Project PRIDE (Promoting Resilience In Discriminatory Environments)

Completed · Not applicable

Conditions studied: Human Immunodeficiency Virus, Sexually Transmitted Infections, Anxiety, Depression, Substance Use Disorders

In brief

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.

Key facts

Study ID

NCT03528135

Run by

University of Houston

People needed

17

Starts

2018-11-09

Expected to finish

2022-04-30

Last updated by the study team

2022-05-25

Who can join

Age: 18 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Self-identification as male
• Self-identification as gay, bisexual, queer, or some other non-heterosexual identity
• Aged 18-25
• HIV-negative as assessed via OraQuick
• Self-report of at least one instance of condomless anal or vaginal sex (insertive or receptive) while not taking Truvada for pre-exposure prophylaxis (PrEP) in the past 60 days
• Self-report of drug use in the past 60 days
• Willingness to complete HIV/STI test, drug test, questionnaires, and randomization
• Willingness to collect and return saliva
• Ability and willingness to stop prescription medication on the day of saliva collection
• Proficient in English

You may not qualify if…

• Failure to meet any inclusion criterion will result in exclusion from the study

Where it is running

• Avenue 360, University of Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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