Alcohol and Sex Risk mHealth-Enhanced Brief Intervention for BLMSM
- Conditions
- Heavy Drinking and Sexual Risk Behavior
- Interventions
- Behavioral: Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinking
- Registration Number
- NCT04821427
- Lead Sponsor
- Boston University Charles River Campus
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 24
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Brief mHealth Intervention + mobile messaging Brief 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
- Primary Outcome Measures
Name Time Method Modified Daily Drinking Questionnaire - Heavy Drinking Episodes Past 30 days Number of heavy drinking episodes NIAAA criteria (5+ drinks)
Sexual Behavior - Extended Survey - Condomless Anal Intercourse 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 Outcome Measures
Name Time Method Goal Systems Assessment Battery - Alcohol 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.
Goal Systems Assessment Battery - Condom Use 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.
Intervention Acceptability Ratings 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.
Client Satisfaction Questionnaire 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.
Trial Locations
- Locations (1)
Boston University
🇺🇸Boston, Massachusetts, United States