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

Primary Purpose

Human Immunodeficiency Virus Infection, Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AWARENESS for Sexual Minorities
Writing tasks
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AWARENESS for sexual minorities

Writing tasks

Arm Description

Group receives new CBT-based intervention

Group receives writing-based sessions

Outcomes

Primary Outcome Measures

Change in Gene expression
Gene expression related to inflammation measured in blood

Secondary Outcome Measures

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

Full Information

First Posted
May 2, 2017
Last Updated
April 2, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03143205
Brief Title
Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men
Official Title
Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 5, 2017 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
March 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus Infection, Inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AWARENESS for sexual minorities
Arm Type
Experimental
Arm Description
Group receives new CBT-based intervention
Arm Title
Writing tasks
Arm Type
Active Comparator
Arm Description
Group receives writing-based sessions
Intervention Type
Behavioral
Intervention Name(s)
AWARENESS for Sexual Minorities
Intervention Description
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
Intervention Name(s)
Writing tasks
Intervention Description
Writing sessions to explore daily activities.
Primary Outcome Measure Information:
Title
Change in Gene expression
Description
Gene expression related to inflammation measured in blood
Time Frame
Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up
Secondary Outcome Measure Information:
Title
Change in Substance Use
Description
Substance Use measured through Alcohol Smoking and Substance Involvement Screening Test (ASSIST)
Time Frame
Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participant must self-identify as male at the time of screening into the study
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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

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