Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anxiety
  • Depression
  • Human Immunodeficiency Virus
  • Sexually Transmitted Infections
  • Substance Use Disorders
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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

Participation Requirements

Age
Between 18 years and 25 years
Gender
Both males and females

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 follow...

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.

Tracking Information

NCT #
NCT03528135
Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Nathan G Smith, PhD University of Houston