NCT03143205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

May 5, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2019

Completed
Last Updated

October 22, 2024

Status Verified

April 1, 2024

Enrollment Period

1.6 years

First QC Date

May 2, 2017

Last Update Submit

October 18, 2024

Conditions

Human Immunodeficiency Virus InfectionInflammation

Outcome Measures

Primary Outcomes (1)

  • Change in Gene expression

    Gene expression related to inflammation measured in blood

    Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up

Secondary Outcomes (1)

  • Change in Substance Use

    Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up

Study Arms (2)

AWARENESS for sexual minorities

EXPERIMENTAL

Group receives new CBT-based intervention

Behavioral: AWARENESS for Sexual Minorities

Writing tasks

ACTIVE COMPARATOR

Group receives writing-based sessions

Behavioral: Writing tasks

Interventions

AWARENESS for Sexual MinoritiesBEHAVIORAL

9 session, individually delivered, cognitive behavioral intervention focused on modifying sexual minority stress responses to reduce the impact of sexual minority stress experiences.

AWARENESS for sexual minorities
Writing tasksBEHAVIORAL

Writing sessions to explore daily activities.

Writing tasks

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsParticipant must self-identify as male at the time of screening into the study
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

  • Flentje A, Sunder G, Carrico AW, Asam K, Neilands TB, Lisha NE, Dilley J, Flowers E, Kober K, Aouizerat B. Differential gene expression in response to AWARENESS: A randomized controlled trial of an intersectional minority stress intervention. Health Psychol. 2025 Mar;44(3):291-296. doi: 10.1037/hea0001451.

    PMID: 39992775DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeInflammation

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2017

First Posted

May 8, 2017

Study Start

May 5, 2017

Primary Completion

December 1, 2018

Study Completion

March 8, 2019

Last Updated

October 22, 2024

Record last verified: 2024-04

Locations

US(1)