Human Immunodeficiency Virus InfectionNCT03143205
Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men
A study testing AWARENESS for Sexual Minorities and Writing tasks in people with Human Immunodeficiency Virus Infection and Inflammation, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Human Immunodeficiency Virus Infection, Inflammation
- What is being tested?
- AWARENESS for Sexual Minorities and Writing tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2017to 8 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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.
- Being tested
- AWARENESS for Sexual Minorities, Writing tasks
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AWARENESS for Sexual MinoritiesBehavioural
9 session, individually delivered, cognitive behavioral intervention focused on modifying sexual minority stress responses to reduce the impact of sexual minority stress experiences.
Writing tasksBehavioural
Writing sessions to explore daily activities.
| Study group | Role | What they receive |
|---|---|---|
| AWARENESS for sexual minorities | Experimental | Group receives new CBT-based intervention Receives: Behavioral: AWARENESS for Sexual Minorities |
| Writing tasks | Active comparator | Group receives writing-based sessions Receives: Behavioral: Writing tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gene expression
Gene expression related to inflammation measured in blood
Measured: Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up
Secondary outcomes (1)
Change in Substance Use
Substance Use measured through Alcohol Smoking and Substance Involvement Screening Test (ASSIST)
Measured: Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study start5 May 2017
- Primary completion1 Dec 2018
- Study completion8 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency Virus InfectionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143205
- Sponsor's protocol ID
- K23DA039800
- Other IDs
- K23DA039800
- Status last verified
- Apr 2024
- First submitted
- 2 May 2017
- Last updated
- 22 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39992775
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Outcomes in Interventions for Substance Using HIV+ Minority Men
- ClinicalTrials.gov ID
- NCT03143205
- Acronym / sponsor ID
- K23DA039800
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 May 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 8 Mar 2019 (actual)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AWARENESS for sexual minorities | Experimental | Behavioral: AWARENESS for Sexual MinoritiesGroup receives new CBT-based intervention |
| Writing tasks | Active comparator | Behavioral: Writing tasksGroup receives writing-based sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AWARENESS for Sexual Minorities9 session, individually delivered, cognitive behavioral intervention focused on modifying sexual minority stress responses to reduce the impact of sexual minority stress experiences. | Behavioural | AWARENESS for sexual minorities |
| Writing tasksWriting sessions to explore daily activities. | Behavioural | Writing tasks |
Primary outcome
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
1 secondary outcome
Change in Substance Use
Time frame: Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Derived from this study: PubMed 39992775Flentje 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AWARENESS for Sexual Minorities and Writing tasks in people with Human Immunodeficiency Virus Infection and Inflammation, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gene expression (time frame: Baseline, ~9 weeks (at conclusion of intervention), 4 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03143205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.