An interventional study of Conditional Economic Incentive (CEI) in HIV Infections, sponsored by Brown University. Completed at 1 site in Mexico. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Brown University · Not applicable, Interventional, and Prevention
The objective of this R34 application is to prepare for testing innovative user-centered ways to promote PrEP adherence at scale. Our central hypothesis is that adherence to PrEP can be improved among MSW if PrEP is provided for free along with highly-tailored conditional economic incentives (CEI). The specific aims are: Aim 1: To refine the design of PrEP adherence intervention with user-centered conditional economic incentives to maximize sustained adherence behaviors through a user-responsive computerized survey (n=200). We incorporate quantitatively identified preferences for CEIs through a user- responsive computerized survey. We use conjoint analysis to understand preferences for CEI intervention components and how CEIs should be integrated into an optimal combination package to be tested in Aim 2. Aim 2: Measure the extent to which a user-centered CEI intervention can help MSW increase their adherence to free PrEP in a randomized controlled pilot (n=100). Among MSW who accept to take free PrEP, and return at month 1 for a second pill bottle, we will randomize n=100 MSW to either: standard of care (SoC: information, prescription, free PrEP) or CEI (SoC + incentives contingent on sufficiently-high adherence to PrEP). We will assess the primary outcome (biomarker of adherence using scalp hair analysis) at months 3 and 6, as well as secondary outcomes: clinic attendance/retention, medication possession ratio, self-reported PrEP use, and sexual behavioral disinhibition (number of partners, condom use, incident STI). Aim 3: Estimate the preliminary cost-effectiveness of incentives for PrEP adherence to maximize future policy and practice relevance of this promising intervention strategy. Our working hypothesis is that conditional economic incentives for PrEP adherence will be cost-effective in terms of cost per fully- adherent month on PrEP, cost per HIV infection averted, and cost per disability-adjusted life year saved when compared to controls not receiving the conditional incentives. The expected outcome of this R34 is a demonstration that is feasible to implement user-centered CEIs in this context, as well as preliminary efficacy and cost-effectiveness data. The project will have positive impact because it is a critical step toward scaled-up implementation of PrEP in this highly-at-risk population of MSWs in Mexico, with implications for other concentrated epidemics among MSW worldwide.
4,342 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 310 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →Brown University is the lead sponsor of 288 studies on the registry; 38 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 19 (73%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
CEI Group will receive the standard of care (information, prescription, free PrEP) and economic incentives contingent on sufficiently-high adherence to PrEP.
Behavioral: Conditional Economic Incentive (CEI)
SOC Group will receive the standard of care only (information, prescription, free PrEP.)
If hair testing shows that a participant has taken PrEP pills about 5-7 times in the previous week, he will receive a grade "A"; if he has taken PrEP pills about 3-4 times in the previous week he will receive a grade "B"; and if he has taken PrEP pills only 2 times or less, he will receive a grade "C". For those in the CEI group, if participant gets an A, he receives two additional prizes; if he gets a B, he receives one additional prize; and if he gets a C, he receives no additional prizes.
ARV Hair Concentrations
Level of ARV (TDF/FTC) in scalp hair samples
Time frame: 6 months
Clinic attendance/retention
This is a measure of retention in care. As each participant finishes his 6-month study period, retention will be determined by number of quarterly care visits completed.
Time frame: 6 months
Medication adherence
Medication Possession Ratio (MPR) is defined as the number of dispensed pills divided by the number of days between visits which will be derived from pharmacy refill records
Time frame: 6 months
Questionnaire to Assess Self-reported PrEP Use
Self report adherence to assess for change in adherence.
Time frame: 6 months
Reduction in HIV and STI incidence relative to control group
Male sex worker participants will be tested at baseline and 6-month follow-up for HIV and syphilis. Incidence rates for all infections at 6-month follow-up will be compared between the conditional economic incentive (CEI) group and the standard of care (SOC) group.
Time frame: 6 months
Reduction in number of unprotected sex acts relative to control group
Male sex worker participants will be assessed at baseline and 6-month follow-up using self-report measures of frequency of protected and unprotected sex acts with clients. Changes in frequency at 6-month follow-up will be compared between the conditional economic incentive (CEI) group and the standard of care (SOC) group.
Time frame: 6 months
Plan to share: No — Materials generated under this project will be disseminated according to University and NIH policies regarding data sharing. Aggregate-level data collected in this collaboration will ultimately be available for public use. Opportunities for secondary analyses will be available following completion of the three-year project and publication of the main study findings. These findings will be available to the public through scientific meetings and peer-reviewed journals, as well as through a structured policy dissemination process.
Ran from May 2019 to primary completion in Aug 2021, 27 months.
Of 549 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's 27 months is close to that.
Counting every sponsor, half of 559 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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