NCT07720128

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
724

participants targeted

Target at P75+ for not_applicable

Timeline
52mo left

Started May 2027

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
9 months until next milestone

Study Start

First participant enrolled

May 1, 2027

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2031

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2031

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

4 years

First QC Date

July 17, 2026

Last Update Submit

July 22, 2026

Conditions

Advanced HIV Disease

Keywords

HIV/AIDSTransitions of careHospitalizationCommunity Health WorkerSub-Saharan AfricaAdvanced HIV diseaseTuberculosisCryptococcus

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    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.

    Enrollment to up to 1 year

Secondary Outcomes (3)

  • HIV viral suppression

    Enrollment, 3 months and 1 year

  • Retention in HIV care

    At 3 months and 1 year

  • Medication possession ratio

    At 3 months and 12 months

Study Arms (2)

Advanced HIV Re-engagement in Care (ARC)

EXPERIMENTAL

In this trial arm, participants will be provided with the ARC intervention package.

Behavioral: ARC

Standard of Care (SOC)

NO INTERVENTION

In this arm, participants will be managed according to the standard of care.

Interventions

ARCBEHAVIORAL

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.

Advanced HIV Re-engagement in Care (ARC)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (3)

  • 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.

    PMID: 39994735BACKGROUND

  • 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.

    PMID: 35193598BACKGROUND

  • 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.

    PMID: 38314820BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeTuberculosis

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Study Officials

  • Lottie Hachaambwa, MBChB

    Ciheb Zambia

    PRINCIPAL INVESTIGATOR

  • Cassidy Claassen, MD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

  • Michael J Vinikoor, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael J Vinikoor, MD

CONTACT

205-996-2416mjv3@uab.edu

Ike Oyewole

CONTACT

205-934-5191ikeoluwaoyewole@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: ARC is a multi-component intervention. Clients are linked to a community health worker (CHW) who provides support with healthcare navigation, psychosocial support, health education, and support with adherence to medications. This support begins during hospital admission and continues for 3-6 months after discharge. At discharge, a discharge card is provided to clients and care givers to enhance awareness among clients and staff of the problem list, prescribed medications, and follow-up appointments. After discharge, the client's assigned CHW reinforces the discharge plan and monitor client recovery via home visits, which also includes an assessment of vital and warning signs, medication adherence checks, and phone reminders. CHWs are supported by clinicians at the discharging hospital for issues of medication management and readmission to hospital as needed. Clinicians and CHWs meet periodically at the discharging hospital to discuss active clients and findings from home visits.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

July 17, 2026

First Posted

July 22, 2026

Study Start (Estimated)

May 1, 2027

Primary Completion (Estimated)

May 1, 2031

Study Completion (Estimated)

August 1, 2031

Last Updated

July 23, 2026

Record last verified: 2026-07

Locations

ZA(1)