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Mdma Clinical Trials

Project PRIDE: Intervention to Reduce HIV Risk in Young Sexual Minority Men

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Id: NCT03528135

Organisation Name: University of Houston

Overal Status: Completed

Start Date: November 9, 2018

Last Update: May 25, 2022

Lead Sponsor: University of Houston

Brief Summary: The specific aims are to:

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:

Project PRIDE: an eight-session primary HIV-prevention intervention; or
Wait-list control condition: after approximately 5 months, participants will receive Project PRIDE.
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.
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.

  • Human Immunodeficiency Virus
  • Sexually Transmitted Infections
  • Anxiety
  • Depression
  • Substance Use Disorders

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