Project PRIDE (Promoting Resilience In Discriminatory Environments)

NCT ID: NCT03528135

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-09
• Study Completion Date: 2022-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Project PRIDE

Those in the Project PRIDE condition will receive 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 are described in the "Detailed Description" section. The will complete a pre-test, post-test, and follow-up assessment.

Group Type: EXPERIMENTAL

Project PRIDE

Intervention Type: BEHAVIORAL

See arms section.

Wait-list

Those in the wait-list arm will wait approximately 5 months before receiving the intervention. They will complete the same pre-test, post-test, and follow-up assessments as those in the PRIDE arm. After they have completed the follow-up assessment, they will be offered the intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Project PRIDE

See arms section.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Houston

OTHER

Sponsor Role: lead

Responsible Party

Nathan G. Smith

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathan G Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

Avenue 360, University of Houston

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28711116 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

1R21DA041250-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

111889

Identifier Type: -

Identifier Source: org_study_id