ACT-Based PrEP Intervention for HIV Prevention

Overseen By Trisha Arnold, PhD

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Rhode Island Hospital

Disqualifiers: Other PrEP study

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to prevent HIV in young Black men who have sex with men, using Acceptance and Commitment Therapy (ACT). The study compares two groups: one receives a short educational session about pre-exposure prophylaxis (PrEP), while the other receives sessions combining ACT with PrEP education, known as ACTPrEP. The goal is to develop a culturally appropriate program that supports consistent PrEP use. Ideal candidates for this trial are English-speaking Black men who have not taken PrEP in the past three months and have had sex with men during that time.

As an unphased trial, this study offers a unique opportunity to contribute to developing innovative prevention strategies tailored to the community.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that methods based on Acceptance and Commitment Therapy (ACT), such as ACTPrEP, can help people become more adaptable in their thinking. This adaptability can make it easier for young Black men who have sex with men to start using pre-exposure prophylaxis (PrEP) to prevent HIV. Although specific safety data for ACTPrEP is unavailable due to its behavioral nature, PrEP itself has been proven to lower the risk of HIV when used correctly.

PrEP has been tested in other studies and has shown to be effective and generally safe when taken as directed. ACTPrEP supports adherence to the PrEP routine without introducing new medications, so it is expected to be well-tolerated. Overall, ACT-based methods aim to help individuals manage any discomfort with starting or continuing PrEP, making it a promising way to improve health outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ACTPrEP intervention for HIV prevention because it combines Acceptance and Commitment Therapy (ACT) with pre-exposure prophylaxis (PrEP) education. Unlike the standard of care, which typically involves a single educational session, ACTPrEP includes an initial 60-minute session followed by additional sessions at 2, 6, and 12 weeks. This approach aims to enhance adherence and motivation, potentially leading to more consistent use of PrEP and better prevention outcomes. By integrating behavioral therapy with medical prevention, ACTPrEP offers a comprehensive strategy that addresses both psychological and practical barriers to PrEP usage.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

Research shows that Acceptance and Commitment Therapy (ACT), when combined with pre-exposure prophylaxis (PrEP), can help young Black men who have sex with men (YBMSM) consistently take PrEP. In this trial, participants in the ACTPrEP arm will receive ACT-based interventions to support regular PrEP use. Regular PrEP use has been proven to lower the risk of contracting HIV. Studies indicate that ACT can help individuals manage short-term discomfort and increase their willingness to start using PrEP. This method focuses on helping individuals commit to regular PrEP use, which is crucial for its effectiveness. By supporting regular use, ACTPrEP aims to enhance HIV prevention for those at risk. Meanwhile, the control group will receive an enhanced standard of care, including a PrEP education session. ^{1 2 3 4 6}

Who Is on the Research Team?

Trisha Arnold, PhD

Principal Investigator

Rhode Island Hospital

Are You a Good Fit for This Trial?

This trial is for young Black men, aged 18-34, who have sex with men and are interested in HIV prevention. They must not have taken PrEP in the past 3 months, be English-speaking, assigned male at birth, and meet CDC guidelines for PrEP use. Those already in another PrEP study or unable to consent are excluded.

Inclusion Criteria

Able to give consent

I was assigned male at birth.

English speaking

Exclusion Criteria

Participating in another PrEP study

I am unable to give my consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the ACTPrEP intervention, including a 60-minute initial session and 30-minute sessions at 2, 6, and 12 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with secondary outcomes assessed over 24 weeks

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ACTPrEP
• Enhanced Standard of Care

Trial Overview The trial is testing a new Acceptance and Commitment Therapy (ACT)-based intervention called ACTPrEP against an enhanced standard of care. It's designed specifically for young Black MSM to increase engagement with Pre-exposure Prophylaxis (PrEP) as an HIV preventive measure.

How Is the Trial Designed?

Group I: ACTPrEP Experimental Treatment 1 Intervention

ACTPrEP will include a 60-minute initial session and 30-minute sessions at 2, 6, and 12 weeks.

Group II: Control Group Active Control 1 Intervention

Control group will include one 30-minute PrEP education session.

ACTPrEP is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Truvada for:

• HIV-1 pre-exposure prophylaxis

Approved in European Union as Truvada for:

• HIV-1 pre-exposure prophylaxis

Approved in Canada as Truvada for:

• HIV-1 pre-exposure prophylaxis

Who Is Running the Clinical Trial?

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

University of Mississippi Medical Center

Collaborator

Trials

185

Recruited

200,000+

Published Research Related to This Trial

Preexposure prophylaxis (PrEP) has been proven effective in reducing the risk of HIV acquisition, particularly with the approval of the combination drug emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for sexual HIV prevention.

The success of PrEP is closely linked to adherence; therefore, understanding how to encourage and maintain adherence in high-risk populations is crucial for maximizing its public health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preexposure prophylaxis for HIV prevention: where have we been and where are we going? Baeten, JM., Haberer, JE., Liu, AY., et al.[2022]

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]

HIV pre-exposure prophylaxis (PrEP) is a highly effective and safe antiretroviral medication that significantly reduces the risk of HIV infection in individuals at high risk due to sexual practices or intravenous drug use.

Despite its proven efficacy, PrEP remains underutilized in the U.S., and initial testing for HIV, hepatitis B, and renal function is necessary before starting treatment, with ongoing monitoring required for both approved oral medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Exposure Prophylaxis for HIV in Primary Care and Beyond. Drallmeier, T., Meyr, A.[2022]

In a study involving 4747 participants, those with plasma tenofovir concentrations above 40 ng/mL had an estimated 88% to 91% protective effect against HIV, highlighting the importance of adherence to PrEP for its efficacy.

The majority of participants who remained uninfected showed high adherence to PrEP, with 71% maintaining effective drug levels, while only 5 out of 29 individuals who contracted HIV were consistently adherent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV protective efficacy and correlates of tenofovir blood concentrations in a clinical trial of PrEP for HIV prevention. Donnell, D., Baeten, JM., Bumpus, NN., et al.[2022]

HIV pre-exposure prophylaxis (PrEP) trials using antiretroviral drugs have shown varying levels of success, indicating that while some trials are effective, there is still potential for improvement.

A key factor affecting the outcomes of these trials is poor adherence to the medication, highlighting the importance of managing adherence in clinical settings and in the development of future PrEP options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring concentration response in HIV pre-exposure prophylaxis to optimize clinical care and trial design. Hendrix, CW.[2022]

This systematic review aims to evaluate the effectiveness and acceptability of technology-based interventions (TBIs) in promoting the HIV preexposure prophylaxis (PrEP) care continuum, with a comprehensive search of multiple databases and a focus on randomized controlled trials and quasi-experimental studies.

The review will provide insights into successful strategies and lessons learned from existing literature, which will help inform future intervention designs for promoting PrEP care, with results expected by summer 2022.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-Based Interventions to Promote the HIV Preexposure Prophylaxis (PrEP) Care Continuum: Protocol for a Systematic Review. Hong, C., Abrams, LS., Holloway, IW.[2023]

Text message support for HIV pre-exposure prophylaxis (PrEP) has demonstrated clinical trial evidence of effectiveness, making it a key strategy for improving patient care and adherence.

Other innovative strategies, such as telemedicine, same-day prescriptions, and patient navigation, show promise in reducing barriers to PrEP access, although they require further evidence to confirm their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of HIV Pre-exposure Prophylaxis Streamlining Strategies. Siegler, AJ., Steehler, K., Sales, JM., et al.[2023]

In a study involving 1069 clients, 557 (60.5%) enrolled in a PrEP program, indicating strong interest in this HIV prevention method among men who have sex with men (MSM) and transgender women in real-world clinical settings.

Factors influencing enrollment included being from Miami or Washington, DC, self-referral, prior awareness of PrEP, and having multiple sexual encounters with HIV-infected partners, highlighting the importance of targeted outreach and education in increasing PrEP uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High interest in preexposure prophylaxis among men who have sex with men at risk for HIV infection: baseline data from the US PrEP demonstration project. Cohen, SE., Vittinghoff, E., Bacon, O., et al.[2023]

In a study involving 939 men who have sex with men (MSM) in China, those using daily pre-exposure prophylaxis (PrEP) showed a high rate of HIV self-testing (HIVST) usage (74.5%) and secondary distribution of kits to partners (52.8%), indicating the feasibility of HIVST in real-world settings.

The results suggest that HIVST could potentially replace facility-based HIV testing to some extent, especially for MSM on daily PrEP, highlighting the importance of innovative testing methods in HIV prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based HIV Self-Testing Among Men Who Have Sex With Men Through Pre-exposure Prophylaxis: 3-Month Prospective Cohort Analysis From China. Zhang, J., Tucker, J., Tang, W., et al.[2021]

HIV preexposure prophylaxis (PrEP) has transitioned from research to routine clinical implementation, showing that it can be effectively delivered in various healthcare settings, including health maintenance organizations, STI clinics, and primary care practices.

Key components for successful PrEP delivery include regular HIV and STI testing, adherence support, and monitoring for potential side effects, which are essential for optimizing its use in preventing HIV transmission.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Implementation of HIV Preexposure Prophylaxis: Lessons Learned From Three Clinical Settings. Marcus, JL., Volk, JE., Pinder, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12228006/

Acceptance-Based Pre-Exposure Prophylaxis Intervention ... This study aims to develop and test an intervention, ACTPrEP, to increase PrEP use among young Black men who have sex with men.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212144723000297

Development of an acceptance based PrEP intervention ... Interventions informed by ACT can help YBMSM endure short-term discomfort and increase willingness to initiate PrEP.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10062414/

Development of An Acceptance Based PrEP Intervention ... Pre-exposure prophylaxis (PrEP) for HIV involves taking antiretroviral medication prior to potential HIV exposure to prevent HIV and has been proven highly ...

4. withpower.com withpower.com/trial/phase-7-2021-af669

ACT-Based PrEP Intervention for HIV Prevention Pre-exposure prophylaxis (PrEP) has been shown to effectively reduce the risk of HIV infection when used consistently, and adherence to PrEP is crucial for its ...

5. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(23)00252-2/fulltext

Optimal strategies to improve uptake of and adherence ... The primary outcomes were uptake and adherence to HIV prevention options over 24 months, measured by self-reported PrEP use and adherence, consistent condom use ...

6. gilead.com gilead.com/news/news-details/2024/gilead-presents-additional-efficacy-safety-and-demographic-data-from-purpose-2-trial-at-5th-hiv-research-for-prevention-conference

October 7, 2024 Efficacy and Safety Data Demonstrated 96% Reduction in HIV Infections with Lenacapavir Compared to Background HIV Incidence Among a ...