PrOTECT AL: PrEP Optimization Through Enhanced Continuum Tracking

NCT07231640 | Recruiting

• 2 other identifiers: IRB-300014665R01MH136851-01A1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

PrEP Uptake; HIV Prevention; HIV; PrEP

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Public Health Impact

  Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months post-baseline

Other Outcomes (4)

• Reach

  Quarterly from baseline to 36 months

• Acceptability of the intervention

  Baseline, 18-months, 36- months

• Maintenance

  36 months

Study Arms (1)

PrOTECT AL Implementation Strategy

OTHER

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

Interventions

PrOTECT AL Implementation Strategy OTHER

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.

PrOTECT AL Implementation Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not one of the seven participating sites

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35222, United States

RECRUITING

Study Officials

• Michael Mugavero, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariel Parman, MPH

CONTACT

205-996-6337; marielparman@uabmc.edu

Bernadette Johnson

CONTACT

205-934-7329; bajohnson@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 17, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)