Advanced HIV Re-engagement in Care
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARC.
- Who it may be relevant to
- Registry conditions: Advanced HIV Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Zambia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- All-cause mortality [Time frame: Enrollment to up to 1 year]
Secondary outcome measures (3)
- HIV viral suppression [Time frame: Enrollment, 3 months and 1 year]
- Retention in HIV care [Time frame: At 3 months and 1 year]
- Medication possession ratio [Time frame: At 3 months and 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Zambia · 1 center
- University Teaching Hospital — Lusaka
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/s1298 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
Identifiers
NCT: NCT07720128 · IRB-300017004