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

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

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 Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines.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

Study Overview

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

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu, Kenya
    • Tuungane Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Institute of Mental Health (NIMH); Impact Research & Development Organization
• Investigators: Principal Investigator: Wafaa El-Sadr, MD, MPH, MPA, Columbia University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2019
• Primary Completion (ACTUAL): March 10, 2022
• Study Completion (ACTUAL): March 10, 2022

Study Registration Dates

• First Submitted: June 12, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (ACTUAL): June 17, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Adherence; HIV prevention; Pre-exposure prophylaxis (PrEP)
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine
• Other Study ID Numbers: AAAS3722; R01MH110051 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes