Clinical trial NCT04821427: Alcohol and Sex Risk mHealth-Enhanced Brief Intervention for BLMSM
Official title: Feasibility of an mHealth + Brief Intervention for Heavy Drinking African American and Latino MSM: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heavy Drinking and Sexual Risk Behavior
Keywords: heavy drinking
sexual risk behavior
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 24
Sex: MALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Daily Drinking Questionnaire - Heavy Drinking Episodes
timeFrame: Past 30 days
measure: Sexual Behavior - Extended Survey - Condomless Anal Intercourse
timeFrame: Past 30 days
Secondary outcomes:
measure: Goal Systems Assessment Battery - Alcohol
timeFrame: Past 30 days
measure: Goal Systems Assessment Battery - Condom Use
timeFrame: Past 30 days
measure: Client Satisfaction Questionnaire
timeFrame: 2 months post-baseline
measure: Intervention Acceptability Ratings
timeFrame: 2 months post-baseline
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
affiliation: Boston University
name: Kathryn E Chavez, MA
role: PRINCIPAL_INVESTIGATOR
References: