An interventional study of ARC in Advanced HIV Disease, sponsored by University of Alabama at Birmingham. Not yet recruiting at 1 site in Zambia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Health services research
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.
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.
3,035 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 306 are open to participants now.
This study's planned enrollment of 724 is above the median of 96 across 2,251 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Compared within Acquired Immunodeficiency Syndrome, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this trial arm, participants will be provided with the ARC intervention package.
Behavioral: ARC
In this arm, participants will be managed according to the standard of care.
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.
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.
Time frame: Enrollment to up to 1 year
HIV viral suppression
HIV RNA concentration in plasma
Time frame: Enrollment, 3 months and 1 year
Retention in HIV care
No gap of \>28 days without documented possession of antiretroviral therapy medications
Time frame: At 3 months and 1 year
Medication possession ratio
Number of days with possession of antiretroviral medications divided by the time interval of interest
Time frame: At 3 months and 12 months
Plan to share: Undecided — 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.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →
University of Alabama at Birmingham →