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NCT Number: NCT04821427

Alcohol and Sex Risk mHealth-Enhanced Brief Intervention for BLMSM

Randomized controlled pilot trial to test the feasibility and efficacy of a brief intervention with app-based messaging to reduce sexual risk behavior and heavy drinking among Black/African American and Hispanic/Latino MSM.

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Key information

Conditions

Heavy Drinking and Sexual Risk Behavior

Age range

21 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Boston University

Boston, Massachusetts, 02215, United States

About this study

This study seeks to develop and provide an initial test of a brief intervention to reduce alcohol use and sex risk behavior among Black and Latino men who have sex with men [BLMSM]. The study seeks to recruit BLMSM who are non-monogamous, not currently on pre-exposure prophylaxis [PrEP], have engaged in condomless anal intercourse over the past 6 months, who have engaged in heavy drinking defined as >14 drinks per week or at least 1 heavy drinking episode (5+ drinks on a single occasion) in the past month. All participants will complete baseline measures about past month behavior and if eligible will be assigned to the intervention condition or an assessment only condition. The intervention consists of a single brief video-conferencing intervention coupled with 4 weeks of mobile-messaging related to individualized goals about alcohol use and sexual behavior. Follow-up assessments are scheduled for 4 weeks after baseline (upon completion of the mobile-messaging component of the intervention) and 2 months after baseline. Primary outcomes are feasibility and acceptability of the intervention and mobile-messaging components. Secondary outcomes are changes in frequency of condomless anal intercourse and heavy drinking episodes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Black/African American or Latino/Hispanic
  • At least one heavy drinking episode in past month
  • At least one episode of condomless anal intercourse with another man in the past 6 months
  • Own a smartphone
  • English speaking

Exclusion criteria

  • HIV+
  • Currently on PrEP
  • Monogamous/exclusive relationship
  • Past or current treatment for alcohol (past 3 years)
  • Current or past psychiatric treatment (past 3 months)
  • Diagnosis of Bipolar Disorder or Schizophrenia
  • Brief Michigan Alcoholism Screening Test score >5
  • Lifetime diagnosis of substance use disorder
  • ASSIST score of >/=27 for any individual substance

Treatment and study plan

Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinking

Behavioral

The intervention is a brief, motivational video-conferencing intervention followed by four weeks of app-based, interactive mobile messages to reduce heavy episodic drinking and sexual risk behavior (condomless anal intercourse) among Black/African American and Hispanic/Latino men who have sex with men

Primary outcomes

  1. Modified Daily Drinking Questionnaire - Heavy Drinking Episodes

    Time frame: Past 30 days

    Number of heavy drinking episodes NIAAA criteria (5+ drinks)

  2. Sexual Behavior - Extended Survey - Condomless Anal Intercourse

    Time frame: Past 30 days

    Frequency of condomless anal intercourse. This is an open ended question where the Participant reports the frequency of condomless anal intercourse over the past 30 days.

Secondary outcomes

  1. Goal Systems Assessment Battery - Alcohol

    Time frame: Past 30 days

    Ratings of self-regulatory capacities related to reducing alcohol use. Items are 5-point Likert scale. There are 4 subscales utilized including planning, monitoring, self-efficacy and value. Higher scores indicates better outcomes.

  2. Goal Systems Assessment Battery - Condom Use

    Time frame: Past 30 days

    Ratings of self-regulatory capacities related to using condoms. Items are 5-point Likert scale. There are 4 subscales utilized including planning, monitoring, self-efficacy and value. Higher scores indicates better outcomes.

  3. Client Satisfaction Questionnaire

    Time frame: 2 months post-baseline

    8-item Client Satisfaction Questionnaire answered on a 4-point scale. Mean scale score is 1-4. Higher scores reflect a better outcome.

  4. Intervention Acceptability Ratings

    Time frame: 2 months post-baseline

    10-item Acceptability Measure of the overall intervention answered on a 5-point Likert scale (strongly disagree to strongly agree) used to assess the acceptability of the video-conferencing brief intervention and the mobile messages. Mean scale range is 1-5. Higher scores reflect a better outcome.

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Registry information

Official study title

Feasibility of an mHealth + Brief Intervention for Heavy Drinking African American and Latino MSM: A Pilot Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2021
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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