Getting to Zero Among Black MSM in the American South

HIV Prevention Trials Network

Status: Suspended

Conditions: HIV Infections

Treatments: Behavioral: Peer Support; Behavioral: Social Media Influencers; Other: Health Equity; Other: Standard-of-care; Behavioral: Intersectional Stigma Reduction

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT05075967

HPTN 096

Details and patient eligibility

About

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.

Enrollment: 4,800 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,800 participants in 2 patient groups

Integrated Strategy

Experimental group

Description:

Black MSM living in intervention communities will have access to the HPTN 096 integrated strategy in addition to standard HIV prevention and care services available in their communities. The integrated strategy includes a combination of four community-, organizational-, and interpersonal-level components designed to impact individual-level outcomes.

Treatment:

Behavioral: Intersectional Stigma Reduction

Other: Health Equity

Behavioral: Social Media Influencers

Behavioral: Peer Support

Standard-of-care

Other group

Description:

Black MSM living in standard-of-care communities will have access to standard HIV prevention and care services available in their communities.

Treatment:

Other: Standard-of-care