Implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Suppression Goals in Alabama
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: COAST-AL.
- Who it may be relevant to
- Registry conditions: HIV, HIV Linkage to Care, HIV Testing, HIV Treatment. Basic parameters: from 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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
- 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
Primary outcome measures
- Time to viral suppression [Time frame: From HIV diagnosis to 1 year]
- Proportion of zctas with >15% population HIV tested [Time frame: 3 year intervention period]
Secondary outcome measures (2)
- Proportion linked to care within 30 days [Time frame: 3 year intervention period]
- Days from diagnosis to initiation of ART [Time frame: 3 year intervention period]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
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. PMID 39481580
Identifiers
NCT: NCT05384145 · IRB-300009300 · 5R01AI169671-03