Trial Outcomes & Findings for PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency (NCT NCT04712994)
NCT ID: NCT04712994
Last Updated: 2025-01-08
Results Overview
Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services
COMPLETED
NA
1958 participants
6 months
2025-01-08
Participant Flow
The enrollment number in the protocol section (1958) includes the sum of participants who started in the participant flow module below (1919), as well as the 39 additional health care workers who provided cross-sectional data in the intervention group during the intervention period. There was no drop-off between consent and enrollment.
Unit of analysis: Facilities
Participant milestones
| Measure |
PrEP Optimization Strategies
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator
Four facilities will be assigned to the comparator group.
|
|---|---|---|
|
Baseline Period (3 Months)
STARTED
|
480 4
|
480 4
|
|
Baseline Period (3 Months)
COMPLETED
|
480 4
|
480 4
|
|
Baseline Period (3 Months)
NOT COMPLETED
|
0 0
|
0 0
|
|
Intervention Period (3 Months)
STARTED
|
481 4
|
479 4
|
|
Intervention Period (3 Months)
COMPLETED
|
481 4
|
479 4
|
|
Intervention Period (3 Months)
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency
Baseline characteristics by cohort
| Measure |
PrEP Optimization Strategies -- Baseline
n=480 Participants
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator -- Baseline
n=480 Participants
Four facilities will be assigned to the comparator group.
|
PrEP Optimization Strategies -- Intervention Period
n=481 Participants
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator -- Intervention Period
n=479 Participants
Four facilities will be assigned to the comparator group.
|
Total
n=1920 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
24 years
n=5 Participants
|
25 years
n=7 Participants
|
25 years
n=5 Participants
|
25 years
n=4 Participants
|
25 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
480 Participants
n=5 Participants
|
480 Participants
n=7 Participants
|
481 Participants
n=5 Participants
|
479 Participants
n=4 Participants
|
1920 Participants
n=21 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
|
|
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
|
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
480 Participants
n=5 Participants
|
480 Participants
n=7 Participants
|
481 Participants
n=5 Participants
|
479 Participants
n=4 Participants
|
1920 Participants
n=21 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
|
|
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
|
|
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
|
|
Region of Enrollment
Kenya
|
480 participants
n=5 Participants
|
480 participants
n=7 Participants
|
481 participants
n=5 Participants
|
479 participants
n=4 Participants
|
960 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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
| Measure |
PrEP Optimization Strategies
n=961 Participants
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator
n=958 Participants
Four facilities will be assigned to the comparator group.
|
|---|---|---|
|
PrEP Penetration
Baseline
|
30 Participants
|
17 Participants
|
|
PrEP Penetration
Intervention
|
46 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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
Outcome measures
| Measure |
PrEP Optimization Strategies
n=961 Participants
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator
n=958 Participants
Four facilities will be assigned to the comparator group.
|
|---|---|---|
|
PrEP Fidelity
Baseline
|
14 Participants
|
4 Participants
|
|
PrEP Fidelity
Intervention
|
28 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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 works
Outcome measures
| Measure |
PrEP Optimization Strategies
n=384 Participants
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator
n=384 Participants
Four facilities will be assigned to the comparator group.
|
|---|---|---|
|
Timeliness of Services
Baseline
|
18 minutes
Interval 12.0 to 36.0
|
16 minutes
Interval 10.0 to 33.0
|
|
Timeliness of Services
Intervention
|
17 minutes
Interval 11.0 to 29.0
|
14 minutes
Interval 9.0 to 27.5
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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
| Measure |
PrEP Optimization Strategies
n=384 Participants
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator
n=384 Participants
Four facilities will be assigned to the comparator group.
|
|---|---|---|
|
Waiting Time
Intervention
|
55 minutes
Interval 31.0 to 80.0
|
29 minutes
Interval 14.0 to 46.5
|
|
Waiting Time
Baseline
|
49 minutes
Interval 22.5 to 77.0
|
37 minutes
Interval 14.5 to 74.0
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This outcome was assessed on a group of 39 HCW who were involved in delivering the implementation strategy package. These are not a subset of the women enrolled in the study, hence the numbers are not concordant.
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
| Measure |
PrEP Optimization Strategies
n=39 Participants
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator
Four facilities will be assigned to the comparator group.
|
|---|---|---|
|
HCW Acceptability
|
20.0 score on a scale
Interval 16.0 to 20.0
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This outcome was assessed on a group of 39 HCW who were involved in delivering the implementation strategy package. These are not a subset of the women enrolled in the study, hence the numbers are not concordant.
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
| Measure |
PrEP Optimization Strategies
n=39 Participants
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator
Four facilities will be assigned to the comparator group.
|
|---|---|---|
|
Health Care Worker (HCW) Appropriateness
|
19.5 score on a scale
Interval 16.0 to 20.0
|
—
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: 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 6 item exit survey of clients to assess their satisfaction with services received at the facility, 1 (worse) to 4 (better) scale. The minimum score on the 6 items is 6 points (scoring 1 on each of the 6 items) while the maximum is 24 points (scoring 4 on each of the 6 items). A higher score indicates a better outcome. The sub-scores on each of the 4 items are summed.
Outcome measures
| Measure |
PrEP Optimization Strategies
n=961 Participants
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator
n=958 Participants
Four facilities will be assigned to the comparator group.
|
|---|---|---|
|
Client Satisfaction
Baseline
|
21.0 score on a scale
Interval 19.0 to 23.0
|
23.0 score on a scale
Interval 20.0 to 23.0
|
|
Client Satisfaction
Intervention
|
23.0 score on a scale
Interval 21.0 to 23.0
|
23.0 score on a scale
Interval 20.0 to 24.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
| Measure |
PrEP Optimization Strategies
n=34 Participants
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator
n=17 Participants
Four facilities will be assigned to the comparator group.
|
|---|---|---|
|
PrEP Uptake
Baseline
|
0 Participants
|
1 Participants
|
|
PrEP Uptake
Intervention
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
| Measure |
PrEP Optimization Strategies
n=36 Participants
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator
n=17 Participants
Four facilities will be assigned to the comparator group.
|
|---|---|---|
|
PrEP Continuation
Baseline
|
1 Participants
|
1 Participants
|
|
PrEP Continuation
Intervention
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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.
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 monthsPopulation: During preparatory activities for data collection, it was determined that it was not feasible to collect efficiency this outcome was neither collected nor compared.
Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: 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
| Measure |
PrEP Optimization Strategies
n=961 Participants
Four facilities will be assigned to the intervention group. The intervention group will receive a pre-identified package of interventions (PrEP video counselling, HIV Self-Testing, and optimized delivery and prescription processes).
PrEP Optimization Interventions: A bundle of strategies (video-based PrEP counselling, HIV Self-Testing \[HIVST\] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes) will be implemented in the intervention group.
|
Comparator
n=958 Participants
Four facilities will be assigned to the comparator group.
|
|---|---|---|
|
Client PrEP Knowledge
Baseline
|
5 Participants
|
0 Participants
|
|
Client PrEP Knowledge
Intervention
|
56 Participants
|
5 Participants
|
Adverse Events
PrEP Optimization Strategies
Comparator
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place