Heavy Drinking and Sexual Risk BehaviorNCT03522948
Alcohol and Sex Risk Intervention for MSM Supplement
A study testing Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM in people with Heavy Drinking and Sexual Risk Behavior, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Open pilot trial to test the feasibility and efficacy of a brief intervention with text messaging to reduce sexual risk behavior and heavy drinking among 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 intervention with text messaging to reduce sexual risk and heavy drinking among MSM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Nov 2017to 17 May 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Non-monogamous bisexual/gay male with Kinsey score indicating mainly homosexual identification, heavy drinking, UAI in past 3 months.
- -
Who cannot join
- HIV+ Past or current tx for alcohol use (past 3 years), bipolar disorder or schizophrenia Current psychiatric treatment Medications contraindicated by alcohol Medical conditions contraindicated by alcohol Substance specific ASSIST scores of 27 or greater
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alcohol and Implicit Process in Sexual Risk Behavior in MSM- Supplement
Open pilot trial to test the feasibility and efficacy of a brief intervention with text messaging to reduce sexual risk behavior and heavy drinking among 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 among men who have sex with men. The study seeks to recruit MSM who are non-monogamous, have engaged in unprotected anal intercourse over the past 3 months, and 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. This intervention consists of a single brief in-person intervention coupled with 4 weeks of text messaging related to individualized goals about alcohol use and sexual behavior. Follow-up assessments are scheduled for within 1 week of completion of the text messaging component of the intervention. Primary outcomes are feasibility and acceptability of the intervention and message components. Secondary outcomes are changes in frequency of unprotected intercourse and heavy drinking episodes.
- Conditions
- Heavy Drinking and Sexual Risk Behavior
- Being tested
- Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM
- 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 intervention with text messaging to reduce sexual risk and heavy drinking among MSMBehavioural
Also called Intervention to reduce heavy drinking and sex risk among MSM
Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use
| Study group | Role | What they receive |
|---|---|---|
| Open pilot | Experimental | The intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men. Receives: Behavioral: Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Satisfaction Scale
3-item modification of Client Satisfaction Questionnaire. Three 5-point Likert scale is used to assess "intervention satisfaction" [very dissatisfied - very satisfied]; degree to which intervention helped alcohol use [no effect to helped a great deal], and intervention helped sexual behavior decisions [no effect - helped a great deal]. Mean scale range is 1-5. Higher scores reflect a better outcome
Measured: Participants complete the measure 5-6 weeks following baseline.
Secondary outcomes (2)
Frequency of Heavy Episodic Drinking Measure From the Alcohol Use Disorders Identification Test
This measure is a 5-point Likert scale item which asks participants to report "How often do you have six or more drinks on one occasion?" Response options range from "never" to "daily or almost daily." This measure is completed at baseline and 5 to 6 weeks after baseline. Higher scores reflect worse outcomes. Responses reflect current perceptions of past drinking. Range 0-4
Measured: Participants report frequency of heavy drinking episodes as part of the AUDIT-C questionnaire. The question is presented at baseline and at follow-up which occurs 5-6 weeks following baseline. There is no timeframe specified in the question itself.
Frequency of Condomless Anal Intercourse.
Single item measure of number of times that individual engaged in unprotected intercourse. Range is 0-30 for baseline (reflecting 0-90 range for past 3 months divided by 3) and range is 0-30 for follow-up. Higher scores reflect a worse outcome.
Measured: Frequency of condomless anal intercourse (CAI) over the past 3 months at baseline (divided by 3 for monthly CAI) and rate frequency of condomless anal intercourse over the past month at follow-up assessment that occurs 5-6 weeks following baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start7 Nov 2017
- Primary completion17 May 2018
- Study completion17 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Open pilot study to test feasibility of intervention
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Tibor Palfai, Boston University Charles River Campus
- Investigators
- Tibor Palfai, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522948
- Sponsor's protocol ID
- 3468
- Other IDs
- 3R01AA022301-02S1
- Status last verified
- Jan 2021
- First submitted
- 18 Apr 2018
- Last updated
- 11 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol and Implicit Process in Sexual Risk Behavior in MSM- Supplement
- ClinicalTrials.gov ID
- NCT03522948
- Acronym / sponsor ID
- 3468
- Conditions
- Heavy Drinking and Sexual Risk Behavior
- Keywords
- heavy drinking, sexual risk behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 7 Nov 2017 (actual)
- Primary completion
- 17 May 2018 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 14 May 2018 (actual)
- Results
- Posted 11 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open pilot trial to test the feasibility and efficacy of a brief intervention with text messaging to reduce sexual risk behavior and heavy drinking among 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 among men who have sex with men. The study seeks to recruit MSM who are non-monogamous, have engaged in unprotected anal intercourse over the past 3 months, and 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. This intervention consists of a single brief in-person intervention coupled with 4 weeks of text messaging related to individualized goals about alcohol use and sexual behavior. Follow-up assessments are scheduled for within 1 week of completion of the text messaging component of the intervention. Primary outcomes are feasibility and acceptability of the intervention and message components. Secondary outcomes are changes in frequency of unprotected intercourse and heavy drinking episodes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open pilot study to test feasibility of intervention
| Arm | Type | Receives |
|---|---|---|
| Open pilot | Experimental | Behavioral: Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSMThe intervention is a brief, in-person motivational intervention followed by 4 weeks of text messaging to reduce heavy episodic drinking and sexual risk behavior (unprotected anal intercourse) among men-who-have-sex-with-men. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Non-monogamous bisexual/gay male with Kinsey score indicating mainly homosexual identification, heavy drinking, UAI in past 3 months.
- -
Key exclusion criteria (2 listed)
- HIV+ Past or current tx for alcohol use (past 3 years), bipolar disorder or schizophrenia Current psychiatric treatment Medications contraindicated by alcohol Medical conditions contraindicated by alcohol Substance specific ASSIST scores of 27 or greater
- -
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 intervention with text messaging to reduce sexual risk and heavy drinking among MSMAlso: Intervention to reduce heavy drinking and sex risk among MSMCombines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use | Behavioural | Open pilot |
Primary outcome
Intervention Satisfaction Scale
Time frame: Participants complete the measure 5-6 weeks following baseline.
3-item modification of Client Satisfaction Questionnaire. Three 5-point Likert scale is used to assess "intervention satisfaction" [very dissatisfied - very satisfied]; degree to which intervention helped alcohol use [no effect to helped a great deal], and intervention helped sexual behavior decisions [no effect - helped a great deal]. Mean scale range is 1-5. Higher scores reflect a better outcome
2 secondary outcomes
Frequency of Heavy Episodic Drinking Measure From the Alcohol Use Disorders Identification Test
Time frame: Participants report frequency of heavy drinking episodes as part of the AUDIT-C questionnaire. The question is presented at baseline and at follow-up which occurs 5-6 weeks following baseline. There is no timeframe specified in the question itself.
Frequency of Condomless Anal Intercourse.
Time frame: Frequency of condomless anal intercourse (CAI) over the past 3 months at baseline (divided by 3 for monthly CAI) and rate frequency of condomless anal intercourse over the past month at follow-up assessment that occurs 5-6 weeks following baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Tibor Palfai, PhD 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 intervention with text messaging to reduce sexual risk and heavy drinking among MSM 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 2 inclusion and 2 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 11 Feb 2021. 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?
Yes. Results are posted in the registry (first posted 11 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intervention Satisfaction Scale (time frame: Participants complete the measure 5-6 weeks following baseline.). 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 11 Feb 2021.