Clinical trial NCT05075967: Getting to Zero Among Black MSM in the American South
Official title: Getting to Zero Among Black Men Who Have Sex With Men (MSM) in the American South: Testing an Integrated Strategy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: HIV Infections
Keywords: Pre-exposure Prophylaxis (PrEP)
Men who have Sex with Men (MSM)
Black Men who have Sex with Men (Black MSM)
HIV Incidence
Viral Suppression
Status-neutral Approach
Southern United States
Health Equity
Social Media Influencers (SMI)
Intersectional Stigma Reduction
Peer Support
Black Treatment Advocates Networks (BTAN)
Ending the HIV Epidemic (EHE)
Black AIDS Institute (BAI)
Culturally Responsive Intersectional Stigma Prevention (CRISP)
Integrated Strategy
Community-randomized
Social determinants of health
Community mobilization
Community-based participatory research
Lead sponsor: HIV Prevention Trials Network
Sponsor class: NETWORK
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2021-10-13
Enrollment: 4800
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 16 communities will participate in the study, each made up of one or more counties selected from the southern counties and states identified in the Ending the HIV Epidemic (EHE) plan. The communities will be matched into 8 pairs based on population, HIV prevalence and viral suppression. Within each pair, one community will be randomized by public ceremony to receive the components of the integrated strategy, and the other will serve as the standard-of-care (SOC).

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 control communities for the cross-sectional assessments.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: The baseline and post-implementation assessment participants will be persons who:

* Self-identify as Black man (inclusive of cisgender and transgender men)
* Self-report a lifetime history of sex with other men
* Are at least 15 years of age
* Self-report current residence in the community of interest
* Are willing and able to provide informed consent
* Agree to complete a short questionnaire
* Agree to provide two blood samples (one by fingerstick and another by venipuncture).

HIV status will not be ascertained prior to participation in these assessments and eligible Black MSM may participate regardless of HIV status.

Primary outcomes:
measure: Viral suppression in Black MSM living with diagnosed HIV
timeFrame: Measured with data available at the end of the three year intervention
measure: Viral suppression in Black MSM living with diagnosed HIV
timeFrame: Measured within six months after the end of the three year intervention
measure: PrEP use by Black MSM not living with HIV
timeFrame: Measured within six months after the end of the three year intervention
measure: PrEP use by Black MSM not living with HIV
timeFrame: Measured with data available at the end of the three year intervention
Secondary outcomes:
measure: Self-reported HIV Testing behavior in Black MSM
timeFrame: Measured within six months after the end of the three year intervention
measure: Compare social support in Black MSM in the intervention to the SOC communities
timeFrame: Measured within six months after the end of the three year intervention
measure: Compare intersectional stigma in Black MSM in the intervention to the SOC communities
timeFrame: Measured within six months after the end of the three year intervention
measure: Compare barriers to healthcare in Black MSM in the intervention to the SOC communities
timeFrame: Measured within six months after the end of the three year intervention
measure: Compare individual agency in Black MSM in the intervention to the SOC communities
timeFrame: Measured within six months after the end of the three year intervention
measure: Viral suppression within 6 months of new diagnosis in Black MSM living with HIV
timeFrame: Measured with data available at the end of the three year intervention
measure: Tracking EHE implementation activities for Black MSM
timeFrame: Measured with data available at the end of the three year intervention
measure: Tracking EHE implementation activities for Black MSM
timeFrame: Measured with data available at the end of the three year intervention
measure: Care quality of Black MSM needs at HCFs participating in CRISP
timeFrame: Measured with data available at the end of the three year intervention
measure: Care quality of Black MSM needs at HCFs participating in CRISP
timeFrame: Measured with data available at the end of the three year intervention
measure: Care quality of Black MSM needs at HCFs participating in CRISP
timeFrame: Measured with data available at the end of the three year intervention
measure: Responsiveness to Black MSM needs at HCFs participating in CRISP
timeFrame: Measured with data available at the end of the three year intervention
measure: Responsiveness to Black MSM needs at HCFs participating in CRISP
timeFrame: Measured with data available at the end of the three year intervention
measure: Responsiveness to Black MSM needs at HCFs participating in CRISP
timeFrame: Measured with data available at the end of the three year intervention
Other outcomes:
Locations:
city: Durham
country: United States
facility: FHI 360
state: North Carolina
Study officials:
affiliation: Yale University
name: LaRon Nelson, PhD
role: STUDY_CHAIR
affiliation: Johns Hopkins University
name: Chris Beyrer, MD
role: STUDY_CHAIR
References: