An interventional study of Peer Support (PS) and Reminder and Resource Transfer (RRT) in HIV, sponsored by Columbia University. Completed at 1 site in Kenya. Open to female participants aged 18 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-29.
Sponsored by Columbia University · Not applicable, Interventional, and Prevention
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 Thereafter, the study-specific adherence interventions will be withdrawn and PrEP continued for an additional 12 months with standard support as per national guidelines.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.
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.
Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
Of its 172 completed or terminated interventional studies of FDA-regulated products, 142 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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]
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]
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.
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.
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.
PrEP Adherence between PS and RRT arms
Proportion of participants with ARV in plasma at 12-month visit
Time frame: 12 months
PrEP Adherence between PS and RRT arms, any visit
Proportion of participants with detectable ARV in plasma at any visit
Time frame: At all visits
PrEP Adherence between PS and RRT arms, self-report
Proportion who report \> 90% adherence by self-report
Time frame: At all visits
PrEP adherence across PS and RRT arms
Proportion of participants with ARV in plasma at 18- and 24- month visits
Time frame: 18 and 24 months
HIV risk behavior during PrEP use, propensity score
Comparison of sexual risk propensity score
Time frame: 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
Time frame: Baseline, 6, 12, 18, and 24 months
Feasibility of PS and RRT interventions, intervention delivery
Proportion of expected intervention sessions delivered
Time frame: 24 months
Feasibility of PS and RRT interventions, study visit retention
Proportion of participants retained at each study visit
Time frame: 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
Time frame: 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
Time frame: 24 months
Safety of PrEP including social harms
Discontinuation rates of PrEP due to an AE or drug toxicity and occurrence of social harms
Time frame: 24 months
Discontinuation of PrEP
Discontinuation rates of PrEP due to situational changes, dislike of PrEP
Time frame: 24 months
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Plan to share: No
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