Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-03-03 @ 10:03 AM
Study NCT ID:
NCT03213366
Status:
COMPLETED
Last Update Posted:
2019-11-06
First Post:
2017-03-28
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Social Media Based Peer-Led Intervention for HIV Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vpatel@montefiore.org', 'phone': '718.920-7102', 'title': 'Dr. Viraj V Patel', 'organization': 'Albert Einstein College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were tracked for a period of 12 weeks.', 'description': 'There was no risk for serious or adverse events. All of the the risk were minimal. None of the participants were at risk of mortality.', 'eventGroups': [{'id': 'EG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': '8 Peer Leaders (PLs) will be randomly assigned to the E-PrEP arm. Each of the PLs will recruit at least 15 participants into a private social media group on one of several social media platforms. PLs will then deliver a behavioral intervention over a 6 week period, posting information and engaging participants in a discussion about PrEP, PrEP access, and other related health issues. All contents will be formatted to be both mobile device accessible.\n\nIntervention contents and targets were informed by a systematic review of PrEP barriers and facilitators, a locally conducted qualitative study, and key informant and peer leader inputs. The contents were developed or adapted by study staff and peer leaders. Components and associated text have been designed to engage participants in online discussions about PrEP and related health and social topics. Posts will also include information about linkage-to-care, and insurance access. New contents will be posted almost daily.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BxNow - General Health Campaign', 'description': 'BxNow is an attention-matched control. Eight of the 16 PLs will be randomly assigned to the BxNow arm. The BxNow campaign will be a 6-week long social media intervention about general health wellness topics chosen and administered by the PLs assigned into this arm. Similarly to the intervention group, PLs in the BxNow arm will create private social media groups and recruit participants into these private groups. General health information in the BxNow arm will be posted with the same frequency as in the intervention arm.\n\nBxNow - General Health Campaign: BxNow will focus on general health topics unrelated to HIV or sexual health (i.e. fitness, nutrition, smoking), as chosen by PLs. Contents will be developed or adapted by PLs and posted almost daily. Posts will also include information about linkage-to-care and insurance access. At the end of the intervention, BxNow participants will be exposed to E-PrEP components at the end of the trial.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 0, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Intending to Start Using PrEP Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'OG001', 'title': 'BxNow- General Health Control Arm', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'Yes', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks', 'categories': [{'title': 'Yes', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'categories': [{'title': 'Yes', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5783', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0095', 'ciLowerLimit': '-0.04676', 'ciUpperLimit': '0.02776', 'groupDescription': 'At 6 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3185', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.01692', 'ciLowerLimit': '-0.05318', 'ciUpperLimit': '0.01933', 'groupDescription': 'At 12 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, 6 weeks, and 12 weeks', 'description': 'This primary outcome is intention to use PrEP in the next month measured at baseline, 6 weeks, and 12 weeks. This was assessed with a yes/no question (dichotomous variable). However, this variable does not include anyone who reported PrEP use at either 6 or 12 weeks.\n\nThis outcome will inform sample size calculations for a subsequent fully powered trial.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each of the rows indicates the number of participants who indicated intending to use PrEP at each time point (Baseline vs. 6 weeks vs. 12 weeks).'}, {'type': 'PRIMARY', 'title': 'Number of Participants Using PrEP Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'OG001', 'title': 'BxNow- General Health Control Arm', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': '6 weeks', 'categories': [{'title': 'Yes', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': '12 weeks', 'categories': [{'title': 'Yes', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.07863', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03674', 'ciLowerLimit': '-0.00516', 'ciUpperLimit': '0.07863', 'groupDescription': 'At 6 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1999', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02594', 'ciLowerLimit': '-0.01648', 'ciUpperLimit': '0.06836', 'groupDescription': 'At 12 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at baseline, 6 weeks, and 12 weeks', 'description': 'This outcome is the number of participants who self-report using PrEP at baseline, 6 weeks, or 12 weeks. This was measure by a yes/no question asking if the participant currently uses PrEP (dichotomous variable).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in PrEP Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'OG001', 'title': 'BxNow- General Health Control Arm', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '1.86', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks', 'categories': [{'measurements': [{'value': '1.86', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '1.83', 'spread': '0.46', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '1.83', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.73', 'spread': '0.55', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8963', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.000443', 'groupDescription': 'At 6 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3229', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.004308', 'groupDescription': 'At 12 weeks', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, 6 weeks, and 12 weeks', 'description': 'Self-reported PrEP related knowledge.\n\nParticipants were asked two questions about PrEP knowledge. For each question, they got one point if the answer was correct.\n\nScale range from 0-2. The score were added and the average of the sum was reported.\n\nThe higher the score, the higher the knowledge of PrEP.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PrEP Awareness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'OG001', 'title': 'BxNow- General Health Control Arm', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.14', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '4.02', 'spread': '0.88', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks', 'categories': [{'measurements': [{'value': '4.29', 'spread': '0.96', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '0.91', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '4.52', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '4.19', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2433', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.008705', 'pValueComment': 'This t-test was for the random effects model not for comparing the difference between the arms.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0839', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.01358', 'groupDescription': 'At 12 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks, 12 weeks', 'description': 'Awareness about PrEP.\n\nPrEP awareness was measured with one question, scored 1 to 5. The mean for each arm was calculated at each time point.\n\nThe higher the score, the higher the level of awareness about PrEP.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'T'}, {'type': 'SECONDARY', 'title': 'PrEP Stigma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'OG001', 'title': 'BxNow- General Health Control Arm', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '6.25', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '6.78', 'spread': '2.39', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks', 'categories': [{'measurements': [{'value': '5.40', 'spread': '2.55', 'groupId': 'OG000'}, {'value': '6.24', 'spread': '2.87', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '5.12', 'spread': '2.34', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '2.53', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2114', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.302', 'groupDescription': 'At 6 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.03149', 'groupDescription': 'At 12 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks, 12 weeks', 'description': 'Any stigma the participant might have about PrEP or those who use PrEP\n\nTo measure PrEP Stigma we asked 3 questions, using a Likert scale (from 1-4; 1= Strongly Disagree, 4=Strongly Agree). The scores were summed for each participant. The scores range from 1-12, with higher scores indicating higher levels of PrEP Stigma.\n\nThe higher the score, the higher the level of PrEP stigma.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Communication About PrEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'OG001', 'title': 'BxNow- General Health Control Arm', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.42', 'spread': '2.38', 'groupId': 'OG000'}, {'value': '8.24', 'spread': '2.29', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks', 'categories': [{'measurements': [{'value': '9.14', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '8.60', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '8.94', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '8.32', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0124', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0278', 'groupDescription': 'At 6 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0022', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.03052', 'groupDescription': 'At 12 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks, 12 weeks', 'description': 'Discussion of PrEP with friends, partners, or family. Communication about PrEP was measured with 2 questions, using a Likert scale ( from 1-5;1=Not at all, 5= Extremely). The scores of the 2 questions were summed for each participant.\n\nThe scores range from 1-10, with higher the score indicating higher the level of communication about PrEP (i.e. higher scores indicates participants communicating more about PrEP).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'PrEP Barriers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'OG001', 'title': 'BxNow- General Health Control Arm', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '17.80', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '18.73', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks', 'categories': [{'measurements': [{'value': '17.11', 'spread': '5.17', 'groupId': 'OG000'}, {'value': '18.76', 'spread': '5.22', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '16.55', 'spread': '4.92', 'groupId': 'OG000'}, {'value': '17.84', 'spread': '5.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.05747', 'groupDescription': 'At 6 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.133', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.05101', 'groupDescription': 'At 12 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 6 weeks, 12 weeks', 'description': 'Any Barriers to PrEP uptake.\n\nTo measure barriers to PrEP uptake, 7 items were used. Each item was measured using a likert scale ( from 1-4; 1=Strongly Disagree, 4= Strongly Agree). The scores of each question were summed for each participant (scale scores ranged 1-28, with higher scores indicating higher levels of PrEP Barriers).\n\nThe higher the score, the higher the number of PrEP Barriers.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Self-efficacy About Using PrEP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'OG001', 'title': 'BxNow- General Health Control Arm', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '8.26', 'spread': '2.39', 'groupId': 'OG000'}, {'value': '8.19', 'spread': '2.35', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks', 'categories': [{'measurements': [{'value': '8.88', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '8.49', 'spread': '1.86', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'categories': [{'measurements': [{'value': '8.75', 'spread': '1.97', 'groupId': 'OG000'}, {'value': '8.13', 'spread': '2.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0818', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.0209', 'groupDescription': 'At 6 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0334', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Slope', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.03103', 'groupDescription': 'At 12 weeks.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, 6 weeks, and 12 weeks', 'description': 'Self-reported answer to questions about self-efficacy of using PrEP. There were two questions to measure self-efficacy of PrEP using a Likert scale (ranging from 1-5; 1=Not at all, 5=Extremely). The scores from both questions were summed for each participant. The scale range from 1-10 with higher scores indicating higher the levels of PrEP self-efficacy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Self-reported HIV Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'OG001', 'title': 'BxNow- General Health Control Arm', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'title': '1 month', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': '3 months or less', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': '4 to 6 months', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}, {'title': '7 to 12 months', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'More than 12 months', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'I have never been tested for STI', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'title': '1 month', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': '3 months or less', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': '4 to 6 months', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': '7 to 12 months', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': 'More than 12 months', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'I have never been tested for STI', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'title': '1 month', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}, {'title': '3 months or less', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}, {'title': '4 to 6 months', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': '7 to 12 months', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'More than 12 months', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'I have never been tested for STI', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at baseline, 6 weeks, and 12 weeks', 'description': 'Self-reported HIV testing at baseline, 6 weeks, and 12 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each row indicates when the participant who responded to the survey at baseline, 6 weeks, and 12 weeks.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Self-reported Linkage-to-Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'OG001', 'title': 'BxNow- General Health Control Arm', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}], 'classes': [{'title': 'Baseline- Visit in the past 12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks- Visit in the past 6 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': '12 Weeks- Visit in the past 12 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'No', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'at baseline, 6 weeks, and 12 weeks', 'description': 'Self-reported information about health care access (i.e. going to a medical appointment).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Each row has the number of participants who access healthcare at each time point in the "yes" category, and the number of people who did not access healthcare in the "no" category. (Baseline vs. 6 weeks vs. 12 weeks).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Trust in the Peer by Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'OG001', 'title': 'BxNow- General Health Control Arm', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.4', 'spread': '4.15', 'groupId': 'OG000'}, {'value': '14.32', 'spread': '4.27', 'groupId': 'OG001'}]}]}, {'title': '6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.06', 'spread': '4.48', 'groupId': 'OG000'}, {'value': '15.71', 'spread': '4.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at baseline and 6 weeks', 'description': "The scale measure the level of trust the Participant had on the Peer's online post.\n\nTrust in the Peer Leader was measured using 4 questions, each scored from 1-7 (1=Strongly Disagree, 7=Strongly Agree). The score for the 4 questions was summed for each participant. The score ranged from 1-28 with higher scores indicating a higher level of trust the participant had in their Peer Leader.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The total number of participants who completed baseline study was 81 for e-prep and 71 for control. The analysis for 6 weeks included only the people who completed the survey at each that time period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'FG001', 'title': 'BxNow-General Health Control Arm:', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '7', 'numSubjects': '81'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '71'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '5', 'numSubjects': '72'}, {'groupId': 'FG001', 'numUnits': '5', 'numSubjects': '67'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '2', 'numSubjects': '9'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'typeUnitsAnalyzed': 'Peers'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'E-PrEP- Peer-Led Intervention About PrEP', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: The E-PrEP campaign focused on delivering information about PrEP. The materials were composed of 6 weeks of publicly available PrEP educations materials selected by peer advisors prior to the intervention (i.e. information on how to talk to your doctor about PrEP, where to get PrEP, side effects, etc.). The materials mapped out onto Diffusion of Innovation (DOI) and Information, Motivation, Behavior (IMB) domains. Peer leaders framed the E-PrEP materials in their own words when posting the materials to their online private group.'}, {'id': 'BG001', 'title': 'BxNow- General Health Control Arm', 'description': 'We recruited Peer Leaders over a 5-week period and then randomly assigned them to the 2 arms. Peer Leaders were blinded to their study condition. Peer leaders recruited study participants via their existing online social networks to complete an online eligibility screener and baseline survey. Study participants were then directed to join a private online group, facilitated and moderated by the peer leader who had recruited them.\n\nContent: BxNow focused on a broad range of health topics prioritized by the peer leaders assigned to this arm, but did not include any contents about HIV or PrEP (i.e. depression, anxiety, suicide, intimate partner violence, drug use, awareness of sexually transmitted infections). BxNow was attention matched to the E-PrEP intervention timeline (6 weeks of materials) for both time and day of posts and frequency of posts. As with E-PrEP, standardized BxNow contents were delivered by peer leaders, framed using their own words.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.28', 'spread': '2.83', 'groupId': 'BG000'}, {'value': '23.32', 'spread': '3.39', 'groupId': 'BG001'}, {'value': '23.84', 'spread': '2.83', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Gender Identity', 'categories': [{'title': 'Male', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}, {'title': 'Female/Transfemale', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Transmale', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Gender Non-conforming/Gender Non-Binary', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Queer', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'Latinx/Hispanic', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Non-Hispanic Black', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Residence', 'classes': [{'categories': [{'title': 'Bronx', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Brooklyn', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Manhattan', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Queens', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Staten Island', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sexual Identity', 'classes': [{'categories': [{'title': 'Gay/Homosexual', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'Queer', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Bisexual', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Heterosexual/Straight', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education Level', 'classes': [{'categories': [{'title': 'High School or Less', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'Some College', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': 'College and Beyond', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Employment', 'classes': [{'title': 'Full Time', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Part Time', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'Unemployed', 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Disable', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Student', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants had the option to select more than one answer in order to best describe their employment status (not mutually exclusive).', 'unitOfMeasure': 'Participants'}, {'title': 'Income', 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Less than $10,000', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': '$10,000-$19,999', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': '$20,000-$29,999', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '$30,000-$39,999', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': '$40,000-more', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Living Situation', 'classes': [{'categories': [{'title': "Don't have a place to live", 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Temporary Living Situation', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Parents/Family', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': 'Partner/Boyfriend/Husband', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Roomates', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Alone', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Wife/Females Partner/Girlfriend', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Health Insurance', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}, {'title': 'No', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': "I don't kno", 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-27', 'size': 432499, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-04T16:51', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Both Peer Leaders and participants will be masked to the group randomized to. The statistician, who will be analyzing the data, will also be masked to group assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'There will be two groups of Peer Leaders recruited. One group of Peer Leaders will be randomized to deliver the E-PrEP intervention and the second group of peer leaders will be randomized to deliver a general health campaign (control).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-25', 'studyFirstSubmitDate': '2017-03-28', 'resultsFirstSubmitDate': '2019-04-25', 'studyFirstSubmitQcDate': '2017-07-07', 'lastUpdatePostDateStruct': {'date': '2019-11-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-12', 'studyFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Self-reported HIV Testing', 'timeFrame': 'at baseline, 6 weeks, and 12 weeks', 'description': 'Self-reported HIV testing at baseline, 6 weeks, and 12 weeks.'}, {'measure': 'Number of Participants With Self-reported Linkage-to-Care', 'timeFrame': 'at baseline, 6 weeks, and 12 weeks', 'description': 'Self-reported information about health care access (i.e. going to a medical appointment).'}, {'measure': 'Trust in the Peer by Participant', 'timeFrame': 'at baseline and 6 weeks', 'description': "The scale measure the level of trust the Participant had on the Peer's online post.\n\nTrust in the Peer Leader was measured using 4 questions, each scored from 1-7 (1=Strongly Disagree, 7=Strongly Agree). The score for the 4 questions was summed for each participant. The score ranged from 1-28 with higher scores indicating a higher level of trust the participant had in their Peer Leader."}], 'primaryOutcomes': [{'measure': 'Number of Participants Intending to Start Using PrEP Over Time', 'timeFrame': 'baseline, 6 weeks, and 12 weeks', 'description': 'This primary outcome is intention to use PrEP in the next month measured at baseline, 6 weeks, and 12 weeks. This was assessed with a yes/no question (dichotomous variable). However, this variable does not include anyone who reported PrEP use at either 6 or 12 weeks.\n\nThis outcome will inform sample size calculations for a subsequent fully powered trial.'}, {'measure': 'Number of Participants Using PrEP Over Time', 'timeFrame': 'at baseline, 6 weeks, and 12 weeks', 'description': 'This outcome is the number of participants who self-report using PrEP at baseline, 6 weeks, or 12 weeks. This was measure by a yes/no question asking if the participant currently uses PrEP (dichotomous variable).'}], 'secondaryOutcomes': [{'measure': 'Change in PrEP Knowledge', 'timeFrame': 'at baseline, 6 weeks, and 12 weeks', 'description': 'Self-reported PrEP related knowledge.\n\nParticipants were asked two questions about PrEP knowledge. For each question, they got one point if the answer was correct.\n\nScale range from 0-2. The score were added and the average of the sum was reported.\n\nThe higher the score, the higher the knowledge of PrEP.'}, {'measure': 'PrEP Awareness', 'timeFrame': 'baseline, 6 weeks, 12 weeks', 'description': 'Awareness about PrEP.\n\nPrEP awareness was measured with one question, scored 1 to 5. The mean for each arm was calculated at each time point.\n\nThe higher the score, the higher the level of awareness about PrEP.'}, {'measure': 'PrEP Stigma', 'timeFrame': 'baseline, 6 weeks, 12 weeks', 'description': 'Any stigma the participant might have about PrEP or those who use PrEP\n\nTo measure PrEP Stigma we asked 3 questions, using a Likert scale (from 1-4; 1= Strongly Disagree, 4=Strongly Agree). The scores were summed for each participant. The scores range from 1-12, with higher scores indicating higher levels of PrEP Stigma.\n\nThe higher the score, the higher the level of PrEP stigma.'}, {'measure': 'Communication About PrEP', 'timeFrame': 'baseline, 6 weeks, 12 weeks', 'description': 'Discussion of PrEP with friends, partners, or family. Communication about PrEP was measured with 2 questions, using a Likert scale ( from 1-5;1=Not at all, 5= Extremely). The scores of the 2 questions were summed for each participant.\n\nThe scores range from 1-10, with higher the score indicating higher the level of communication about PrEP (i.e. higher scores indicates participants communicating more about PrEP).'}, {'measure': 'PrEP Barriers', 'timeFrame': 'baseline, 6 weeks, 12 weeks', 'description': 'Any Barriers to PrEP uptake.\n\nTo measure barriers to PrEP uptake, 7 items were used. Each item was measured using a likert scale ( from 1-4; 1=Strongly Disagree, 4= Strongly Agree). The scores of each question were summed for each participant (scale scores ranged 1-28, with higher scores indicating higher levels of PrEP Barriers).\n\nThe higher the score, the higher the number of PrEP Barriers.'}, {'measure': 'Self-efficacy About Using PrEP', 'timeFrame': 'at baseline, 6 weeks, and 12 weeks', 'description': 'Self-reported answer to questions about self-efficacy of using PrEP. There were two questions to measure self-efficacy of PrEP using a Likert scale (ranging from 1-5; 1=Not at all, 5=Extremely). The scores from both questions were summed for each participant. The scale range from 1-10 with higher scores indicating higher the levels of PrEP self-efficacy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PrEP', 'HIV prevention', 'Public Health Social Media Campaign', 'Peer Intervention'], 'conditions': ['HIV Prevention', 'PrEP Uptake']}, 'referencesModule': {'references': [{'pmid': '30154071', 'type': 'DERIVED', 'citation': 'Patel VV, Ginsburg Z, Golub SA, Horvath KJ, Rios N, Mayer KH, Kim RS, Arnsten JH. Empowering With PrEP (E-PrEP), a Peer-Led Social Media-Based Intervention to Facilitate HIV Preexposure Prophylaxis Adoption Among Young Black and Latinx Gay and Bisexual Men: Protocol for a Cluster Randomized Controlled Trial. JMIR Res Protoc. 2018 Aug 28;7(8):e11375. doi: 10.2196/11375.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of E-PrEP on reaching young men of color who have sex with men (YMCSM) at high-risk of HIV infection to reduce HIV acquisition. E-PrEP is a peer-designed social media-based health intervention to increase PrEP awareness, knowledge, and motivation as a tool for HIV prevention and to increase linkage to primary care.', 'detailedDescription': "This study examines a social media based peer-led and delivered intervention focused on increasing PrEP adoption in young men of color who have sex with men (YMCSM). While prior efficacy trials have included YMCSM 18-29, we will focus on PrEP in YMCSM outside clinical trial settings. Rather than an alternative medium for implementation of existing interventions designed for in-person contact, social media may be a true 'game changer' to engage hard to reach individuals. While many online behavioral interventions exist, including some that use social media, this will be one of the few studies to use and test social media to facilitate uptake of a biomedical intervention. E-PrEP will connect the target population (YMCSM) to a new prevention tool (PrEP) through rapid linkage to medical care, accelerating diffusion of PrEP. Given the paucity of data regarding social media-based interventions to change health-related behavior, E-PrEP may have a marked impact on future bio-behavioral interventions, especially those that include diffusion of innovation. Social media offers the power of scale and efficiency for large potential impact, even with relatively low-intensity interventions. Similarly, PrEP, if widely adopted in high-risk populations and offered with behavioral interventions, could markedly decrease HIV infection rates. Social media-based, peer-led approaches like E-PrEP could be used to enhance efforts by community-based and other organizations that employ internet-assisted or peer-outreach strategies to improve health.\n\nPrimary Aim: To test the feasibility and preliminary efficacy of E-PrEP for increasing PrEP adoption in a cluster-randomized controlled trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Including participants who self-identify as male or transgender individual and also have sex with men.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Transgender individual; Ages 18-29; Have had unprotected anal sex with a male partner in the prior 12 months; Fluent in English or Spanish; Are HIV-negative or unknown status (self-report); Identify as Black and/or Latino\n\nExclusion Criteria:\n\n* YMCSM who do not consent/assent to study; not currently using at least one of 2 social media sites that will be used for the E-PrEP intervention (not using Facebook, or Instagram), and do not live in New York City.'}, 'identificationModule': {'nctId': 'NCT03213366', 'briefTitle': 'Social Media Based Peer-Led Intervention for HIV Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Montefiore Medical Center'}, 'officialTitle': 'Empowering With PrEP Cluster-Randomized Controlled Trial: A Social Media Based Peer-Led Intervention for HIV Prevention', 'orgStudyIdInfo': {'id': '2016-7263'}, 'secondaryIdInfos': [{'id': '5K23MH102118-04', 'link': 'https://reporter.nih.gov/quickSearch/5K23MH102118-04', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'E-PrEP- Peer-Led Intervention about PrEP', 'description': '8 Peer Leaders (PLs) will be randomly assigned to the E-PrEP arm. Each of the PLs will recruit at least 15 participants into a private social media group on one of several social media platforms. PLs will then deliver a behavioral intervention over a 6 week period, posting information and engaging participants in a discussion about PrEP, PrEP access, and other related health issues. All contents will be formatted to be both mobile device accessible.', 'interventionNames': ['Behavioral: E-PrEP- Peer-Led Intervention about PrEP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BxNow - General Health Campaign', 'description': 'BxNow is an attention-matched control. Eight of the 16 PLs will be randomly assigned to the BxNow arm. The BxNow campaign will be a 6-week long social media intervention about general health wellness topics chosen and administered by the PLs assigned into this arm. Similarly to the intervention group, PLs in the BxNow arm will create private social media groups and recruit participants into these private groups. General health information in the BxNow arm will be posted with the same frequency as in the intervention arm.', 'interventionNames': ['Behavioral: BxNow - General Health Campaign']}], 'interventions': [{'name': 'E-PrEP- Peer-Led Intervention about PrEP', 'type': 'BEHAVIORAL', 'description': 'Intervention contents and targets were informed by a systematic review of PrEP barriers and facilitators, a locally conducted qualitative study, and key informant and peer leader inputs. The contents were developed or adapted by study staff and peer leaders. Components and associated text have been designed to engage participants in online discussions about PrEP and related health and social topics. Posts will also include information about linkage-to-care, and insurance access. New contents will be posted almost daily.', 'armGroupLabels': ['E-PrEP- Peer-Led Intervention about PrEP']}, {'name': 'BxNow - General Health Campaign', 'type': 'BEHAVIORAL', 'description': 'BxNow will focus on general health topics unrelated to HIV or sexual health (i.e. fitness, nutrition, smoking), as chosen by PLs. Contents will be developed or adapted by PLs and posted almost daily. Posts will also include information about linkage-to-care and insurance access. At the end of the intervention, BxNow participants will be exposed to E-PrEP components at the end of the trial.', 'armGroupLabels': ['BxNow - General Health Campaign']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Viraj Patel, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montefiore Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montefiore Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, {'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Viraj V. Patel', 'investigatorAffiliation': 'Montefiore Medical Center'}}}}