HPTN 096

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

Study Summary
Summary Coming Soon

 

HPTN 096

 

HPTN 096

 

HPTN 096

 

HPTN 096

 

 

Study Documents

 

HPTN 096 Study Design

HPTN 096 Study Design

 

 

 

Study Details

Protocol Status: Pending
Study Purpose:

The purpose of HPTN 096 is to assess an integrated, HIV status-neutral, population-based approach designed to reduce HIV incidence among Black MSM in the U.S. South by increasing HIV testing, pre-exposure prophylaxis (PrEP) use among Black MSM living without HIV, and viral suppression rates among Black MSM living with HIV.

Study Design:

This will be a community-randomized intervention package that includes a combination of community-, organizational-, interpersonal-level interventions. Cross-sectional baseline and endpoint assessments will be conducted at the start and end of the 3 year intervention period to measure study outcomes, including HIV recency as a proxy for HIV incidence.

Prior to implementation of the full study, the team will conduct a pilot in order to establish partnerships within each participating community, conduct implementation of the intervention components, identify challenges and improve the interventions. The pilot will take place in a subset of both intervention and standard-of-care (control) communities. During the pilot phase, all communities will be preparing for full study implementation after the pilot ends.

Baseline and Post-intervention Cross-Sectional Assessments: Two cross-sectional assessments will be conducted for this study: one at baseline, the other after the three-year intervention ends. A starfish sampling approach (the combination of venue-time-based and respondent-driven sampling) will be employed to recruit and enroll individual participants in both intervention and standard-of-care (control) communities to complete the cross-sectional assessments. These brief assessments will include optional HIV rapid testing, blood collection and the completion of two surveys.

Baseline Assessment: 16 communities, 100 Black MSM per community, 1600 total

Post-intervention Assessment: 16 communities, 200 Black MSM per community, 3200 total

Study Population:

Adolescent (>15 years old) and adult Black MSM. The intersectional stigma reduction intervention will focus on staff at health service facilities that serve this population.

Study Size:
Study Duration:

Once the pilot is complete, full study implementation will take place over three years.

Treatment Regimen:

The four components that make up the intervention package are described below:

1) Health equity: This community-level intervention will use a nationally replicable community coalition model (Black Treatment Advocate’s Networks Plus [BTAN+]), enhanced for HPTN 096, to promote health equity for Black MSM through capacity-building for leadership and advocacy in achieving health equity, community mobilization and education, cross-sector cooperation, sensitization of local service providers to the needs of Black MSM, and facilitating linkage of Black MSM to those service providers.

2) Social media influencers: In this community-level intervention, social media influencers (SMI) will provide tailored messaging prioritizing Black MSM in intervention communities on the topics of HIV testing promotion, PrEP awareness and promotion and the benefits of viral suppression messaging.

3) Intersectional stigma reduction: This organizational-level intervention will take place in healthcare facilities and is designed to optimize the healthcare environment for Black MSM by addressing the intersectional experience of racism, sexual stigma, gender nonconformity stigma, and HIV-related stigma through training, collaborative quality improvement and technical assistance.

4) Peer support: In this interpersonal-level intervention, Black MSM will be trained as HIV peer support workers to provide emotional and practical support to Black MSM. Once trained, they will have demonstrated competencies in HIV testing and diagnoses, PrEP uptake, ART adherence, intersectional stigma, local resources, the multi-cultural facets of the epidemic and the provision of emotional support.

Primary Objectives:

1) 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

2) 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:

1) 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

2) 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

3) 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

4) 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)

5) 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:

Exploratory Objectives include:

1) 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

2) 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)

3) 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)

4) To use mathematical modeling to
i) 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
ii) estimate the longer-term impact of the integrated strategy on HIV incidence among Black MSM in the southern US
iii) estimate the contribution to the overall impact on HIV incidence made by each of the integrated strategy components

5) 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

6) 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