NCT03674983

PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico

Completed NA Last updated 9 August 2024

What this trial tests

NA trial testing Conditional Economic Incentive (CEI) in HIV Infections in 310 participants. Completed in 30 August 2021.

Timeline

15 May 2019

Primary endpoint
30 August 2021

30 August 2021

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	310
Start date	15 May 2019
Primary completion	30 August 2021
Estimated completion	30 August 2021
Sites	1 location across Mexico

Drugs / interventions tested

• Conditional Economic Incentive (CEI)

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

Brown University

Who can join

18 and older, male only, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Conditional economic incentives to improve HIV prevention and treatment in low-income and middle-income countries.
   Galárraga O, Sosa-Rubí SG. · · 2019 · cited 58× · PMID 31578955 · DOI 10.1016/s2352-3018(19)30233-4
2. Preferences for Conditional Economic Incentives to Improve Pre-exposure Prophylaxis Adherence: A Discrete Choice Experiment Among Male Sex Workers in Mexico.
   Salinas-Rodríguez A, Sosa-Rubí SG, Chivardi C, Rodríguez-Franco R, et al · · 2022 · cited 15× · PMID 34453239 · DOI 10.1007/s10461-021-03443-1
3. Cost-Effectiveness of Using Conditional Economic Incentives to Improve Pre-exposure Prophylaxis Adherence Among Male Sex Workers.
   Chivardi C, Zamudio-Sosa A, Wilson-Barthes M, Alarid-Escudero F, et al · · 2025 · cited 1× · PMID 40205318 · DOI 10.1007/s41669-025-00569-z
4. Incentivizing adherence to pre-exposure prophylaxis for HIV prevention: a randomized pilot trial among male sex workers in Mexico.
   Galárraga O, Wilson-Barthes M, Chivardi C, Gras-Allain N, et al · · 2025 · cited 1× · PMID 39002005 · DOI 10.1007/s10198-024-01705-y
5. Barriers and facilitators to scaling up access to HIV pre-exposure prophylaxis among key populations: A qualitative study of the incentive-based PrEP Seguro program in Mexico.
   Reichheld SJ, Pellowski JA, Wilson-Barthes M, Galárraga O. · · 2023 · PMID 38099208 · DOI 10.1016/j.ssmqr.2023.100357