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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03143205
• Other study ID #: K23DA039800
• Secondary ID: K23DA039800
• Status: Completed
• Phase: N/A
• Start date: May 5, 2017
• Est. completion date: March 8, 2019

Study information

• Verified date: April 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 8, 2019
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus Infection
• Inflammation

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.
• Writing tasks
Writing sessions to explore daily activities.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Gene expression	Gene expression related to inflammation measured in blood	Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up
Secondary	Change in Substance Use	Substance Use measured through Alcohol Smoking and Substance Involvement Screening Test (ASSIST)	Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up