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Integrated Strategy for PrEP Uptake in HIV Prevention

N/A
Waitlist Available
Research Sponsored by HIV Prevention Trials Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self-report a lifetime history of sex with other men
Are at least 15 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured with data available at the end of the three year intervention
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to see if an integrated strategy approach can increase uptake and use of pre-exposure prophylaxis (PrEP) and viral suppression rates among Black MSM in the southern United States.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on community-based interventions rather than medications or medical procedures directly administered to participants, specific side effects are not anticipated as part of the intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had sexual relations with other men in my lifetime.
Select...
I am 15 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured with data available at the end of the three year intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured with data available at the end of the three year intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PrEP use by Black MSM not living with HIV
Viral suppression in Black MSM living with diagnosed HIV
Secondary study objectives
Care quality of Black MSM needs at HCFs participating in CRISP
Compare barriers to healthcare in Black MSM in the intervention to the SOC communities
Compare individual agency in Black MSM in the intervention to the SOC communities
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard-of-careExperimental Treatment1 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 StrategyExperimental Treatment4 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Peer Support
2011
N/A
~6610

Find a Location

Who is running the clinical trial?

HIV Prevention Trials NetworkLead Sponsor
30 Previous Clinical Trials
563,878 Total Patients Enrolled
Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)UNKNOWN
3 Previous Clinical Trials
368 Total Patients Enrolled
LaRon Nelson, PhDStudy ChairYale University
1 Previous Clinical Trials
549 Total Patients Enrolled
Chris Beyrer, MDStudy ChairJohns Hopkins University
Robert Remien, PhDStudy ChairNY State Psychiatric Institute and Columbia University

Media Library

Health Equity Clinical Trial Eligibility Overview. Trial Name: NCT05075967 — N/A
Human Immunodeficiency Virus Infection Research Study Groups: Standard-of-care, Integrated Strategy
Human Immunodeficiency Virus Infection Clinical Trial 2023: Health Equity Highlights & Side Effects. Trial Name: NCT05075967 — N/A
Health Equity 2023 Treatment Timeline for Medical Study. Trial Name: NCT05075967 — N/A
~2361 spots leftby Jun 2027