Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06183502
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-12-14
Brief Title:
HIVSTD Risk and PrEP Implementation Messaging Among Gay Bisexual and Other Men Who Have Sex With Men
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Understanding HIVSTD 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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIC-DROP
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 mens strategies to prevent HIVSexually 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
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 complex6 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 mens 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 BlackAfrican American Black and HispanicLatino 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 mens 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 eg 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
MSM are the most highly impacted groups by HIV in the US with transmission largely driven by high per-act risk MSM Among MSM BlackAfrican American Black and HispanicLatino 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 mens 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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01PS005244 | NIH | None | httpsreporternihgovquickSearchU01PS005244 |