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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03143205
Other study ID # K23DA039800
Secondary ID K23DA039800
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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