PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

Study Overview
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Brief Summary
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This study tests strategies for improving PrEP implementation in maternal and child health clinics using a difference-in-difference approach.

Detailed Description
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This study aims to improve integrated delivery of PrEP to women seeking health services in maternal and child health clinics by piloting and evaluating four strategies or bundles of strategies for optimized PrEP delivery. Strategies to be tested include a pre-developed package of strategies (video counseling, HIV self-testing, and optimized delivery).

Official Title
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PrEPARE: PrEP in Pregnancy, Accelerating Reach and Efficiency

Conditions
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Pre-Exposure Prophylaxis, HIV Infections, Pregnancy Related

Intervention / Treatment
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* Other: PrEP Optimization Interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women receiving Maternal and Child Health (MCH) services HCW participating in satisfaction surveys Exclusion Criteria: Unwilling or unable to provide informed consent
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A difference-in-difference design will be used; this is a quasi-experimental design that compares data before an intervention is introduced to data after the intervention is introduced and compares that with the expected change before and after in comparison clinics. One package of interventions (video-based PrEP counseling, HIV Self-Testing [HIVST], and optimized PrEP delivery) will be implemented at four intervention facilities and here will be 4 comparison facilities will undergo the same data collection procedures.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrEP Optimization Strategies<br>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). | Other: PrEP Optimization Interventions<br>* 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.<br>|
| No Intervention: Comparator<br>Four facilities will be assigned to the comparator group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PrEP penetration | Proportion of women who are screened for PrEP / total women receiving antenatal or postnatal services | 6 months | 
| Change in PrEP fidelity | Proportion of women who receive all PrEP specific steps in a visit: HIV testing, HIV risk screening, PrEP counseling | 6 months | 
| Change in timeliness of services | Time (minutes) spent receiving services from health care works | 6 months | 
| Change in time waiting | Time (minutes) spent waiting to receive services | 6 months | 
| Change in HCW acceptability | Average Acceptability of Intervention Measures (AIM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale | 6 months | 
| Change in health care worker (HCW) appropriateness | Average Intervention Appropriateness Measure (IAM) score, 1 (Completely disagree) to 5 (Completely Agree) Likert scale | 6 months | 
| Change in client satisfaction | Exit survey of clients to assess their satisfaction with services received at the facility, 1 (worse) to 4 (better) scale | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PrEP uptake | Proportion of women who accept PrEP among those offered | 6 months | 
| Change in PrEP continuation | Proportion of women who present for a refill among those initially prescribed PrEP | 6 months | 
| Change in PrEP adherence | Proportion of women who have >80 percent adherence to PrEP by pill count among those initially prescribed PrEP | 6 months | 
| Change in PrEP efficiency | Patient flow mapping to identify more efficient client flows with fewer transitions between physical spaces and providers | 6 months | 
| Change client PrEP knowledge | Average score of PrEP information questions based on content covered in counseling sessions | 6 months |