Electronic SBI(RT) for MSM in Argentina

NCT05542914 | Terminated

• 1 other identifier: STUDY00002530
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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

Substance Abuse; HIV

Keywords

SBIRT; HIV Prevention; MSM

Outcome Measures

Primary Outcomes (3)

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

  Will tabulate the percentage of MSM testing clients at Nexo who accept entry into the study vs those who refuse entry

  8 months

• Retention Rate: percent of participants who complete e-SBI

  Will calculate the percent of participants who fully complete the e-SBI vs participants who do not complete the intervention

  6 months

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

  Will use the last question on the TFA questionnaire "Overall, how acceptable is the e-SBI to you?" to calculate mean overall acceptability and percent of participants who rate acceptability at 4 or higher.

  6 months

Secondary Outcomes (4)

• the percent of MSM with moderate or high-risk substance use who enter MHP from either RCT condition

  6 months

• the percent of MHP participants who complete all four sessions

  6 months

• Mean overall acceptability rating of MHP from the TFA questionnaire

  6 months

• percentage of sessions conducted by each MHP counselor that meet criteria for MI proficiency

  6 months

Other Outcomes (3)

• Occasions of drug use during the past month

  30 days

• Occasions of heavy alcohol consumption (5+ drinks) during the past month

  30 days

• Occasions of anal intercourse during the past month with a partner who is HIV positive or of unknown serostatus .

  30 days

Study Arms (2)

e-SBI

EXPERIMENTAL

Electronic Screening and Brief Intervention for substance use and HIV risk reduction

Behavioral: electronic screening and brief intervention.; Behavioral: Men's Health Project (MHP)

Assessment Only

ACTIVE COMPARATOR

These individuals complete only the screening instruments, no brief intervention

Behavioral: electronic screening and brief intervention.; Behavioral: Men's Health Project (MHP)

Interventions

electronic screening and brief intervention. BEHAVIORAL

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.

Assessment Only; e-SBI

Men's Health Project (MHP) BEHAVIORAL

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.

Assessment Only; e-SBI

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identifies as male or cis-gender male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in Stage 1 Focus Groups (FGs) and in-depth interviews (IDIs):
• Man who has had sex with men in the past 6 months;
• 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.
• Participants in Stage 1 e-SBI pilot and the Stage 2 RCT:
• Man who has had sex with men in the past 6 months
• years of age or older;
• Currently seeking an HIV test at Nexo
• \. Score of moderate or high risk drug or alcohol use based on the ASSIST and AUDIT, respectively

You may not qualify if:

• be in need of acute detoxification, as demonstrated by physical withdrawal symptoms or a history of withdrawal, such as previous delirium tremens or seizures
• reported regular use of opioids
• enrolled in concurrent drug- or alcohol-related treatment.

Sponsors & Collaborators

• Florida State University: lead
• Nexo Asociacion Civil: collaborator

Study Sites (1)

Nexo Asociacion Civil

Buenos Aires, C1022AAD, Argentina

Location

Related Publications (1)

• Balan IC, Marone RO, Barreda V, Naar S, Wang Y. 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. JMIR Res Protoc. 2024 Mar 14;13:e56683. doi: 10.2196/56683.

  PMID: 38483463 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Ivan C Balan

  Florida State University, College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 16, 2022
• Study Start: November 1, 2022
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting 6 months after publication of main study findings.
• Access Criteria: We will collaborate with and make our data available to other researchers for additional/secondary analyses. Dr. Balán and the research team will develop a process to review and approve data release based on concept sheets submitted by interested investigators and whether the data request is for new lines of analysis. Formal data sharing agreements will be developed to guide and encourage further data mining of the proposed datasets for various purposes

Locations

AR (1)