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NCT Number: NCT07428577

Tracking and Continuity of Care in Advanced HIV Disease

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Helen Joseph Hospital

Johannesburg, Gauteng, South Africa

Location status: Recruiting

Location contact

Elizabeth Kachingwe

CONTACT

[email protected]

‪27 61 066 3132‬

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Linkage to primary care ART

    Time frame: 8 weeks after hospital discharge

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

Secondary outcomes

  1. Referral documentation

    Time frame: 8 weeks after hospital discharge

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

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Kachingwe

CONTACT

[email protected]

‪27 61 066 3132‬

Linda Sande

CONTACT

[email protected]

27 63 115 1952

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • HE2RO, University of the Witwatersrand

Registry information

Acronym: TRACK-AHD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 23, 2026
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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