Alcohol and Sex Risk mHealth-Enhanced Brief Intervention for BLMSM

Study Overview
=================
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.

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

Conditions
-----------------
Heavy Drinking and Sexual Risk Behavior

Intervention / Treatment
-----------------
* Behavioral: Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinking


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brief mHealth Intervention + mobile messaging<br>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<br>* 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<br>|
| No Intervention: Assessment Only<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heavy drinking, sexual risk behavior