HIV/STD Risk and PrEP Implementation Messaging Among Gay, Bisexual, and Other Men Who Have Sex With Men

NCT06183502 | Suspended

• 2 other identifiers: STUDY00005355U01PS005244
• Study Type: observational
• Target: 1,275
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this observational study is to learn about awareness around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors in men having sex with men. The main objective is to study a prospective cohort of MSM in Atlanta, Chicago, and San Diego to understand men's strategies to prevent HIV/Sexually Transmissible Infections (STIs), including PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors Participants will complete:

• Quantitative surveys quarterly
• HIV/ STI testing every 6 months
• Qualitative assessments: focus group discussions and in-depth interviews

Conditions

Sexually Transmitted Infections; Gay; Pre Exposure Prophylaxis

Keywords

MSM; Gay; Pre exposure Prophylaxis; STI

Outcome Measures

Primary Outcomes (4)

• Monitoring Measure: Survey reports

  As a prospective observation cohort study, a primary purpose of this study is to monitor real-world, community- (non-clinic) -based HIV prevention behavior (PrEP use/adherence, condom use/adherence), including uptake and transitions among prevention modality (condom, daily oral, episodic oral, long-acting injectable) in an effort to identify patterns and gaps in HIV protection in order to develop more effective messaging to close those gaps. Rapid reports to Centers for Disease Control and Prevention (CDC) after each wave of data collection will summarize gaps in prevention and recommend the most advantageous messages to address gaps.

  3 months, 6 months, 9 months,12 months,15 months,18 months

• Change in condom and PrEP use and adherence based on messages for current PrEP users

  The purpose of Qualitative assessments; Focus Group Discussion is to understand men's awareness of PrEP messages, preferences for PrEP messages, and perceived impact/efficacy of HIV prevention and PrEP messages

  3 months, 6 months, 9 months,12 months,15 months,18 months

• Change in condom and PrEP use and adherence based on messages for current non adherent PrEP users

  The purpose of Qualitative assessments; Focus Group Discussion is to understand men's awareness of PrEP messages, preferences for PrEP messages, and perceived impact/efficacy of HIV prevention and PrEP messages

  3 months, 6 months, 9 months,12 months,15 months,18 months

• Change in condom and PrEP use and adherence based on messages for people who never used PrEP

  The purpose of Qualitative assessments; Focus Group Discussion is to understand men's awareness of PrEP messages, preferences for PrEP messages, and perceived impact/efficacy of HIV prevention and PrEP messages

  3 months, 6 months, 9 months,12 months,15 months,18 months

Secondary Outcomes (2)

• Change in number of HIV diagnoses

  Baseline, 6 months, 12 months, 18 months

• Change in number of STI diagnoses

  Baseline, 6 months, 12 months, 18 months

Study Arms (1)

MSM using or not using Pre-exposure prophylaxis

60% of MSM using PrEP at baseline in Atlanta, Chicago, and San Diego to develop knowledge around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors. 40% of MSM not using PrEP at baseline in Atlanta, Chicago, and San Diego to develop knowledge around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors.

Behavioral: Quantitative survey; Procedure: HIV and STI testing; Behavioral: Qualitative Assessment

Interventions

Quantitative survey BEHAVIORAL

Quantitative surveys will be conducted through Alchemer, a HIPPA-compliant online survey system previously used by our group in collaborative research with CDC and supported by the Emory University Center for AIDS Research (CFAR). Surveys will be optimized for participants to take them through a personal computer, mobile phone, tablet, or the SMART study app. For participants who do not have any of these devices or prefer not to take the survey from their device, each city will have a research space where participants can schedule a convenient time to take the survey on a computer or tablet that the study will provide for that purpose.

MSM using or not using Pre-exposure prophylaxis

HIV and STI testing PROCEDURE

The research team has developed and validated procedures for self-collection of specimens for testing for STIs (syphilis, urethral, rectal, and pharyngeal gonorrhea/chlamydia) and HIV self-testing. All participants will be mailed self-collection kits to provide samples for STIs (urine, rectal swab, and pharyngeal swab for gonorrhea/chlamydia; dried blood spot (DBS) for syphilis testing) and HIV (HIV 4th generation testing on DBS specimens in a CLIA-certified laboratory). Participants will be asked to collect specimens for their STI and HIV testing (every 6 months) and return them to Molecular Testing Labs. For participants who prefer in-person procedures, they will meet study staff who will provide them with the STI and HIV self-collection kit and instructions and provide a room for participants to collect their specimens.

MSM using or not using Pre-exposure prophylaxis

Qualitative Assessment BEHAVIORAL

Focus group discussions (n=up to 48 men for 3 qualitative assessments; total n=up to 144 men) as a part of the study consisting of 9 to 12 focus group discussions (FGD) with an average of 8 (range 3-10) participants in each (3 per city). These focus groups will be conducted once during the first year of the study. FGD will be conducted by a trained moderator using a semi-structured interview guide developed in collaboration with CDC scientists. For the FGD, in each city, there will be one FGD with men who have never used PrEP, one with men who are using PrEP and report no adherence issues, and one with men who are currently using PrEP or used PrEP previously and report sub-optimal adherence. In-Depth Interviews (IDIs) A series of 90 in-depth interviews (same n=up to 45 men for each of 3 qualitative assessments) will be conducted over 18 months: up to 45 IDIs each 6 months apart, with up to 15 IDIs per city each wave.

MSM using or not using Pre-exposure prophylaxis

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male sex assigned at birth, currently identify as male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary recruitment sources will be through online targeted advertisements to adult men in the three metropolitan areas (Atlanta, Detroit, and San Diego), including social media channels, such as Facebook, Instagram or Snapchat, Grindr, and other dating apps. Additionally, recruitment will be done through referrals from local clinics and community-based organizations. These organizations may provide palm cards or QR codes for interested participants to reach the eligibility screening survey.

You may qualify if:

• Male at birth
• Self-identify as Cis-gender Male
• Ages 18 or older
• ≥1 Male anal sex partner in the 6 months before the baseline screener
• Live in or near Atlanta, Chicago, or San Diego
• Owns cell phone with data service
• Willing to download a health-related app to their cell phone as part of the research study
• Willing to participate in a 2-year cohort study with quarterly surveys and HIV and mailed STI self-testing
• Able to provide ≥ 2 means of contact
• Not currently enrolled in another HIV prevention clinical trial
• Not currently living with HIV

You may not qualify if:

• Female at birth
• Do not self-identify as Cis-gender Male
• Individuals \< 18 years of age
• HIV positive status
• No male anal sex partner in the 6 months before the baseline interview
• Does not own a mobile phone with data service
• Not willing to download a health-related app to their cell phone as part of the research study
• Live outside the metro Atlanta Metropolitan Statistical Area and/or planning to move from the Atlanta area in the next 2 years
• Currently enrolled in an HIV prevention or treatment clinical trial

Sponsors & Collaborators

• Emory University: lead
• San Diego State University: collaborator
• University of Chicago: collaborator
• CDC Foundation: collaborator

Study Sites (3)

San Diego State University

San Diego, California, 92182, United States

Location

Emory University

Atlanta, Georgia, 30307, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases; Homosexuality

Interventions

Seroconversion

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sexuality; Sexual Behavior; Behavior

Intervention Hierarchy (Ancestors)

Immune System Phenomena

Study Officials

• Patrick Sullivan, DVM

  Rollins School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 27, 2023
• Study Start: June 29, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 6 years following primary publication
• Access Criteria: Investigators will share data with researchers who provide a methodologically sound proposal. Proposals should be directed to the PI. In order to gain access, data requestors will need to sign a data access agreement

Locations

US (3)