Getting to Zero Among HHI MSM in the American South

Getting to Zero Among Highest HIV Incidence (HHI) Men Who Have Sex With Men (MSM) in the American South: Testing an Integrated Strategy

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HIV Infections
• Intervention / Treatment: Behavioral: Health Access Coalitions; Behavioral: Social Media; Behavioral: Peer Support; Behavioral: Promoting Human Autonomy Support & Empathy (PHASE)

• Study Type: Interventional
• Enrollment (Estimated): 2700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • FHI 360

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Cross-Sectional HHI MSM Client Assessment Inclusion Criteria

• 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

Cross-Sectional HHI MSM Client Assessment Exclusion Criteria

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.

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HHI MSM Clients In-depth Interviews (IDIs) Inclusion Criteria

• Met inclusion criteria for the cross-sectional HHI MSM client assessment
• Completed the cross-sectional HHI MSM client assessment
• Willing and able to provide assent/consent

HHI MSM Clients IDIs Exclusion Criteria

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.

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PHASE HCF Staff IDIs Inclusion Criteria

• 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

PHASE HCF Staff IDIs Exclusion Criteria

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate whether the HPTN 096 integrated strategy increases viral suppression (<200 copies/mL) in HHI MSM living with HIV at PHASE healthcare facilities.	Viral suppression of the most recent viral load done among all HHI MSM living with HIV who had a viral load measurement at the HCF in the previous 12 months (Source: EMR).	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.	Self-report of PrEP initiation and adherence in the previous 12 months (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [questionnaires])	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.	Repeat PrEP prescriptions among HHI MSM not living with HIV in the previous 12 months (Source: EMR).	Month 12
To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities.	Self-reported scale measuring autonomy support (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [questionnaires, healthcare climate section])	Months 4, 15, 27
To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities.	Individual-level qualitative data with a subset of HHI MSM exploring autonomy support (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [qualitative interviews]).	Month 17 and 27
To assess how autonomy support, social support, stigma, barriers to healthcare and individual agency among HHI MSM at PHASE healthcare facilities are associated with engagement in care (including PrEP prescription and viral suppression).	Self-reported data related to autonomy support, social support, stigma, barriers to healthcare, individual agency (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [questionnaires])	Months 4, 15, 27
To assess how autonomy support, social support, stigma, barriers to healthcare and individual agency among HHI MSM at PHASE healthcare facilities are associated with engagement in care (including PrEP prescription and viral suppression).	Any PrEP prescription in last 12 months for HHI MSM not living with HIV (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [case report forms])	Months 4, 15, 27
To assess how autonomy support, social support, stigma, barriers to healthcare and individual agency among HHI MSM at PHASE healthcare facilities are associated with engagement in care (including PrEP prescription and viral suppression).	Viral load suppression and retention in care in last 12 months in HHI MSM living with HIV (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [case report forms]).	Months 4, 15, 27

Collaborators and Investigators

• Sponsor: HIV Prevention Trials Network
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: LaRon Nelson, PhD, Yale University School of Nursing; Study Chair: Chris Beyrer, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: August 19, 2021
• First Submitted That Met QC Criteria: September 29, 2021
• First Posted (Actual): October 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Peer Support; Pre-exposure Prophylaxis (PrEP); Viral Suppression; Social determinants of health; Community mobilization; HIV Incidence; Status-neutral Approach; Southern United States; Social Media Influencers (SMI); Intersectional Stigma Reduction; Ending the HIV Epidemic (EHE); Integrated Strategy; Community-randomized; Community-based participatory research (CBPR); Health Resources and Services Administration (HRSA); Promoting Human Autonomy Support & Empathy (PHASE); Electronic Medical Record (EMR)
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; HIV Infections; Behavioral Disciplines and Activities; Behavioral Sciences; Sociology; Social Sciences; Media Exposure
• Other Study ID Numbers: HPTN 096; UM1AI068619 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No