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

NCT ID: NCT03988387

Last Updated: 2022-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-31
• Study Completion Date: 2022-03-10

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 Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines.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

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Peer Support PS)

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

Group Type: EXPERIMENTAL

Peer Support (PS)

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Reminder and Resource Transfer (RRT)

Intervention Type: BEHAVIORAL

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.

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Impact Research & Development Organization

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wafaa El-Sadr, MD, MPH, MPA

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Tuungane Centre

Kisumu, , Kenya

Countries

Kenya

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

R01MH110051

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAS3722

Identifier Type: -

Identifier Source: org_study_id