Clinical trial NCT06015581: Scaling Up Implementation Strategies to Improve the DIAGNOSE and PREVENT Pillars for Young MSM in Florida
Official title: Scaling Up Implementation Strategies to Improve the DIAGNOSE and PREVENT Pillars for Young MSM in Florida
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Lead sponsor: Florida State University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Nova Southeastern University
First posted: 2023-08-29
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped Wedged Design with a second randomization
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this study, investigators will test the YACHT package in 42 FDOH contracted Counseling, Testing and Referral (CTR) agencies across Florida's seven End the HIV Epidemic (EHE) counties. The study is powered on both effectiveness outcomes (number of HIV tests of Young Sexual Minority Men - YSMM) and implementation outcomes, consistent with a type 2 hybrid trial. It is hypothesized that YACHT will improve providers' fidelity to Tailored Motivational Interviewing (TMI) when delivering risk reduction counseling (RRC) and PrEP referrals (implementation outcomes) and will increase testing among YSMM (effectiveness outcome). Investigators will use an innovative stepped wedge design to test the YACHT package, including a second randomization to explore ongoing quality management (QM) with mystery shoppers (MS) as a sustainment strategy. The study also contains a qualitative component based on the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to further understand the context of implementation and sustainment (sequential explanatory mixed methods).

Detailed description: Primary Aim: To test the effect of YACHT to improve fidelity to DIAGNOSE and PREVENT EBPs in 42 FDOH contracted CTR agencies in the seven Florida EHE counties. The primary effectiveness outcome is the number of HIV tests among YSMM. The primary implementation outcome is developmentally and culturally responsive delivery of competent EBPs (RRC, PrEP referral, TMI) based on MS assessments.

Secondary Aim 1: To assess the effect of continued QM (ongoing MS feedback) in sustaining the primary outcomes.

Secondary Aim 2: To utilize mixed methods based on the EPIS framework to understand barriers and facilitators of successful implementation and sustainment of youth-specific EBPs within CTR to improve the DIAGNOSE and PREVENT pillars for YSMM.

In the proposed study, investigators will test the YACHT package in 42 FDOH contracted CTR agencies across Florida's seven EHE counties. The study is powered on both effectiveness outcomes (number of HIV tests of YSMM) and implementation outcomes (EBP fidelity), consistent with a type 2 hybrid trial. The investigative team hypothesizes that YACHT will improve providers' fidelity to TMI when delivering RRC and PrEP referrals (implementation outcomes) and will increase testing among YSMM (effectiveness outcome). The study will use an innovative stepped wedge design to test the YACHT package, including a second randomization to explore ongoing QM with MS as a sustainment strategy.

Primary effectiveness outcome: The primary outcome is # of tests of YSMM (ages 15-29), as reported in aggregate at the agency- and county-level. Investigators expect that the YACHT package will improve the number of HIV tests administered to YSMM at each agency. As an exploratory outcome, FDOH has recently begun tracking PrEP uptake, defined as ≥1 day of TDF/FTC prescribed for PrEP. Both the testing and PrEP data are currently reported in a standardized fashion to FDOH. Data will be aggregated within agencies and will be requested biannually. Data will be managed into quarterly windows to correspond to the data collection intervals in the stepped wedge design.

Primary implementation outcomes: Procedures for MS are described in C4a Exploration and domains are described in Preliminary Studies (section C1c). Using the pre-established MS domains, investigators will compute an overall agency score using the pooled scores from the two MS conducted each quarter. Pooled scores will be presented to reduce potential selection bias and confounding based on whether the same or a different provider interacted with the shoppers at either agency visit, and to account for the variability across shoppers. Domain sub-scores will also be created using psychometrically tested subscales for: 1) LGBT visibility, 2) medical form inclusivity, 3) perceived clinic environment, 4) privacy and confidentiality, 5) relationship context, 6) RRC, 7) safer sex education, 8) PrEP information and referral, 9) perceived provider competency, and 10) patient-provider interactions. For ease of interpretability across domains, investigators will normalize the pooled average scores into percentiles.

Eligibility criteria: Inclusion Criteria:

* Site inclusion: All Florida Department of Health (FDOH) contracted or direct service agencies (k=42) across all seven EHE counties that meet eligibility criteria: 1) provide HIV CTR, and 2) tested a minimum of 24 tests to YSMM in the last year.
* Provider Inclusion: Provide CTR at eligible sites.

Exclusion Criteria:

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Primary outcomes:
measure: Testing of YSMM from FDOH Surveillance
timeFrame: 54 months plus 12 months prior to the study start
measure: Service quality via Mystery Shopper Assessments composite
timeFrame: Quarterly from Month 7 to Month 54
Secondary outcomes:
Other outcomes:
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