Clinical trial NCT05384145: Implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Suppression Goals in Alabama
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV
HIV Linkage to Care
HIV Testing
HIV Treatment
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Mobile County Health Deparment
name: Alabama Department of Public Health
First posted: 2022-05-20
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Time to viral suppression
timeFrame: From HIV diagnosis to 1 year
measure: Proportion of zctas with >15% population HIV tested
timeFrame: 3 year intervention period
Secondary outcomes:
measure: Proportion linked to care within 30 days
timeFrame: 3 year intervention period
measure: Days from diagnosis to initiation of ART
timeFrame: 3 year intervention period
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: