HIV/AIDSIPADZNCT04033718
Inpatient Package to Reduce HIV and AIDS-related Death in Zambia
A study testing Inpatient lab bundling and Inpatient navigation in people with HIV/AIDS and Transitions of Care, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
Early post-discharge mortality is high among HIV-infected Zambians admitted to the hospital. Likely this is in part due to missed opportunities to identify lethal coinfections and optimize HIV care during admission (and before discharge). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Transitions of Care, Hospitalization
- What is being tested?
- Inpatient lab bundling and Inpatient navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteZambia
- Study dates
- 1 Oct 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 18+ years old
- HIV-positive (by self-report or DCT result in UTH file)
- Resident of Lusaka
- Admitted to the hospital
Who cannot join
- Too sick to provide informed consent (based on clinician opinion)
- Likely to be discharged in the next 48 hours (based on clinician opinion)
Trial locations and contacts
1 site in 1 country.
About this study
Early post-discharge mortality is high among HIV-infected Zambians admitted to the hospital. Likely this is in part due to missed opportunities to identify lethal coinfections and optimize HIV care during admission (and before discharge). In this study the investigators will develop and pilot a new approach to inpatient HIV care that follows international guidelines for management of advanced HIV disease.
- Conditions
- HIV/AIDS, Transitions of Care, Hospitalization, Tuberculosis, HIV Testing, Cryptococcosis
- Being tested
- Inpatient lab bundling, Inpatient navigation
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Tuberculosis, Cryptococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inpatient lab bundlingDiagnostic test
The investigators will provide patients a package of diagnostic tests at the time of admission to comprehensively assess for HIV coinfections and treatment failure. These labs are all recommended in advanced HIV guidelines but in this study we will provide all tests as a bundle rather than step-by-step as suggested in guidelines.
Inpatient navigationBehavioural
Participants will be assigned a patient navigator who will support the patient and bedsider (treatment supporter/guardian) during the hospitalization. The navigator will be an HIV counselor who can provide counseling and health education, as well as support specimen transport, obtaining results, booking tests in other departments, linkages to ART clinic, and discharge planning
| Study group | Role | What they receive |
|---|---|---|
| Inpatient lab bundling plus navigation | Experimental | Testing for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach. Additional inpatient support from a patient navigator Receives: Diagnostic Test: Inpatient lab bundling; Behavioral: Inpatient navigation |
| Inpatient lab bundling alone | Experimental | Testing for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach. Receives: Diagnostic Test: Inpatient lab bundling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coinfection diagnosis
Positive test for tuberculosis or cryptococcus on admission
Measured: Through hospital discharge, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Oct 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Teaching Hospital, University of Maryland
- Responsible party
- Principal investigator, Michael Vinikoor, University of Alabama at Birmingham
- Investigators
- Michael J Vinikoor, MD, Principal investigator, Assistant Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033718
- Sponsor's protocol ID
- 300003461
- Acronym
- IPADZ
- Status last verified
- Aug 2024
- First submitted
- 23 Jul 2019
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inpatient Package to Reduce HIV and AIDS-related Death in Zambia
- ClinicalTrials.gov ID
- NCT04033718
- Acronym / sponsor ID
- IPADZ / 300003461
- Conditions
- HIV/AIDS, Transitions of Care, Hospitalization, Tuberculosis, HIV Testing, Cryptococcosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University Teaching Hospital, University of Maryland
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 26 Jul 2019 (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.
Early post-discharge mortality is high among HIV-infected Zambians admitted to the hospital. Likely this is in part due to missed opportunities to identify lethal coinfections and optimize HIV care during admission (and before discharge). In this study the investigators will develop and pilot a new approach to inpatient HIV care that follows international guidelines for management of advanced HIV disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inpatient lab bundling plus navigation | Experimental | Diagnostic Test: Inpatient lab bundling, Behavioral: Inpatient navigationTesting for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach. Additional inpatient support from a patient navigator |
| Inpatient lab bundling alone | Experimental | Diagnostic Test: Inpatient lab bundlingTesting for CD4 count, tuberculosis, cryptococcus, and HIV RNA with samples collected in a bundle-type approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18+ years old
- HIV-positive (by self-report or DCT result in UTH file)
- Resident of Lusaka
- Admitted to the hospital
Key exclusion criteria (2 listed)
- Too sick to provide informed consent (based on clinician opinion)
- Likely to be discharged in the next 48 hours (based on clinician opinion)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inpatient lab bundlingThe investigators will provide patients a package of diagnostic tests at the time of admission to comprehensively assess for HIV coinfections and treatment failure. These labs are all recommended in advanced HIV guidelines but in this study we will provide all tests as a bundle rather than step-by-step as suggested in guidelines. | Diagnostic test | Inpatient lab bundling alone, Inpatient lab bundling plus navigation |
| Inpatient navigationParticipants will be assigned a patient navigator who will support the patient and bedsider (treatment supporter/guardian) during the hospitalization. The navigator will be an HIV counselor who can provide counseling and health education, as well as support specimen transport, obtaining results, booking tests in other departments, linkages to ART clinic, and discharge planning | Behavioural | Inpatient lab bundling plus navigation |
Primary outcome
Coinfection diagnosis
Time frame: Through hospital discharge, an average of 2 weeks
Positive test for tuberculosis or cryptococcus on admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Michael J Vinikoor, MD principal investigator
Assistant Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inpatient lab bundling and Inpatient navigation in people with HIV/AIDS and Transitions of Care, run by University of Alabama at Birmingham at 1 site in Zambia.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 9 Aug 2024. 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 Zambia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coinfection diagnosis (time frame: Through hospital discharge, an average of 2 weeks). 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 9 Aug 2024.