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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03143205
Enrollment
40
Registered
2017-05-08
Start date
2017-05-05
Completion date
2019-03-08
Last updated
2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human Immunodeficiency Virus Infection, Inflammation

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.

Interventions

BEHAVIORALAWARENESS 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.

BEHAVIORALWriting tasks

Writing sessions to explore daily activities.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Gene expressionBaseline, ~9 weeks (at conclusion of intervention), 4 month follow-upGene expression related to inflammation measured in blood

Secondary

MeasureTime frameDescription
Change in Substance UseBaseline, ~9 weeks (at conclusion of intervention), 4 month follow-upSubstance Use measured through Alcohol Smoking and Substance Involvement Screening Test (ASSIST)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026