Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2025-12-27 @ 9:29 PM
Study NCT ID:
NCT03755661
Status:
COMPLETED
Last Update Posted:
2021-05-06
First Post:
2018-11-26
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
MI With Text Messaging to Reduce Sexual Risk and Hazardous Drinking Among MSM
Sponsor:
Boston University Charles River Campus
Organization:
Study Overview
Official Title:
Alcohol and Implicit Process in Sexual Risk Behavior in MSM Supplement
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MI&TXT4MSM
Brief 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. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 3R01AA022301-02S1 | NIH | None | https://reporter.nih.gov/quic… | View |