Heavy Drinking and Sexual Risk BehaviorNCT04821427
Alcohol and Sex Risk mHealth-Enhanced Brief Intervention for BLMSM
A study testing Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinking in people with Heavy Drinking and Sexual Risk Behavior, run by Boston University Charles River Campus at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heavy Drinking and Sexual Risk Behavior
- What is being tested?
- Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2021to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Brief Michigan Alcoholism Screening Test score >5
- Lifetime diagnosis of substance use disorder
- ASSIST score of >/=27 for any individual substance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Heavy Drinking and Sexual Risk Behavior
- Being tested
- Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinking
- Keywords
- heavy drinking, sexual risk behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinkingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Daily Drinking Questionnaire - Heavy Drinking Episodes
Number of heavy drinking episodes NIAAA criteria (5+ drinks)
Measured: 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.
Measured: Past 30 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start4 Apr 2021
- Primary completion15 Sep 2021
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heavy Drinking and Sexual Risk BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kathryn E Chavez, MA, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821427
- Sponsor's protocol ID
- 5479E
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2021
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an mHealth + Brief Intervention for Heavy Drinking African American and Latino MSM: A Pilot Study
- ClinicalTrials.gov ID
- NCT04821427
- Acronym / sponsor ID
- 5479E
- Conditions
- Heavy Drinking and Sexual Risk Behavior
- Keywords
- heavy drinking, sexual risk behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 4 Apr 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief mHealth Intervention + mobile messaging | Experimental | Behavioral: Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinkingThe intervention is a brief, motivational video-conferencing intervention followed by four weeks of app-based, interactive mobile messages |
| Assessment Only | No intervention | –This is an assessment only condition. No intervention following completion of baseline surveys will be administered. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- HIV+
- Currently on PrEP
- Monogamous/exclusive relationship
- Past or current treatment for alcohol (past 3 years)
- Current or past psychiatric treatment (past 3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinkingThe 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 | Behavioural | Brief mHealth Intervention + mobile messaging |
Primary outcome
Modified Daily Drinking Questionnaire - Heavy Drinking Episodes
Time frame: Past 30 days
Number of heavy drinking episodes NIAAA criteria (5+ drinks)
Sexual Behavior - Extended Survey - Condomless Anal Intercourse
Time frame: Past 30 days
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.
4 secondary outcomes
Goal Systems Assessment Battery - Alcohol
Time frame: Past 30 days
Goal Systems Assessment Battery - Condom Use
Time frame: Past 30 days
Client Satisfaction Questionnaire
Time frame: 2 months post-baseline
Intervention Acceptability Ratings
Time frame: 2 months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn E Chavez, MA principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinking in people with Heavy Drinking and Sexual Risk Behavior, run by Boston University Charles River Campus at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Daily Drinking Questionnaire - Heavy Drinking Episodes (time frame: Past 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.