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PrOTECT AL: PrEP Optimization Through Enhanced Continuum Tracking

PrOTECT AL: PrEP Optimization Through Enhanced Continuum Tracking

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07231640
Acronym
PrOTECT AL
Enrollment
56
Registered
2025-11-17
Start date
2026-02-09
Completion date
2030-04-01
Last updated
2026-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, HIV Prevention, PrEP, PrEP Uptake

Brief summary

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

OTHERPrOTECT 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 PrEP indications recorded; and AL counties served. These elements can be filtered down by race, age, and gender. Additional proposed modifications, will include an PrEP coverage map, showing where the greatest unmet needs are for PrEP service delivery in the state as well as a PrEP equity scores, clinic performance indicator that will be populate every 3-months.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AdoptionQuarterly from baseline to 36 monthsThe primary outcome is the change over time of the proportion of PrEP prescriptions to Black persons with a PrEP indication (i.e. PrEP coverage) compared to the proportion of PrEP prescriptions to White persons with a PrEP indication.

Secondary

MeasureTime frameDescription
Public Health ImpactBaseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months post-baselineInvestigators will conduct segmented linear regression models to compare PrEP-to-need ration (PNR) and PrEP coverage in AL in the pre and post dashboard intervention phases, with PNR and PrEP coverage assessed in 6-month intervals.

Countries

United States

Contacts

CONTACTMariel Parman, MPH
marielparman@uabmc.edu205-996-6337
CONTACTBernadette Johnson
bajohnson@uabmc.edu205-934-7329
PRINCIPAL_INVESTIGATORMichael Mugavero, MD

University of Alabama at Birmingham

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026