FPI Strategy for HIV Prevention

(FPI Trial)

Overseen By SHINE Research Program

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Inability to understand consent, others

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

Compensation: Varies

Number of Visits: 8

20400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a strategy called FPI to boost HIV testing, improve access to preventive medicines like PrEP, and promote safe practices such as condom use. The focus is on reaching individuals in specific community locations, such as barbershops and grocery stores, in certain Miami neighborhoods with high HIV rates. Individuals who frequent these community spots and understand the study details are well-suited to join this trial. As an unphased trial, this study provides a unique opportunity to contribute to community health improvements and access preventive care strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the FPI strategy is safe for HIV prevention?

Research has shown that the FPI strategy aims to make HIV testing more accessible and connect people with prevention services. This includes linking individuals to Pre-exposure prophylaxis (PrEP), a medication that helps prevent HIV infection. PrEP is considered safe and has already received FDA approval for people at high risk of HIV.

Although specific safety details for FPI are not provided, PrEP is generally well-tolerated. Some individuals might experience mild side effects, such as an upset stomach or headaches, but these usually resolve on their own. It is important to note that any new program, like FPI, undergoes thorough testing to ensure participant safety. If any safety issues arise, they are promptly addressed to protect everyone involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the FPI strategy for HIV prevention because it's a fresh approach that aims to engage communities directly through coordinated outreach events. Unlike traditional methods like antiretroviral therapy or pre-exposure prophylaxis (PrEP) that focus on medication-based prevention, FPI emphasizes community involvement and education, potentially reaching individuals who might not access healthcare through conventional channels. By hosting events in local areas, FPI seeks to gather valuable data and insights directly from residents, which could lead to more tailored and effective prevention strategies. This proactive, community-centered approach holds promise for expanding the reach of HIV prevention efforts.

What evidence suggests that the FPI strategy is effective for HIV prevention?

Research has shown that the FPI strategy effectively encourages behaviors that prevent HIV. In a study of 457 people at risk of HIV, participants who received enhanced risk reduction counseling—part of the FPI strategy—reduced their number of unprotected sexual acts more than those who did not. This trial will include an FPI Group, where participants will receive the FPI intervention to raise awareness and increase the use of preventive measures like PrEP (a daily pill to prevent HIV) and condoms. The approach aims to improve knowledge and access, which are key to reducing the risk of HIV. Early findings suggest that FPI could help more people take steps to protect themselves from HIV. ^{3 6 7 8 9}

Who Is on the Research Team?

Sannisha Dale, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for anyone at community events in Miami's predominantly Black neighborhoods with high HIV rates, like barbershops, beauty salons, corner stores, laundromats, and car service providers. It's not for those who can't fully understand the consent process or study procedures.

Inclusion Criteria

You are an individual present at any of the "five points" in predominantly Black communities in Miami with a high HIV prevalence, such as barbershops, hair/beauty salons, corner stores/grocery stores/neighborhood restaurants, laundromats and car service providers.

Exclusion Criteria

Individuals who are unable to completely and fully understand the informed (verbal) consent process and the study procedures.

Timeline for a Trial Participant

Pre-intervention Assessment

Pre-assessment events to capture information from residents/participants via survey

1.5 months

Multiple events (4-5 hours each)

FPI Intervention

Participants receive the FPI intervention at coordinated outreach events

21 months

Multiple outreach events (4-5 hours each)

Follow-up

Participants are monitored for changes in PrEP knowledge, prescription, HIV testing, and condom use/access

23 months

What Are the Treatments Tested in This Trial?

Interventions

• FPI

Trial Overview The study tests the 'Five Point Initiative' (FPI) strategy to see if it boosts HIV testing, knowledge about PrEP (a medication to prevent HIV), prescription linkage for PrEP, and condom use and access in these communities.

How Is the Trial Designed?

Group I: FPI Group Experimental Treatment 1 Intervention

Participants in this group will receive the FPI intervention at any FPI coordinated outreach event (4-5 hours) during a 21 month period

Group II: Pre-intervention Assessment Group Active Control 1 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 Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The annual incidence of HIV infection in the United States has remained around 40,000 cases for over 15 years, highlighting the need for effective prevention strategies.

The article reviews the efficacy of current national HIV prevention strategies and suggests that opt-out HIV testing and evidence-based prevention methods should be prioritized in a new comprehensive national prevention plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based efforts to prevent HIV infection: an overview of current status and future challenges. Holtgrave, D.[2019]

A strategic approach to HIV prevention in South Africa emphasizes scaling up existing interventions like male circumcision and early antiretroviral therapy (ART) initiation, which are low-cost and highly effective, to maximize impact immediately.

The long-term success of HIV prevention efforts heavily relies on the successful development and scaling of a vaccine, while also considering the introduction of new methods like intravaginal rings and long-acting antiretroviral drugs if existing interventions cannot be sufficiently expanded.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximising HIV prevention by balancing the opportunities of today with the promises of tomorrow: a modelling study. Smith, JA., Anderson, SJ., Harris, KL., et al.[2022]

In a study of 457 individuals at risk of HIV, enhanced risk reduction counseling (5 sessions) led to a greater reduction in unprotected sexual acts compared to standard counseling (2 sessions), particularly for those at higher risk.

While both counseling approaches showed similar adherence to post-exposure prophylaxis (PEP), enhanced counseling was necessary for individuals with higher baseline risk to effectively reduce HIV seroconversion rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized noninferiority trial of standard versus enhanced risk reduction and adherence counseling for individuals receiving post-exposure prophylaxis following sexual exposures to HIV. Roland, ME., Neilands, TB., Krone, MR., et al.[2021]

Integrated interventions targeting multiple behaviors in people living with HIV (PLWH) significantly reduced unprotected sex, with an odds ratio of 0.74, indicating a 26% reduction in risk.

These interventions also showed marginal improvements in medication adherence and achieving undetectable viral loads, suggesting they can enhance both prevention and care outcomes for PLWH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of integrated interventions on transmission risk and care continuum outcomes in persons living with HIV: meta-analysis, 1996-2014. Crepaz, N., Baack, BN., Higa, DH., et al.[2018]

No single strategy can fully control the HIV pandemic, but a combination of interventions like knowledge of HIV status, behavioral changes, and antiretroviral medications can help reduce transmission.

There is a significant opportunity to create tailored 'prevention packages' that combine various effective strategies to meet the specific needs of different populations, aiming for high coverage and measurable reductions in HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination HIV prevention: significance, challenges, and opportunities. Kurth, AE., Celum, C., Baeten, JM., et al.[2021]

Motivational interviewing (MI) counseling significantly improved the initiation of antiretroviral therapy (ART) among HIV-positive people who inject drugs (PWID), with 29 out of 30 participants starting treatment compared to 68 out of 85 in the control group.

Despite the successful initiation of ART, both groups showed similar rates of treatment discontinuation and a low number of participants achieving HIV viral suppression over a 12-month follow-up, indicating that while MI counseling aids in starting treatment, further support may be needed for long-term adherence and viral control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational Interviewing as an Intervention to Improve Antiretroviral Treatment Initiation among People who Inject Drugs (PWID): A Pilot Study in Jakarta and Bandung, Indonesia. Sukmaningrum, E., Ayu, AP., Wongso, LV., et al.[2023]

A randomized controlled trial involving 73 HIV-infected adults who use drugs showed that a 16-week abstinence-reinforcing contingency management (CM) intervention significantly reduced HIV viral load (VL) by an average of 0.64 log10 copies/mL compared to a control group.

Despite the reduction in viral load, the CM intervention did not significantly improve drug abstinence or adherence to antiretroviral therapy, leaving the exact mechanism of its effectiveness unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abstinence-reinforcing contingency management improves HIV viral load suppression among HIV-infected people who use drugs: A randomized controlled trial. Cunningham, CO., Arnsten, JH., Zhang, C., et al.[2021]

The CDC has identified effective interventions for HIV prevention among HIV-positive individuals, but the uptake of these interventions has varied significantly across different settings, such as community organizations and medical clinics.

Challenges in implementing these interventions highlight the need for tailored strategies, as some programs, like those for methadone clinics and HIV-positive youth, have faced particularly low adoption rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing packaged HIV-prevention interventions for HIV-positive individuals: considerations for clinic-based and community-based interventions. Collins, CB., Hearn, KD., Whittier, DN., et al.[2021]

In a study of 1281 HIV-infected patients starting antiretroviral therapy, maintaining over 95% adherence during the first 4 months was crucial for long-term virological success, highlighting the importance of patient experience and support systems.

The study found that the risk of developing AIDS was highest in the first year after starting treatment, particularly for patients with CD4 counts below 50/mm3, while serious adverse events related to antiretroviral therapy occurred in 30% of patients over 5 years, mostly within the first 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Outcome of HIV-infected patients after 5 years of antiretroviral therapy including a protease inhibitor: the Aproco/Copilote Cohort]. Le Moing, V., Chêne, G., Spire, B., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10463742/

Five point initiative: a community-informed bundled ... Outcomes of FPI included (a) survey information (e.g., knowledge of and access to PrEP, barriers to care) and pilot data (acceptability and ...

2. withpower.com withpower.com/trial/phase-hiv-2024-efb30

FPI Strategy for HIV Prevention (FPI Trial) In a study of 457 individuals at risk of HIV, enhanced risk reduction counseling (5 sessions) led to a greater reduction in unprotected sexual acts compared to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10384104/

The Evolution of HIV Pre-Exposure Prophylaxis and Future ... TDF administered as a single drug alone demonstrated a reduction of 49% in HIV incidence, while the combination of FTC/TDF showed a reduction of 4.4%. The ...

4. mdpi.com mdpi.com/2076-393X/13/8/844

Counterfactual Groups to Assess Vaccine or Treatment ... We investigated use of counterfactual groups to assess treatment efficacy. Methods: We used data from placebo arms of two previous HIV prevention efficacy ...

5. cdc.gov cdc.gov/hiv-data/nhss/national-hiv-prevention-and-care-outcomes.html

National HIV Prevention and Care Objectives | HIV Data In 2022, over 80% of people with diagnosed HIV were linked to care within one month of diagnosis. Only 76% had received some care, 54% were ...

6. nimh.nih.gov nimh.nih.gov/health/trials/hiv-aids

HIV/AIDS - National Institute of Mental Health (NIMH) - NIH This study is testing a new program designed to improve access to HIV testing and help connect people with available treatment or prevention services, based on ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2012/021752Orig1s030OtherR.pdf

021752Orig1s030 - accessdata.fda.gov Safety trial to be conducted through collection of data from a subgroup of HIV seroconverters taking Truvada for pre-exposure prophylaxis ...

8. dhs.wisconsin.gov dhs.wisconsin.gov/dms/memos/admin/dms-admin-22-02atttachment1.pdf

Fraud Prevention and Investigation Program (FPIP) The FPIP was developed as a result of a state and local planning effort. Participants in that planning process considered past Public Assistance Fraud ...

9. thefpi.org thefpi.org/about/fpi-projects/

FPI Collaborative Projects FPI researchers have developed disease progression models that characterize the temporal ordering of clinical and biomarker changes in the genetic forms of FTD.