HPTN 096 is a community-randomized, controlled, hybrid-type III implementation effectiveness study. It is designed to evaluate an integrated strategy approach to increase the uptake and use of pre-exposure prophylaxis (PrEP) and viral suppression rates among Black MSM in the southern United States. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
4,800
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.
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: * HIV/sexually transmitted infections (STI) testing promotion * PrEP (and general HIV prevention) awareness and promotion * 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.
FHI 360
Durham, North Carolina, United States
Viral suppression in Black MSM living with diagnosed HIV
(primary) The ratio of the number of Black MSM living with diagnosed HIV who are virally suppressed (\<200 copies/mL) as measured by HIV surveillance data divided by the number of Black MSM living with diagnosed HIV as measured by HIV surveillance data
Time frame: Measured with data available at the end of the three year intervention
Viral suppression in Black MSM living with diagnosed HIV
(supportive) HIV viral load measured in the cross-sectional assessments
Time frame: Measured within six months after the end of the three year intervention
PrEP use by Black MSM not living with HIV
(primary) The presence of PrEP agents measured in a dried blood spot (DBS) collected during the cross-sectional assessments
Time frame: Measured within six months after the end of the three year intervention
PrEP use by Black MSM not living with HIV
(supportive) The ratio of the number of Black men with PrEP prescriptions (from AIDSVu) divided by the number of Black men with PrEP indications (from CDC)
Time frame: Measured with data available at the end of the three year intervention
Self-reported HIV Testing behavior in Black MSM
Responses to survey questions collected during the post implementation cross-sectional assessment
Time frame: Measured within six months after the end of the three year intervention
Compare social support in Black MSM in the intervention to the SOC communities
Responses to survey questions collected during the post-implementation cross-sectional assessment
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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.
Peer support workers will be trained and compensated to provide emotional and practical support services. 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. Once trained, the peer-support workers will have demonstrated competencies in the following domains: * HIV, PrEP, nPEP, other HIV prevention options and ART education * Adherence to PrEP, ART and medical care * HIV/STI testing * New HIV diagnosis * Addressing intersectional stigma (anti-Black racism, sexual stigmas, HIV-related stigma) * Self-care * Information about national and local resources and assistance programs, Black MSM-centered health services, and the cost and insurance coverage of medications and medical care * Multicultural competency (as it relates to the HIV epidemic for Black MSM in the southern US)
Black MSM living in standard-of-care communities will have access to standard HIV prevention and care services available in their communities.
Time frame: Measured within six months after the end of the three year intervention
Compare intersectional stigma in Black MSM in the intervention to the SOC communities
Responses to survey questions collected during the post-implementation cross-sectional assessment
Time frame: Measured within six months after the end of the three year intervention
Compare barriers to healthcare in Black MSM in the intervention to the SOC communities
Responses to survey questions collected during the post-implementation cross-sectional assessment
Time frame: Measured within six months after the end of the three year intervention
Compare individual agency in Black MSM in the intervention to the SOC communities
Responses to survey questions collected during the post-implementation cross-sectional assessment
Time frame: Measured within six months after the end of the three year intervention
Viral suppression within 6 months of new diagnosis in Black MSM living with HIV
The ratio of the number of Black MSM with HIV newly diagnosed in Year 3 who have a suppressed viral load (VL) within six months of diagnosis as measured by HIV surveillance data divided by the number of Black MSM with HIV newly diagnosed in Year 3 based on HIV surveillance data
Time frame: Measured with data available at the end of the three year intervention
Tracking EHE implementation activities for Black MSM
Information about EHE implementation activities affecting Black MSM in the EHE plans of all intervention and control communities
Time frame: Measured with data available at the end of the three year intervention
Tracking EHE implementation activities for Black MSM
Information about EHE implementation activities affecting Black MSM in additional information from local health departments and EHE committees
Time frame: Measured with data available at the end of the three year intervention
Care quality of Black MSM needs at HCFs participating in CRISP
Self-reported survey data from health care workers who participate in the CRISP component
Time frame: Measured with data available at the end of the three year intervention
Care quality of Black MSM needs at HCFs participating in CRISP
Aggregated, facility-level independent ratings of HCF workers
Time frame: Measured with data available at the end of the three year intervention
Care quality of Black MSM needs at HCFs participating in CRISP
Self-reported survey data from Black MSM receiving services at HCFs participating in CRISP activities
Time frame: Measured with data available at the end of the three year intervention
Responsiveness to Black MSM needs at HCFs participating in CRISP
Self-reported survey data from health care workers who participate in the CRISP component
Time frame: Measured with data available at the end of the three year intervention
Responsiveness to Black MSM needs at HCFs participating in CRISP
Aggregated, facility-level independent ratings of HCF workers
Time frame: Measured with data available at the end of the three year intervention
Responsiveness to Black MSM needs at HCFs participating in CRISP
Self-reported survey data from Black MSM receiving services at HCFs participating in CRISP activities
Time frame: Measured with data available at the end of the three year intervention