Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-30 @ 4:23 AM
Study NCT ID:
NCT05482360
Status:
COMPLETED
Last Update Posted:
2025-02-26
First Post:
2022-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya
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': '978 460 2331', 'title': 'Anjuli Wagner, PI', 'organization': 'University of Washington'}, 'certainAgreement': {'piSponsorEmployee': True}}, '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders', 'otherNumAtRisk': 800, 'deathsNumAtRisk': 800, 'otherNumAffected': 0, 'seriousNumAtRisk': 800, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.', 'otherNumAtRisk': 836, 'deathsNumAtRisk': 836, 'otherNumAffected': 0, 'seriousNumAtRisk': 836, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders', 'otherNumAtRisk': 841, 'deathsNumAtRisk': 841, 'otherNumAffected': 0, 'seriousNumAtRisk': 841, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Comparator for Package 2', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.', 'otherNumAtRisk': 841, 'deathsNumAtRisk': 841, 'otherNumAffected': 0, 'seriousNumAtRisk': 841, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders', 'otherNumAtRisk': 839, 'deathsNumAtRisk': 839, 'otherNumAffected': 0, 'seriousNumAtRisk': 839, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Comparator for Package 3', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.', 'otherNumAtRisk': 815, 'deathsNumAtRisk': 815, 'otherNumAffected': 0, 'seriousNumAtRisk': 815, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in PrEP Penetration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '800', 'groupId': 'OG000'}, {'value': '836', 'groupId': 'OG001'}, {'value': '841', 'groupId': 'OG002'}, {'value': '841', 'groupId': 'OG003'}, {'value': '839', 'groupId': 'OG004'}, {'value': '815', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG003', 'title': 'Comparator for Package 2', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG004', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG005', 'title': 'Comparator for Package 3', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '415', 'groupId': 'OG003'}, {'value': '419', 'groupId': 'OG004'}, {'value': '406', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '23', 'groupId': 'OG005'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '439', 'groupId': 'OG002'}, {'value': '426', 'groupId': 'OG003'}, {'value': '420', 'groupId': 'OG004'}, {'value': '409', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '146', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}]}]}], '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': 'Change in PrEP Fidelity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '327', 'groupId': 'OG000'}, {'value': '322', 'groupId': 'OG001'}, {'value': '365', 'groupId': 'OG002'}, {'value': '342', 'groupId': 'OG003'}, {'value': '309', 'groupId': 'OG004'}, {'value': '299', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG003', 'title': 'Comparator for Package 2', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG004', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG005', 'title': 'Comparator for Package 3', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}, {'value': '174', 'groupId': 'OG002'}, {'value': '172', 'groupId': 'OG003'}, {'value': '161', 'groupId': 'OG004'}, {'value': '136', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '23', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '148', 'groupId': 'OG004'}, {'value': '163', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}], '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. Assessed among the subset of women who are due for an HIV test, as per Kenyan guidelines, which is a subset of the overall sample.', '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'}, {'value': '383', 'groupId': 'OG002'}, {'value': '384', 'groupId': 'OG003'}, {'value': '384', 'groupId': 'OG004'}, {'value': '384', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG003', 'title': 'Comparator for Package 2', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG004', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG005', 'title': 'Comparator for Package 3', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}, {'value': '192', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '29'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '26.5'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '23'}, {'value': '12', 'groupId': 'OG003', 'lowerLimit': '8', 'upperLimit': '21'}, {'value': '14', 'groupId': 'OG004', 'lowerLimit': '8', 'upperLimit': '29'}, {'value': '15', 'groupId': 'OG005', 'lowerLimit': '10', 'upperLimit': '29'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}, {'value': '192', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '31.5'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '21.5'}, {'value': '13', 'groupId': 'OG002', 'lowerLimit': '9', 'upperLimit': '22'}, {'value': '15', 'groupId': 'OG003', 'lowerLimit': '10.5', 'upperLimit': '26'}, {'value': '15', 'groupId': 'OG004', 'lowerLimit': '10.5', 'upperLimit': '28.5'}, {'value': '15', 'groupId': 'OG005', 'lowerLimit': '10', 'upperLimit': '29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Time (minutes) spent receiving services from health care workers', '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'}, {'value': '383', 'groupId': 'OG002'}, {'value': '384', 'groupId': 'OG003'}, {'value': '384', 'groupId': 'OG004'}, {'value': '384', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG003', 'title': 'Comparator for Package 2', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG004', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG005', 'title': 'Comparator for Package 3', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}, {'value': '192', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '77.5'}, {'value': '33', 'groupId': 'OG001', 'lowerLimit': '13.', 'upperLimit': '57.5'}, {'value': '37', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '66'}, {'value': '33', 'groupId': 'OG003', 'lowerLimit': '14.5', 'upperLimit': '63'}, {'value': '47', 'groupId': 'OG004', 'lowerLimit': '22', 'upperLimit': '81'}, {'value': '32.5', 'groupId': 'OG005', 'lowerLimit': '16', 'upperLimit': '69'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '192', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}, {'value': '192', 'groupId': 'OG003'}, {'value': '192', 'groupId': 'OG004'}, {'value': '192', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000', 'lowerLimit': '28', 'upperLimit': '64'}, {'value': '38', 'groupId': 'OG001', 'lowerLimit': '14.5', 'upperLimit': '73'}, {'value': '43', 'groupId': 'OG002', 'lowerLimit': '25', 'upperLimit': '66.5'}, {'value': '31.5', 'groupId': 'OG003', 'lowerLimit': '15', 'upperLimit': '56'}, {'value': '35.5', 'groupId': 'OG004', 'lowerLimit': '23', 'upperLimit': '58'}, {'value': '35', 'groupId': 'OG005', 'lowerLimit': '14', 'upperLimit': '71.5'}]}]}], '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': '64', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG001', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG002', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}], 'classes': [{'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '20'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '20'}]}]}], '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': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was assessed on a group of 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': '64', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG001', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG002', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '20'}, {'value': '19', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '20'}, {'value': '20', 'groupId': 'OG002', 'lowerLimit': '17', 'upperLimit': '20'}]}]}], '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': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome was assessed on a group of 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': '800', 'groupId': 'OG000'}, {'value': '836', 'groupId': 'OG001'}, {'value': '841', 'groupId': 'OG002'}, {'value': '841', 'groupId': 'OG003'}, {'value': '839', 'groupId': 'OG004'}, {'value': '815', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG003', 'title': 'Comparator for Package 2', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG004', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG005', 'title': 'Comparator for Package 3', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '415', 'groupId': 'OG003'}, {'value': '419', 'groupId': 'OG004'}, {'value': '406', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '23'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '23'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '22'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '20', 'upperLimit': '22'}, {'value': '22', 'groupId': 'OG004', 'lowerLimit': '20', 'upperLimit': '23'}, {'value': '21', 'groupId': 'OG005', 'lowerLimit': '20', 'upperLimit': '23'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '439', 'groupId': 'OG002'}, {'value': '426', 'groupId': 'OG003'}, {'value': '420', 'groupId': 'OG004'}, {'value': '409', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '22'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '22'}, {'value': '21', 'groupId': 'OG002', 'lowerLimit': '20', 'upperLimit': '22'}, {'value': '21', 'groupId': 'OG003', 'lowerLimit': '20', 'upperLimit': '22'}, {'value': '22', 'groupId': 'OG004', 'lowerLimit': '21', 'upperLimit': '23'}, {'value': '22', 'groupId': 'OG005', 'lowerLimit': '20', 'upperLimit': '23'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Total on 7 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 7 items is 7 points (scoring 1 on each of the 7 items) while the maximum is 24 points (scoring 4 on each of the 7 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.', 'unitOfMeasure': 'units 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': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '107', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG003', 'title': 'Comparator for Package 2', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG004', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG005', 'title': 'Comparator for Package 3', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}]}]}], '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': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '107', 'groupId': 'OG004'}, {'value': '35', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG003', 'title': 'Comparator for Package 2', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG004', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG005', 'title': 'Comparator for Package 3', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '75', 'groupId': 'OG004'}, {'value': '17', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}], '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': 'Client PrEP Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '800', 'groupId': 'OG000'}, {'value': '836', 'groupId': 'OG001'}, {'value': '841', 'groupId': 'OG002'}, {'value': '841', 'groupId': 'OG003'}, {'value': '839', 'groupId': 'OG004'}, {'value': '815', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG003', 'title': 'Comparator for Package 2', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG004', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG005', 'title': 'Comparator for Package 3', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '392', 'groupId': 'OG000'}, {'value': '420', 'groupId': 'OG001'}, {'value': '402', 'groupId': 'OG002'}, {'value': '415', 'groupId': 'OG003'}, {'value': '419', 'groupId': 'OG004'}, {'value': '406', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '416', 'groupId': 'OG001'}, {'value': '439', 'groupId': 'OG002'}, {'value': '426', 'groupId': 'OG003'}, {'value': '420', 'groupId': 'OG004'}, {'value': '409', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], '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.'}, {'type': 'SECONDARY', 'title': 'PrEP Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and never received any implementation strategy.'}, {'id': 'OG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG003', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG004', 'title': 'Comparison for Package 2', 'description': '4 facilities were assigned to the comparator group and never received any implementation strategy.'}, {'id': 'OG005', 'title': 'Comparison for Package 3', 'description': '4 facilities were assigned to the comparator group and never received any implementation strategy.'}], '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. It was not feasible to extract patient adherence information because routine program data at each facility different substantially in how it quantified adherence to PrEP; it was not possible, nor meaningful to collect or analyze these data.'}, {'type': 'SECONDARY', 'title': 'PrEP Efficiency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'units': 'Facility', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG003', 'title': 'Comparator for Package 2', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'OG004', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'OG005', 'title': 'Comparator for Package 3', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}], 'timeFrame': '6 months', 'description': 'Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Facility', 'denomUnitsSelected': 'Facility', '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. It was not feasible to quantify efficiency in the way in which we originally envisioned due to the heterogeneity between sites and within sites on how service provision was organized and delivered.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'FG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'FG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'FG003', 'title': 'Comparator for Package 2', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'FG004', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'FG005', 'title': 'Comparator for Package 3', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}], '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': '392'}, {'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': '420'}, {'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': 'FG002', 'numUnits': '4', 'numSubjects': '402'}, {'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': 'FG003', 'numUnits': '4', 'numSubjects': '415'}, {'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': 'FG004', 'numUnits': '4', 'numSubjects': '419'}, {'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': 'FG005', 'numUnits': '4', 'numSubjects': '406'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '392'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '420'}, {'groupId': 'FG002', 'numUnits': '4', 'numSubjects': '402'}, {'groupId': 'FG003', 'numUnits': '4', 'numSubjects': '415'}, {'groupId': 'FG004', 'numUnits': '4', 'numSubjects': '419'}, {'groupId': 'FG005', 'numUnits': '4', 'numSubjects': '406'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', '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': '408'}, {'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': '416'}, {'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': 'FG002', 'numUnits': '4', 'numSubjects': '439'}, {'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': 'FG003', 'numUnits': '4', 'numSubjects': '426'}, {'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': 'FG004', 'numUnits': '4', 'numSubjects': '420'}, {'groupId': 'FG005', 'numUnits': '4', 'numSubjects': '409'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '4', 'numSubjects': '408'}, {'groupId': 'FG001', 'numUnits': '4', 'numSubjects': '416'}, {'groupId': 'FG002', 'numUnits': '4', 'numSubjects': '439'}, {'groupId': 'FG003', 'numUnits': '4', 'numSubjects': '426'}, {'groupId': 'FG004', 'numUnits': '4', 'numSubjects': '420'}, {'groupId': 'FG005', 'numUnits': '4', 'numSubjects': '409'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG003', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG004', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG005', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'Facilities', 'preAssignmentDetails': 'The enrollment number in the protocol section (5,173) includes the sum of participants who started in the participant flow module below (4,972), as well as the 201 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': '392', 'groupId': 'BG000'}, {'value': '420', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}, {'value': '415', 'groupId': 'BG003'}, {'value': '419', 'groupId': 'BG004'}, {'value': '406', 'groupId': 'BG005'}, {'value': '2454', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'BG001', 'title': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'BG002', 'title': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'BG003', 'title': 'Comparator for Package 2', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'BG004', 'title': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH\n\nPrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders'}, {'id': 'BG005', 'title': 'Comparator for Package 3', 'description': '4 facilities were assigned to the comparator group and did not receive any implementation strategies.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '28'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '29'}, {'value': '23.5', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '28'}, {'value': '24', 'groupId': 'BG003', 'lowerLimit': '22', 'upperLimit': '29'}, {'value': '24', 'groupId': 'BG004', 'lowerLimit': '21', 'upperLimit': '27'}, {'value': '24', 'groupId': 'BG005', 'lowerLimit': '21', 'upperLimit': '29'}, {'value': '24', 'groupId': 'BG006', 'lowerLimit': '21', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '392', 'groupId': 'BG000'}, {'value': '420', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}, {'value': '415', 'groupId': 'BG003'}, {'value': '419', 'groupId': 'BG004'}, {'value': '406', 'groupId': 'BG005'}, {'value': '2454', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], '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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '392', 'groupId': 'BG000'}, {'value': '420', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}, {'value': '415', 'groupId': 'BG003'}, {'value': '419', 'groupId': 'BG004'}, {'value': '406', 'groupId': 'BG005'}, {'value': '2454', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Kenya', 'categories': [{'measurements': [{'value': '392', 'groupId': 'BG000'}, {'value': '420', 'groupId': 'BG001'}, {'value': '402', 'groupId': 'BG002'}, {'value': '415', 'groupId': 'BG003'}, {'value': '419', 'groupId': 'BG004'}, {'value': '406', 'groupId': 'BG005'}, {'value': '2454', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-22', 'size': 1708187, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-01-23T14:16', 'hasProtocol': True}, {'date': '2020-12-17', 'size': 724012, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-02-01T16:15', '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. Three rounds of difference-in-differences tests will be used to evaluate three PrEP optimization interventions, identified by stakeholders based on qualitative information. Each of the three rounds will include 4 facilities receiving the intervention and 4 facilities serving as an ongoing concurrent comparator group; these 4 facilities will not receive any of the packages of interventions, but will undergo the same data collection procedures.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2022-07-26', 'resultsFirstSubmitDate': '2024-12-15', 'studyFirstSubmitQcDate': '2022-07-28', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-04', 'studyFirstPostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in PrEP Penetration', 'timeFrame': '6 months', 'description': 'Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services'}, {'measure': 'Change in 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. Assessed among the subset of women who are due for an HIV test, as per Kenyan guidelines, which is a subset of the overall sample.'}, {'measure': 'Timeliness of Services', 'timeFrame': '6 months', 'description': 'Time (minutes) spent receiving services from health care workers'}, {'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 7 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 7 items is 7 points (scoring 1 on each of the 7 items) while the maximum is 24 points (scoring 4 on each of the 7 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': 'Client PrEP Knowledge', 'timeFrame': '6 months', 'description': 'Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions'}, {'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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pre-Exposure Prophylaxis', 'HIV Infections', 'Pregnancy Related']}, 'descriptionModule': {'briefSummary': 'This study tests strategies for improving PrEP implementation in maternal and child health clinics using an interrupted time series.', '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 three packages of strategies identified by stakeholders.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '15 Years', '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': 'NCT05482360', 'acronym': 'PrEPARE', 'briefTitle': 'Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Testing Implementation Strategies to Improve Delivery of Pre-exposure Prophylaxis (PrEP) for Pregnant and Postpartum Women in Kenya (K01)', 'orgStudyIdInfo': {'id': 'STUDY00008392-A'}, 'secondaryIdInfos': [{'id': 'K01MH121124', 'link': 'https://reporter.nih.gov/quickSearch/K01MH121124', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Package 1', 'description': 'Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH', 'interventionNames': ['Other: PrEP Optimization Interventions']}, {'type': 'NO_INTERVENTION', 'label': 'Comparator for Package 1', 'description': '4 facilities were assigned to the comparator group and never received any implementation strategy.'}, {'type': 'EXPERIMENTAL', 'label': 'Package 2', 'description': 'Package 2: Three implementation strategies including task shifting PrEP counseling from clinicians/nurses to HIV testing services providers (HTS), training different cadres, and dispensing PrEP in MCH', 'interventionNames': ['Other: PrEP Optimization Interventions']}, {'type': 'EXPERIMENTAL', 'label': 'Package 3', 'description': 'Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH', 'interventionNames': ['Other: PrEP Optimization Interventions']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison for Package 2', 'description': '4 facilities were assigned to the comparator group and never received any implementation strategy.'}, {'type': 'NO_INTERVENTION', 'label': 'Comparison for Package 3', 'description': '4 facilities were assigned to the comparator group and never received any implementation strategy.'}], 'interventions': [{'name': 'PrEP Optimization Interventions', 'type': 'OTHER', 'description': 'There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders', 'armGroupLabels': ['Package 1', 'Package 2', 'Package 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Homa Bay', 'country': 'Kenya', 'facility': 'Ober Health Center', 'geoPoint': {'lat': -0.52731, 'lon': 34.45714}}], 'overallOfficials': [{'name': 'Anjuli Wagner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Global Health', 'investigatorFullName': 'Anjuli Wagner', 'investigatorAffiliation': 'University of Washington'}}}}