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

April 11, 2024 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AWARENESS for sexual minorities
Group receives new CBT-based intervention
Behavioral: 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.
Active Comparator: Writing tasks
Group receives writing-based sessions
Behavioral: Writing tasks
Writing sessions to explore daily activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2017

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

March 8, 2019

Study Registration Dates

First Submitted

May 2, 2017

First Submitted That Met QC Criteria

May 3, 2017

First Posted (Actual)

May 8, 2017

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23DA039800 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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