Advanced HIV Disease
Conditions
Keywords
HIV/AIDS, Transitions of care, Hospitalization, Community Health Worker, Sub-Saharan Africa, Advanced HIV disease, Tuberculosis, Cryptococcus
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.
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
BEHAVIORALARC
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.
Sponsors
University of Alabama at Birmingham
Ciheb Zambia
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Zambia
Contacts
CONTACTMichael J Vinikoor, MD
CONTACTIke Oyewole
PRINCIPAL_INVESTIGATORLottie Hachaambwa, MBChB
Ciheb Zambia
PRINCIPAL_INVESTIGATORCassidy Claassen, MD
University of Maryland, Baltimore
PRINCIPAL_INVESTIGATORMichael J Vinikoor, MD
University of Alabama at Birmingham
Outcome results
None listed