Clinical trial NCT03528135: Project PRIDE (Promoting Resilience In Discriminatory Environments)
Official title: Project PRIDE: Intervention to Reduce HIV Risk in Young Sexual Minority Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Sexually Transmitted Infections
Anxiety
Depression
Substance Use Disorders
Lead sponsor: University of Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-05-17
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in 60-Day Condomless Anal Sex in the Absence of PrEP from pre-test to 5 months
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Secondary outcomes:
measure: Salivary cortisol
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: 60-Day Drug Use
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: 60-Day Self-Reported Drug/Alcohol Use
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: Loneliness
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: Self Esteem
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: Coping
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: Racist Discrimination
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: Anti-Gay/Bisexual Discrimination
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: Gay/Bisexual Identity
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: Internalized Homonegativity
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: Anxiety
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: Depression
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: HIV
timeFrame: Pre-test, approximately 5 months after pre-test
measure: Gonorrhea
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: Chlamydia
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: Syphilis
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: 60-Day Vaginal Sex
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
measure: 60-Day Oral Sex
timeFrame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Other outcomes:
Locations:
city: Houston
country: United States
facility: Avenue 360, University of Houston
state: Texas
Study officials:
affiliation: University of Houston
name: Nathan G Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith NG, Hart TA, Kidwai A, Vernon JRG, Blais M, Adam B. Results of a Pilot Study to Ameliorate Psychological and Behavioral Outcomes of Minority Stress Among Young Gay and Bisexual Men. Behav Ther. 2017 Sep;48(5):664-677. doi: 10.1016/j.beth.2017.03.005. Epub 2017 Apr 4.
citation: Smith NG, Hart TA, Moody C, Willis AC, Andersen MA, Blais M, Adam B. Project PRIDE: A cognitive-behavioral group intervention to reduce HIV risk behaviors among HIV-negative young gay and bisexual men. Cognitive and Behavioral Practice 23:398-411, 2016.