Implementation Strategies for HIV Prevention

(YACHT Trial)

Overseen By Sara Green, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

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 aims to improve HIV prevention strategies by testing a package called YACHT in various counseling and referral centers in Florida. The focus is on enhancing risk reduction counseling and referrals for PrEP (a medication to prevent HIV) to increase HIV testing among young sexual minority men. The trial will evaluate both the package's effectiveness and its ease of use at the centers. It suits agencies that provide HIV counseling and have tested at least 24 young sexual minority men in the past year. As an unphased trial, this study offers participants the chance to contribute to innovative HIV prevention strategies that could benefit their community.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the YACHT package is safe for implementation in HIV prevention?

Research shows no direct evidence on the safety of the YACHT package itself. However, the YACHT package is not a drug or medical device. It focuses on improving healthcare delivery, so it doesn't share the same safety concerns as medications.

The YACHT package is designed to help healthcare providers offer better advice and referrals for HIV prevention. It aims to increase HIV testing and care for young men in sexual minority groups. As an "implementation strategy," it primarily involves training and improving processes for healthcare providers.

The study is labeled as "Not Applicable" phase, indicating the package doesn't pose direct health risks to participants. Instead, it enhances service delivery, making it generally easy to accept. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring new ways to boost HIV prevention strategies. Traditional HIV prevention often relies on methods like condom use, pre-exposure prophylaxis (PrEP), and regular testing. However, this trial is testing an "Implementation Package" that uses Continuous Quality Improvement (CQI) to potentially enhance how these existing methods are applied. By focusing on improving the quality and consistency of HIV prevention practices, there's hope for reducing new infections more effectively. Additionally, the trial's use of the EPIS framework for qualitative interviews aims to gather insights from healthcare providers, which could lead to better understanding and refinement of HIV prevention efforts at a systemic level.

What evidence suggests that the YACHT package is effective for HIV prevention?

Research shows that the YACHT package, part of the Implementation Package arm in this trial, increases HIV testing among young men in sexual minority groups. Studies have found that this program raises the number of HIV tests conducted at each participating location. The YACHT package also aims to enhance healthcare providers' adherence to proven counseling and referral practices. Early results suggest that YACHT leads to more individuals starting PrEP (a medication to prevent HIV) and accessing other HIV prevention services. By comparing testing numbers before and after implementing YACHT, researchers observe a positive impact on testing rates. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for HIV Counseling, Testing and Referral (CTR) providers at Florida Department of Health agencies in EHE counties. They must have conducted at least 24 HIV tests for Young Sexual Minority Men (YSMM) in the past year.

Inclusion Criteria

You must provide CTR at qualified locations.

This study includes 42 FDOH contracted or direct service agencies across all seven EHE counties which provide HIV CTR and have tested a minimum of 24 tests to YSMM in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Testing the YACHT package in 42 FDOH contracted CTR agencies to improve fidelity to DIAGNOSE and PREVENT EBPs

54 months

Quarterly visits

Quality Management

Ongoing quality management with mystery shoppers as a sustainment strategy

From Month 7 to Month 54

Two visits per quarter

Follow-up

Participants are monitored for effectiveness and implementation outcomes after the main trial

12 months

What Are the Treatments Tested in This Trial?

Interventions

• YACHT package

Trial Overview The YACHT package is being tested to see if it improves how well providers use Tailored Motivational Interviewing during risk reduction counseling and PrEP referrals, as well as increasing HIV testing among YSMM. The study uses a stepped wedge design with mystery shopper feedback.

How Is the Trial Designed?

Group I: Observation Experimental Treatment 1 Intervention

Usual Care

Group II: Implementation Package Experimental Treatment 2 Interventions

Continuous Quality Improvement (CQI)

Group III: EPIS Qualitative Active Control 1 Intervention

5 providers of 42 sites will participate in Exploration, Preparation, Implementation, Sustainment (EPIS) qualitative interviews (N=210)

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Nova Southeastern University

Collaborator

Trials

103

Recruited

12,000+

Citations

1. researchprotocols.org researchprotocols.org/2024/1/e63191

The Young Adult Centered Healthforce Training (YACHT ... This study tests whether the YACHT program increases HIV testing among young sexual minority men and fidelity to evidence-based CTR among testing providers.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11618015/

The Young Adult Centered Healthforce Training (YACHT ... Primary Effectiveness Outcome​​ We expect that the YACHT package will improve the number of HIV tests administered to young sexual minority men at each agency. ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39566048/

The Young Adult Centered Healthforce Training (YACHT) ... The study will evaluate whether YACHT leads to increased HIV testing by comparing numbers of young sexual minority men testing for HIV before versus after ...

4. researchgate.net researchgate.net/publication/381779460_The_YACHT_Program_Protocol_Young_Adult_Centered_HealthForce_Training_to_Increase_HIV_Testing_and_Pre-exposure_Prophylaxis_PrEP_Referrals_among_Young_Sexual_Minority_Men_in_Florida_Preprint

The YACHT Program Protocol - HIV Testing Primary outcomes include rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation verified by clinical medical records.

5. pure.johnshopkins.edu pure.johnshopkins.edu/en/publications/the-young-adult-centered-healthforce-training-yacht-program-to-in

The Young Adult Centered Healthforce Training (YACHT ... The study will evaluate whether YACHT leads to increased HIV testing by comparing numbers of young sexual minority men testing for HIV before versus after ...