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NCT07428577Recruiting

Tracking and Continuity of Care in Advanced HIV Disease

Source: ClinicalTrials.gov · Last updated 31 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
19 Feb 2026
Start date
24 Feb 2026
Primary completion date
31 Dec 2026
Lead sponsor
Boston University
Diseases
HIV
NCT number
NCT07428577

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 24 Feb 2026 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Not physically, mentally, or emotionally able to participate in the study prior to discharge, in the opinion of facility or study staff

Other illness

  • Confined to tuberculosis isolation ward or other wards for patients with acute infectious disease that requires isolation procedures

Other

  • Unable to communicate in any of the languages into which the questionnaire has been translated or that is known to the research assistant

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Helen Joseph Hospital
Coordinator of this site? Confirm its status
JohannesburgSouth AfricaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.