HivCOLAHNCT03158844
HIV Care Cascade and Linkage to Antiretroviral Therapy Among Hospitalized Adults in Lusaka, Zambia
An observational study of Hiv, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
The population of inpatients is large in Zambia; however, because of poor linkages between hospitals and community HIV care, there are few data to analyze their engagement in HIV care before and after hospitalization. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Hiv
- How many people
- 250 participants
- Where
- 1 siteZambia
- Study dates
- 16 May 2017to 31 May 2018
- Phase
- Observational
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In part 1, people will be recruited in a random fashion from HIV-infected patients hospitalized at the University Teaching Hospital (UTH) as documented in their UTH medical file regardless of their HIV treatment status. The bed spaces in the wards will be enumerated and using a random number generator the team will select patients for screening for study inclusion.
Who may be able to join
- 18 years or older
- HIV-infected as documented in the UTH file
- Admitted to Internal Medicine Ward at UTH
Who cannot join
- Unable to provide informed consent
- Not planning to remain in Lusaka province for 3 months after discharge
Trial locations and contacts
1 site in 1 country.
About this study
The population of inpatients is large in Zambia; however, because of poor linkages between hospitals and community HIV care, there are few data to analyze their engagement in HIV care before and after hospitalization. The goal of the study is to learn more about Zambian adults who are HIV-infected and get hospitalized. The purpose of this study is to gather formative, preliminary data, to be used in future grant applications to improve linkage and engagement in HIV care in Zambia.
Read the detailed description
The main objective of this study is to generate preliminary data on the outcomes of Zambian HIV-infected individuals after discharge from University Teaching Hospital (UTH) Internal Medicine wards which can inform development of a linkage intervention. Our central hypothesis is that in Sub-Saharan African settings like Zambia hospitalizations among HIV-infected individuals are driven by suboptimal linkage and initiation of ART following HIV diagnosis. Specific Aims: (a) Characterize the distribution of hospitalized 300 HIV-infected adults across the HIV care continuum. (b) Identify structural, psychosocial, clinic, and medical factors that predict suboptimal linkage to care and ART initiation after 90 days of hospital discharge among HIV-infected Zambians.
- Conditions
- Hiv
- Being tested
- Standard of care
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Routine standard of care per Ministry of Health protocol, including blood draws and examinations.
| Study group | Role | What they receive |
|---|---|---|
| HIV+ patients (Standard of care) | 300 HIV-infected and hospitalized adult patients at the University Teaching Hospital (UTH) will be recruited. Receives: Other: Standard of care | |
| Health systems informants | 15 key Zambian health systems informants and leaders who can discuss inpatient care and the process of linking hospitalized patients to HIV care. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable HIV viral load at 90 days post-discharge
Numerator is number with HIV RNA <1000 c/mL tested at 90 days after hospital discharge; denominator is the # enrolled
Measured: 90 days after hospital discharge
Secondary outcomes (3)
Proportion of HIV-infected inpatients who are on ART upon admission
Numerator is number who report taking ART up to the time of admission; denominator is the # enrolled
Measured: Baseline
Mortality rate
Mortality from time of enrollment to 90 days after discharge
Measured: 90 days after hospital discharge
ART initiation
Proportion not on ART upon admission to hospital who are on ART at 90 days after hospital discharge
Measured: Baseline and 90 days 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 posted18 May 2017
- Study start16 May 2017
- Primary completion28 Feb 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University Teaching Hospital, Centre for Infectious Disease Research in Zambia
- Responsible party
- Principal investigator, Michael Vinikoor, University of Alabama at Birmingham
- Investigators
- Michael J Vinikoor, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158844
- Sponsor's protocol ID
- F160812007
- Acronym
- COLAH
- Status last verified
- Aug 2018
- First submitted
- 8 May 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV Care Cascade and Linkage to Antiretroviral Therapy Among Hospitalized Adults in Lusaka, Zambia
- ClinicalTrials.gov ID
- NCT03158844
- Acronym / sponsor ID
- COLAH / F160812007
- Conditions
- Hiv
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University Teaching Hospital, Centre for Infectious Disease Research in Zambia
- Study start
- 16 May 2017 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 18 May 2017 (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.
The population of inpatients is large in Zambia; however, because of poor linkages between hospitals and community HIV care, there are few data to analyze their engagement in HIV care before and after hospitalization. The goal of the study is to learn more about Zambian adults who are HIV-infected and get hospitalized. The purpose of this study is to gather formative, preliminary data, to be used in future grant applications to improve linkage and engagement in HIV care in Zambia.
Detailed description
The main objective of this study is to generate preliminary data on the outcomes of Zambian HIV-infected individuals after discharge from University Teaching Hospital (UTH) Internal Medicine wards which can inform development of a linkage intervention. Our central hypothesis is that in Sub-Saharan African settings like Zambia hospitalizations among HIV-infected individuals are driven by suboptimal linkage and initiation of ART following HIV diagnosis. Specific Aims: (a) Characterize the distribution of hospitalized 300 HIV-infected adults across the HIV care continuum. (b) Identify structural, psychosocial, clinic, and medical factors that predict suboptimal linkage to care and ART initiation after 90 days of hospital discharge among HIV-infected Zambians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV+ patients (Standard of care) | – | Other: Standard of care300 HIV-infected and hospitalized adult patients at the University Teaching Hospital (UTH) will be recruited. |
| Health systems informants | – | Other: Standard of care15 key Zambian health systems informants and leaders who can discuss inpatient care and the process of linking hospitalized patients to HIV care. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In part 1, people will be recruited in a random fashion from HIV-infected patients hospitalized at the University Teaching Hospital (UTH) as documented in their UTH medical file regardless of their HIV treatment status. The bed spaces in the wards will be enumerated and using a random number generator the team will select patients for screening for study inclusion.
Key inclusion criteria (3 listed)
- 18 years or older
- HIV-infected as documented in the UTH file
- Admitted to Internal Medicine Ward at UTH
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Not planning to remain in Lusaka province for 3 months after discharge
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 |
|---|---|---|
| Standard of careRoutine standard of care per Ministry of Health protocol, including blood draws and examinations. | Other | HIV+ patients (Standard of care), Health systems informants |
Primary outcome
Undetectable HIV viral load at 90 days post-discharge
Time frame: 90 days after hospital discharge
Numerator is number with HIV RNA <1000 c/mL tested at 90 days after hospital discharge; denominator is the # enrolled
3 secondary outcomes
Proportion of HIV-infected inpatients who are on ART upon admission
Time frame: Baseline
Mortality rate
Time frame: 90 days after hospital discharge
ART initiation
Time frame: Baseline and 90 days after hospital discharge
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 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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
University of Alabama at Birmingham
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 Hiv, 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 3 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 19 Sep 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?
Undetectable HIV viral load at 90 days post-discharge (time frame: 90 days 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 19 Sep 2024.