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

Trial Summary

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 data supports the effectiveness of the FPI treatment for HIV prevention?

The research suggests that integrated interventions, which target multiple behaviors at once, can improve HIV prevention and care outcomes. This implies that a comprehensive approach like FPI might be effective in preventing HIV. ^{1 2 3 4 5}

How does the FPI Strategy for HIV Prevention differ from other HIV prevention treatments?

The FPI Strategy for HIV Prevention is unique because it likely involves a combination of different prevention methods tailored to specific populations, aiming to maximize effectiveness by integrating various evidence-based strategies. This approach contrasts with single-method strategies by addressing multiple aspects of HIV prevention simultaneously, potentially offering a more comprehensive solution. ^{1 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Sannisha Dale, PhD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England 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. [2018]

2. United Arab Emirates 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. [2023]

3. Ireland 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. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Implementing packaged HIV-prevention interventions for HIV-positive individuals: considerations for clinic-based and community-based interventions. [2021]

5. France pubmed.ncbi.nlm.nih.gov

[Outcome of HIV-infected patients after 5 years of antiretroviral therapy including a protease inhibitor: the Aproco/Copilote Cohort]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Combination HIV prevention: significance, challenges, and opportunities. [2021]

8. United States 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. [2021]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Maximising HIV prevention by balancing the opportunities of today with the promises of tomorrow: a modelling study. [2022]