Integrated Strategy for PrEP Uptake in HIV Prevention

Overseen By Theresa Gamble, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: HIV Prevention Trials Network

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

4800 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

LaRon Nelson, PhD

Principal Investigator

Yale University

Chris Beyrer, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for Black men, including cisgender and transgender, who have had sexual relations with other men. Participants must be at least 15 years old, live in the study area, and consent to a questionnaire and blood tests. HIV status doesn't matter for joining.

Inclusion Criteria

I have had sexual relations with other men in my lifetime.

I identify as a Black man, including if I am transgender.

Are willing and able to provide informed consent

Exclusion Criteria

N/A

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of the integrated strategy to increase PrEP uptake and viral suppression among Black MSM

3 years

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

Treatment Details

Interventions

• Intersectional Stigma Reduction
• Peer Support
• Social Media Influencers

Trial Overview The study is testing an approach that combines health equity efforts, stigma reduction strategies, standard care enhancements, social media influencer involvement, and peer support to improve PrEP use and viral suppression among Black MSM in the South.

Participant Groups

Group I: Standard-of-care Experimental Treatment 1 Intervention

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

Group II: Integrated Strategy Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

HIV Prevention Trials Network

Lead Sponsor

Trials

31

Recruited

569,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+

Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

Collaborator

Trials

4

Recruited

5,200+