HIVPrOTECT ALNCT07231640
PrOTECT AL: PrEP Optimization Through Enhanced Continuum Tracking
A study testing PrOTECT AL Implementation Strategy in people with HIV and PrEP, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, PrEP, PrEP Uptake
- What is being tested?
- PrOTECT AL Implementation Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2026to Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not one of the seven participating sites
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35222
Mariel Parman, 205-996-6337, marielparman@uabmc.edu
Bernadette Johnson, 205-934-7329, bajohnson@uabmc.edu
About this study
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.
Read the 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.
- Conditions
- HIV, PrEP, PrEP Uptake, HIV Prevention
- Being tested
- PrOTECT AL Implementation Strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrOTECT AL Implementation StrategyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: PrOTECT AL Implementation Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Quarterly from baseline to 36 months
Secondary outcomes (1)
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.
Measured: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start9 Feb 2026
- Primary completionJan 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michael J Mugavero, MD, University of Alabama at Birmingham
- Investigators
- Michael Mugavero, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231640
- Sponsor's protocol ID
- IRB-300014665
- Other IDs
- R01MH136851-01A1
- Acronym
- PrOTECT AL
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PrOTECT AL: PrEP Optimization Through Enhanced Continuum Tracking
- ClinicalTrials.gov ID
- NCT07231640
- Acronym / sponsor ID
- PrOTECT AL / IRB-300014665
- Conditions
- HIV, PrEP, PrEP Uptake, HIV Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PrOTECT AL Implementation Strategy | Other | Other: PrOTECT AL Implementation StrategyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Not one of the seven participating sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrOTECT AL Implementation Strategywith 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 |
Primary outcome
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.
1 secondary outcome
Public Health Impact
Time frame: Baseline, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months post-baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Mugavero, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrOTECT AL Implementation Strategy in people with HIV and PrEP, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariel Parman, MPH (205-996-6337, marielparman@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption (time frame: Quarterly from baseline to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.