Electronic SBI(RT) for MSM in Argentina

NCT05542914 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-06-27

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

electronic screening and brief intervention.

e-SBIs is an evidence based approach to engage non-treatment-seeking individuals who use substances to reduce use or enter treatment. It consists of completing screening instruments related to substance use and sexual risk behavior and receiving a tablet-based, Motivational Interviewing intervention to help individuals build motivation to reduce their use and plans to achieve their substance use and HIV risk reduction goals.

BEHAVIORAL

Men's Health Project (MHP)

This intervention will be offered to participants with moderate or greater severity substance use. This is a 4-session Motivational interviewing based intervention that has shown efficacy in prior studies. We are providing this as a possible referral program for study participants (either arm) who are interested in receiving substance abuse intervention.

Sponsors & Collaborators

  • Nexo Asociacion Civil

    collaborator UNKNOWN
  • Florida State University

    lead OTHER

Principal Investigators

  • Ivan C Balan · Florida State University, College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-03-15
Completion
2025-03-15

Countries

  • Argentina

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05542914 on ClinicalTrials.gov