Human Immunodeficiency VirusNCT03528135
Project PRIDE (Promoting Resilience In Discriminatory Environments)
A study testing Project PRIDE in people with Human Immunodeficiency Virus and Sexually Transmitted Infections, run by University of Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, Sexually Transmitted Infections, Anxiety
- What is being tested?
- Project PRIDE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Failure to meet any inclusion criterion will result in exclusion from the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Avenue 360, University of Houston
Houston, Texas, 77204
About this study
Official title: Project PRIDE: Intervention to Reduce HIV Risk in Young Sexual Minority Men
The specific aims are to:
- 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:
- Project PRIDE: an eight-session primary HIV-prevention intervention; or
- Wait-list control condition: after approximately 5 months, participants will receive Project PRIDE.
- 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.
- 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.
Read the 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
- Being tested
- Project PRIDE
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Anxiety Disorders, Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project PRIDEBehavioural
See arms section.
| Study group | Role | What they receive |
|---|---|---|
| Project PRIDE | Experimental | 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. Receives: Behavioral: Project PRIDE |
| Wait-list | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in 60-Day Condomless Anal Sex in the Absence of PrEP from pre-test to 5 months
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Secondary outcomes (18)
Salivary cortisol
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
60-Day Drug Use
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
60-Day Self-Reported Drug/Alcohol Use
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Loneliness
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Self Esteem
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Coping
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Racist Discrimination
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Anti-Gay/Bisexual Discrimination
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Gay/Bisexual Identity
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
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Internalized Homonegativity
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Anxiety
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Depression
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
HIV
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.
Measured: Pre-test, approximately 5 months after pre-test
Gonorrhea
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Chlamydia
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Syphilis
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
60-Day Vaginal Sex
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
60-Day Oral Sex
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.
Measured: Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start9 Nov 2018
- Primary completion30 Nov 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Nathan G. Smith, University of Houston
- Investigators
- Nathan G Smith, PhD, Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528135
- Sponsor's protocol ID
- 111889
- Other IDs
- 1R21DA041250-01A1
- Status last verified
- May 2022
- First submitted
- 26 Mar 2018
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28711116Smith 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project PRIDE: Intervention to Reduce HIV Risk in Young Sexual Minority Men
- ClinicalTrials.gov ID
- NCT03528135
- Acronym / sponsor ID
- 111889
- Conditions
- Human Immunodeficiency Virus, Sexually Transmitted Infections, Anxiety, Depression, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 17 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The specific aims are to:
- 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:
- Project PRIDE: an eight-session primary HIV-prevention intervention; or
- Wait-list control condition: after approximately 5 months, participants will receive Project PRIDE.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Project PRIDE | Experimental | Behavioral: Project PRIDEThose 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. |
| Wait-list | No intervention | –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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- Failure to meet any inclusion criterion will result in exclusion from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project PRIDESee arms section. | Behavioural | Project PRIDE |
Primary outcome
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.
18 secondary outcomes
Salivary cortisol
Time frame: 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
60-Day Self-Reported Drug/Alcohol Use
Time frame: 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
Self Esteem
Time frame: 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
Racist Discrimination
Time frame: 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
Gay/Bisexual Identity
Time frame: 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
Anxiety
Time frame: 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
HIV
Time frame: 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
Chlamydia
Time frame: 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
60-Day Vaginal Sex
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Background: PubMed 28711116Smith 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.
- BackgroundSmith 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan G Smith, PhD principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project PRIDE in people with Human Immunodeficiency Virus and Sexually Transmitted Infections, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03528135, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.