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OpenTrials
Enrolling by Invitation

NCT Number: NCT05075967

Getting to Zero Among HHI MSM in the American South

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.

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Key information

Conditions

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

Age range

15 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

FHI 360

Durham, North Carolina, 27701, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

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.

Primary outcomes

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

    Time frame: Month 12

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

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

    Time frame: Month 12

    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)

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

    Time frame: Month 12

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

Secondary outcomes

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

    Time frame: Month 12

    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).

  2. 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.

    Time frame: Months 4, 15, 27

    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])

  3. 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.

    Time frame: Month 12

    Repeat PrEP prescriptions among HHI MSM not living with HIV in the previous 12 months (Source: EMR).

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

    Time frame: Months 4, 15, 27

    Self-reported scale measuring autonomy support (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs [questionnaires, healthcare climate section])

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

    Time frame: Month 17 and 27

    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]).

  6. 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).

    Time frame: Months 4, 15, 27

    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])

  7. 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).

    Time frame: Months 4, 15, 27

    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])

  8. 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).

    Time frame: Months 4, 15, 27

    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]).

Sponsors and collaborators

Lead sponsor

HIV Prevention Trials Network

Network

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 13, 2021
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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