Alcohol and Sex Risk mHealth-Enhanced Brief Intervention for BLMSM

Heavy Drinking and Sexual Risk Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04821427
• Other study ID #: 5479E
• Status: Recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: July 2021

Study information

• Verified date: April 2021
• Source: Boston University Charles River Campus
• Contact: Kathryn E Chavez, MA
• Phone: 3237173311
• Email: kathryn.eve.chavez[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Heavy Drinking and Sexual Risk Behavior

Intervention

Behavioral:
• 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 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

Locations

Country	Name	City	State
United States	Boston University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston University Charles River Campus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Daily Drinking Questionnaire - Heavy Drinking Episodes	Number of heavy drinking episodes NIAAA criteria (5+ drinks)	Past 30 days
Primary	Sexual Behavior - Extended Survey - Condomless Anal Intercourse	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.	Past 30 days
Secondary	Goal Systems Assessment Battery - Alcohol	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.	Past 30 days
Secondary	Goal Systems Assessment Battery - Condom Use	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.	Past 30 days
Secondary	Client Satisfaction Questionnaire	8-item Client Satisfaction Questionnaire answered on a 4-point scale. Mean scale score is 1-4. Higher scores reflect a better outcome.	2 months post-baseline
Secondary	Intervention Acceptability Ratings	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.	2 months post-baseline