Alcohol and Sex Risk mHealth-Enhanced Brief Intervention for BLMSM

Boston University Charles River Campus

Status: Unknown

Conditions: Heavy Drinking and Sexual Risk Behavior

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04821427

5479E

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Brief mHealth Intervention + mobile messaging

Experimental group

Description:

The intervention is a brief, motivational video-conferencing intervention followed by four weeks of app-based, interactive mobile messages

Treatment:

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

Assessment Only

No Intervention group

Description:

This is an assessment only condition. No intervention following completion of baseline surveys will be administered.