HivFPINCT06062342
Five Point Initiative: A Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities
A study testing FPI in people with Hiv, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of the FPI bundled implementation strategy in increasing HIV testing, Pre-exposure prophylaxis (PrEP) linkage (e.g., prescription) and knowledge, and condom use/access. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- FPI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,400 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2024to 30 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
SHINE Research Program contact
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Sannisha Dale, PhD, (305) 243-6714, sdale@med.miami.edu
Sannisha Dale, PhD
About this study
Official title: Five Point Initiative: A Cluster Randomized Trial of a Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities
The purpose of this study is to assess the effectiveness of the FPI bundled implementation strategy in increasing HIV testing, Pre-exposure prophylaxis (PrEP) linkage (e.g., prescription) and knowledge, and condom use/access.
- Conditions
- Hiv
- Being tested
- FPI
- Keywords
- HIV prevention, HIV testing, PrEP, Implementation Science
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FPIBehavioural
The FPI intervention will be conducted twice per month (across 21 months) in a zip code, and each event will last approximately 4-5 hours. At the event, participants will receive HIV testing, PrEP linkage (e.g., prescription) and knowledge, and condom and use/access.
| Study group | Role | What they receive |
|---|---|---|
| FPI Group | Experimental | Participants in this group will receive the FPI intervention at any FPI coordinated outreach event (4-5 hours) during a 21 month period Receives: Behavioral: FPI |
| Pre-intervention Assessment Group | No intervention | We will conduct pre-assessment events (4-5 hours) during 1.5 months in each zip code (prior to the introduction of the FPI intervention) to capture information from residents /participants via survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of residents with recent HIV testing
Will be reported as proportion of residents with recent (within 12 months) HIV testing as measured by Five Point Initiative - Community Survey
Measured: Up to 23 months
Change in number of residents with PrEP prescription
Will be reported as proportion of residents with PrEP prescription as measured by Five Point Initiative - Community Survey
Measured: Up to 23 months
Change in PrEP knowledge as measured by Five Point Initiative - Community Survey
Will be reported as the proportion of residents that indicated 'Yes' on the survey.
Measured: Baseline and up to 23 months
Secondary outcomes (4)
Change in condom use as measured by Five Point Initiative - Community Survey
Will be reported as the proportion of residents that indicated 'No' on the survey
Measured: Baseline and up to 23 months
Change in condom access as measured by Five Point Initiative - Community Survey
Will be reported as the proportion of residents that indicated 'Yes' on the survey
Measured: Baseline and up to 23 months
Proportion of residents with recent HIV testing by health organizations
Proportion of residents with recent (within 12 months) HIV testing by each of the participating health organizations.
Measured: Up to 23 months
Number of residents with PrEP prescription by health organizations
Number of residents with PrEP prescription by each of the participating health organizations.
Measured: Up to 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start2 Feb 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a stepped wedge trial and all zip codes cross over from pre-assessment period (control) to active intervention. The time/order in which zip codes enter the stepped wedge is the unity of randomization.
- Masking
- None (open label)
- Enrolment
- 20,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sannisha K Dale, University of Miami
- Investigators
- Sannisha Dale, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062342
- Sponsor's protocol ID
- 20230484
- Other IDs
- 1R01MH134269-01
- Acronym
- FPI
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2023
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five Point Initiative: A Cluster Randomized Trial of a Bundled Implementation Strategy to Address the HIV Epidemic in Black Communities
- ClinicalTrials.gov ID
- NCT06062342
- Acronym / sponsor ID
- FPI / 20230484
- Conditions
- Hiv
- Keywords
- HIV prevention, HIV testing, PrEP, Implementation Science
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20,400 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effectiveness of the FPI bundled implementation strategy in increasing HIV testing, Pre-exposure prophylaxis (PrEP) linkage (e.g., prescription) and knowledge, and condom use/access.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a stepped wedge trial and all zip codes cross over from pre-assessment period (control) to active intervention. The time/order in which zip codes enter the stepped wedge is the unity of randomization.
| Arm | Type | Receives |
|---|---|---|
| FPI Group | Experimental | Behavioral: FPIParticipants in this group will receive the FPI intervention at any FPI coordinated outreach event (4-5 hours) during a 21 month period |
| Pre-intervention Assessment Group | No intervention | –We will conduct pre-assessment events (4-5 hours) during 1.5 months in each zip code (prior to the introduction of the FPI intervention) to capture information from residents /participants via survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FPIThe FPI intervention will be conducted twice per month (across 21 months) in a zip code, and each event will last approximately 4-5 hours. At the event, participants will receive HIV testing, PrEP linkage (e.g., prescription) and knowledge, and condom and use/access. | Behavioural | FPI Group |
Primary outcome
Change in number of residents with recent HIV testing
Time frame: Up to 23 months
Will be reported as proportion of residents with recent (within 12 months) HIV testing as measured by Five Point Initiative - Community Survey
Change in number of residents with PrEP prescription
Time frame: Up to 23 months
Will be reported as proportion of residents with PrEP prescription as measured by Five Point Initiative - Community Survey
Change in PrEP knowledge as measured by Five Point Initiative - Community Survey
Time frame: Baseline and up to 23 months
Will be reported as the proportion of residents that indicated 'Yes' on the survey.
4 secondary outcomes
Change in condom use as measured by Five Point Initiative - Community Survey
Time frame: Baseline and up to 23 months
Change in condom access as measured by Five Point Initiative - Community Survey
Time frame: Baseline and up to 23 months
Proportion of residents with recent HIV testing by health organizations
Time frame: Up to 23 months
Number of residents with PrEP prescription by health organizations
Time frame: Up to 23 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
SHINE Research Program contact
Sannisha Dale, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FPI in people with Hiv, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sannisha Dale, PhD ((305) 243-6714, sdale@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of residents with recent HIV testing (time frame: Up to 23 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.