Alcohol; Harmful UseMI&TXT4MSMNCT03755661
MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM
A study testing MI&TXT4MSM in people with Alcohol; Harmful Use and Sex, Unsafe, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This is a small pilot study to provide effect size estimates for a brief intervention designed to reduce hazardous drinking and sexual risk behavior among men who have sex with men. 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
- Alcohol; Harmful Use, Sex, Unsafe
- What is being tested?
- MI&TXT4MSM
- 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
- 9 Oct 2018to 9 Mar 2020
- 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
- At least 1 heavy drinking episode or consumption of more than 14 drinks per week over the past month
- At least 1 condomless anal sex episode in past 3 months
- Score of 3 or greater on the Kinsey Scale (Kinsey et al., 1948) indicating at least "equally heterosexual and homosexual". Scale ranges from 0 (exclusively heterosexual) to 6 (exclusively homosexual)
Who cannot join
- Alcohol treatment currently or in past 3 years
- Bipolar disorder or schizophrenia treatment
- Exclusive monogamous relationship
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Department of Psychological and Brain Science
Boston, Massachusetts, 02215
About this study
Official title: Alcohol and Implicit Process in Sexual Risk Behavior in MSM Supplement
This is a small pilot study to provide effect size estimates for a brief intervention designed to reduce hazardous drinking and sexual risk behavior among men who have sex with men. The intervention consists of an "in-person" brief motivational intervention followed by a series of text messages related to alcohol and sexual risk reduction. The primary outcome is heavy drinking episodes and frequency of condomless anal intercourse at 3 months.
Read the detailed description
This is a pilot study designed to provide initial effect size estimates for an intervention addressing hazardous drinking and sexual risk behavior among men who have sex with men. In this study, 24 participants initially recruited through advertisements in the community will be randomly assigned to either Assessment Only or Intervention Condition. Those in the Assessment Only condition will complete baseline, 6-week, 3-month and 6-month assessments. Those in the intervention condition will receive a 50-min brief intervention in person followed by 6 weeks of tailored app-based messaging to support the intervention content, then another 6-weeks of goal setting text-based messages. Data will be analyzed to determine effect sizes of the intervention on key alcohol use and sex risk outcomes. The primary outcome will be 3-month outcomes, controlling for corresponding baseline outcomes.
- Conditions
- Alcohol; Harmful Use, Sex, Unsafe
- Being tested
- MI&TXT4MSM
- Medical subject headings
- Unsafe Sex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MI&TXT4MSMBehavioural
brief in-person intervention followed by text messaging
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This intervention arm is a combined in-person text messaging intervention Receives: Behavioral: MI&TXT4MSM |
| Assessment Only Control | No intervention | The is the assessment only comparison condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)
Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion [no scale]. Higher score is a worse outcome, range 0-30
Measured: 30 days
Number of Condomless Anal Intercourse Episodes (CAI) From the Sexual Behaviors Survey (Gordon et al., 2007) is Used to Measure Sexual Risk [Main Time Point at 3 Month Follow-up]
Frequency of CAI in past 90 days. This is an open ended question where the Participant report the frequency of condomless anal intercourse episodes over a period of 90 days [no scale] Range from 0-90
Measured: 90 days
Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month
Average quantity of alcohol use per week in the past 30 days. Participants complete a seven day calendar which reflects the typical number of standard drinks that they have consumed for each day of the week over the past 30 days. The number of drinks can range from 0 to an unlimited high number. A higher number of drinks listed in the week is reflective of a worse outcome
Measured: 30 days
Secondary outcomes (1)
Young Adult Alcohol Consequences Questionnaire [Alcohol]
Number of alcohol-related consequences in the past month. This is the 48-item Yes/No version of the YAACQ. The range for the score is 0-48. Higher score is a worse outcome
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start9 Oct 2018
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
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 Alcohol; Harmful UseStudies 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
- Model description
- Participants are randomly assigned to one of two groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755661
- Sponsor's protocol ID
- 3468a
- Other IDs
- 3R01AA022301-02S1
- Acronym
- MI&TXT4MSM
- Status last verified
- Mar 2021
- First submitted
- 26 Nov 2018
- Last updated
- 6 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared following release within one year of the trial end to investigators who make specific requests in writing regarding analysis plans. Plans will be reviewed with co-investigators to ensure that there is no overlap with planned analyses. Specific de-identified data set will be provided to other researchers after this review
Study at a glance
From the registry record, last updated by the sponsor on 6 May 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
- NCT03755661
- Acronym / sponsor ID
- MI&TXT4MSM / 3468a
- Conditions
- Alcohol; Harmful Use, Sex, Unsafe
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Posted 6 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a small pilot study to provide effect size estimates for a brief intervention designed to reduce hazardous drinking and sexual risk behavior among men who have sex with men. The intervention consists of an "in-person" brief motivational intervention followed by a series of text messages related to alcohol and sexual risk reduction. The primary outcome is heavy drinking episodes and frequency of condomless anal intercourse at 3 months.
Detailed description
This is a pilot study designed to provide initial effect size estimates for an intervention addressing hazardous drinking and sexual risk behavior among men who have sex with men. In this study, 24 participants initially recruited through advertisements in the community will be randomly assigned to either Assessment Only or Intervention Condition. Those in the Assessment Only condition will complete baseline, 6-week, 3-month and 6-month assessments. Those in the intervention condition will receive a 50-min brief intervention in person followed by 6 weeks of tailored app-based messaging to support the intervention content, then another 6-weeks of goal setting text-based messages. Data will be analyzed to determine effect sizes of the intervention on key alcohol use and sex risk outcomes. The primary outcome will be 3-month outcomes, controlling for corresponding baseline outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two groups
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MI&TXT4MSMThis intervention arm is a combined in-person text messaging intervention |
| Assessment Only Control | No intervention | –The is the assessment only comparison condition |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- At least 1 heavy drinking episode or consumption of more than 14 drinks per week over the past month
- At least 1 condomless anal sex episode in past 3 months
- Score of 3 or greater on the Kinsey Scale (Kinsey et al., 1948) indicating at least "equally heterosexual and homosexual". Scale ranges from 0 (exclusively heterosexual) to 6 (exclusively homosexual)
Key exclusion criteria (3 listed)
- Alcohol treatment currently or in past 3 years
- Bipolar disorder or schizophrenia treatment
- Exclusive monogamous relationship
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 |
|---|---|---|
| MI&TXT4MSMbrief in-person intervention followed by text messaging | Behavioural | Intervention |
Primary outcome
Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion)
Time frame: 30 days
Number of heavy drinking episodes in the past 30 days. This question is an open ended question that asks the participant to report the number of times in the past 30 days that he has consumed 5 or more drinks on a single occasion [no scale]. Higher score is a worse outcome, range 0-30
Number of Condomless Anal Intercourse Episodes (CAI) From the Sexual Behaviors Survey (Gordon et al., 2007) is Used to Measure Sexual Risk [Main Time Point at 3 Month Follow-up]
Time frame: 90 days
Frequency of CAI in past 90 days. This is an open ended question where the Participant report the frequency of condomless anal intercourse episodes over a period of 90 days [no scale] Range from 0-90
Modified Daily Drinking Questionnaire- Typical Number of Standard Drinks Per Week Over the Past Month
Time frame: 30 days
Average quantity of alcohol use per week in the past 30 days. Participants complete a seven day calendar which reflects the typical number of standard drinks that they have consumed for each day of the week over the past 30 days. The number of drinks can range from 0 to an unlimited high number. A higher number of drinks listed in the week is reflective of a worse outcome
1 secondary outcome
Young Adult Alcohol Consequences Questionnaire [Alcohol]
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be shared following release within one year of the trial end to investigators who make specific requests in writing regarding analysis plans. Plans will be reviewed with co-investigators to ensure that there is no overlap with planned analyses. Specific de-identified data set will be provided to other researchers after this review
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MI&TXT4MSM in people with Alcohol; Harmful Use and Sex, Unsafe, 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 3 inclusion and 3 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 6 May 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 6 May 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?
Number of Heavy Drinking Episodes NIAAA Criteria (5 or More Drinks on a Single Occasion) (time frame: 30 days). The study lists 3 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 6 May 2021.