Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT04712994
Status:
COMPLETED
Last Update Posted:
2025-01-08
First Post:
2020-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anjuliw@uw.edu', 'phone': '9784602331', 'title': 'Anjuli Wagner', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 cross-sectional visit. In this cross-sectional study, there were no participants followed longitudinally. Adverse events were not collected systematically within this minimal risk, cross-sectional study.', 'description': 'We have revised the Participant Flow module, which should now allow these numbers to be consistent.', 'eventGroups': [{'id': 'EG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.', 'otherNumAtRisk': 961, 'deathsNumAtRisk': 961, 'otherNumAffected': 0, 'seriousNumAtRisk': 961, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.', 'otherNumAtRisk': 961, 'deathsNumAtRisk': 958, 'otherNumAffected': 0, 'seriousNumAtRisk': 958, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PrEP Penetration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '961', 'groupId': 'OG000'}, {'value': '958', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.'}, {'type': 'PRIMARY', 'title': 'PrEP Fidelity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '961', 'groupId': 'OG000'}, {'value': '958', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.'}, {'type': 'PRIMARY', 'title': 'Timeliness of Services', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '36'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '33'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '29'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '27.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Time (minutes) spent receiving services from health care works', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.'}, {'type': 'PRIMARY', 'title': 'Waiting Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '384', 'groupId': 'OG000'}, {'value': '384', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '22.5', 'upperLimit': '77'}, {'value': '37', 'groupId': 'OG001', 'lowerLimit': '14.5', 'upperLimit': '74'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '80'}, {'value': '29', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '46.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Time (minutes) spent waiting to receive services', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.'}, {'type': 'PRIMARY', 'title': 'HCW Acceptability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '20.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Total on 4 item Acceptability of Intervention Measures (AIM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale. The minimum score on the 4 items is 4 points (scoring 1 on each of the 4 items) while the maximum is 20 points (scoring 5 on each of the 4 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was assessed on a group of 39 HCW who were involved in delivering the implementation strategy package. These are not a subset of the women enrolled in the study, hence the numbers are not concordant.'}, {'type': 'PRIMARY', 'title': 'Health Care Worker (HCW) Appropriateness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '20.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Total on 4 item Intervention Appropriateness Measure (IAM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale. The minimum score on the 4 items is 4 points (scoring 1 on each of the 4 items) while the maximum is 20 points (scoring 5 on each of the 4 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was assessed on a group of 39 HCW who were involved in delivering the implementation strategy package. These are not a subset of the women enrolled in the study, hence the numbers are not concordant.'}, {'type': 'PRIMARY', 'title': 'Client Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '961', 'groupId': 'OG000'}, {'value': '958', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '23.0'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '23.0'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '21.0', 'upperLimit': '23.0'}, {'value': '23.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '24.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Total on 6 item exit survey of clients to assess their satisfaction with services received at the facility, 1 (worse) to 4 (better) scale. The minimum score on the 6 items is 6 points (scoring 1 on each of the 6 items) while the maximum is 24 points (scoring 4 on each of the 6 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.'}, {'type': 'SECONDARY', 'title': 'PrEP Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Proportion of women who accept PrEP among those offered', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.\n\nThis analysis population is a subset of the total because it only includes those who were offered PrEP, as noted in the denominator description of the indicator.'}, {'type': 'SECONDARY', 'title': 'PrEP Continuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Proportion of women who present for a refill among those initially prescribed PrEP', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.\n\nThis analysis population is a subset of the total because it only includes those who were initially prescribed PrEP, as noted in the denominator description of the indicator.'}, {'type': 'SECONDARY', 'title': 'PrEP Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.'}], 'timeFrame': '6 months', 'description': 'Proportion of women who have \\>80 percent adherence to PrEP by pill count among those initially prescribed PrEP', 'reportingStatus': 'POSTED', 'populationDescription': 'During preparatory activities for data collection, it was determined that it was not feasible to extract patient adherence information; this outcome was neither collected nor compared.'}, {'type': 'SECONDARY', 'title': 'PrEP Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.'}], 'timeFrame': '6 months', 'description': 'Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers', 'reportingStatus': 'POSTED', 'populationDescription': 'During preparatory activities for data collection, it was determined that it was not feasible to collect efficiency this outcome was neither collected nor compared.'}, {'type': 'SECONDARY', 'title': 'Client PrEP Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '961', 'groupId': 'OG000'}, {'value': '958', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'OG001', 'title': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '480', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '481', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total population includes cross sectional groups from 2 time periods. The population analyzed above is a summation of the participants analyzed in the 2 periods. This is a difference in differences design with 2 time periods.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'FG001', 'title': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.'}], 'periods': [{'title': 'Baseline Period (3 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.', 'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '480'}, {'comment': 'The total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.', 'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '480'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '480'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '480'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}, {'title': 'Intervention Period (3 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'The total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.', 'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '481'}, {'comment': 'The total population includes cross-sectional, independent groups from 2 time periods. The populations in the baseline and intervention periods are NOT expected to be the same, as they are independent, cross-sectional samples. This is a difference in differences design with 2 time periods.', 'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '479'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '481'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '479'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Facilities', 'preAssignmentDetails': 'The enrollment number in the protocol section (1958) includes the sum of participants who started in the participant flow module below (1919), as well as the 39 additional health care workers who provided cross-sectional data in the intervention group during the intervention period. There was no drop-off between consent and enrollment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}, {'value': '479', 'groupId': 'BG003'}, {'value': '1920', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'PrEP Optimization Strategies -- Baseline', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'BG001', 'title': 'Comparator -- Baseline', 'description': 'Four facilities will be assigned to the comparator group.'}, {'id': 'BG002', 'title': 'PrEP Optimization Strategies -- Intervention Period', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).\n\nPrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.'}, {'id': 'BG003', 'title': 'Comparator -- Intervention Period', 'description': 'Four facilities will be assigned to the comparator group.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '29'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '21', 'upperLimit': '30'}, {'value': '25', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '30'}, {'value': '25', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '30'}, {'value': '25', 'groupId': 'BG004', 'lowerLimit': '21', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '480', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}, {'value': '479', 'groupId': 'BG003'}, {'value': '1920', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '480', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}, {'value': '479', 'groupId': 'BG003'}, {'value': '1920', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kenya', 'categories': [{'measurements': [{'value': '480', 'groupId': 'BG000'}, {'value': '480', 'groupId': 'BG001'}, {'value': '481', 'groupId': 'BG002'}, {'value': '479', 'groupId': 'BG003'}, {'value': '960', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-22', 'size': 1192925, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-02T13:02', 'hasProtocol': True}, {'date': '2021-02-16', 'size': 723342, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-01T15:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A difference-in-difference design will be used; this is a quasi-experimental design that compares data before an intervention is introduced to data after the intervention is introduced and compares that with the expected change before and after in comparison clinics. One package of interventions (video-based PrEP counseling, HIV Self-Testing \\[HIVST\\], and optimized PrEP delivery) will be implemented at four intervention facilities and here will be 4 comparison facilities will undergo the same data collection procedures.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1958}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-30', 'studyFirstSubmitDate': '2020-12-30', 'resultsFirstSubmitDate': '2024-02-02', 'studyFirstSubmitQcDate': '2021-01-14', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-30', 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PrEP Penetration', 'timeFrame': '6 months', 'description': 'Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services'}, {'measure': 'PrEP Fidelity', 'timeFrame': '6 months', 'description': 'Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling'}, {'measure': 'Timeliness of Services', 'timeFrame': '6 months', 'description': 'Time (minutes) spent receiving services from health care works'}, {'measure': 'Waiting Time', 'timeFrame': '6 months', 'description': 'Time (minutes) spent waiting to receive services'}, {'measure': 'HCW Acceptability', 'timeFrame': '6 months', 'description': 'Total on 4 item Acceptability of Intervention Measures (AIM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale. The minimum score on the 4 items is 4 points (scoring 1 on each of the 4 items) while the maximum is 20 points (scoring 5 on each of the 4 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.'}, {'measure': 'Health Care Worker (HCW) Appropriateness', 'timeFrame': '6 months', 'description': 'Total on 4 item Intervention Appropriateness Measure (IAM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale. The minimum score on the 4 items is 4 points (scoring 1 on each of the 4 items) while the maximum is 20 points (scoring 5 on each of the 4 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.'}, {'measure': 'Client Satisfaction', 'timeFrame': '6 months', 'description': 'Total on 6 item exit survey of clients to assess their satisfaction with services received at the facility, 1 (worse) to 4 (better) scale. The minimum score on the 6 items is 6 points (scoring 1 on each of the 6 items) while the maximum is 24 points (scoring 4 on each of the 6 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.'}], 'secondaryOutcomes': [{'measure': 'PrEP Uptake', 'timeFrame': '6 months', 'description': 'Proportion of women who accept PrEP among those offered'}, {'measure': 'PrEP Continuation', 'timeFrame': '6 months', 'description': 'Proportion of women who present for a refill among those initially prescribed PrEP'}, {'measure': 'PrEP Adherence', 'timeFrame': '6 months', 'description': 'Proportion of women who have \\>80 percent adherence to PrEP by pill count among those initially prescribed PrEP'}, {'measure': 'PrEP Efficiency', 'timeFrame': '6 months', 'description': 'Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers'}, {'measure': 'Client PrEP Knowledge', 'timeFrame': '6 months', 'description': 'Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-Exposure Prophylaxis', 'HIV Infections', 'Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '38045529', 'type': 'DERIVED', 'citation': 'Sila J, Wagner AD, Abuna F, Dettinger JC, Odhiambo B, Ngumbau N, Oketch G, Sifuna E, Gomez L, Hicks S, John-Stewart G, Kinuthia J. An implementation strategy package (video education, HIV self-testing, and co-location) improves PrEP implementation for pregnant women in antenatal care clinics in western Kenya. Front Reprod Health. 2023 Nov 17;5:1205503. doi: 10.3389/frph.2023.1205503. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.', 'detailedDescription': 'This study aims to improve integrated delivery of PrEP to women seeking health services in maternal and child health clinics by piloting and evaluating four strategies or bundles of strategies for optimized PrEP delivery. Strategies to be tested include a pre-developed package of strategies (video counseling, HIV self-testing, and optimized delivery).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Anyone presenting for maternal child health services can be included in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys\n\nExclusion Criteria:\n\n* Unwilling or unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04712994', 'briefTitle': 'PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency', 'orgStudyIdInfo': {'id': 'STUDY00008392'}, 'secondaryIdInfos': [{'id': 'R01HD094630', 'link': 'https://reporter.nih.gov/quickSearch/R01HD094630', 'type': 'NIH'}, {'id': 'R01AI125498', 'link': 'https://reporter.nih.gov/quickSearch/R01AI125498', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PrEP Optimization Strategies', 'description': 'Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).', 'interventionNames': ['Other: PrEP Optimization Interventions']}, {'type': 'NO_INTERVENTION', 'label': 'Comparator', 'description': 'Four facilities will be assigned to the comparator group.'}], 'interventions': [{'name': 'PrEP Optimization Interventions', 'type': 'OTHER', 'description': 'A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \\[HIVST\\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.', 'armGroupLabels': ['PrEP Optimization Strategies']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Homa Bay', 'country': 'Kenya', 'facility': 'Kendu Sub-District Hospital', 'geoPoint': {'lat': -0.52731, 'lon': 34.45714}}, {'city': 'Homa Bay', 'country': 'Kenya', 'facility': 'Ober Health Center', 'geoPoint': {'lat': -0.52731, 'lon': 34.45714}}, {'city': 'Kisumu', 'country': 'Kenya', 'facility': 'Masogo Sub-County Hospital', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Kisumu', 'country': 'Kenya', 'facility': 'Nyahera Sub Sub County Hospital', 'geoPoint': {'lat': -0.10221, 'lon': 34.76171}}, {'city': 'Siaya', 'country': 'Kenya', 'facility': 'Bondo County Referral Hospital', 'geoPoint': {'lat': 0.0607, 'lon': 34.28806}}, {'city': 'Siaya', 'country': 'Kenya', 'facility': 'Madiany Sub County Hospital', 'geoPoint': {'lat': 0.0607, 'lon': 34.28806}}, {'city': 'Siaya', 'country': 'Kenya', 'facility': 'Malanga Health Center', 'geoPoint': {'lat': 0.0607, 'lon': 34.28806}}, {'city': 'Siaya', 'country': 'Kenya', 'facility': 'Uyawi Sub County Hospital', 'geoPoint': {'lat': 0.0607, 'lon': 34.28806}}], 'overallOfficials': [{'name': 'Grace John-Stewart, MD, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, School of Medicine: Global Health', 'investigatorFullName': 'Grace John-Stewart', 'investigatorAffiliation': 'University of Washington'}}}}