NCT03528135

Project PRIDE (Promoting Resilience In Discriminatory Environments)

Completed NA Last updated 25 May 2022

What this trial tests

NA trial testing Project PRIDE in Human Immunodeficiency Virus in 17 participants. Completed in 30 April 2022.

Timeline

9 November 2018

Primary endpoint
30 November 2021

30 April 2022

Quick facts

Lead sponsor	University of Houston
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	17
Start date	9 November 2018
Primary completion	30 November 2021
Estimated completion	30 April 2022
Sites	1 location across United States

Drugs / interventions tested

• Project PRIDE

Conditions studied

• Human Immunodeficiency Virus — all drugs for Human Immunodeficiency Virus →
• Sexually Transmitted Infections — all drugs for Sexually Transmitted Infections →
• Anxiety — all drugs for Anxiety →
• Depression — all drugs for Depression →

Sponsor

University of Houston

Who can join

Adults 18 to 25, any sex, with Human Immunodeficiency Virus or Sexually Transmitted Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.