About this trial
Despite the scale-up of HIV testing and the implementation of the universal test-and-treat policy, a substantial proportion of people living with HIV (PLHIV) continue to present with advanced HIV disease (AHD), defined by a CD4 count below 200 cells/µL and/or WHO clinical staging of stage 3 or 4. Global and regional analyses estimate that nearly half of hospitalized PLHIV meet criteria for AHD, with similar findings reported in South Africa. Patients with AHD face high risks of opportunistic infections, hospitalization, and mortality, and frequently disengage from care after discharge. This study aims to examine inpatient and post-discharge care pathways for individuals with AHD in South Africa, identify gaps in continuity of care between hospitals and primary healthcare (PHC) facilities, and generate evidence to inform strategies that strengthen linkage, retention, and long-term outcomes.
A prospective cohort study with a nested process evaluation will be conducted at Helen Joseph Hospital, a large public tertiary facility in Johannesburg. Adult patients (≥18 years) admitted with HIV-related conditions and meeting AHD criteria will be consecutively enrolled once deemed clinically stable. Data will be collected through structured inpatient interviews, medical-record reviews, and follow-up telephone interviews at four- and eight-weeks post-discharge to assess linkage to PHC services, ART continuation, and readmissions. Quantitative data will be analyzed descriptively using standard statistical methods.
This study will generate a detailed understanding of how patients with AHD transition from inpatient to outpatient HIV care, highlighting critical points where continuity of care fails. Findings will identify system- and patient-level barriers to effective linkage and retention and inform interventions to improve post-discharge outcomes. The study poses minimal risk to participants, involving only structured interviews and review of existing medical records, with no invasive procedures.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Known HIV positive status
Admitted to inpatient care for an AHD-related illness
Aged 18 years and above
Able to provide written consent or consent using a thumbprint
Disqualifiers
Confined to tuberculosis isolation ward or other wards for patients with acute infectious disease that requires isolation procedures
Not physically, mentally, or emotionally able to participate in the study prior to discharge, in the opinion of facility or study staff
Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant
Trial population
Adults aged 18 or older admitted to a medical (not surgical, obstetric, or psychiatric) unit at the Helen Joseph hospital with an HIV-related condition.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Linkage to primary care ART
Self-reported proportion of discharged patients who successfully return to PHC facilities and start, resume, or continue ART.
Secondary outcomes
Referral documentation
Completeness and quality of discharge documentation, including referrals to PHC and follow-up instructions
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Boston University
Lead sponsor
Bill and Melinda Gates Foundation
Collaborator
HE2RO, University of the Witwatersrand
Collaborator