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

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.

Study Overview

• Status: Recruiting
• Conditions: Heavy Drinking and Sexual Risk Behavior
• Intervention / Treatment: Behavioral: Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinking

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.

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kathryn E Chavez, MA; Phone Number: 3237173311; Email: kathryn.eve.chavez@gmail.com
• Study Contact Backup: Name: Tibor P Palfai, PhD; Phone Number: 6173539345; Email: palfai@Bu.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Boston University
      • Contact: Tibor P Palfai, PhD; Phone Number: 617-353-9345; Email: palfai@bu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brief mHealth Intervention + mobile messaging; The intervention is a brief, motivational video-conferencing intervention followed by four weeks of app-based, interactive mobile messages	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
No Intervention: Assessment Only; This is an assessment only condition. No intervention following completion of baseline surveys will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Daily Drinking Questionnaire - Heavy Drinking Episodes	Number of heavy drinking episodes NIAAA criteria (5+ drinks)	Past 30 days
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Investigators: Principal Investigator: Kathryn E Chavez, MA, Boston University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 3, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: sexual risk behavior; heavy drinking
• Other Study ID Numbers: 5479E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: under discussion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No