Getting to Zero Among HHI MSM in the American South

NCT05075967 | Enrolling By Invitation DMC

• 2 other identifiers: HPTN 096UM1AI068619
• Study Type: interventional
• Target: 2,700
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pre-exposure Prophylaxis (PrEP); HIV Incidence; Viral Suppression; Status-neutral Approach; Southern United States; Social Media Influencers (SMI); Intersectional Stigma Reduction; Peer Support; Ending the HIV Epidemic (EHE); Integrated Strategy; Community-randomized; Social determinants of health; Community mobilization; Community-based participatory research (CBPR); Health Resources and Services Administration (HRSA); Promoting Human Autonomy Support & Empathy (PHASE); Electronic Medical Record (EMR)

Outcome Measures

Primary Outcomes (3)

• To evaluate whether the HPTN 096 integrated strategy increases the number of HHI MSM clients at PHASE healthcare facilities.

  Number of HHI MSM with a visit at the HCF in the previous 12 months (Source: EMR).

  Month 12

• To evaluate whether the HPTN 096 integrated strategy increases retention in care among HHI MSM living with HIV at PHASE healthcare facilities.

  Number of HHI MSM living with HIV with at least two HIV medical visits to the HCF at least 90 days apart within the previous 12 months (Source: EMR)

  Month 12

• To evaluate whether the HPTN 096 integrated strategy increases PrEP prescriptions for HHI MSM not living with HIV at PHASE healthcare facilities.

  Any PrEP prescription among all HHI MSM without HIV with a medical visit at the HCF within the previous 12 months (Source: EMR).

  Month 12

Secondary Outcomes (8)

• To evaluate whether the HPTN 096 integrated strategy increases viral suppression (<200 copies/mL) in HHI MSM living with HIV at PHASE healthcare facilities.

  Month 12

• To evaluate whether the HPTN 096 integrated strategy increases PrEP initiation, adherence and persistence for HHI MSM not living with HIV at PHASE healthcare facilities.

  Months 4, 15, 27

• To evaluate whether the HPTN 096 integrated strategy increases PrEP initiation, adherence and persistence for HHI MSM not living with HIV at PHASE healthcare facilities.

  Month 12

• To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities.

  Months 4, 15, 27

• To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities.

  Month 17 and 27

Study Arms (1)

Integrated Strategy

EXPERIMENTAL

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.

Behavioral: Health Access Coalitions; Behavioral: Social Media; Behavioral: Peer Support; Behavioral: Promoting Human Autonomy Support & Empathy (PHASE)

Interventions

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.

Integrated Strategy

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.

Integrated Strategy

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.

Integrated Strategy

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).

Integrated Strategy

Eligibility Criteria

• Age: 15 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Man
• Self-reports a lifetime history of anal sex with another man (i.e., at any time in their life)
• Determined to be HHI within the study community per Centers for Disease Control and Prevention surveillance data
• Willing and able to provide consent to participate in the study
• Have a medical visit scheduled during the designated sampling period at a PHASE treatment or prevention healthcare facility

You may not qualify if:

• Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives, will be excluded from the cross-sectional assessment.
• There are no co-enrollment restrictions for participation in this assessment.
• \----------------------------------------
• Completed the cross-sectional HHI MSM client assessment
• Willing and able to provide assent/consent
• Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives, will be excluded from the qualitative interview.
• There are no co-enrollment restrictions for these interviews.
• \----------------------------------------
• Is a staff member at a participating PHASE facility
• Participated in at least one PHASE activity (e.g., attended a PHASE Foundation training, participated in Extension of Community Healthcare Outcomes training, member of PHASE quality improvement team)
• Willing and able to provide consent
• Individuals who have any condition that, in the opinion of the Investigator of Record (IoR) or designee, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives, will be excluded from the qualitative interview.
• There are no co-enrollment restrictions for these interviews
• \----------------------------------------

Sponsors & Collaborators

• HIV Prevention Trials Network: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

FHI 360

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

HIV Infections

Interventions

Media Exposure

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sociology; Social Sciences; Behavioral Sciences; Behavioral Disciplines and Activities

Study Officials

• LaRon Nelson, PhD

  Yale University School of Nursing

  STUDY CHAIR

• Chris Beyrer, MD

  Duke University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: October 13, 2021
• Study Start: December 10, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)