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

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.

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Key information

Conditions

Human Immunodeficiency Virus Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Inflammation Lentivirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AWARENESS for Sexual Minorities

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

Behavioral

Writing sessions to explore daily activities.

Primary outcomes

Change in Gene expression

Time frame: Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up

Gene expression related to inflammation measured in blood

Secondary outcomes

Change in Substance Use

Time frame: Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up

Substance Use measured through Alcohol Smoking and Substance Involvement Screening Test (ASSIST)

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start: 2017
Primary completion: 2018
Study completion: 2019
First posted: May 8, 2017
Registry last updated: Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed