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RecruitingNCT05384145COAST-ALUpdated May 18, 2026

Implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Suppression Goals in Alabama

An interventional study of COAST-AL in HIV, HIV Linkage to Care and HIV Testing, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
13 Years and older
Sex
All
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Study summary

The purpose of this study is to adapt and evaluate a combination intervention that includes: (1) a data-driven approach to directed community-based HIV testing to areas with high need, (2) Project Connect to expedite linkage to care at time of diagnosis, (3) and a Rapid ART (antiretroviral therapy)Start program, all in Mobile County Health Department (MCHD) jurisdictions in Alabama.

Read the detailed description

Aim 1. Adapt and integrate COAST-AL using a pre-implementation formative assessment guided by the CFIR. In-depth interviews and clinic observations with community clinic providers, clinic administrators, and MCHD and Alabama Department of Public Health (ADPH) officials will inform targeted Community-based testing, linkage through Project Connect, and Rapid Start into existing work flows (inner setting, process), identify opportunities to use publicly available data to inform testing outreach (outer setting), and explore provider attitudes towards Rapid Start (individuals).

Aim 2. Assess the clinical and implementation effectiveness of COAST-AL in six AL counties served by MCHD. Using RE-AIM, the investigators will evaluate the effects of COAST-AL on clinical and implementation outcomes on progress towards EHE goals. The primary clinical effectiveness outcome is days to viral suppression (VS) for new HIV diagnoses. The primary implementation outcome is the proportion of Zip Code Tabulation Areas with at least 15% of adult population tested for HIV (Reach).

Aim 3. Utilize a community-academic partnership to identify implementation strategies to support maintenance and future dissemination of COAST-AL. Using interviews, concept mapping, and nominal group techniques to inform implementation mapping, the investigators will work collaboratively with local and state health department stakeholders to identify and prioritize implementation strategies to sustain and implement COAST-AL in other health departments across AL and rural EHE(Ending the Epidemic)-focus states.

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Conditions studied

  • HIV
  • HIV Linkage to Care
  • HIV Testing
  • HIV Treatment
03

In context

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
13 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • AIM 1 \& 3:
  • Fit into one of the following categories:

    1) MCHD leadership, 2) ADPH leadership, 3) clinic administrators, 4) outreach testing specialists, 5) linkage coordinators and community health workers, 6) physicians, 7) nurses, 8) counselors all working at HIV care facilities in the six MCHD jurisdiction counties.

  • Over the age of 18 years old.

AIM 2: (IDIs)

  • Over the age of 13 years old
  • Tested for HIV in MCHD jurisdiction from time of COASTAL implementation to 36 months post-implementation start date.

Exclusion criteria

Exclusion Criteria:

  • Exclusion criteria include unwillingness or inability to provide informed consent.
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Other
    COAST-AL

    This combination intervention includes three CDC evidence based interventions: (1) a data-driven approach to direct Community-based HIV testing to areas with high need, (2) Project Connect to expedite linkage to care at time of diagnosis, (3) and a Rapid ART Start program, all in MCHD jurisdictions in Alabama

    Other: COAST-AL

Interventions

  • OtherCOAST-AL

    This combination intervention includes three CDC evidence based interventions: (1) a data-driven approach to direct Community-based HIV testing to areas with high need, (2) Project Connect to expedite linkage to care at time of diagnosis, (3) and a Rapid ART Start program, all in MCHD jurisdictions in Alabama

06

What researchers measure

Primary outcomes

  1. Time to viral suppression

    Effectiveness outcome: Using ADPH EHARS data of all newly diagnosed individuals in MCHD jurisdiction during the study period

    Time frame: From HIV diagnosis to 1 year

  2. Proportion of zctas with >15% population HIV tested

    Implementation outcome: Using commercial lab data sets (Quest/LabCorp) and ADPH data

    Time frame: 3 year intervention period

Secondary outcomes

  1. Proportion linked to care within 30 days

    Effectiveness outcome: Using MCHD FH clinic eHR data

    Time frame: 3 year intervention period

  2. Days from diagnosis to initiation of ART

    Effectiveness outcome: Using MCHD FH clinic eHR data

    Time frame: 3 year intervention period

07

Study locations

1 of 1 sites recruiting
  • University of Alabama at Birmingham
    Birmingham, Alabama 35222, United States
    Recruiting
08

References and documents

Publications

  • Hearld LR, Pratt MC, Smith D, Parman M, Murphree R, Michaels KP, Woods-Crawford S, Rana AI, Matthews LT. Integrating existing and novel methods to understand organizational context: A case study of an academic-public health department partnership. Ann Epidemiol. 2024 Dec;100:34-41. doi: 10.1016/j.annepidem.2024.10.005. Epub 2024 Oct 29. PubMed 39481580 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05384145
Lead sponsor
University of Alabama at Birmingham
Collaborators
Mobile County Health Deparment, Alabama Department of Public Health
Responsible party
Aadia Rana (Professor, University of Alabama at Birmingham) — Principal investigator
First posted
May 20, 2022
Start date
Mar 27, 2024
Primary completion
Jan 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
May 18, 2026

Study contacts

Mariel Parman
Contact
marielparman@uabmc.edu
205-996-6337
Bernadette Johnson
Contact
bajohnson@uabmc.edu
2059347329

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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