HIV Infections
Conditions
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)
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.
Interventions
BEHAVIORALHealth 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).
BEHAVIORALSocial 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.
BEHAVIORALPeer 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.
BEHAVIORALPromoting 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.
Sponsors
HIV Prevention Trials Network
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate whether the HPTN 096 integrated strategy increases the number of HHI MSM clients at PHASE healthcare facilities. | Month 12 | Number of HHI MSM with a visit at the HCF in the previous 12 months (Source: EMR). |
| To evaluate whether the HPTN 096 integrated strategy increases retention in care among HHI MSM living with HIV at PHASE healthcare facilities. | 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) |
| To evaluate whether the HPTN 096 integrated strategy increases PrEP prescriptions for HHI MSM not living with HIV at PHASE healthcare facilities. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
| 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 | Self-report of PrEP initiation and adherence in the previous 12 months (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs \[questionnaires\]) |
| To assess changes in the experience of autonomy support among HHI MSM at PHASE healthcare facilities. | Months 4, 15, 27 | Self-reported scale measuring autonomy support (Source: Cross-sectional assessment in sample of HHI MSM at PHASE HCFs \[questionnaires, healthcare climate section\]) |
| 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). | 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 \[questionnaires\]) |
Countries
United States
Contacts
STUDY_CHAIRLaRon Nelson, PhD
Yale University School of Nursing
STUDY_CHAIRChris Beyrer, MD
Duke University
Outcome results
None listed