Tracking and Continuity of Care in Advanced HIV Disease (TRACK-AHD)

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced HIV Disease

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Elizabeth Kachingwe; Phone Number: ‪27 61 066 3132‬; Email: ekachingwe@heroza.org
• Study Contact Backup: Name: Linda Sande; Phone Number: 27 63 115 1952; Email: lsande@heroza.org

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa
      • Recruiting
      • Helen Joseph Hospital
      • Contact: Elizabeth Kachingwe; Phone Number: ‪27 61 066 3132‬; Email: ekachingwe@heroza.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Referral documentation	Completeness and quality of discharge documentation, including referrals to PHC and follow-up instructions	8 weeks after hospital discharge

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: Bill and Melinda Gates Foundation; HE2RO, University of the Witwatersrand
• Investigators: Principal Investigator: Sydney Rosen, Boston University

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: February 19, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: South Africa; Inpatient care; Advanced HIV disease
• Other Study ID Numbers: H-46416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will post completely anonymized, coded data sets generated by the study (interviews) to a public repository after all analysis and publication has been completed. Medical record will not be owned by the study and cannot be posted.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No