TerminatedNot Applicable

Electronic SBI(RT) for MSM in Argentina

Stopped: The study was terminated by NIH on March 21, 2025 due to new guidelines.

Argentina196 participantsStarted 2022-11-01

Plain-language summary

Men who have sex with men (MSM) are disproportionally affected by HIV and substance abuse in the U.S., Europe, and Latin America. However, as in the general population, identifying and engaging MSM with problematic substance use (PSU) into treatment is a significant challenge, which results in the great majority of MSM with PSU never receiving treatment. The proposed study seeks to develop and pilot an electronic-Screening, Brief Intervention, Referral to Treatment (e-SBI-RT)program tailored for MSM awaiting their HIV test at Nexo Asociacion Civil, our community partners in Buenos Aires. The tablet-based e-SBI will integrate substance use and sexual risk behavior screeners and individually tailored Motivational Interviewing (MI) as the BI. We will also adapt and pilot the implementation of the Young Men's Health Project (from YMHP to MHP) a four-session MI-based intervention that effectively reduced substance use and condomless anal intercourse among substance using MSM. The Specific Aims of this R34 study are to: 1) develop the e-SBI intervention for MSM in an HIV testing context to reduce substance use and HIV risk behavior (Primary); 2) assess the feasibility and acceptability of integrating e-SBI into the HIV testing process at Nexo; and 3) assess the feasibility and acceptability of implementing adapted YMHP at Nexo. In Stage 1 (Development) we will develop e-SBI, adapt YMHP into MHP, train MHP counselors, and pilot e-SBI with 50 MSM coming to Nexo for HIV testing. In Stage 2 (RCT Pilot), we will randomize 200 MSM coming to Nexo for HIV testing at a 3:1 ratio (eSBI: Screening Assessments Only-SA) to assess the feasibility and acceptability of e-SBI among MSM coming to Nexo for HIV testing and establish and pilot the RCT process for a future trial. As a secondary aim, we will assess uptake, acceptability, and feasibility of delivering MHP to participants with low or moderate risk substance use and subsequent referrals to substance abuse treatment among participants with high-risk substance use or dependence. Lastly, we will explore preliminary findings on substance use and sexual risk reduction outcomes.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Man who has had sex with men in the past 6 months;
. 18 years of age or older;
. Recently sought an HIV test at Nexo;
. Reports using drugs least once per month in the past 6 months and/or score 4 or greater on the AUDIT C, suggesting moderate risk alcohol use.
. Man who has had sex with men in the past 6 months
. 18 years of age or older;
. Currently seeking an HIV test at Nexo

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recruitment Rate: Percent of MSM testing clients at Nexo who accept entry into the study

Timeframe: 8 months

Retention Rate: percent of participants who complete e-SBI

Timeframe: 6 months

Mean overall acceptability rating of e-SBI from the TFA questionnaire

Timeframe: 6 months

Trial details

NCT IDNCT05542914

SponsorFlorida State University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-15

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