Advanced HIV DiseaseTRACK-AHDNCT07428577
Tracking and Continuity of Care in Advanced HIV Disease
An observational study of Advanced HIV Disease, run by Boston University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced HIV Disease
- How many people
- 150 participants
- Where
- 1 siteSouth Africa
- Study dates
- 24 Feb 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Helen Joseph Hospital
Johannesburg, Gauteng
Elizabeth Kachingwe, 27 61 066 3132, ekachingwe@heroza.org
About this study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Linkage to primary care ART
Self-reported proportion of discharged patients who successfully return to PHC facilities and start, resume, or continue ART.
Measured: 8 weeks after hospital discharge
Secondary outcomes (1)
Referral documentation
Completeness and quality of discharge documentation, including referrals to PHC and follow-up instructions
Measured: 8 weeks after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start24 Feb 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced HIV DiseaseStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, HE2RO, University of the Witwatersrand
- Responsible party
- Sponsor
- Investigators
- Sydney Rosen, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428577
- Sponsor's protocol ID
- H-46416
- Acronym
- TRACK-AHD
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2026
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tracking and Continuity of Care in Advanced HIV Disease
- ClinicalTrials.gov ID
- NCT07428577
- Acronym / sponsor ID
- TRACK-AHD / H-46416
- Conditions
- Advanced HIV Disease
- Keywords
- Advanced HIV disease, South Africa, Inpatient care
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, HE2RO, University of the Witwatersrand
- Study start
- 24 Feb 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Referral documentation
Time frame: 8 weeks after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sydney Rosen principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced HIV Disease, run by Boston University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Kachingwe (27 61 066 3132, ekachingwe@heroza.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to primary care ART (time frame: 8 weeks after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.