Project PRIDE (Promoting Resilience In Discriminatory Environments)

May 23, 2022 updated by: Nathan G. Smith, University of Houston

Project PRIDE: Intervention to Reduce HIV Risk in Young Sexual Minority Men

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77204
        • Avenue 360, University of Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 21 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Project PRIDE
See arms section.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in 60-Day Condomless Anal Sex in the Absence of PrEP from pre-test to 5 months
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Frequency of condomless anal sex in the absence of pre-exposure prophylaxis (i.e., use of Truvada to prevent HIV) will be assessed using the Timeline Followback method (Robinson, Sobell, Sobell, & Leo, 2014), a calendar-based method for assessing the type and frequency of sexual contact and is sensitive to changes over time. This measure will be administered separately from the other measures, using an Excel document. Each participant will complete a 60-day Timeline Followback for sexual behaviors.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Salivary cortisol
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Salivary cortisol will be completed by all participants who will be provided with kits and detailed oral and written instructions for proper saliva collection to measure diurnal cortisol. Participants will collect their saliva at pre, post, and follow-up. Participants will collect saliva (1) upon awakening, (2) 30 minutes after awakening and prior to brushing teeth, (3) 90 minutes after awakening, and (4) before going to bed and note collection times in writing. Samples 1-3 are required as an assessment of the cortisol awaking response (CAR). Sample 4 represents a potential lower-limit because hormone levels are typically down-regulated to a low-point prior to going to sleep. Participants will be instructed to avoid eating, drinking beverages other than water, smoking, or chewing gum 30 minutes before saliva collection.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
60-Day Drug Use
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
All HIV-negative participants will provide a urine sample for toxicology, using the RapidCheck 9 Multi-Drug Test Panel to validate self-reports and assess drugs used. The RapidCheck 9 Multi-Drug Test Panel is a rapid, one-step diagnostic test that screens for nine targeted illicit and prescription drugs and their metabolites at the minimum cutoff sensitivity levels established by the National Institute on Drug Abuse. The nine targeted drugs are tetrahydrocannabinol (THC), Cocaine, phencyclidine (PCP), Opiates, Methamphetamine including Ecstasy, Methadone, Amphetamines, Barbiturates, and Benzodiazepines. Urine samples will be collected at Avenue 360. Study personnel will complete the testing of urine using the RapidCheck 9 Multi-Drug Test Panel at Avenue 360. The results of the RapidCheck 9 will be entered into an online survey hosted by Qualtrics with the participant's study identification (ID) number. Urine will be discarded after testing and will not leave Avenue 360.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
60-Day Self-Reported Drug/Alcohol Use
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Self-reported drug/alcohol use will be assessed using the Timeline Followback method (Robinson, Sobell, Sobell, & Leo, 2014), a calendar-based method for assessing drug and alcohol use frequency and amount that is sensitive to changes in use. This measure will be administered separately from the other measures, using an Excel document. Each participant will complete a 60-day Timeline Followback for alcohol use, cocaine/crack, and methamphetamines. Each Excel document will be saved on the password-protected University of Houston laptop and identified by the participant study ID.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Loneliness
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Loneliness will be measured using the UCLA Loneliness Scale (Russell, 1996), a 20-item scale that measures experiences of loneliness. Cronbach alphas ranged from .89 to .94.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Self Esteem
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Self esteem will be measured by the Rosenberg Self-esteem Scale (Rosenberg, 1965), a 10-item scale that measures feelings of self worth. Cronbach alpha was .87.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Coping
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Coping will be measured using the Ways of Coping Questionnaire (WOC) (S. Folkman & Lazarus, 1988), a 66-item measure that assesses the degree to which participants use certain coping strategies to deal with a stressor. Cronbach alphas ranged from .61 to .79.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Racist Discrimination
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Racist discrimination will be measured among ethnic/racial minority participants only using the Racial Microaggressions Scale (Torres-Harding, Andrade Jr, & Romero Diaz, 2012), a 32-item measure of racist invalidations. Cronbach alpha ranged from .78 to .89.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Anti-Gay/Bisexual Discrimination
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Anti-GB discrimination will be measured by the Heterosexist Harassment, Rejection, and Discrimination Scale (Szymanski, 2006), a 14-item scale that measures experiences of sexual orientation-based discrimination. Cronbach alphas ranged from .74 to .89.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Gay/Bisexual Identity
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Gay/bisexual identity will be measured by the Lesbian, Gay, and Bisexual Identity Scale (Mohr & Kendra, 2011), a 27-item scale that measures facets of gay and bisexual identity. Cronbach's alpha ranged from .76 to .89
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Internalized Homonegativity
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Internalized homonegativity will be measured by the Nungesser Homosexuality Attitudes Inventory-Revised (Nungesser, 1983), a 36-item scale measuring negative attitudes towards one's own homosexuality. Cronbach alpha was .94.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Anxiety
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Anxiety will be measured using the state version of the State-Trait Inventory for Cognitive and Somatic Anxiety (Grös, Antony, Simms, & McCabe, 2007), a 21-item scale measuring cognitive and somatic symptoms of anxiety. Cronbach alpha was .92.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Depression
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Depression will be measured using the Center for Epidemiologic Studies Depression Scale (Radloff, 1977), a 20-item scale measuring depressive symptoms. Cronbach alphas ranged from .84 to .90.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
HIV
Time Frame: Pre-test, approximately 5 months after pre-test
All participants will be screened for HIV (rapid OraQuick test) with pre- and post-test counseling. Pre-test counseling will include a description of the test and meaning of test results, discussion of possible responses to positive results, the possible consequences of disclosing HIV information, and legal protections against unauthorized disclosure. Post-test counseling will include the results and discussion of their meaning, referrals for treatment if indicated, and a review of risk-reduction strategies. The pre- and post-test counseling protocol will follow the State of Texas Health Department protocols and will be in adherence with Texas laws governing HIV testing and confidentiality. HIV/STI testing and pre- and post-test counseling will be administered by trained staff at Avenue 360. In addition to referral to treatment, those testing positive for HIV will be excluded from the study.
Pre-test, approximately 5 months after pre-test
Gonorrhea
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
All participants will be tested for gonorrhea (via urine test) with pre- and post-test counseling. Pre-test counseling will include a description of the tests and meaning of test results, discussion of possible responses to positive results, the possible consequences of disclosing STI information, and legal protections against unauthorized disclosure. Post-test counseling will include the results and discussion of their meaning, referrals for treatment if indicated, and a review of risk-reduction strategies. The pre- and post-test counseling protocol will follow the State of Texas Health Department protocols and will be in adherence with Texas laws governing STI testing and confidentiality. STI testing and pre- and post-test counseling will be administered by trained staff at Avenue 360.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Chlamydia
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
All participants will be tested for chlamydia (via urine test) with pre- and post-test counseling. Pre-test counseling will include a description of the tests and meaning of test results, discussion of possible responses to positive results, the possible consequences of disclosing STI information, and legal protections against unauthorized disclosure. Post-test counseling will include the results and discussion of their meaning, referrals for treatment if indicated, and a review of risk-reduction strategies. The pre- and post-test counseling protocol will follow the State of Texas Health Department protocols and will be in adherence with Texas laws governing STI testing and confidentiality. STI testing and pre- and post-test counseling will be administered by trained staff at Avenue 360.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Syphilis
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
All participants will be tested for syphilis (via blood test) with pre- and post-test counseling. Pre-test counseling will include a description of the tests and meaning of test results, discussion of possible responses to positive results, the possible consequences of disclosing STI information, and legal protections against unauthorized disclosure. Post-test counseling will include the results and discussion of their meaning, referrals for treatment if indicated, and a review of risk-reduction strategies. The pre- and post-test counseling protocol will follow the State of Texas Health Department protocols and will be in adherence with Texas laws governing STI testing and confidentiality. STI testing and pre- and post-test counseling will be administered by trained staff at Avenue 360.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
60-Day Vaginal Sex
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Vaginal sex frequency will be assessed using the Timeline Followback method (Robinson, Sobell, Sobell, & Leo, 2014), a calendar-based method for assessing the type and frequency of sexual contact and is sensitive to changes over time. This measure will be administered separately from the other measures, using an Excel document. Each participant will complete a 60-day Timeline Followback for sexual behaviors.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
60-Day Oral Sex
Time Frame: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Oral sex frequency will be assessed using the Timeline Followback method (Robinson, Sobell, Sobell, & Leo, 2014), a calendar-based method for assessing the type and frequency of sexual contact and is sensitive to changes over time. This measure will be administered separately from the other measures, using an Excel document. Each participant will complete a 60-day Timeline Followback for sexual behaviors.
Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Houston

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nathan G Smith, PhD, University of Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 111889
  • 1R21DA041250-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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