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

NCT05384145 | Recruiting DMC

• 2 other identifiers: IRB-3000093005R01AI169671-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV; HIV Linkage to Care; HIV Testing; HIV Treatment

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Proportion linked to care within 30 days

  3 year intervention period

• Days from diagnosis to initiation of ART

  3 year intervention period

Study Arms (1)

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

Other: COAST-AL

Interventions

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

COAST-AL

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Mobile County Health Deparment: collaborator
• Alabama Department of Public Health: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35222, United States

RECRUITING

Central Study Contacts

Mariel Parman

CONTACT

205-996-6337; marielparman@uabmc.edu

Bernadette Johnson

CONTACT

2059347329; bajohnson@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: May 20, 2022
• Study Start: March 27, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)