| Registry | NCT07720128, acronym ARC |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, health services research |
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| Enrollment | 724 (Estimated) |
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| Sponsor | University of Alabama at Birmingham (Other); collaborators: Ciheb Zambia, University of Maryland, Baltimore |
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| Conditions | Advanced HIV Disease |
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| Interventions | ARC (Behavioral) |
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| Dates | start 2027-05-01 (estimated), primary completion 2031-05-01 (estimated), completion 2031-08-01 (estimated), first posted 2026-07-22, last updated 2026-07-23 |
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| Locations | 1 site in Zambia |
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Related Papers Related Patents Related Grants Related Experts
All trials for Advanced HIV Disease All trials of ARC
-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| Advanced HIV Re-engagement in Care (ARC) | Experimental | Behavioral: ARC | In this trial arm, participants will be provided with the ARC intervention package. |
| Standard of Care (SOC) | No intervention | | In this arm, participants will be managed according to the standard of care. |
- 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.
+Outcome measures
Primary outcomes
- All-cause mortality [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
- HIV viral suppression [Enrollment, 3 months and 1 year]: HIV RNA concentration in plasma
- Retention in HIV care [At 3 months and 1 year]: No gap of >28 days without documented possession of antiretroviral therapy medications
- Medication possession ratio [At 3 months and 12 months]: Number of days with possession of antiretroviral medications divided by the time interval of interest
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| University Teaching Hospital | Lusaka | Zambia | |
+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. PMID 39994735
- 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 35193598
- 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 38314820
+Investigators
- Lottie Hachaambwa, MBChB, Principal investigator, Ciheb Zambia
- Cassidy Claassen, MD, Principal investigator, University of Maryland, Baltimore
- Michael J Vinikoor, MD, Principal investigator, University of Alabama at Birmingham