- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03674983
PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico
July 25, 2023 updated by: Omar Galarraga, PhD, Brown University
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
310
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
DF
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Mexico City, DF, Mexico
- National Institute of Public Health (INSP) / Clinica Condesa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CEI Group
CEI Group will receive the standard of care (information, prescription, free PrEP) and economic incentives contingent on sufficiently-high adherence to 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.
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No Intervention: SOC Group
SOC Group will receive the standard of care only (information, prescription, free PrEP.)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ARV Hair Concentrations
Time Frame: 6 months
|
Level of ARV (TDF/FTC) in scalp hair samples
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinic attendance/retention
Time Frame: 6 months
|
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.
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6 months
|
Medication adherence
Time Frame: 6 months
|
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
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6 months
|
Questionnaire to Assess Self-reported PrEP Use
Time Frame: 6 months
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Self report adherence to assess for change in adherence.
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6 months
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Reduction in HIV and STI incidence relative to control group
Time Frame: 6 months
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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.
|
6 months
|
Reduction in number of unprotected sex acts relative to control group
Time Frame: 6 months
|
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.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Omar Galarraga, PhD, Brown University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2019
Primary Completion (Actual)
August 30, 2021
Study Completion (Actual)
August 30, 2021
Study Registration Dates
First Submitted
August 10, 2018
First Submitted That Met QC Criteria
September 14, 2018
First Posted (Actual)
September 18, 2018
Study Record Updates
Last Update Posted (Actual)
July 27, 2023
Last Update Submitted That Met QC Criteria
July 25, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Urogenital Diseases
- Genital Diseases
- HIV Infections
Other Study ID Numbers
- 1R34MH114664-01 (U.S. NIH Grant/Contract)
- 5R34MH114664-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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