Getting to Zero Among HHI MSM in the American South

Official title

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

Overview

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.

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 sup
• 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 achiev
• 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 H

Primary outcome measures

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

Secondary outcome measures (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. [Time frame: 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. [Time frame: 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. [Time frame: Month 12]
• To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities. [Time frame: Months 4, 15, 27]
• To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities. [Time frame: 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). [Time frame: 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). [Time frame: 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). [Time frame: Months 4, 15, 27]

Eligibility criteria

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.

\----------------------------------------

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.

\----------------------------------------

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

\----------------------------------------

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• FHI 360 — Durham

Identifiers

NCT: NCT05075967 · HPTN 096 · UM1AI068619

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗