Advanced HIV Re-engagement in Care (ARC)
July 22, 2026 updated by: Michael Vinikoor, University of Alabama at Birmingham
Adults who are hospitalized in Lusaka, Zambia, and found to have advanced HIV disease will be enrolled and randomly assigned to receive the ARC intervention or standard of care.
All participants will then be followed through the end of the hospitalization and for up to 1 year after discharge from hospital.
Study Overview
Detailed Description
The ARC intervention includes support from a community health worker that begins during admission and continues after discharge to address gaps in the care cascade for HIV and serious coinfections and comorbidities.
ARC components were previously developed and pilot tested at hospitals in Zambia.
Study Type
Interventional
Enrollment (Estimated)
724
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael J Vinikoor, MD
- Phone Number: 205-996-2416
- Email: mjv3@uab.edu
Study Contact Backup
- Name: Ike Oyewole
- Phone Number: 205-934-5191
- Email: ikeoluwaoyewole@uabmc.edu
Study Locations
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Lusaka, Zambia
- University Teaching Hospital
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Contact:
- Lottie Hachaambwa, MBChB
- Phone Number: 260976435603
- Email: lhachaambwa@cihebzambia.org
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Living with HIV
- Advanced HIV defined as CD4 <350 cells/mm3 or WHO stage 3 or 4 event
- Currently admitted to study hospital's internal medicine department
Exclusion Criteria:
- Planning to reside outside Lusaka after discharge
- Too sick to provide informed consent
- Known to have advanced cancer (defined as requiring chemo/radiation therapy or referred to hospice) other than Kaposi Sarcoma
- Known to have end stage kidney disease
- Known to have end stage liver disease
- No access to a telephone
- Currently incarcerated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Advanced HIV Re-engagement in Care (ARC)
In this trial arm, participants will be provided with the ARC intervention package.
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ARC is a multi-component package of support delivered primarily by a community health worker.
It is oriented towards the medical and psychosocial and sociobehavioral challenges of advanced HIV disease and hospitalization.
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No Intervention: Standard of Care (SOC)
In this arm, participants will be managed according to the standard of care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause mortality
Time Frame: Enrollment to up to 1 year
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Mortality will be ascertained as follows.
All participants will receive monthly phone check-ins and if they don't respond a study staff member will trace their whereabouts in the community.
This process will lead investigators to find out about deaths.
In addition, investigators may be informed by a hospital staff member where a participant was admitted and died.
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Enrollment to up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HIV viral suppression
Time Frame: Enrollment, 3 months and 1 year
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HIV RNA concentration in plasma
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Enrollment, 3 months and 1 year
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Retention in HIV care
Time Frame: At 3 months and 1 year
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No gap of >28 days without documented possession of antiretroviral therapy medications
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At 3 months and 1 year
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Medication possession ratio
Time Frame: At 3 months and 12 months
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Number of days with possession of antiretroviral medications divided by the time interval of interest
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At 3 months and 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael J Vinikoor, MD, University of Alabama at Birmingham
- Principal Investigator: Cassidy Claassen, MD, University of Maryland, Baltimore
- Principal Investigator: Lottie Hachaambwa, MBChB, Ciheb Zambia
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bwalya C, Stoebenau K, Muchanga G, Mwale M, Maambo C, Banda S, Halwiindi P, Mwango LK, Baumhart C, Mbewe N, Mwitumwa M, Mulenga P, Charurat M, Mutale W, Vinikoor MJ, Claassen CW. Hospitalized with HIV in Zambia: individual and system factors driving the high burden of admissions and post-discharge mortality in the era of HIV epidemic control. AIDS Res Ther. 2025 Feb 24;22(1):22. doi: 10.1186/s12981-024-00689-2.
- Mbewe N, Vinikoor MJ, Fwoloshi S, Mwitumwa M, Lakhi S, Sivile S, Yavatkar M, Lindsay B, Stafford K, Hachaambwa L, Mulenga L, Claassen CW. Advanced HIV disease management practices within inpatient medicine units at a referral hospital in Zambia: a retrospective chart review. AIDS Res Ther. 2022 Feb 22;19(1):10. doi: 10.1186/s12981-022-00433-8.
- Ford N, Ehrenkranz P, Jarvis J. Advanced HIV as a Neglected Disease. N Engl J Med. 2024 Feb 8;390(6):487-489. doi: 10.1056/NEJMp2313777. Epub 2024 Feb 3. No abstract available.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2027
Primary Completion (Estimated)
May 1, 2031
Study Completion (Estimated)
August 1, 2031
Study Registration Dates
First Submitted
July 17, 2026
First Submitted That Met QC Criteria
July 17, 2026
First Posted (Actual)
July 22, 2026
Study Record Updates
Last Update Posted (Actual)
July 23, 2026
Last Update Submitted That Met QC Criteria
July 22, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Blood-Borne Infections
- Urogenital Diseases
- Genital Diseases
- Immune System Diseases
- Infections
- RNA Virus Infections
- Virus Diseases
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Slow Virus Diseases
- Gram-Positive Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Actinomycetales Infections
- Mycobacterium Infections
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Tuberculosis
Other Study ID Numbers
- IRB-300017004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
IPD is likely to be shared; however, at this time, certain details still need to be clarified in order to align with both sponsor requirements and new data sharing laws in Zambia.
Please contact the PIs for more information if required.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.