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NCT Number: NCT05384145

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

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.

Recruiting

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Key information

Age range

13 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35222, United States

Location status: Recruiting

Location contact

Mariel Parman, MPH

CONTACT

[email protected]

205-996-6337

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • AIM 1 & 3:
  • Fit into one of the following categories:
  • 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 include unwillingness or inability to provide informed consent.

Treatment and study plan

COAST-AL

Other

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

Primary outcomes

  1. Time to viral suppression

    Time frame: From HIV diagnosis to 1 year

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

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

    Time frame: 3 year intervention period

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

Secondary outcomes

  1. Proportion linked to care within 30 days

    Time frame: 3 year intervention period

    Effectiveness outcome: Using MCHD FH clinic eHR data

  2. Days from diagnosis to initiation of ART

    Time frame: 3 year intervention period

    Effectiveness outcome: Using MCHD FH clinic eHR data

Study contacts

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

Bernadette Johnson

CONTACT

[email protected]

2059347329

Mariel Parman

CONTACT

[email protected]

205-996-6337

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Alabama Department of Public Health
  • Mobile County Health Deparment

Registry information

Official study title

A Type 2 Hybrid Effectiveness-implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Suppression Goals in Coastal Alabama

Acronym: COAST-AL

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
May 20, 2022
Registry last updated
May 18, 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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