PrEP Adherence Programs for HIV Prevention

(C4+3MV Trial)

Recruiting at 1 trial location

Overseen By LaRon Nelson, PhD, RN, FNP, FNAP, FNYAM, FAA

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Yale University

Must be taking: PrEP

Disqualifiers: HIV, Health issues, others

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

Compensation: Varies

Number of Visits: Unknown

500 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn if two interventions-C4 and C4+3MV-can improve PrEP adherence (taking medication to prevent HIV) among Black men who have sex with men (MSM). The study will also explore the most effective ways to support participants in continuing their PrEP use over time. The main questions it aims to answer are: * Does the C4 program help participants take PrEP more regularly? * Does adding the 3MV intervention to C4 provide additional support for adherence? Researchers will compare two intervention strategies to see if they result in better PrEP adherence: * C4 Intervention: A program focused on individualized care coordination and addressing structural needs. * C4 + 3MV Intervention: A combination of care coordination with additional behavioral change sessions. Participants will: * Participate in PrEP education and counseling sessions. * Have their PrEP use monitored through dried blood spot (DBS) tests. * Complete questionnaires about their experiences and challenges with PrEP. Receive support sessions tailored to address individual barriers to PrEP adherence.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the focus is on improving adherence to PrEP, it seems likely that you can continue your current medications unless they interfere with PrEP.

What data supports the effectiveness of the treatment C4 + 3MV Program, C4 Program, Comprehensive Connected Cancer Care for HIV prevention?

The C4 Program, which is part of the treatment, has been shown to help Black men who have sex with men start and stick to using PrEP, a medication that can prevent HIV. This approach uses culturally informed and client-centered care coordination to improve adherence, which is crucial for PrEP's effectiveness. ^{1 2 3 4 5}

Is the PrEP Adherence Program safe for humans?

The studies reviewed focus on the effectiveness and adherence to PrEP (pre-exposure prophylaxis) for HIV prevention, but they do not provide specific safety data for the PrEP Adherence Program or related programs like C4 + 3MV or C4 Program. However, PrEP itself, which includes medications like Truvada, has been approved by the FDA and is generally considered safe for use in humans. ^{1 6 7 8 9}

What makes the C4 + 3MV Program unique for HIV prevention?

The C4 + 3MV Program is unique because it uses a client-centered care coordination model specifically designed to improve PrEP adherence among Black men who have sex with men, a group that is often underrepresented in HIV prevention efforts. This approach focuses on culturally informed and personalized support to enhance adherence, which is crucial for the effectiveness of PrEP. ^{1 4 6 10 11}

Eligibility Criteria

This trial is for Black men who have sex with men (MSM) interested in improving their adherence to PrEP, a medication regimen that helps prevent HIV. Participants should be willing to undergo education and counseling sessions, have their medication use monitored via blood tests, and complete questionnaires.

Inclusion Criteria

Self-identify as Black people

I am eligible for or currently on PrEP medication.

I identify as male.

Exclusion Criteria

Participating in another clinical trial with conflicting outcomes

I am unable to understand and give consent for treatment.

I am currently diagnosed with HIV.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Participants experience a 3-month control period before interventions begin

3 months

Intervention

Participants receive either the C4 intervention or the C4 + 3MV intervention to improve PrEP adherence

9 months

Regular counseling sessions and DBS testing

Follow-up

Participants are monitored for PrEP adherence and other outcomes after the intervention

12 months

Data collection at 0, 3, 6, 9, and 12 months

Treatment Details

Interventions

• C4 + 3MV Program
• C4 Program

Trial Overview The study compares two strategies: the C4 Program focusing on personalized care coordination, and the C4 + 3MV Program which adds behavioral change sessions. The goal is to see which method better supports regular PrEP usage among participants.

Participant Groups

Group I: C4 Intervention Experimental Treatment 1 Intervention

Participants in this arm will receive care coordination and support through the C4 intervention. This program focuses on addressing structural barriers, such as healthcare access and mental health, to improve PrEP adherence. Participants will also attend regular counseling sessions and have their PrEP use monitored through dried blood spot (DBS) tests.

Group II: C4 + 3MV Intervention Experimental Treatment 1 Intervention

Participants in this arm will receive the C4 intervention, along with the 3MV (Many Men, Many Voices) behavioral intervention. The 3MV program aims to reduce stigma, promote safer behaviors, and increase self-efficacy. This arm integrates both structural and behavioral approaches to enhance PrEP adherence. Participants will complete counseling sessions, group activities, and DBS testing for monitoring adherence.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

Adherence to antiretroviral-based pre-exposure prophylaxis (PrEP) is crucial for preventing new HIV infections, and understanding how to support sustained adherence is essential for effective PrEP programs.

Key recommendations from four major PrEP trials emphasize the importance of participant-centered approaches, tailored strategies beyond just education, and addressing individual contexts to enhance adherence to PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. Amico, KR., Mansoor, LE., Corneli, A., et al.[2023]

A systematic review identified 16 studies on alternative HIV preexposure prophylaxis (PrEP) care delivery models, highlighting promising approaches like pharmacist prescribers, telePrEP, and mail-in testing to enhance access to PrEP services.

Despite the low risk of bias in most studies, none met the established criteria for evidence-based interventions, indicating a need for further research to validate these alternative models in improving PrEP delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of alternative HIV preexposure prophylaxis care delivery models to improve preexposure prophylaxis services. Kamitani, E., Mizuno, Y., DeLuca, JB., et al.[2023]

In a pilot study involving 61 adults interested in PrEP, those receiving strengths-based case management (SBCM) showed a higher rate of completing a provider visit (53.3%) compared to the control group (32.3%), suggesting that SBCM can effectively facilitate access to PrEP care.

Overall, 34% of participants initiated PrEP within 12 weeks, with no significant difference in the time to initiation between the SBCM and control groups, indicating that while SBCM helps with provider visits, it may not speed up the actual start of PrEP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Study of Passive versus Active PrEP Patient Navigation for a Heterogeneous Population at Risk for HIV in South Florida. Doblecki-Lewis, S., Butts, S., Botero, V., et al.[2020]

The 'I Am Men's Health' program successfully improved adherence to PrEP among 23 young men of color at high risk for HIV, achieving an average adherence rate of 73% over a 28-week period.

This innovative approach to promoting PrEP adherence may serve as a model for future large-scale HIV prevention efforts, particularly in communities with high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I Am Men's Health: Generating Adherence to HIV Pre-Exposure Prophylaxis (PrEP) in Young Men of Color Who Have Sex with Men. Daughtridge, GW., Conyngham, SC., Ramirez, N., et al.[2022]

In a study involving 3065 high-risk HIV-negative adults, the incidence of HIV-1 was very low at 1.1 cases per 1000 person-years, showing that both daily and on-demand PrEP are effective in preventing HIV infection.

There was no significant difference in HIV-1 incidence between those using daily PrEP and those using on-demand PrEP, indicating that on-demand PrEP is a valid alternative, providing flexibility for men who have sex with men (MSM) in their HIV prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study. Molina, JM., Ghosn, J., Assoumou, L., et al.[2022]

Among 3121 individuals who started pre-exposure prophylaxis (PrEP) from 2014 to 2017, only 42% remained active on PrEP by April 2018, highlighting challenges in maintaining treatment adherence.

Active PrEP patients had a significantly lower HIV incidence of 0.1 cases per 100 person-years compared to 2.1 cases per 100 person-years among those who discontinued, indicating that continuous PrEP use is crucial for effective HIV prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind the gaps: prescription coverage and HIV incidence among patients receiving pre-exposure prophylaxis from a large federally qualified health center in Los Angeles, California : Mind the Gaps: Cobertura de recetas e incidencia de VIH entre pacientes recibiendo profilaxis pre-exposición de un centro de salud grande y federalmente calificado en Los Ángeles, CA. Shover, CL., Shoptaw, S., Javanbakht, M., et al.[2023]

A PrEP adherence intervention was successfully implemented in a clinical trial involving 1147 participants, leading to a significant increase in adherence from 75.7% to 84.1% after counseling sessions.

The intervention, based on cognitive-behavioral principles, was particularly effective for participants who reported barriers such as travel and forgetfulness, highlighting the importance of tailored support in improving PrEP adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intervention to support HIV preexposure prophylaxis adherence in HIV-serodiscordant couples in Uganda. Psaros, C., Haberer, JE., Katabira, E., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Pre-exposure prophylaxis initiation and adherence among Black men who have sex with men (MSM) in three US cities: results from the HPTN 073 study. [2022]

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

Adherence support approaches in biomedical HIV prevention trials: experiences, insights and future directions from four multisite prevention trials. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Systematic review of alternative HIV preexposure prophylaxis care delivery models to improve preexposure prophylaxis services. [2023]

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

A Randomized Study of Passive versus Active PrEP Patient Navigation for a Heterogeneous Population at Risk for HIV in South Florida. [2020]

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

Understanding patient motivations for HIV pre-exposure prophylaxis initiation and adherence. [2021]

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

I Am Men's Health: Generating Adherence to HIV Pre-Exposure Prophylaxis (PrEP) in Young Men of Color Who Have Sex with Men. [2022]

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

The Unanticipated Benefits of PrEP for Young Black Gay, Bisexual, and Other Men Who Have Sex with Men. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Daily and on-demand HIV pre-exposure prophylaxis with emtricitabine and tenofovir disoproxil (ANRS PREVENIR): a prospective observational cohort study. [2022]

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

Mind the gaps: prescription coverage and HIV incidence among patients receiving pre-exposure prophylaxis from a large federally qualified health center in Los Angeles, California : Mind the Gaps: Cobertura de recetas e incidencia de VIH entre pacientes recibiendo profilaxis pre-exposición de un centro de salud grande y federalmente calificado en Los Ángeles, CA. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Untangling the cost-effectiveness knot: who is oral antiretroviral HIV pre-exposure prophylaxis really for? [2014]

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

An intervention to support HIV preexposure prophylaxis adherence in HIV-serodiscordant couples in Uganda. [2022]