Tracking and Continuity of Care in Advanced HIV Disease

NCT07428577 | Recruiting

• 1 other identifier: H-46416
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced HIV Disease

Keywords

Advanced HIV disease; South Africa; Inpatient care

Outcome Measures

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.

  8 weeks after hospital discharge

Secondary Outcomes (1)

• Referral documentation

  8 weeks after hospital discharge

Study Arms (1)

Prospective cohort

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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
• Consent to be contacted after discharge and can provide contact information

You may not qualify if:

• 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

Sponsors & Collaborators

• Bill and Melinda Gates Foundation: collaborator
• HE2RO, University of the Witwatersrand: collaborator
• Boston University: lead

Study Sites (1)

Helen Joseph Hospital

Johannesburg, Gauteng, South Africa

RECRUITING

Study Officials

• Sydney Rosen

  Boston University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Kachingwe

CONTACT

‪27 61 066 3132‬; ekachingwe@heroza.org

Linda Sande

CONTACT

27 63 115 1952; lsande@heroza.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 23, 2026
• Study Start: February 24, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1)