Trial Outcomes & Findings for Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya (NCT NCT05482360)

Results Overview

Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5173 participants

Primary outcome timeframe

6 months

Results posted on

2025-02-26

Participant Flow

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.

Unit of analysis: Facilities

Participant milestones

Participant milestones
Measure	Package 1 Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 1 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 2 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 PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 2 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 3 Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 3 4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Baseline Period (3 Months) STARTED	392 4	420 4	402 4	415 4	419 4	406 4
Baseline Period (3 Months) COMPLETED	392 4	420 4	402 4	415 4	419 4	406 4
Baseline Period (3 Months) NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0
Intervention Period (3 Months) STARTED	408 4	416 4	439 4	426 4	420 4	409 4
Intervention Period (3 Months) COMPLETED	408 4	416 4	439 4	426 4	420 4	409 4
Intervention Period (3 Months) NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing Implementation Strategies to Improve Delivery of PrEP for Pregnant and Postpartum Women in Kenya

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Package 1 n=392 Participants Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 1 n=420 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 2 n=402 Participants 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 PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 2 n=415 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 3 n=419 Participants Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 3 n=406 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Total n=2454 Participants Total of all reporting groups
Age, Continuous	24 years n=5 Participants	25 years n=7 Participants	23.5 years n=5 Participants	24 years n=4 Participants	24 years n=21 Participants	24 years n=8 Participants	24 years n=8 Participants
Sex: Female, Male Female	392 Participants n=5 Participants	420 Participants n=7 Participants	402 Participants n=5 Participants	415 Participants n=4 Participants	419 Participants n=21 Participants	406 Participants n=8 Participants	2454 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	392 Participants n=5 Participants	420 Participants n=7 Participants	402 Participants n=5 Participants	415 Participants n=4 Participants	419 Participants n=21 Participants	406 Participants n=8 Participants	2454 Participants n=8 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Region of Enrollment Kenya	392 participants n=5 Participants	420 participants n=7 Participants	402 participants n=5 Participants	415 participants n=4 Participants	419 participants n=21 Participants	406 participants n=8 Participants	2454 participants n=8 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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.

Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services

Outcome measures

Outcome measures
Measure	Package 1 n=800 Participants Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 1 n=836 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 2 n=841 Participants 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 PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 2 n=841 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 3 n=839 Participants Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 3 n=815 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Change in PrEP Penetration Baseline	13 Participants	23 Participants	35 Participants	3 Participants	49 Participants	23 Participants
Change in PrEP Penetration Intervention	23 Participants	7 Participants	93 Participants	22 Participants	146 Participants	27 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Package 1 n=327 Participants Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 1 n=322 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 2 n=365 Participants 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 PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 2 n=342 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 3 n=309 Participants Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 3 n=299 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Change in PrEP Fidelity Baseline	9 Participants	8 Participants	15 Participants	1 Participants	23 Participants	14 Participants
Change in PrEP Fidelity Intervention	9 Participants	2 Participants	55 Participants	8 Participants	61 Participants	8 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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.

Time (minutes) spent receiving services from health care workers

Outcome measures

Outcome measures
Measure	Package 1 n=384 Participants Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 1 n=384 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 2 n=383 Participants 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 PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 2 n=384 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 3 n=384 Participants Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 3 n=384 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Timeliness of Services Baseline	15 minutes Interval 10.0 to 29.0	14 minutes Interval 9.5 to 26.5	13 minutes Interval 9.0 to 23.0	12 minutes Interval 8.0 to 21.0	14 minutes Interval 8.0 to 29.0	15 minutes Interval 10.0 to 29.0
Timeliness of Services Intervention	15 minutes Interval 10.0 to 31.5	12 minutes Interval 8.5 to 21.5	13 minutes Interval 9.0 to 22.0	15 minutes Interval 10.5 to 26.0	15 minutes Interval 10.5 to 28.5	15 minutes Interval 10.0 to 29.0

PRIMARY outcome

Timeframe: 6 months

Population: 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.

Time (minutes) spent waiting to receive services

Outcome measures

Outcome measures
Measure	Package 1 n=384 Participants Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 1 n=384 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 2 n=383 Participants 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 PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 2 n=384 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 3 n=384 Participants Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 3 n=384 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Waiting Time Baseline	47 minutes Interval 22.0 to 77.5	33 minutes Interval to 57.5	37 minutes Interval 18.0 to 66.0	33 minutes Interval 14.5 to 63.0	47 minutes Interval 22.0 to 81.0	32.5 minutes Interval 16.0 to 69.0
Waiting Time Intervention	42.5 minutes Interval 28.0 to 64.0	38 minutes Interval 14.5 to 73.0	43 minutes Interval 25.0 to 66.5	31.5 minutes Interval 15.0 to 56.0	35.5 minutes Interval 23.0 to 58.0	35 minutes Interval 14.0 to 71.5

PRIMARY outcome

Timeframe: 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Package 1 n=64 Participants Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 1 n=92 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 2 n=45 Participants 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 PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 2 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 3 Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 3 4 facilities were assigned to the comparator group and did not receive any implementation strategies.
HCW Acceptability	18.5 units on a scale Interval 16.0 to 20.0	18 units on a scale Interval 16.0 to 20.0	20 units on a scale Interval 18.0 to 20.0	—	—	—

PRIMARY outcome

Timeframe: 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Package 1 n=64 Participants Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 1 n=92 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 2 n=45 Participants 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 PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 2 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 3 Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 3 4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Health Care Worker (HCW) Appropriateness	18 units on a scale Interval 16.0 to 20.0	19 units on a scale Interval 16.0 to 20.0	20 units on a scale Interval 17.0 to 20.0	—	—	—

PRIMARY outcome

Timeframe: 6 months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Package 1 n=800 Participants Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 1 n=836 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 2 n=841 Participants 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 PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 2 n=841 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 3 n=839 Participants Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 3 n=815 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Client Satisfaction Baseline	22 units on a scale Interval 20.0 to 23.0	22 units on a scale Interval 20.0 to 23.0	21 units on a scale Interval 20.0 to 22.0	20 units on a scale Interval 20.0 to 22.0	22 units on a scale Interval 20.0 to 23.0	21 units on a scale Interval 20.0 to 23.0
Client Satisfaction Intervention	21 units on a scale Interval 20.0 to 22.0	21 units on a scale Interval 20.0 to 22.0	21 units on a scale Interval 20.0 to 22.0	21 units on a scale Interval 20.0 to 22.0	22 units on a scale Interval 21.0 to 23.0	22 units on a scale Interval 20.0 to 23.0

SECONDARY outcome

Timeframe: 6 months

Population: 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. This 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.

Proportion of women who accept PrEP among those offered

Outcome measures

Outcome measures
Measure	Package 1 n=32 Participants Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 1 n=31 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 2 n=77 Participants 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 PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 2 n=23 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 3 n=107 Participants Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 3 n=35 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.
PrEP Uptake Baseline	2 Participants	2 Participants	2 Participants	0 Participants	7 Participants	4 Participants
PrEP Uptake Intervention	2 Participants	3 Participants	15 Participants	5 Participants	11 Participants	4 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 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. This 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.

Proportion of women who present for a refill among those initially prescribed PrEP

Outcome measures

Outcome measures
Measure	Package 1 n=32 Participants Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 1 n=31 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 2 n=77 Participants 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 PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 2 n=23 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 3 n=107 Participants Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 3 n=35 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.
PrEP Continuation Baseline	2 Participants	6 Participants	2 Participants	0 Participants	5 Participants	8 Participants
PrEP Continuation Intervention	6 Participants	1 Participants	15 Participants	5 Participants	9 Participants	5 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 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.

Number of participants with perfect knowledge on PrEP information questions based on content covered in counseling sessions

Outcome measures

Outcome measures
Measure	Package 1 n=800 Participants Package 1: Three implementation strategies including fast tracking, provider re-training, and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 1 n=836 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 2 n=841 Participants 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 PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 2 n=841 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.	Package 3 n=839 Participants Package 3: Three implementation strategies including use of PrEP educational materials, PrEP health talks in waiting bays and dispensing PrEP in MCH PrEP Optimization Interventions: There were three bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders	Comparator for Package 3 n=815 Participants 4 facilities were assigned to the comparator group and did not receive any implementation strategies.
Client PrEP Knowledge Baseline	3 Participants	6 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Client PrEP Knowledge Intervention	3 Participants	1 Participants	1 Participants	2 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 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.

Proportion of women who have \>80 percent adherence to PrEP by pill count among those initially prescribed PrEP

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: 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.

Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers

Outcome measures

Other adverse events

Adverse event data not reported

Additional Information

Anjuli Wagner, PI

University of Washington

Phone: 978 460 2331

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place