Alcohol and Sex Risk Intervention for MSM Supplement
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|ClinicalTrials.gov Identifier: NCT03522948|
Recruitment Status : Completed
First Posted : May 14, 2018
Last Update Posted : January 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heavy Drinking and Sexual Risk Behavior||Behavioral: Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open pilot study to test feasibility of intervention|
|Masking:||None (Open Label)|
|Official Title:||Alcohol and Implicit Process in Sexual Risk Behavior in MSM- Supplement|
|Actual Study Start Date :||November 7, 2017|
|Actual Primary Completion Date :||May 17, 2018|
|Actual Study Completion Date :||May 17, 2018|
Experimental: Open pilot
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.
Behavioral: Brief intervention with text messaging to reduce sexual risk and heavy drinking 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
Other Name: Intervention to reduce heavy drinking and sex risk among MSM
- 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
- 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 follow-up which occurs 5-6 weeks following baseline. There is no timeframe specified in the question itself. ]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
- Frequency of unprotected anal intercourse. [ Time Frame: Participants rate frequency of unprotected anal intercourse over the past 3 months at baseline and rate frequency of unprotected anal intercourse over the past month at follow-up assessment that occurs 5-6 weeks following baseline. ]Single item measure of number of times that individual engaged in unprotected intercourse. Range is 0-90 for baseline and range is 0-30 for follow-up. Higher scores reflect a worse outcome.
- Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for behavior goal of "Using condoms every time you have sex with a partner of unknown HIV status". [ Time Frame: This measure was taken at baseline and at follow-up. There is no specific timeframe indicated on the questions as the measure indicates current goal cognitions. The measure is completed at baseline and 5 to 6 weeks following baseline. ]This GSAB battery consists of 4 subscales comprised of 4 Likert scale items each ranging from 0-4. The subscales indicate value, self-efficacy, planning, and monitoring related to the behavior change goal. The mean subscale range is from 0-4. Higher scores reflect better self-regulatory outcomes
- Goal Systems Assessment Battery (Karoly & Ruehlman, 1995) for behavior goal of "Reducing alcohol use". [ Time Frame: This measure was taken at baseline and at follow-up. There is no specific timeframe indicated in the measure as it is used to indicate current goal cognitions. The measure is completed at baseline and 5 to 6 weeks following baseline. ]This GSAB battery consists of 4 subscales comprised of 4 Likert scale items each ranging from 0-4. The subscales indicate value, self-efficacy, planning, and monitoring related to the behavior change goal. The mean subscale range is from 0-4. Higher scores reflect better self-regulatory outcomes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522948
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Tibor Palfai, PhD||Boston University|