Randomized Placebo-Controlled Trial to Assess the Impact of Oral Naltrexone on HIV Treatment Outcomes Among HIV-1 Infected Men Who Have Sex with Men and Transgender Women with Alcohol Use Disorders in Lima, Peru, 2014-2015 (ICPSR 39780)
Version Date: Apr 23, 2026 View help for published
Principal Investigator(s): View help for Principal Investigator(s)
Ann Duerr, Fred Hutchinson Cancer Research Center
Series:
https://doi.org/10.3886/ICPSR39780.v1
Version V1
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Summary View help for Summary
The Seek, Test, Treat and Retain (STTR) Collaboration Project involved over twenty studies in the fields of HIV and drug abuse. These studies were independently developed, but were chosen for the collaboration because they focused on one or more steps of the HIV treatment cascade: Seek, Test, Treat and Retain. These studies were grouped into Criminal Justice-related studies and Vulnerable Population-related studies. The data collected by these studies included twelve common domains (e.g. demographic characteristics, mental health) in each of which a shared questionnaire or instrument was taken up by the studies and adapted to fit the study. This repository contains the collected data and documentation from the STTR collaboration.
This study in particular, assesses outcomes of Oral Naltrexone on HIV Treatment among HIV-1 infected men in Lima, Peru. A randomized blinded placebo-controlled clinical trial was conducted to determine if oral naltrexone (NTX) would improve the likelihood that HIV-infected participants with alcohol use disorders (AUDs) remain engaged in care and become highly adherent to antiretroviral therapy (ART), with acceptable safety.
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Geographic Coverage View help for Geographic Coverage
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City
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Users are reminded that these data are to be used solely for statistical analysis and reporting of aggregated information, and not for the investigation of specific individuals or organizations. Access to the data is restricted. Users interested in obtaining these data must complete a Restricted Data Use Agreement. Data are provided via ICPSR's Virtual Data Enclave (VDE). Apply for access to these data through the ICPSR VDE portal. Information and instructions are available within the data portal. For further assistance please reference the VDE Guide to learn about the application process, about using the VDE, and how to request disclosure review of VDE output.
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Data Collection Notes View help for Data Collection Notes
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This is a Fast Track Release. Users should consult the principal investigator(s) if further information is needed.
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This study includes data files from monthly, quarterly, and annual collection intervals. It also includes a study summary, study questionnaires, and supplemental study data documentation.
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Some documentation files in this study are written in Spanish. There are accompanying document versions in English.
Study Purpose View help for Study Purpose
The purpose of the study is to determine if oral NTX will improve the likelihood that HIV-1 infected participants with alcohol use disorders will achieve viral suppression (VL less than 400) and maximal viral suppression (VL less than 50) at 24 weeks.
Study Design View help for Study Design
This is a Phase IV randomized, double-blind, placebo-controlled study of the efficacy of treating AUDs using oral NTX daily for 6 months to newly diagnosed HIV-1 infected MSM and transgender women with no previous experience to ART in Lima, Peru. This is a study that plans to enroll 159 diagnosed HIV seropositive MSM and transgender women who will be started on antiretroviral therapy and randomized 2:1 to receive either oral NTX (N=106) or a placebo (N=53), in addition to standard medical management counseling for the reduction of alcohol consumption.
Sample View help for Sample
The sample was compiled based on the following protocol:
Participants who test HIV positive (as part of the SABES study) and have a score of 8 or more on the AUDIT questionnaire are referred to IMPACTA for screening for AHORA-L. Participants may also be referred from other sources and complete the AUDIT questionnaire at IMPACTA. All MSM and transgender women with chronic HIV infection, who report having had 5 or more drinks in a single day in the past month, are referred to IMPACTA's Clinical Research Sites for screening for AUDs and potential participation in this study. All diagnosed HIV-1 infected MSM and transgender women receive more robust referral services. This is implemented through a peer navigators system which is supported by conditional cash transfers, providing transportation, increased hours of service provision at the Barranco and San Miguel Clinical Research Sites, etc.
Time Method View help for Time Method
Universe View help for Universe
HIV-1 infected men in Lima, Peru who have sex with men (MSM) and transgender women.
Unit(s) of Observation View help for Unit(s) of Observation
Data Type(s) View help for Data Type(s)
Mode of Data Collection View help for Mode of Data Collection
Description of Variables View help for Description of Variables
The interview data covers sexual behavior, mental health, social influences, and medical history. Additionally, data consists of blood tests, urine toxicology tests, breath analyzer, and physical exams (STI).
Presence of Common Scales View help for Presence of Common Scales
Center for Epidemiologic Studies-Depression Scale (CES-D), HIV Stigma Scale, Social Support Scale, Alcohol Craving Scale, Visual Analog Scale
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The public-use data files in this collection are available for access by the general public. Access does not require affiliation with an ICPSR member institution.
ICPSR usually offers files in multiple formats for researchers to be able to access data and documentation in formats that work well within their needs. If you have questions about the accessibility of materials distributed by ICPSR or require further assistance, please visit ICPSR’s Accessibility Center.
One or more files in this data collection have special restrictions. Restricted data files are not available for direct download from the website; click on the Restricted Data button to learn more.
This study is maintained and distributed by the National Addiction and Health Data Archive Program (NAHDAP). NAHDAP is supported by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health (NIH).