PrOTECT AL: PrEP Optimization Through Enhanced Continuum Tracking

ConditionsHIV PrEP PrEP Uptake HIV Prevention

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Not one of the seven participating sites

Trial design

Design model

Single group

Treatments tested in this trial

PrOTECT AL Implementation Strategy
Other intervention
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.

Treatment groups

56 Participants

are divided into 1 treatment group

Group A: PrOTECT AL Implementation StrategyOther 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Quarterly from baseline to 36 months

Secondary outcomes

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.

Time frame

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

Other outcomes

Reach

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

Time frame

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)

Time frame

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)

Time frame

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).

Time frame

baseline, 18-months, 36-months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

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