Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men

Not Applicable

Completed

• Conditions: Inflammation; Human Immunodeficiency Virus Infection
• Interventions: Behavioral: Writing tasks; Behavioral: AWARENESS for Sexual Minorities

• Registration Number: NCT03143205
• Lead Sponsor: University of California, San Francisco

Brief Summary

This is a pilot study of a new 9-session individually delivered cognitive behavioral intervention targeting sexual minority stress. In this study, 40 HIV+ men sexual minority men will be recruited for the study then will be randomly assigned to either the new 9 session intervention or a writing task condition.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-03
• Study Start: 2017-05-05
• Study First Posted: 2017-05-08
• Primary Completion: 2018-12-01
• Study Completion: 2019-03-08
• Status Verified: 2024-04
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• Provide evidence or documentation of HIV positive status (e.g. a letter of diagnosis or medication bottles with matched photo ID)
• Be English speaking
• Be able to consent
• Sexual activity with a man in the 3 years prior to initial contact or identification as gay or bisexual
• Not currently be enrolled in formal substance abuse treatment
• Report at least one occasion of drinking 5 or more drinks or of using an illicit substance in the previous 3 months, but not meet criteria for a severe substance use disorder.

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Exclusion Criteria

• Presence of a severe substance use disorder
• Presence of current symptoms consistent with schizophrenia or bipolar disorder, which would indicate that an intervention targeting these symptoms would be more appropriate.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Writing tasks	Writing tasks	Group receives writing-based sessions
AWARENESS for sexual minorities	AWARENESS for Sexual Minorities	Group receives new CBT-based intervention

Primary Outcome Measures

Name	Time	Method
Change in Gene expression	Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up	Gene expression related to inflammation measured in blood

Secondary Outcome Measures

Name	Time	Method
Change in Substance Use	Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up	Substance Use measured through Alcohol Smoking and Substance Involvement Screening Test (ASSIST)

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States