Clinical trial NCT03988387: IPREP Study #2: Evaluating Enhanced PrEP Packages for Young Female Sex Workers in Kisumu, Kenya
Official title: IPrEP, Study #2: Evaluating the Effectiveness, Feasibility and Acceptability of Enhanced Pre-exposure Prophylaxis (PrEP) Packages for Young Female Sex Workers in Kisumu, Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: Pre-exposure prophylaxis (PrEP)
HIV prevention
Adherence
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Impact Research & Development Organization
name: National Institute of Mental Health (NIMH)
First posted: 2019-06-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines.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

Eligibility criteria: 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

Primary outcomes:
measure: PrEP Adherence between PS and RRT arms
timeFrame: 12 months
Secondary outcomes:
measure: PrEP Adherence between PS and RRT arms, any visit
timeFrame: At all visits
measure: PrEP Adherence between PS and RRT arms, self-report
timeFrame: At all visits
measure: PrEP adherence across PS and RRT arms
timeFrame: 18 and 24 months
measure: HIV risk behavior during PrEP use, propensity score
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: HIV risk behavior during PrEP use, unprotected sex
timeFrame: Baseline, 6, 12, 18, and 24 months
measure: Feasibility of PS and RRT interventions, intervention delivery
timeFrame: 24 months
measure: Feasibility of PS and RRT interventions, study visit retention
timeFrame: 24 months
measure: Completion of study visits between PS and RRT
timeFrame: 12, 18 and 24 months
measure: Scaled perception of PrEP, PS and RRT
timeFrame: 24 months
measure: Safety of PrEP including social harms
timeFrame: 24 months
measure: Discontinuation of PrEP
timeFrame: 24 months
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Tuungane Centre
Study officials:
affiliation: Columbia University
name: Wafaa El-Sadr, MD, MPH, MPA
role: PRINCIPAL_INVESTIGATOR
References: