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

NCT03988387 | Completed

• 2 other identifiers: AAAS3722R01MH110051
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines.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

Conditions

HIV

Keywords

Pre-exposure prophylaxis (PrEP); HIV prevention; Adherence

Outcome Measures

Primary Outcomes (1)

• PrEP Adherence between PS and RRT arms

  Proportion of participants with ARV in plasma at 12-month visit

  12 months

Secondary Outcomes (11)

• PrEP Adherence between PS and RRT arms, any visit

  At all visits

• PrEP Adherence between PS and RRT arms, self-report

  At all visits

• PrEP adherence across PS and RRT arms

  18 and 24 months

• HIV risk behavior during PrEP use, propensity score

  Baseline, 6, 12, 18, and 24 months

• HIV risk behavior during PrEP use, unprotected sex

  Baseline, 6, 12, 18, and 24 months

Study Arms (2)

Peer Support PS)

EXPERIMENTAL

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

Behavioral: Peer Support (PS); Drug: daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]

Reminders and Resource Transfer (RRT)

EXPERIMENTAL

Participants randomized to the RRT arm will receive weekly SMS text messages and resource transfers to enhance adherence to PrEP.

Behavioral: Reminder and Resource Transfer (RRT); Drug: daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]

Interventions

Peer Support (PS) 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.

Peer Support PS)

Reminder and Resource Transfer (RRT) 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.

Reminders and Resource Transfer (RRT)

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

Peer Support PS); Reminders and Resource Transfer (RRT)

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Impact Research & Development Organization: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Tuungane Centre

Kisumu, Kenya

Location

MeSH Terms

Interventions

Emtricitabine; Tenofovir

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Wafaa El-Sadr, MD, MPH, MPA

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 17, 2019
• Study Start: October 31, 2019
• Primary Completion: March 10, 2022
• Study Completion: March 10, 2022
• Last Updated: September 29, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)