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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05384145
Acronym
COAST-AL
Enrollment
80
Registered
2022-05-20
Start date
2024-03-27
Completion date
2027-05-31
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, HIV Linkage to Care, HIV Testing, HIV Treatment

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.

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.

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

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
Mobile County Health Deparment
CollaboratorUNKNOWN
Alabama Department of Public Health
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
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

*

Design outcomes

Primary

MeasureTime frameDescription
Time to viral suppressionFrom HIV diagnosis to 1 yearEffectiveness outcome: Using ADPH EHARS data of all newly diagnosed individuals in MCHD jurisdiction during the study period
Proportion of zctas with >15% population HIV tested3 year intervention periodImplementation outcome: Using commercial lab data sets (Quest/LabCorp) and ADPH data

Secondary

MeasureTime frameDescription
Proportion linked to care within 30 days3 year intervention periodEffectiveness outcome: Using MCHD FH clinic eHR data
Days from diagnosis to initiation of ART3 year intervention periodEffectiveness outcome: Using MCHD FH clinic eHR data

Countries

United States

Contacts

CONTACTMariel Parman
marielparman@uabmc.edu205-996-6337
CONTACTBernadette Johnson
bajohnson@uabmc.edu2059347329

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 19, 2026