PrOTECT AL: PrEP Optimization Through Enhanced Continuum Tracking (PrOTECT AL)

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.

Study Overview

• Status: Recruiting
• Conditions: PrEP; HIV; HIV Prevention; PrEP Uptake
• Intervention / Treatment: Other: PrOTECT AL Implementation Strategy

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.

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariel Parman, MPH; Phone Number: 205-996-6337; Email: marielparman@uabmc.edu
• Study Contact Backup: Name: Bernadette Johnson; Phone Number: 205-934-7329; Email: bajohnson@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35222
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Mariel Parman; Phone Number: 205-996-6337; Email: marielparman@uabmc.edu
      • Contact: Bernadette Johnson; Phone Number: 205-934-7329; Email: bajohnson@uabmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: PrOTECT AL Implementation Strategy; The PrOTECT AL dashboard consisted of a public-facing homepage 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.

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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adoption	The 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.	Quarterly from baseline to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Public Health Impact	Investigators 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.	Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months post-baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reach	The number of PrEP prescriptions at the clinic-level and evaluating if there is increase in prescriptions over time.	Quarterly from baseline to 36 months
Acceptability of the intervention	Investigators will conduct internet-based surveys to assess clinic member attitudes regarding the acceptability of prescribing PrEP and the dashboard. Survey measures are based on a validated survey instrument, the Acceptability of Intervention Measure (AIM)	Baseline, 18-months, 36- months
Maintenance	Using the administrative web-metric data, investigators will examine longitudinal patterns in dashboard use for each clinic to determine whether changes in behaviors were sustained over time, using the Clinical Sustainability Assessment Tool (CSAT)	36 months
Feasibility of the intervention	Investigators will conduct internet-based surveys to assess clinic member attitudes regarding the feasibility of prescribing PrEP and the dashboard. Survey measures are based on a validated survey instrument, the Feasibility of Intervention Measure (FIM).	baseline, 18-months, 36-months

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Michael Mugavero, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: November 4, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 17, 2025

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB-300014665; R01MH136851-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No