NCT04821427

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

April 4, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

July 23, 2026

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

March 23, 2021

Last Update Submit

July 22, 2026

Conditions

Heavy Drinking and Sexual Risk Behavior

Keywords

heavy drinkingsexual risk behavior

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Goal Systems Assessment Battery - Alcohol

    Past 30 days

  • Goal Systems Assessment Battery - Condom Use

    Past 30 days

  • Client Satisfaction Questionnaire

    2 months post-baseline

  • Intervention Acceptability Ratings

    2 months post-baseline

Study Arms (2)

Brief mHealth Intervention + mobile messaging

EXPERIMENTAL

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

Assessment Only

NO INTERVENTION

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

Interventions

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

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

Brief mHealth Intervention + mobile messaging

Eligibility Criteria

Age21 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University

Boston, Massachusetts, 02215, United States

Location

Study Officials

  • Kathryn E Chavez, MA

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 29, 2021

Study Start

April 4, 2021

Primary Completion

September 15, 2021

Study Completion

September 15, 2021

Last Updated

July 23, 2026

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)