Advanced HIV Re-engagement in Care (ARC)

July 17, 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

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Locations

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
Experimental: Advanced HIV Re-engagement in Care (ARC)
In this trial arm, participants will be provided with the ARC intervention package.
Behavioral: ARC
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.
No Intervention: Standard of Care (SOC)
In this arm, participants will be managed according to the standard of care.

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
We will ascertain mortality as follows. All participants will receive monthly phone check-ins and if they don't respond a staff member will trace their whereabouts in the community. This process will lead us to learning about deaths. In addition, we may be informed by a hospital staff member where a participant was admitted and died.
Enrollment to up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV viral suppression
Time Frame: Enrollment, 3 months and 1 year
HIV RNA concentration in plasma
Enrollment, 3 months and 1 year
Retention in HIV care
Time Frame: At 3 months and 1 year
No gap of >28 days without documented possession of antiretroviral therapy medications
At 3 months and 1 year
Medication possession ratio
Time Frame: At 3 months and 12 months
Number of days with possession of antiretroviral medications divided by the time interval of interest
At 3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Collaborators

University of Maryland, Baltimore
Ciheb Zambia

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

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 22, 2026

Last Update Submitted That Met QC Criteria

July 17, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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, we need to clarify the details in order to align with sponsor requirements and new data sharing laws in Zambia

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.

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