Clinical trial NCT06183502: HIV/STD Risk and PrEP Implementation Messaging Among Gay, Bisexual, and Other Men Who Have Sex with Men
Official title: Understanding HIV/STD Risk and Enhancing PrEP Implementation Messaging in a Diverse Community-Based Sample of Gay, Bisexual, and Other Men Who Have Sex with Men in a Transformational Era (MIC-DROP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sexually Transmitted Infections
Gay
Pre Exposure Prophylaxis
Keywords: MSM
Gay
Pre exposure Prophylaxis
STI
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: San Diego State University
name: University of Chicago
name: CDC Foundation
First posted: 2023-12-27
Enrollment: 1275
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Detailed description: The prevention of HIV in the United States is in a transformational era. In just a decade since the first finding of efficacy for daily oral PrEP, there has been a proliferation of new PrEP agents, including long-acting injectable PrEP, and regimens, including "event-driven" (also called "on demand" or 2-1-1 dosing) PrEP. There has also been new knowledge about the impact of antiretrovirals (ARVs) on the treatment of HIV, and an emergent understanding that people living with HIV who take ARVs and maintain a suppressed viral load are incapable of transmitting HIV to their sexual partners. In this context, the idea of "protected" sex - which historically meant sex protected by condoms - has become much more complex.6 Men who have sex with men (MSM) and others at risk for acquiring HIV are now making decisions about how to reduce their risks of HIV infection in a world where there are many more options to reduce risks of infection, and where those options also interact with the HIV status and viral suppression status of their sex partners. Understanding men's preferences for prevention products and strategies and what choices are being made by men with varying risk profiles is critical to public health responses and programs to reduce new HIV infections.

MSM are the most highly impacted groups by HIV in the US, with transmission largely driven by high per-act risk MSM. Among MSM, Black/African American (Black) and Hispanic/Latino (Hispanic) men experience nested health inequities: in 2020 Black men comprised 13% of US men and 38% of MSM diagnosed with HIV, and Hispanic men comprised 19% of US men and 33% of MSM diagnosed with HIV. Uptake of daily oral PrEP use by Black and Hispanic MSM has been slow and the extent of PrEP use among these men has not been equitable in light of their disproportionate impact in the HIV epidemic. Similarly, HIV incidence is concentrated in young MSM of all races. Thus, research to increase our understanding of men's awareness of, attitudes for and use of new prevention options must prioritize the equitable engagement of Black, Hispanic, and younger MSM.

The next 5 years will be a period of rapid changes in the fallout of new PrEP options and will likely see the introduction of new PrEP modalities (e.g., long-acting injectable PrEP, lower frequency oral dosing). Understanding the choices and patterns of PrEP use and the reasons and motivations for those choices among geographically, racially, and ethnically diverse groups of MSM will be a critical part of monitoring the public health response and informing public health programs and messaging. Ideally, public health messaging will be driven by up-to-date information about the perceptions, preferences, and practices of those MSM at the highest risk of HIV acquisition. During this era of rapid change in the available PrEP options, it is critical to have a robust system of real-time monitoring for PrEP preferences, what prevention options men are choosing, and what messages might be most impactful to support the appropriate uptake of PrEP and persistence on PrEP. Because the investigators expect numerous changes in the availability of PrEP products and treatment guidelines, it is also critical to be able to process and interpret these data in a timely way, to best support nimble decisions in prevention messaging and programs in response to a changing landscape of prevention options

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Monitoring Measure: Survey reports
timeFrame: 3 months, 6 months, 9 months,12 months,15 months,18 months
measure: Change in condom and PrEP use and adherence based on messages for current PrEP users
timeFrame: 3 months, 6 months, 9 months,12 months,15 months,18 months
measure: Change in condom and PrEP use and adherence based on messages for current non adherent PrEP users
timeFrame: 3 months, 6 months, 9 months,12 months,15 months,18 months
measure: Change in condom and PrEP use and adherence based on messages for people who never used PrEP
timeFrame: 3 months, 6 months, 9 months,12 months,15 months,18 months
Secondary outcomes:
measure: Change in number of HIV diagnoses
timeFrame: Baseline, 6 months, 12 months, 18 months
measure: Change in number of STI diagnoses
timeFrame: Baseline, 6 months, 12 months, 18 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: Rollins School of Public Health
name: Patrick Sullivan, DVM
role: PRINCIPAL_INVESTIGATOR
References: