Alcohol and Sex Risk mHealth-Enhanced Brief Intervention for BLMSM

NCT ID: NCT04821427

Last Updated: 2021-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-30

Study Completion Date

2021-07-31

Brief Summary

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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

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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.

Conditions

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Heavy Drinking and Sexual Risk Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Brief mHealth Intervention + mobile messaging

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

Group Type EXPERIMENTAL

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

Intervention Type BEHAVIORAL

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

Assessment Only

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Boston University Charles River Campus

OTHER

Sponsor Role lead

Responsible Party

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Kathryn Chavez

Clinical Psychology Doctoral Candidate, Department of Psychological and Brain Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kathryn E Chavez, MA

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston University

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathryn E Chavez, MA

Role: CONTACT

3237173311

Tibor P Palfai, PhD

Role: CONTACT

6173539345

Facility Contacts

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Tibor P Palfai, PhD

Role: primary

617-353-9345

Other Identifiers

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5479E

Identifier Type: -

Identifier Source: org_study_id

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