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NCT Number: NCT07231640

PrOTECT AL: PrEP Optimization Through Enhanced Continuum Tracking

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.

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Key information

Conditions

HIV HIV Prevention PrEP Uptake PreP

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Adoption

    Time frame: Quarterly from baseline to 36 months

    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.

Secondary outcomes

  1. Public Health Impact

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

    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.

Other outcomes

  1. Reach

    Time frame: Quarterly from baseline to 36 months

    The number of PrEP prescriptions at the clinic-level and evaluating if there is increase in prescriptions over time.

  2. Acceptability of the intervention

    Time frame: Baseline, 18-months, 36- months

    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)

  3. Maintenance

    Time frame: 36 months

    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)

  4. Feasibility of the intervention

    Time frame: baseline, 18-months, 36-months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Bernadette Johnson

CONTACT

[email protected]

205-934-7329

Mariel Parman, MPH

CONTACT

[email protected]

205-996-6337

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Acronym: PrOTECT AL

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Nov 17, 2025
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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