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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: Completed NA study, sponsored by University of Houston.
NCT03528135 is a NA study that has completed, run by University of Houston. The registered enrollment target is 17 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Frequency of condomless anal sex in the absence of pre-exposure prophylaxis (i.e., use of Truvada to prevent HIV) will be assessed using the Timeline Followback method (Robinson, Sobell, Sobell, \& Leo, 2014), a calendar-based method for assessing the type and frequency of sexual contact and is sensitive to changes over time. This measure will be administered separately from the other measures, using an Excel document. Each participant will complete a 60-day Timeline Followback for sexual behavi
Interventions
- BEHAVIORAL Project PRIDE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2018-11-09 |
| Est. Completion | 2022-04-30 |
| Phase | NA |
What the finished NCT03528135 record still lists
NCT03528135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Project PRIDE is the first listed.
NCT03528135 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03528135's enrollment target sits among peer trials
17 1871st of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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