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

HIV Clinical Trial

— COAST-AL  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05384145
• Other study ID #: IRB-300009300
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: Mariel Parman
• Phone: 205-996-6337
• Email: marielparman[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: May 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years and older

Eligibility

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 include unwillingness or inability to provide informed consent.

Related Conditions & MeSH terms

• HIV
• HIV Testing

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Alabama Department of Public Health, Mobile County Health Deparment

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to viral suppression	Effectiveness outcome: Using ADPH EHARS data of all newly diagnosed individuals in MCHD jurisdiction during the study period	From HIV diagnosis to 1 year
Primary	Proportion of zctas with >15% population HIV tested	Implementation outcome: Using commercial lab data sets (Quest/LabCorp) and ADPH data	3 year intervention period
Secondary	Proportion linked to care within 30 days	Effectiveness outcome: Using MCHD FH clinic eHR data	3 year intervention period
Secondary	Days from diagnosis to initiation of ART	Effectiveness outcome: Using MCHD FH clinic eHR data	3 year intervention period