CompletedNot Applicable

Alcohol and Sex Risk mHealth-Enhanced Brief Intervention for BLMSM

United States24 participantsStarted 2021-04-04

Plain-language 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.

Who can participate

Age range

21 Years – 50 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Modified Daily Drinking Questionnaire - Heavy Drinking Episodes

Timeframe: Past 30 days

Sexual Behavior - Extended Survey - Condomless Anal Intercourse

Timeframe: Past 30 days

Trial details

NCT IDNCT04821427

SponsorBoston University Charles River Campus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-15

View on ClinicalTrials.gov More Heavy Drinking and Sexual Risk Behavior trials