HIV InfectionsNCT03674983
PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico
A study testing Conditional Economic Incentive (CEI) in people with HIV Infections, run by Brown University at 1 site in Mexico.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Conditional Economic Incentive (CEI)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteMexico
- Study dates
- 15 May 2019to 30 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
National Institute of Public Health (INSP) / Clinica Condesa
Mexico City, Mexico City
About this study
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
- Being tested
- Conditional Economic Incentive (CEI)
- Keywords
- adherence, AIDS prevention, Anti-Retroviral Agents, Behavioral Economics, Biological Markers, Cost-effectiveness, MSM, HIV Prevention, PrEP
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conditional Economic Incentive (CEI)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Conditional Economic Incentive (CEI) |
| SOC Group | No intervention | SOC Group will receive the standard of care only (information, prescription, free PrEP.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ARV Hair Concentrations
Level of ARV (TDF/FTC) in scalp hair samples
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 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
Measured: 6 months
Questionnaire to Assess Self-reported PrEP Use
Self report adherence to assess for change in adherence.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start15 May 2019
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT)., University of California, San Francisco, Mexican National Institute of Public Health
- Responsible party
- Principal investigator, Omar Galarraga, PhD, Brown University
- Investigators
- Omar Galarraga, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674983
- Sponsor's protocol ID
- 1R34MH114664-01
- Other IDs
- 5R34MH114664-02
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2018
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 34837988Reichheld 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.
PubMed 38099208Salinas-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.
PubMed 34453239Galarraga 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.
PubMed 39002005Chivardi 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.
PubMed 40205318
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico
- ClinicalTrials.gov ID
- NCT03674983
- Acronym / sponsor ID
- 1R34MH114664-01
- Conditions
- HIV Infections
- Keywords
- adherence, AIDS prevention, Anti-Retroviral Agents, Behavioral Economics, Biological Markers, Cost-effectiveness, MSM, HIV Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT)., University of California, San Francisco, Mexican National Institute of Public Health
- Study start
- 15 May 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CEI Group | Experimental | Behavioral: Conditional Economic Incentive (CEI)CEI Group will receive the standard of care (information, prescription, free PrEP) and economic incentives contingent on sufficiently-high adherence to PrEP. |
| SOC Group | No intervention | –SOC Group will receive the standard of care only (information, prescription, free PrEP.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conditional Economic Incentive (CEI)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. | Behavioural | CEI Group |
Primary outcome
ARV Hair Concentrations
Time frame: 6 months
Level of ARV (TDF/FTC) in scalp hair samples
5 secondary outcomes
Clinic attendance/retention
Time frame: 6 months
Medication adherence
Time frame: 6 months
Questionnaire to Assess Self-reported PrEP Use
Time frame: 6 months
Reduction in HIV and STI incidence relative to control group
Time frame: 6 months
Reduction in number of unprotected sex acts relative to control group
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Background: PubMed 34837988Kadiamada-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.
- Background: PubMed 38099208Reichheld 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.
- Results publication: PubMed 34453239Salinas-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.
- Results publication: PubMed 39002005Galarraga 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.
- Derived from this study: PubMed 40205318Chivardi 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.
- Individual participant dataSharing planned: 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.
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Omar Galarraga, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conditional Economic Incentive (CEI) in people with HIV Infections, run by Brown University at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ARV Hair Concentrations (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03674983, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.