Getting to Zero Among HHI MSM in the American South
NCT05075967 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2700
Last updated 2026-03-13
Summary
This study will evaluate a status-neutral integrated strategy to improve access to and uptake of HIV prevention and treatment services for the highest HIV incidence (HHI) men who have sex with men (MSM) in participating communities. The ultimate goal is to establish a strategy to reduce HIV incidence among HHI MSM in the southern United States (US) by increasing the number of HHI MSM accessing prevention and treatment services, increasing uptake and use of pre-exposure prophylaxis (PrEP) among those living without HIV and increasing retention in care, and thus viral suppression, among those living with HIV.
Conditions
- HIV Infections
Interventions
- BEHAVIORAL
-
Health Access Coalitions
This component will use a community coalition program as its base model for reducing structural barriers, shaping community social norms and raising awareness to reduce HIV among HHI MSM. This will be achieved through: 1) facilitating a reduction in social, structural, and policy barriers to HIV testing, PrEP, and viral suppression through fostering collective efficacy, promoting norms within the local service sectors (e.g., social, legal, economic, etc.), and advancing advocacy efforts that support the strategic prioritization of access to resources and services for HHI MSM; and 2) amplifying awareness, education, and capacity building around HIV prevention and treatment resources and messaging (including other HPTN 096 components).
- BEHAVIORAL
-
Social Media
A robust social media strategy will be used to reach and engage HHI MSM throughout each participating community. Utilizing a multitude of social media communication and marketing tactics, social media content will be used to educate and empower HHI MSM so that they can make informed decisions and behavioral changes to stop HIV acquisition and transmission, with emphasis on accessing HIV prevention and treatment services, the uptake of PrEP and the importance of staying engaged in care and achieving viral suppression. In addition, the strategy will promote other study components, encouraging HHI MSM to engage in care at PHASE healthcare facilities (HCFs), seek help from peer supporters and take advantage of the environmental changes put in place via the health access coalitions.
- BEHAVIORAL
-
Peer Support
Peer supporters, who may possess a shared and/or lived experience, will provide HHI MSM with emotional and practical support, using a HIV-status neutral approach, as well as share information on locally available sexual health and HIV-related resources and support services. Peers may provide support in-person or virtually and may be housed at local community-based organizations. In addition, when appropriate, the use of PHASE HCFs will be encouraged for those seeking healthcare services.
- BEHAVIORAL
-
Promoting Human Autonomy Support & Empathy (PHASE)
The PHASE component is an HCF-level practice improvement program designed to enhance the provision of healthcare services for HHI MSM. PHASE aims to create an autonomy-supportive healthcare environment that supports HHI MSM engagement in HIV-related care and services and helps to promote increased HIV and sexually transmitted infection testing, PrEP and antiretroviral therapy uptake, retention in care, and viral suppression rates for HHI MSM. The primary study outcomes will be collected at all HCFs participating in PHASE.
Sponsors & Collaborators
-
National Institute of Allergy and Infectious Diseases (NIAID)
collaborator NIH -
HIV Prevention Trials Network
lead NETWORK
Principal Investigators
-
LaRon Nelson, PhD · Yale University School of Nursing
-
Chris Beyrer, MD · Duke University
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 15 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-12-10
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
Countries
- United States
Study Locations
More Related Trials
-
A Mobile Intervention to Improve Uptake of PrEP for Southern Black MSM
NCT03308097 ·Status: COMPLETED ·Phase: NA
-
Enhancing Recruitment, Linkage to Care and Treatment for HIV-Infected MSM in the United States
NCT02663219 ·Status: COMPLETED ·Phase: NA
-
SNS and PrEP Initiation and Adherence in Black SMM
NCT05499962 ·Status: UNKNOWN ·Phase: NA
-
A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence)
NCT04121962 ·Status: COMPLETED ·Phase: NA
-
Implementation of Rapid HIV Self-Testing Among MSM Project
NCT04219878 ·Status: COMPLETED ·Phase: NA
-
An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South
NCT05087680 ·Status: RECRUITING ·Phase: NA
-
Accelerated PrEP Access for Black MSM and TW
NCT04329442 ·Status: WITHDRAWN ·Phase: NA
-
Serosorting Intervention for HIV Negative MSM
NCT02128594 ·Status: COMPLETED ·Phase: NA
-
Development of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black MSM
NCT05769270 ·Status: TERMINATED ·Phase: NA
-
HPTN 073 Black Men Who Have Sex With Men (MSM) Pre-Exposure Prophylaxis (PrEP)
NCT01808352 ·Status: COMPLETED
-
Intervention to Enhance PrEP Persistence
NCT06872307 ·Status: RECRUITING ·Phase: NA
-
Testing a Secondary Prevention Intervention for HIV-Positive Black Young Men Who Have Sex With Men
NCT01751594 ·Status: COMPLETED ·Phase: NA
-
Understanding Substance Use and Incident HIV/STI Among Young Black MSM
NCT02503618 ·Status: COMPLETED
-
Seek, Test, and Retain. Linkages for Black HIV+, Substance-Using MSM
NCT01790360 ·Status: COMPLETED ·Phase: NA
-
A Peer-Driven Intervention to Increase PrEP Uptake Among Minority MSM
NCT05161663 ·Status: COMPLETED ·Phase: NA
-
Comprehensive HIV Prevention Package for MSM in Port Elizabeth
NCT02449733 ·Status: COMPLETED ·Phase: NA
-
Being Responsible for Ourselves HIV Risk Reduction for Black MSM
NCT02561286 ·Status: COMPLETED ·Phase: NA
-
PrEP With TDF/FTC to Prevent HIV-1 Acquisition in Young MSM and Transgender Women of Color
NCT02367807 ·Status: COMPLETED
-
Parrying the Pitfalls of PrEP: Project PEACH
NCT05072093 ·Status: COMPLETED ·Phase: PHASE4
-
Five Point Initiative: A Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities
NCT06062342 ·Status: RECRUITING ·Phase: NA
-
HIV/STD Risk and PrEP Implementation Messaging Among Gay, Bisexual, and Other Men Who Have Sex With Men
NCT06183502 ·Status: SUSPENDED
-
A Network Intervention for Reducing Sexual Risk for HIV With African American Men Who Have Sex With Men (AA MSM)
NCT00691041 ·Status: COMPLETED ·Phase: NA
-
Reducing HIV Risk With High Risk HIV Negative Black MSM-Passport to Wellness
NCT02932384 ·Status: COMPLETED ·Phase: NA
-
Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men
NCT02572401 ·Status: COMPLETED ·Phase: NA
-
Resilient HIV Implementation Science With SGM Youths Using Evidence
NCT06350682 ·Status: ENROLLING_BY_INVITATION ·Phase: NA