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

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 Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines.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

Conditions

• HIV

Interventions

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.

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.

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.

Sponsors & Collaborators

• Impact Research & Development Organization

  collaborator OTHER

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Wafaa El-Sadr, MD, MPH, MPA · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

24 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-31

Primary Completion

2022-03-10

Completion

2022-03-10

Countries

• Kenya

Study Locations