HIVCOAST-ALNCT05384145
Implementation Trial to Evaluate a Population Health Combination Intervention to Meet HIV Testing, Linkage, and Viral Suppression Goals in Alabama
A study testing COAST-AL in people with HIV and HIV Linkage to Care, run by University of Alabama at Birmingham at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 13 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, HIV Linkage to Care, HIV Testing
- What is being tested?
- COAST-AL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2024to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Exclusion criteria include unwillingness or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35222
Mariel Parman, MPH, 205-996-6337, marielparman@uabmc.edu
About this study
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
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.
Read the 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.
- Conditions
- HIV, HIV Linkage to Care, HIV Testing, HIV Treatment
- Being tested
- COAST-AL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COAST-ALOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: COAST-AL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to viral suppression
Effectiveness outcome: Using ADPH EHARS data of all newly diagnosed individuals in MCHD jurisdiction during the study period
Measured: 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
Measured: 3 year intervention period
Secondary outcomes (2)
Proportion linked to care within 30 days
Effectiveness outcome: Using MCHD FH clinic eHR data
Measured: 3 year intervention period
Days from diagnosis to initiation of ART
Effectiveness outcome: Using MCHD FH clinic eHR data
Measured: 3 year intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start27 Mar 2024
- Primary completion31 Jan 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Mobile County Health Deparment, Alabama Department of Public Health
- Responsible party
- Principal investigator, Aadia Rana, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384145
- Sponsor's protocol ID
- IRB-300009300
- Other IDs
- 5R01AI169671-03
- Acronym
- COAST-AL
- Status last verified
- May 2026
- First submitted
- 17 May 2022
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39481580
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05384145
- Acronym / sponsor ID
- COAST-AL / IRB-300009300
- Conditions
- HIV, HIV Linkage to Care, HIV Testing, HIV Treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Mobile County Health Deparment, Alabama Department of Public Health
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COAST-AL | Other | Other: COAST-ALThis 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 |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (1 listed)
- Exclusion criteria include unwillingness or inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COAST-ALThis 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 |
Primary outcome
Time to viral suppression
Time frame: From HIV diagnosis to 1 year
Effectiveness outcome: Using ADPH EHARS data of all newly diagnosed individuals in MCHD jurisdiction during the study period
Proportion of zctas with >15% population HIV tested
Time frame: 3 year intervention period
Implementation outcome: Using commercial lab data sets (Quest/LabCorp) and ADPH data
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 39481580Hearld 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing COAST-AL in people with HIV and HIV Linkage to Care, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariel Parman (205-996-6337, marielparman@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to viral suppression (time frame: From HIV diagnosis to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05384145, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.