HIV Infections Clinical Trial
Official title:
PrEP Seguro: Antiretroviral-based HIV Prevention Among Men at High Risk in Mexico
Verified date | July 2023 |
Source | Brown University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 310 |
Est. completion date | August 30, 2021 |
Est. primary completion date | August 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Mexico | National Institute of Public Health (INSP) / Clinica Condesa | Mexico City | DF |
Lead Sponsor | Collaborator |
---|---|
Brown University | Consorcio de Investigación sobre VIH/SIDA/TB (CISIDAT)., Mexican National Institute of Public Health, National Institute of Mental Health (NIMH), University of California, San Francisco |
Mexico,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ARV Hair Concentrations | Level of ARV (TDF/FTC) in scalp hair samples | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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 | 6 months | |
Secondary | Questionnaire to Assess Self-reported PrEP Use | Self report adherence to assess for change in adherence. | 6 months | |
Secondary | 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. | 6 months | |
Secondary | 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. | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |