NCT05542914

Electronic SBI(RT) for MSM in Argentina

Terminated NA Last updated 27 June 2025

What this trial tests

NA trial testing electronic screening and brief intervention. in Substance Abuse in 196 participants. Terminated before completion.

Timeline

1 November 2022

Primary endpoint
15 March 2025

15 March 2025

Quick facts

Lead sponsor	Florida State University
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	196
Start date	1 November 2022
Primary completion	15 March 2025
Estimated completion	15 March 2025
Sites	1 location across Argentina

Drugs / interventions tested

• electronic screening and brief intervention.
• Men's Health Project (MHP)

Conditions studied

• Substance Abuse — all drugs for Substance Abuse →
• HIV — all drugs for HIV →

Sponsor

Florida State University

Who can join

18 and older, male only, with Substance Abuse or HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Integration of an Electronic Screening, Brief Intervention, and Referral to Treatment Program Into an HIV Testing Program to Reduce Substance Use and HIV Risk Behavior Among Men Who Have Sex With Men: Protocol for Intervention Development and a Pilot Randomized Controlled Trial.
   Balán IC, Marone RO, Barreda V, Naar S, et al · · 2024 · PMID 38483463 · DOI 10.2196/56683