Getting to Zero Among HHI MSM in the American South

Part of paid clinical trials in Durham, North Carolina.

Sponsor
HIV Prevention Trials Network
Study ID
NCT05075967
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
MALE
Age
15 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Health Access Coalitions — BEHAVIORAL
    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).
  • Social Media — BEHAVIORAL
    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.
  • Peer Support — BEHAVIORAL
    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.
  • Promoting Human Autonomy Support & Empathy (PHASE) — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Dec 10, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
2,700 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Integrated Strategy
    HPTN 096 is a hybrid implementation-efficacy trial that uses a single arm interrupted time series (ITS) design to test whether a status-neutral integrated strategy improves access to and uptake of HIV prevention and treatment services for HHI MSM. ITS measures a change in slope for the primary outcomes pre- and post-intervention using four one-year look backs of EMR data. The integrated strategy will be delivered in up to five selected communities in the southern US.

Primary Outcome Measure

To evaluate whether the HPTN 096 integrated strategy increases the number of HHI MSM clients at PHASE healthcare facilities. [ Time Frame: Month 12 ]

Locations (1)

FacilityCityStateZIPSite coordinators
FHI 360DurhamNorth Carolina27701-

Find similar trials in Durham, NC

By condition
HIV
By specialty
Infectious disease
By research site
FHI 360· Durham, NC

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