Clinical trial NCT03674983: PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico
Official title: PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: adherence
AIDS prevention
Anti-Retroviral Agents
Behavioral Economics
Biological Markers
Cost-effectiveness
MSM
HIV Prevention
PrEP
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT).
name: University of California, San Francisco
name: Mexican National Institute of Public Health
First posted: 2018-09-18
Enrollment: 310
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Aim 1: discrete choice experiment (DCE) with n=200. Aim 2: randomly assign 100 HIV-negative MSW in a 1:1 ratio either to: the SoC group, or to the CEI group. MSW in the SoC group (n=50) will receive transport reimbursement at baseline, 3 and 6 months. MSW in the CEI group (n=50) will receive transport reimbursement at baseline, 3 and 6 months, and additional incentives based on sufficiently high PrEP adherence at months 3 and 6. All participants will provide hair samples and have optional brief counseling based on hair sample results. Those in the CEI group, will receive additional incentives if concentrations of TDF/FTC in hair samples corroborate that they have been sufficiently adherent in recent weeks. The final incentives (amounts, format, location, etc.) will be based on Aim 1 results. 1-2 weeks after study visits, participants will receive a grade depending on the drug level detected in their scalp hair. The CEI amounts will be distributed depending on grade.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male at birth and self-identifies as male at the time of enrollment
* At least 18 years of age
* Has tested negative for HIV in the past month
* Demonstrates high risk of HIV acquisition defined as having had sex with penetration (oral or anal) with at least 8 male partners in past six months
* Has exchanged or accepted money, drugs or gifts in exchange for sex on at least 8 occasions in the past month
* Willing and capable of providing blood and scalp hair samples for assessments
* Willing and able to provide written informed consent
* Have successfully initiated PrEP and are returning for their second bottle of PrEP pills
* Able to provide a home address or personal telephone number, or able to provide two personal contacts who will be able to know the patient's whereabouts during the study period

Exclusion Criteria

* Under 18 years of age
* Unable to give informed consent due to severe mental or physical illness/substance intoxication at baseline visit
* Presents with severe adverse reactions to PrEP
* The subject will be excluded from the study at his own request for any reason since participation is voluntary

Primary outcomes:
measure: ARV Hair Concentrations
timeFrame: 6 months
Secondary outcomes:
measure: Clinic attendance/retention
timeFrame: 6 months
measure: Medication adherence
timeFrame: 6 months
measure: Questionnaire to Assess Self-reported PrEP Use
timeFrame: 6 months
measure: Reduction in HIV and STI incidence relative to control group
timeFrame: 6 months
measure: Reduction in number of unprotected sex acts relative to control group
timeFrame: 6 months
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: National Institute of Public Health (INSP) / Clinica Condesa
state: DF
Study officials:
affiliation: Brown University
name: Omar Galarraga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kadiamada-Ibarra H, Hawley NL, Sosa-Rubi SG, Wilson-Barthes M, Franco RR, Galarraga O. Barriers and facilitators to pre-exposure prophylaxis uptake among male sex workers in Mexico: an application of the RE-AIM framework. BMC Public Health. 2021 Nov 27;21(1):2174. doi: 10.1186/s12889-021-12167-9.
citation: Reichheld SJ, Pellowski JA, Wilson-Barthes M, Galarraga O. 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. SSM Qual Res Health. 2023 Dec;4:100357. doi: 10.1016/j.ssmqr.2023.100357. Epub 2023 Nov 8.
citation: Salinas-Rodriguez A, Sosa-Rubi SG, Chivardi C, Rodriguez-Franco R, Gandhi M, Mayer KH, Operario D, Gras-Allain N, Vargas-Guadarrama G, Galarraga O. Preferences for Conditional Economic Incentives to Improve Pre-exposure Prophylaxis Adherence: A Discrete Choice Experiment Among Male Sex Workers in Mexico. AIDS Behav. 2022 Mar;26(3):833-842. doi: 10.1007/s10461-021-03443-1. Epub 2021 Aug 27.
citation: Galarraga O, Wilson-Barthes M, Chivardi C, Gras-Allain N, Alarid-Escudero F, Gandhi M, Mayer KH, Operario D. Incentivizing adherence to pre-exposure prophylaxis for HIV prevention: a randomized pilot trial among male sex workers in Mexico. Eur J Health Econ. 2025 Mar;26(2):299-311. doi: 10.1007/s10198-024-01705-y. Epub 2024 Jul 13.