NCT07428577 Tracking and Continuity of Care in Advanced HIV Disease
| NCT ID | NCT07428577 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston University |
| Condition | Advanced HIV Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-02-24 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2026-02-24 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Sydney Rosen
PRINCIPAL INVESTIGATOR
Boston University
Frequently Asked Questions
Who can join the NCT07428577 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced HIV Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07428577 currently recruiting?
Yes, NCT07428577 is actively recruiting participants. Contact the research team at ekachingwe@heroza.org for enrollment information.
Where is the NCT07428577 trial being conducted?
This trial is being conducted at Johannesburg, South Africa.
Who is sponsoring the NCT07428577 clinical trial?
NCT07428577 is sponsored by Boston University. The principal investigator is Sydney Rosen at Boston University. The trial plans to enroll 150 participants.
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