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

Study Overview
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Brief Summary
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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 Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines.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
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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.

Official Title
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IPrEP, Study #2: Evaluating the Effectiveness, Feasibility and Acceptability of Enhanced Pre-exposure Prophylaxis (PrEP) Packages for Young Female Sex Workers in Kisumu, Kenya

Conditions
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HIV

Intervention / Treatment
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* Behavioral: Peer Support (PS)
* Behavioral: Reminder and Resource Transfer (RRT)
* Drug: daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peer Support PS)<br>Participants randomized to the PS arm will be assigned a trained peer supporter (PSr) to enhance adherence to PrEP. | Behavioral: Peer Support (PS)<br>* Participants randomized to the PS arm will be assigned a trained peer supporter. The peer supporters (PSr) will establish rapport and build trusting relationships with participants in order to increase self-efficacy and motivation to adhere to the daily PrEP regimen and to engage in HIV prevention behaviors, in general. The PSrs will assess for facilitators and barriers to PrEP adherence, conduct adherence counseling, and provide ongoing social and practical support (e.g. tailored appointment reminders, accompanying participants to medical appointments, and providing skills building for effective relationships with study site providers). PSrs will communicate with the participant on at least a weekly basis either in person or by phone and will track those who miss scheduled study visits. Participants will be encouraged to contact their PSrs in case of questions or concerns. For any clinical question, the peer supporter will direct the participant to the study nurse.<br>Drug: daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]<br>* All participants will receive a one-month supply of daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF] for the first month of enrollment.<br>|
| Experimental: Reminders and Resource Transfer (RRT)<br>Participants randomized to the RRT arm will receive weekly SMS text messages and resource transfers to enhance adherence to PrEP. | Behavioral: Reminder and Resource Transfer (RRT)<br>* Participants who are randomized to the RRT arm will receive a discrete weekly SMS text (or voice message if participant is illiterate) to encourage healthy behaviors, study engagement and PrEP adherence. Messages will be a general message that the participant has selected and will not have any information identifying the participant as part of the study or describing the purpose of the study. An example text is Remember to look after yourself today, See you tomorrow. Participants will be requested to respond to the message with a brief answer. Participants will be advised that each answered text counts as a point toward resource transfer that can be redeemed at scheduled study visits in the form of a small gift, such as cosmetics, personal care items, accessories, or airtime.The value of the reward increases with points.<br>Drug: daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]<br>* All participants will receive a one-month supply of daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF] for the first month of enrollment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PrEP Adherence between PS and RRT arms | Proportion of participants with ARV in plasma at 12-month visit | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-exposure prophylaxis (PrEP), HIV prevention, Adherence