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NCT03528135 · ClinicalTrials.gov registry record · NA
Project PRIDE (Promoting Resilience In Discriminatory Environments)
A NA study, sponsored by University of Houston.
- Completed
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT03528135 is a NA study that has completed, run by University of Houston. The registered enrollment target is 17 participants.
The verdict
NCT03528135, a NA study, has completed, sponsored by University of Houston.
- COMPLETED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
The specific aims are to: 1. Pilot test a randomized controlled trial of Project PRIDE for feasibility for subsequent research projects. A sample of 123 men aged 18-25 who identify as gay, bisexual, queer, or some other non-heterosexual identity, who are HIV negative, who report at least once instance of condomless anal sex in the absence of PrEP in the past 60 days, and who report drug use at least once in the past 60 days will be recruited and randomized to one of two conditions: 1. Project PRIDE: an eight-session primary HIV-prevention intervention; or 2. Wait-list control condition: after approximately 5 months, participants will receive Project PRIDE. 2. Test the feasibility of obtaining biological measures of stress, drug use, and HIV/sexually transmitted infection (STI) status. To examine the impact of the intervention on stress physiology, participants will provide saliva samples that will be used to assess diurnal stress (i.e., cortisol) at pre-test, post-test, and 3-month follow-up. To substantiate self-report measures, participants will provide urine samples that will be used to assess drug use. Participants will be tested for gonorrhea, and chlamydia at each time point by providing a separate urine sample, HIV via oral swab and for syphilis by providing a blood sample. 3. It is hypothesized that, compared to the wait-list control group, those in the treatment group will report significant reductions in mental health problems (depression, anxiety. loneliness), minority stressors (internalized homonegativity, sexual orientation concealment), substance use (drug and alcohol), condomless anal sex, number of sex partners, and stress-related biomarkers (salivary cortisol). In addition, compared to the wait-list control group, those in the treatment group will report significant improvements in self-esteem.
Interventions
- BEHAVIORAL Project PRIDE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-11-09 |
| Est. Completion | 2022-04-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03528135
The ClinicalTrials.gov registry entry for NCT03528135 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Houston, which has 64 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Project PRIDE is the first listed.
NCT03528135 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03528135 about?
NCT03528135 is a clinical study titled "Project PRIDE (Promoting Resilience In Discriminatory Environments)". The specific aims are to: 1. Pilot test a randomized controlled trial of Project PRIDE for feasibility for subsequent research projects. A sample of 123 men aged 18-25 who identify as gay, bisexual, queer, or some other non-heterosexual identity, who are HIV negative, who report at least once insta...
What is the current status of trial NCT03528135?
This trial is currently completed. It is a NA study. The enrollment target is 17 participants. The study started on 2018-11-09. Estimated completion is 2022-04-30.
What interventions are being tested in trial NCT03528135?
The interventions under investigation include: Project PRIDE (BEHAVIORAL).
Who is sponsoring clinical trial NCT03528135?
This trial is sponsored by University of Houston, which has 64 total clinical trials registered on ClinicalTrials.gov.
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