PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico
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|ClinicalTrials.gov Identifier: NCT03674983|
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : June 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Behavioral: Conditional Economic Incentive (CEI)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico|
|Actual Study Start Date :||May 15, 2019|
|Estimated Primary Completion Date :||June 20, 2020|
|Estimated Study Completion Date :||June 20, 2020|
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.
Behavioral: 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.
No Intervention: SOC Group
SOC Group will receive the standard of care only (information, prescription, free PrEP.)
- ARV Hair Concentrations [ Time Frame: 6 months ]Level of ARV (TDF/FTC) in scalp hair samples
- 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.
- 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
- Questionnaire to Assess Self-reported PrEP Use [ Time Frame: 6 months ]Self report adherence to assess for change in adherence.
- Reduction in HIV and STI incidence relative to control group [ Time Frame: 6 months ]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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674983
|Contact: Omar Galarraga, PhD||401 863 firstname.lastname@example.org|
|National Institute of Public Health (INSP) / Clinica Condesa||Recruiting|
|Mexico City, DF, Mexico|
|Contact: Sandra Gabriela Sosa Rubi, PhD email@example.com|
|Principal Investigator:||Omar Galarraga, PhD||Brown University|