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

NACompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

October 31, 2019

Primary Completion Date

March 10, 2022

Study Completion Date

March 10, 2022

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.

Trial Locations (1)

Unknown

Tuungane Centre, Kisumu

All Listed Sponsors
collaborator

Impact Research & Development Organization

OTHER

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Columbia University

OTHER

NCT03988387 - IPREP Study #2: Evaluating Enhanced PrEP Packages for Young Female Sex Workers in Kisumu, Kenya | Biotech Hunter | Biotech Hunter