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NCT Number: NCT07720128

Advanced HIV Re-engagement in Care

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.

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Key information

Conditions

Advanced HIV Disease Acquired Immunodeficiency Syndrome Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Blood-Borne Infections Communicable Diseases Genital Diseases Gram-Positive Bacterial Infections HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mycobacterium Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Tuberculosis Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARC

Behavioral

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.

Primary outcomes

  1. All-cause mortality

    Time frame: Enrollment to up to 1 year

    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.

Secondary outcomes

  1. HIV viral suppression

    Time frame: Enrollment, 3 months and 1 year

    HIV RNA concentration in plasma

  2. Retention in HIV care

    Time frame: At 3 months and 1 year

    No gap of >28 days without documented possession of antiretroviral therapy medications

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ike Oyewole

CONTACT

[email protected]

205-934-5191

Michael J Vinikoor, MD

CONTACT

[email protected]

205-996-2416

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Ciheb Zambia
  • University of Maryland, Baltimore

Registry information

Acronym: ARC

Important dates

Study start
2027
Primary completion
2031
Study completion
2031
First posted
Jul 22, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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