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

NCT ID: NCT03143205

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-05

Study Completion Date

2019-03-08

Brief Summary

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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

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Conditions

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Human Immunodeficiency Virus Infection Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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AWARENESS for sexual minorities

Group receives new CBT-based intervention

Group Type EXPERIMENTAL

AWARENESS for Sexual Minorities

Intervention Type BEHAVIORAL

9 session, individually delivered, cognitive behavioral intervention focused on modifying sexual minority stress responses to reduce the impact of sexual minority stress experiences.

Writing tasks

Group receives writing-based sessions

Group Type ACTIVE_COMPARATOR

Writing tasks

Intervention Type BEHAVIORAL

Writing sessions to explore daily activities.

Interventions

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AWARENESS for Sexual Minorities

9 session, individually delivered, cognitive behavioral intervention focused on modifying sexual minority stress responses to reduce the impact of sexual minority stress experiences.

Intervention Type BEHAVIORAL

Writing tasks

Writing sessions to explore daily activities.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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Flentje A, Sunder G, Carrico AW, Asam K, Neilands TB, Lisha NE, Dilley J, Flowers E, Kober K, Aouizerat B. Differential gene expression in response to AWARENESS: A randomized controlled trial of an intersectional minority stress intervention. Health Psychol. 2025 Mar;44(3):291-296. doi: 10.1037/hea0001451.

Reference Type DERIVED
PMID: 39992775 (View on PubMed)

Other Identifiers

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K23DA039800

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23DA039800

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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