NCT03528135

Brief Summary

The specific aims are to:

  1. 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:
  2. 2.Project PRIDE: an eight-session primary HIV-prevention intervention; or
  3. 3.Wait-list control condition: after approximately 5 months, participants will receive Project PRIDE.
  4. 4.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.
  5. 5.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

November 9, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

May 25, 2022

Status Verified

May 1, 2022

Enrollment Period

3.1 years

First QC Date

March 26, 2018

Last Update Submit

May 23, 2022

Conditions

Human Immunodeficiency VirusSexually Transmitted InfectionsAnxietyDepressionSubstance Use Disorders

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test

Secondary Outcomes (18)

  • Salivary cortisol

    Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test

  • 60-Day Drug Use

    Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test

  • 60-Day Self-Reported Drug/Alcohol Use

    Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test

  • Loneliness

    Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test

  • Self Esteem

    Pre-test, approximately 2 months after pre-test, approximately 5 months after pre-test

  • +13 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

Project PRIDEBEHAVIORAL

See arms section.

Project PRIDE

Eligibility Criteria

Age18 Years - 25 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsParticipants who self-identify as male (regardless of sex assigned at birth) are eligible.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avenue 360, University of Houston

Houston, Texas, 77204, United States

Location

Related Publications (2)

  • 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.

    PMID: 28711116BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeSexually Transmitted DiseasesAnxiety DisordersDepressionSubstance-Related Disorders

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehaviorChemically-Induced Disorders

Study Officials

  • Nathan G Smith, PhD

    University of Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 26, 2018

First Posted

May 17, 2018

Study Start

November 9, 2018

Primary Completion

November 30, 2021

Study Completion

April 30, 2022

Last Updated

May 25, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)