PrOTECT AL: PrEP Optimization Through Enhanced Continuum Tracking

Overview

The purpose of this study is to enhance and evaluate the implementation of a PrEP Care Continuum data dashboard across seven distinct clinical sites in Alabama. By leveraging real-time data and fostering collaborative partnerships, this project aims to accurately visualize care disparities, allocate resources strategically, identify and address care gaps in the delivery of PrEP services, and gauge its impact on HIV prevention efforts.

Detailed description

Aim 1: Conduct data mapping procedures to inform real-time data capture at agencies providing PrEP (n = 7) and refine the PrOTECT AL dashboard with practice transformation implementation strategies.

Sub-aim 1a: Refine the dashboard through incorporation of 1) quarterly STI incidence data from ADPH overlapped with clinic-PrEP prescription data to aid in visualization of clinic service area PrEP coverage and 2) clinic PrEP equity performance indexes.

Sub-aim 1b: Conduct on-site assessment of organizational readiness via electronic surveys and checklists.

Aim 2: Evaluate implementation outcomes associated with deployment of the PrOTECT AL dashboard and practice transformation implementation strategies, grounded in RE-AIM. Implementation outcomes (e.g., reach, maintenance) will be evaluated at each site, with the primary implementation outcome being change over time of the proportion of PrEP prescriptions to Black persons with a PrEP indication (i.e., adoption based on PrEP coverage) relative to the proportion of PrEP prescriptions to White persons with a PrEP indication.

Aim 3: Evaluate the effectiveness of PrOTECT AL by conducting an interrupted, time-series study of PrEP-to-need ratio (PNR) and PrEP coverage. Investigators will evaluate the hypothesis that implementation of the PrOTECT AL dashboard will result in greater than expected increase in PNR and PrEP coverage.

Interventions

• Other PrOTECT AL Implementation Strategy
  with information on the purpose of the project, resources for finding PrEP services across the state, information on project partners, and reading materials on HIV and prevention efforts across AL. From the website, partners can access the data dashboard via a clinic-specific login where they view both aggregate data and their clinic-level data. Data elements include: number of patients referred for, linked to, prescribed, or discontinued from PrEP within the reporting period (3-month timeframe)

Primary outcome measures

• Adoption [Time frame: Quarterly from baseline to 36 months]

Secondary outcome measures (1)

• Public Health Impact [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months post-baseline]

Eligibility criteria

Inclusion criteria

• currently practicing providers (either a clinician, nurse or medical assistant), OR 2) clinical administrator (e.g., someone in a leadership role within the PrEP clinic), OR 3) a data manager (i.e., someone who collects, enters and or manages data within the clinic) AND
• English speaking
• Age ≥ 18.

Exclusion criteria

• Not one of the seven participating sites

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT07231640 · IRB-300014665 · R01MH136851-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗