IPREP Study #2: Evaluating Enhanced PrEP Packages for Young Female Sex Workers in Kisumu, Kenya

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: Reminder and Resource Transfer (RRT); Behavioral: Peer Support (PS); Drug: daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]

• Registration Number: NCT03988387
• Lead Sponsor: Columbia University

Brief Summary

This is an open-label randomized controlled trial (n=200) in which HIV-negative young female sex workers (FSW) will be randomized to receive oral PrEP combined with specific behavioral and structural adherence interventions, either: (1) Intensive Peer Support (PS) or (2) Reminders and Resource Transfer (RRT).Respondent-driven sampling (RDS) will be used to recruit FSW as potential study participants.The study adherence interventions will be delivered over the first 12-month period in conjunction with PrEP. Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines. Trial participants will be followed for a total of 24 months and attend 11 study visits over this period.

Detailed Description

The overall aim of the proposed study is to compare the effectiveness, feasibility and acceptability of two adherence support interventions, peer support (PS) and reminders plus resource transfer (RRT), in combination with daily oral pre-exposure prophylaxis (PrEP) to optimize PrEP adherence among young in Kisumu, Kenya. Pre-exposure prophylaxis (PrEP) is a promising biomedical HIV prevention intervention. Findings from placebo-controlled efficacy trials highlight the need for adherence support to achieve PrEP efficacy and public health impact.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-06-12
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-17
• Study Start: 2019-10-31
• Primary Completion: 2022-03-10
• Study Completion: 2022-03-10
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Report no previous diagnosis of HIV infection
• Report being a cisgender female or transgender female
• Report being between 18-24 years of age
• Report living or working in study area
• Report intention to stay in study area for 24 months
• Report exchange sex with men for goods, money, favors or other services in past 3 months
• Report no previous or recent (within the last 3 months) PrEP use
• Able to complete study procedures in English, Kiswahili or Dholuo
• Willingness to be randomized and adhere to study interventions according to eligibility, including PrEP

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Exclusion Criteria

• Ineligible for PrEP according to Guidelines on Use of Antiretroviral Drugs for Treating and Preventing HIV Infection in Kenya - 2018 Edition (National AIDS and STI Control Program, 2018)
• Unable to provide informed consent for study procedures
• Any medical, psychiatric, or social condition, or occupational or other responsibility that, in the judgment of the principle investigators, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
• Reports plan to leave area in the next 24 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peer Support PS)	daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]	Participants randomized to the PS arm will be assigned a trained peer supporter (PSr) to enhance adherence to PrEP.
Reminders and Resource Transfer (RRT)	Reminder and Resource Transfer (RRT)	Participants randomized to the RRT arm will receive weekly SMS text messages and resource transfers to enhance adherence to PrEP.
Reminders and Resource Transfer (RRT)	daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]	Participants randomized to the RRT arm will receive weekly SMS text messages and resource transfers to enhance adherence to PrEP.
Peer Support PS)	Peer Support (PS)	Participants randomized to the PS arm will be assigned a trained peer supporter (PSr) to enhance adherence to PrEP.

Primary Outcome Measures

Name	Time	Method
PrEP Adherence between PS and RRT arms	12 months	Proportion of participants with ARV in plasma at 12-month visit

Secondary Outcome Measures

Name	Time	Method
PrEP Adherence between PS and RRT arms, any visit	At all visits	Proportion of participants with detectable ARV in plasma at any visit
PrEP adherence across PS and RRT arms	18 and 24 months	Proportion of participants with ARV in plasma at 18- and 24- month visits
Feasibility of PS and RRT interventions, study visit retention	24 months	Proportion of participants retained at each study visit
Scaled perception of PrEP, PS and RRT	24 months	Scaled perceptions of satisfaction with and utility of PS and RRT intervention components, PrEP, and clinical care
Safety of PrEP including social harms	24 months	Discontinuation rates of PrEP due to an AE or drug toxicity and occurrence of social harms
Discontinuation of PrEP	24 months	Discontinuation rates of PrEP due to situational changes, dislike of PrEP
HIV risk behavior during PrEP use, unprotected sex	Baseline, 6, 12, 18, and 24 months	Proportions of participants reporting unprotected vaginal or anal sex in the prior 30 days
Completion of study visits between PS and RRT	12, 18 and 24 months	Proportion who completed scheduled PrEP study visits in PS and RRT arms at 18 and 24 months compared to proportion who completed these study visits at 12 months
PrEP Adherence between PS and RRT arms, self-report	At all visits	Proportion who report \> 90% adherence by self-report
HIV risk behavior during PrEP use, propensity score	Baseline, 6, 12, 18, and 24 months	Comparison of sexual risk propensity score
Feasibility of PS and RRT interventions, intervention delivery	24 months	Proportion of expected intervention sessions delivered

Trial Locations

Locations (1)

Tuungane Centre; 🇰🇪 Kisumu, Kenya