A program to improve HIV prevention and testing in Black communities
Five Point Initiative: A Cluster Randomized Trial of a Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities
NA · University of Miami · NCT06062342
This study is testing a new program to see if it can help Black communities in Miami get better access to HIV testing, PrEP, and condoms through local events.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami (other) |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06062342 on ClinicalTrials.gov |
What this trial studies
This initiative aims to evaluate the effectiveness of a bundled implementation strategy called the Five Point Initiative (FPI) in enhancing HIV testing, increasing access to Pre-exposure prophylaxis (PrEP), and promoting condom use in predominantly Black communities in Miami. The study will involve community events at key local venues such as barbershops and grocery stores, where participants will be surveyed before and after the intervention. The goal is to assess changes in knowledge and behavior related to HIV prevention and treatment.
Who should consider this trial
Good fit: Ideal candidates include individuals attending community events in high-prevalence areas of Miami who are willing to participate in surveys and interventions.
Not a fit: Patients who have previously participated in the study within the last six months or those unable to understand the consent process may not benefit.
Why it matters
Potential benefit: If successful, this initiative could significantly reduce HIV transmission rates and improve health outcomes in Black communities.
How similar studies have performed: Other studies have shown success with community-based interventions for HIV prevention, indicating that this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any individual present during the community events at the "five points" (barbershop, hair/beauty salon store or salon, corner store/grocery/neighborhood restaurant, laundromats, car service provider \[e.g. gas station, mechanic, car wash\]) in predominantly Black communities in Miami where HIV prevalence is high. * Pre- and Post-assessment: Individuals are only eligible to complete the survey one time during the Pre-Intervention and during the Post-Intervention phases. * Intervention: Individuals are only eligible to participate in the Intervention phase of this study once every 6 months. Exclusion Criteria: * Individuals who are unable to completely and fully understand the informed (verbal) consent process and the study procedures. * Individuals who have previously completed the survey during the Pre-Intervention and Post-Intervention phases. * Individuals who have participated in the Intervention phase of this study within less than 6 months.
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Sannisha Dale, PhD — University of Miami
- Study coordinator: Sannisha Dale, PhD
- Email: sdale@med.miami.edu
- Phone: (305) 243-6714
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hiv, HIV prevention, HIV testing, PrEP, Implementation Science