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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 belowSelect...
I have had sexual relations with other men in my lifetime.
Select...
I am 15 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured with data available at the end of the three year intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured with data available at the end of the three year intervention
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 moreAwards & 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- N/AI have had sexual relations with other men in my lifetime.I identify as a Black man, including if I am transgender.I am 15 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Standard-of-care
- Group 2: Integrated Strategy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.