Project PRIDE (Promoting Resilience In Discriminatory Environments)
Condition: Human Immunodeficiency Virus; Sexually Transmitted Infections; Anxiety; Depression; Substance Use Disorders
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Sexually Transmitted Diseases; Substance-Related Disorders
Study type: Interventional

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.
    

Detailed description: 
      Project PRIDE is a manualized group intervention consisting of 8 weekly sessions, each
      lasting 2.5 hours and consisting of approximately 10 men (estimated number given expected
      attrition). Each session will be co-led by two trained group facilitators. The intervention
      sessions will proceed as follows.

      Sessions 1 and 2 will consist of introductions, setting of ground rules, exploration of
      expectations and apprehensions, a broad exploration of participants' different gay/bisexual
      (GB) identities, and an introduction to the minority stress theory. Special attention will be
      paid to creating a safe space for all participants and the establishment of a non-judgmental,
      sex-positive atmosphere.

      Sessions 3 and 4 will consist of an introduction to the stress and coping model, application
      of the model via a group activity to facilitate understanding, and an exploration of
      GB-associated stressors in different areas of participants' lives (e.g., friendships,
      romantic and/or sexual relationships, school/work, family). Participants will be asked to set
      specific mental and behavioral (i.e., sexual and drug use) health goals using the SMART
      (specific, measurable, attainable, realistic, and time-bound) goal-setting model.

      Session 5 will consist of identifying links between sexual behavior, minority stress, and
      coping, with an emphasis on triggers for sexual risk behavior such as drug use.

      In Sessions 6 and 7 safer sexual practices and sexual communication skills will be addressed
      through group activities and psychoeducation, with an emphasis on harm reduction and
      normalization. Examples of activities include demonstration of proper condom application
      using a penis model, demonstration of opening an internal condom, and watching a video
      regarding the importance of using lubricant during anal sex. An example of sexual
      communication includes the explanation and demonstration of assertive communication, with an
      emphasis on assertive communication regarding one's sexual needs and boundaries. Participants
      will have opportunities for active engagement, such as role-plays to practice assertive
      communication.

      Session 8 will consist of a review of the topics covered in the group and participants'
      experiences in group, with emphasis on what participants learned and what topics participants
      thought they still needed to focus on. The group leaders will seek feedback regarding the
      areas of the intervention that were effective and ineffective. Finally, participants will be
      given a chance to say goodbye to the leaders and other members.

      At pre, post, and follow-up, participants will complete self-report questionnaires,
      containing a demographic questionnaire and the measures listed in section 9. Participants
      will complete all measures on a password-protected laptop computer. In addition, participants
      will complete urine drug tests and tests for HIV, chlamydia, gonorrhea, and syphilis.
      Finally, participants will collect their saliva at four time points at each assessment to
      assess for cortisol awakening response.
    

Intervention name(s): Project PRIDE
Intervention type(s): Behavioral
Intervention description(s): See arms section.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study includes a randomized controlled trial with one intervention condition and one wait-list control condition. All participants will complete the pre-test and be randomized to receive Project PRIDE immediately or to wait approximately 5 months before receiving it. Randomization will occur as follows: for each recruitment wave (n = 41 per wave), 41 sealed envelopes, each containing a card with the condition (14 cards labeled "wait-list" for the wait-list control group; 27 labeled "group to start shortly" for the intervention group), will be pinned to a foam board. Each participant will choose one card and open it. Those in the intervention group will be assigned to one of two groups of 13-14 participants. After completing the 8 sessions, those in the intervention and those in the matched control will complete the post-test. Approximately 3 months later, these participants will complete the follow-up; those in the control will then receive Project PRIDE.
Masking: None (Open Label)
Primary purpose: Prevention