW) that have repeated contact with the women the programme is intended to serve. The final selection of PrEP champions will be made in consultation with the Community Advisory Groups, venues and by the programme who works closely with each of the sites.', 'armGroupLabels': ['Enhanced social media campaign + PrEP champions', 'Enhanced social media campaign + PrEP champions + Community mobilization']}, {'name': 'Community Mobilization', 'type': 'BEHAVIORAL', 'description': 'A PrEP community mobilization team (2 peers, including one woman and one man) will be recruited within each ward to promote PrEP. The team will present information about PrEP and the PrEP programme at the ward councilors meeting, at Learning Support Agent meetings with parents/guardians, at local events/fairs, community meetings and through engaging men, women and parents across the community through informal conversations. Teams will be wearing branded material and will focus on presenting factual information and decreasing PrEP stigma. Each team will focus on promoting PrEP within their own ward over the 6-month period.', 'armGroupLabels': ['Enhanced social media campaign + Community mobilization', 'Enhanced social media campaign + PrEP champions + Community mobilization']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Full-time peer educators employed by the TB HIV Care programme to engage women, layer PrEP promotion across prevention programs, and implement "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to increase young women\'s perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.', 'armGroupLabels': ['Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cape Town', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'TB HIV Care', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}], 'overallOfficials': [{'name': 'Sheree R Schwartz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins Bloomberg School of Public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Aggregate programmatic data will be used to assess trial outcomes rather than individual participant data given the cluster randomized trial design. Therefore, no individual participant data (IPD) will be collected and no sharing plan is required.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'TB HIV Care', 'class': 'OTHER'}, {'name': 'Community Media Trust', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}