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

Columbia University

Status: Completed

Conditions: HIV

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03988387

R01MH110051 (U.S. NIH Grant/Contract)

AAAS3722

Details and patient eligibility

About

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 Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines.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

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Peer Support PS)

Experimental group

Description:

Participants randomized to the PS arm will be assigned a trained peer supporter (PSr) to enhance adherence to PrEP.

Treatment:

Drug: daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]

Behavioral: Peer Support (PS)

Reminders and Resource Transfer (RRT)

Experimental group

Description:

Participants randomized to the RRT arm will receive weekly SMS text messages and resource transfers to enhance adherence to PrEP.

Treatment:

Behavioral: Reminder and Resource Transfer (RRT)

Drug: daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]