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

NCT03674983 | Completed

• 2 other identifiers: 1R34MH114664-015R34MH114664-02
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

adherence; AIDS prevention; Anti-Retroviral Agents; Behavioral Economics; Biological Markers; Cost-effectiveness; MSM; HIV Prevention; PrEP

Outcome Measures

Primary Outcomes (1)

• ARV Hair Concentrations

  Level of ARV (TDF/FTC) in scalp hair samples

  6 months

Secondary Outcomes (5)

• Clinic attendance/retention

  6 months

• Medication adherence

  6 months

• Questionnaire to Assess Self-reported PrEP Use

  6 months

• Reduction in HIV and STI incidence relative to control group

  6 months

• Reduction in number of unprotected sex acts relative to control group

  6 months

Study Arms (2)

CEI Group

EXPERIMENTAL

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

NO INTERVENTION

SOC Group will receive the standard of care only (information, prescription, free PrEP.)

Interventions

Conditional Economic Incentive (CEI) BEHAVIORAL

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.

CEI Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• National Institute of Mental Health (NIMH): collaborator
• Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT).: collaborator
• University of California, San Francisco: collaborator
• Mexican National Institute of Public Health: collaborator

Study Sites (1)

National Institute of Public Health (INSP) / Clinica Condesa

Mexico City, Mexico City, Mexico

Location

Related Publications (5)

• 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.

  PMID: 34837988 BACKGROUND

• 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.

  PMID: 38099208 BACKGROUND

• 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.

  PMID: 34453239 RESULT

• 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.

  PMID: 39002005 RESULT

• Chivardi C, Zamudio-Sosa A, Wilson-Barthes M, Alarid-Escudero F, Gandhi M, Mayer KH, Operario D, Galarraga O. Cost-Effectiveness of Using Conditional Economic Incentives to Improve Pre-exposure Prophylaxis Adherence Among Male Sex Workers. Pharmacoecon Open. 2025 Jul;9(4):649-659. doi: 10.1007/s41669-025-00569-z. Epub 2025 Apr 9.

  PMID: 40205318 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Omar Galarraga, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Health Services, Policy and Practice

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2018
• First Posted: September 18, 2018
• Study Start: May 15, 2019
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2021
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)