HPTN 096

Getting to Zero among Black MSM in the American South: Testing the Efficacy of an Integrated Intervention Strategy

Study Details

Protocol Status: Pending
Study Purpose:

The purpose of this study is to evaluate an integrated, population-based approach designed to reduce human immunodeficiency virus (HIV) incidence among Black men who have sex with men (MSM) in the southern US by increasing HIV testing, uptake and use of pre-exposure prophylaxis (PrEP) among Black MSM living without HIV, and viral suppression rates among Black MSM living with HIV. A status-neutral approach will be taken such that Black MSM, regardless of HIV status (both those living with and without HIV), will be included in the study.

Study Design:

This study is a community-randomized, controlled, hybrid type III implementation effectiveness study. The study will deliver an integrated strategy that includes a combination of four community-, organizational-, and interpersonal-level components designed to impact individual-level outcomes. A cross-sectional assessment will be conducted at baseline and at the end of the 3-year implementation period. Study endpoints will be assessed using study-collected data, routinely collected HIV surveillance data and commercially available prescription data.

Integrated Strategy Components: The four study components are described below.
• Health equity: This community-level structural component will use a standardized, nationally replicable community coalition model (Black Treatment Advocates Networks [BTAN]) to implement an enhanced program model geared to 1) facilitate the effects of the other HPTN 096 interventions by minimizing barriers to HIV testing, PrEP use and viral suppression through sensitizing a local network of service providers (e.g., social, legal, economic sectors) to the needs of Black MSM and maintaining an online platform for exchanging information about the local network that can be used to link Black MSM to resources and services, and 2) amplify the effects of other HPTN 096 components by increasing Black MSM’s receptivity to those activities through the integration and promotion of HPTN 096 into the activities of the community coalition model.
• Social media influencers: In this community-level component, social media influencers (SMI) will be defined for the purposes of this study as users on social media who have established credibility, trust and access to a large audience of Black MSM, and who can persuade them by virtue of their authenticity and reach. SMI will provide tailored messaging for Black MSM in intervention communities on the topics of:
o HIV/sexually transmitted infections (STI) testing promotion
o PrEP (and general HIV prevention) awareness and promotion
o Definition and benefits of viral suppression.
Messages may include direction towards health care facilities (HCFs) involved in the intersectional stigma reduction component and information about the virtual peer support platform or BTAN+ events.• Intersectional stigma reduction: This organizational-level component will take place in HCFs and is designed to improve cultural responsiveness in the provision of HIV prevention and health care services to Black MSM. It is expected to contribute to a reduction in HIV incidence by creating an affirming and autonomy-supportive healthcare environment that supports Black MSM engagement in HIV-related care and services and that promotes increased HIV/STI testing, PrEP uptake and viral suppression rates.
• Virtual peer support: In this interpersonal-level component, peer support workers will be trained and compensated to provide emotional and practical support services via a virtual platform. These peer support workers will have shared lived experiences with those whom they are supporting, be self-reflective of those experiences, and know when to share those experiences with others in an appropriate and supportive manner. These activities will be closely supervised and managed centrally and will not be directly affiliated with any specific HIV prevention or treatment HCF. Once trained, the peer support workers will have demonstrated competencies in the following domains:
o HIV, PrEP, non-occupational post-exposure prophylaxis (nPEP), other HIV prevention options and antiretroviral therapy (ART) education
o Adherence to PrEP, ART and medical care
o HIV/STI testing
o New HIV diagnosis
o Addressing intersectional stigma (anti-Black racism, sexual stigmas, HIV-related stigma)
o Self-care
o Information about national and local resources and assistance programs, Black MSM-centered health services, and the cost and insurance coverage of medications (PrEP/ART) and medical care
o Multicultural competency (as it relates to a range of self-identities and the heterogeneity of the HIV epidemic for Black MSM in the southern US)

Study Population:

The study population for the cross-sectional assessments will be Black MSM in the intervention and control communities. The following study populations will be prioritized for each component of the integrated strategy:
Health equity:
Black MSM and local community
Social media influencers:
Black MSM
Intersectional stigma reduction:
Healthcare facility staff
Virtual peer support:
Black MSM

Study Size:
Study Duration:

Study duration is approximately 6 years total. After a one-year implementation ramp-up phase prior to the start of the implementation period, the integrated strategy will be delivered over three years. The cross-sectional assessments will be conducted prior to and immediately following implementation of the 3-year integrated strategy. Each assessment will take approximately 6 months to complete, and the baseline assessment will take place during the ramp-up period. Laboratory testing, data analysis, and analysis of surveillance data will require approximately 1.5 years after completion of the post-implementation assessment.

Treatment Regimen:
Primary Objectives:

• To increase the proportion of Black MSM living with diagnosed HIV who are virally suppressed (<200 copies/mL) in the intervention communities compared to the SOC communities at the end of the three-year integrated strategy based on HIV surveillance data
• To increase PrEP use by Black MSM not living with HIV in the intervention communities compared to the SOC communities at the end of the three-year integrated strategy based on laboratory data generated from the post-implementation cross-sectional assessment

Secondary Objectives:

• To compare self-reported HIV testing behavior in Black MSM in the intervention communities to the SOC communities at the end of the three-year integrated strategy based on the post-implementation cross-sectional assessment
To compare social support, intersectional stigma, barriers to healthcare, and individual agency in Black MSM in the intervention communities to the SOC communities at the end of the three-year integrated strategy based on the post-implementation cross-sectional assessment
• To increase the proportion of Black MSM living with HIV newly diagnosed in the past year who are virally suppressed (<200 copies/mL) within six months of diagnosis in the intervention communities compared to the SOC communities at the end of the three-year integrated strategy based on HIV surveillance data
• To track ongoing EHE implementation activities for Black MSM (e.g., outlined by the EHE plans) of both intervention and control communities (used for adjustment in analyses and to assess implementation outcomes of acceptability/compatibility)
• To assess measures of care quality, and care responsiveness to Black MSM needs at HCFs participating in the Culturally Responsive Intersectional Stigma Prevention (CRISP) component, pre- and post-implementation (used to assess service outcomes)

Other Objectives:

To compare the estimated HIV incidence in Black MSM in the intervention communities to the SOC communities at the end of the three-year integrated strategy based on laboratory data generated from the post-implementation cross-sectional assessment
• To compare use of antiretroviral drugs by Black MSM living with HIV in the intervention communities to the SOC communities at the end of the three-year integrated strategy based on laboratory data generated from the post-implementation cross-sectional assessment (this analysis will be limited to a subset of communities)
• To compare HIV drug resistance in Black MSM living with HIV in the intervention communities to the SOC communities at the end of the three-year integrated strategy based on laboratory data generated from the post-implementation cross-sectional assessment (this analysis may be limited to a subset of communities)
To use mathematical modeling to
• inform interim analysis by using HIV surveillance data on viral suppression during the trial to predict the expected impact on HIV incidence at the end of the trial
• estimate the longer-term impact of the integrated strategy on HIV incidence among Black MSM in the southern US
• estimate the contribution to the overall impact on HIV incidence made by each of the integrated strategy components
• Using attribution analysis, estimate the contribution made by each of the integrated strategy components (health equity, social influencers, intersectional stigma reduction, and peer support) to changes in viral suppression and PrEP use among Black MSM in the southern US
• Stored specimens may be used for laboratory assessments that include phylogenetic analysis of HIV in the study communities; characterization of HIV; development, validation, evaluation of laboratory assays relevant to the HIV epidemic and study objectives, and testing associated with SARS-CoV-2 and other related viruses.

Study Sites List