Tracking and Continuity of Care in Advanced HIV Disease

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBoston University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: Prospective cohort

Trial outcomes

Primary outcomes

1

Linkage to primary care ART

Self-reported proportion of discharged patients who successfully return to PHC facilities and start, resume, or continue ART.

Time frame
8 weeks after hospital discharge

Secondary outcomes

1

Referral documentation

Completeness and quality of discharge documentation, including referrals to PHC and follow-up instructions

Time frame
8 weeks after hospital discharge

Other outcomes

Sponsors and contacts

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Boston University

Lead sponsor

Bill and Melinda Gates Foundation

Collaborator

HE2RO, University of the Witwatersrand

Collaborator