PrEP Adherence Programs for HIV Prevention

(C4+3MV Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two programs to help Black men who have sex with men take their PrEP medication more regularly. PrEP prevents HIV, and the study compares the effectiveness of a care coordination program called C4 (Comprehensive Connected Cancer Care) with a combination of C4 and additional support sessions called 3MV. Participants will receive counseling, have their medication use monitored, and share their experiences. This trial suits Black men who have had sex with men in the past six months and are either taking or eligible for PrEP. As an unphased trial, it offers participants the chance to contribute to important research that could improve PrEP adherence and HIV prevention strategies.

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 prior data suggests that these interventions are safe for improving PrEP adherence?

Research has shown that the C4 program, one of the interventions being tested, has been safe in earlier studies. In one study, 79% of participants regularly used PrEP, and the program maintained 92% participant involvement over 12 months. This suggests that the program is well-liked and easy to follow.

For the C4 + 3MV intervention, the C4 component has already proven effective in helping people adhere to their PrEP routine. The additional 3MV sessions aim to further assist participants by addressing stigma and encouraging safer behaviors. While specific safety data for the combined program is not available, both components have been used in similar situations without major safety issues.

Overall, these interventions focus on providing support and education, rather than introducing new medications or treatments. This generally makes them low-risk in terms of safety, as they are designed to help participants continue taking a medication they are already using to prevent HIV. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these PrEP adherence programs for HIV prevention because they take a comprehensive approach to tackle the issue. Unlike standard methods that mainly focus on medication adherence alone, the C4 and C4 + 3MV programs also address structural and behavioral barriers that might prevent people from sticking to their PrEP regimen. The C4 program offers care coordination and support to improve healthcare access and mental health, while the C4 + 3MV program adds a unique behavioral element that reduces stigma and boosts self-confidence through group activities. By integrating these innovative strategies, these programs aim to significantly enhance adherence to PrEP, potentially leading to better outcomes in HIV prevention.

What evidence suggests that this trial's interventions could improve PrEP adherence among Black MSM?

Research has shown that the C4 program, one of the interventions in this trial, yields promising results in helping people take PrEP, a medication that prevents HIV. In earlier studies, 79% of participants used PrEP, and 92% remained in the program for a year, indicating its effectiveness in supporting adherence to medication plans.

The C4 + 3MV program, another intervention in this trial, adds extra sessions to the C4 program that focus on behavior change, potentially offering additional benefits. The 3MV component works to reduce stigma and encourage safer habits, which may help people take PrEP more consistently. Both programs in this trial aim to support participants and address challenges in maintaining regular PrEP use. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11412310/

Client-Centered Care Coordination (C4™) for HIV/STI ... PrEP use was 79%, with 91% of PrEP users starting within 30-days. 12-month retention in C4™ was 92%. Care coordination encounters focused primarily on clients' ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6376611/

results from the HPTN 073 study - PMC - PubMed Central Of the 226 men enrolled, 178 participants initiated PrEP (79%), and of these 64% demonstrated PrEP utilization at week 26 (mid‐point of the study) based on ...

3. researchgate.net researchgate.net/publication/331118656_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

Pre-exposure prophylaxis initiation and adherence among ... Annualized HIV incidence was 2.9 (95% CI 1.2 to 7.9) among those who initiated PrEP, compared to 7.7 (95% CI 2.5 to 24.1) among those who did not initiate PrEP ...

4. cdc.gov cdc.gov/mmwr/volumes/69/rr/rr6903a1.htm

Preexposure Prophylaxis for Prevention of HIV Acquisition ... Preexposure prophylaxis (PrEP) with antiretroviral medication has been proven effective in reducing the risk for acquiring human immunodeficiency virus (HIV).

5. hivprep.uw.edu hivprep.uw.edu/pdf/hiv-prep-fundamentals/basic-principles-rationale-hiv-prep/core-concept/all

Basic Principles and Rationale for HIV PrEP - Core Concepts HIV PrEP is Effective: When taken as prescribed, HIV PrEP is more than 90% effective for preventing ... HIV PrEP usage data show major differences in HIV PrEP ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1002/jia2.25223

Pre‐exposure prophylaxis initiation and adherence among ... Of the 226 men enrolled, 178 participants initiated PrEP (79%), and of these 64% demonstrated PrEP utilization at week 26 (mid-point of the ...