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

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 an interrupted time series.

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 three packages of strategies identified by stakeholders.

Official Title
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Testing Implementation Strategies to Improve Delivery of Pre-exposure Prophylaxis (PrEP) for Pregnant and Postpartum Women in Kenya (K01)

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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 100 Years

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: An interrupted-time series 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 controls for time trends. Three rounds of interrupted-time series to evaluate three PrEP optimization interventions, identified by stakeholders based on qualitative information. Each of the three rounds of interrupted-time series evaluations 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PrEP Optimization Strategies<br>Up to 12 facilities will be assigned one of three intervention groups (4 facilities per group). The strategies have no yet been identified but will be through other activities in the PrEPARE study. | Other: PrEP Optimization Interventions<br>* There will be three strategies or bundles of strategies tested determined based on the qualitative information gathered in Aim 1 by stakeholders and are unknown at this time.<br>|
| No Intervention: Comparator<br>Up to 4 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 |