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Alcohol and Sex Risk mHealth-Enhanced Brief Intervention for BLMSM

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04821427
Enrollment
24
Registered
2021-03-29
Start date
2021-04-04
Completion date
2021-09-15
Last updated
2026-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heavy Drinking and Sexual Risk Behavior

Keywords

heavy drinking, sexual risk behavior

Brief summary

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.

Detailed description

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.

Interventions

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

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

Sponsors

Boston University Charles River Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
21 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Modified Daily Drinking Questionnaire - Heavy Drinking EpisodesPast 30 daysNumber of heavy drinking episodes NIAAA criteria (5+ drinks)
Sexual Behavior - Extended Survey - Condomless Anal IntercoursePast 30 daysFrequency 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

MeasureTime frameDescription
Goal Systems Assessment Battery - AlcoholPast 30 daysRatings 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.
Goal Systems Assessment Battery - Condom UsePast 30 daysRatings 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.
Client Satisfaction Questionnaire2 months post-baseline8-item Client Satisfaction Questionnaire answered on a 4-point scale. Mean scale score is 1-4. Higher scores reflect a better outcome.
Intervention Acceptability Ratings2 months post-baseline10-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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKathryn E Chavez, MA

Boston University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 24, 2026