HIV-1-infectionNCT04517825
More Than a Machine: Make Point-of-care HIV-1 Viral Load Testing Effective in Rural Uganda
An observational study of HIV-1-infection, run by University of North Carolina, Chapel Hill at 2 sites in Uganda.
Trial summary
This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- Cepheid Xpert HIV-1 Viral Load Assay
- How many people
- 242 participants
- Where
- 2 sitesUganda
- Study dates
- 8 Aug 2020to 30 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 18 years or older receiving care at the Bugoye Health Center Antiretroviral therapy clinic
Who may be able to join
- Adult patients aged 18 years or older receiving care at the Bugoye Health Center Antiretroviral therapy clinic
Who cannot join
- Patients unwilling or unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites
Bugoye Level III Health Centre
Bugoye, Kasese
Mbarara University of Science and Technology (MUST)
Mbarara, PO Box 1410
About this study
Official title: IGHID 11920 - More Than a Machine: Exploring the Ancillary Systems and Processes Required to Make Point-of-care HIV-1 Viral Load Testing Effective in Rural Western Uganda
This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda.
The central hypothesis is that implementation of PoC HIV-1 testing without accompanying modifications to clinic triage and flow, laboratory processes, and existing protocols guiding adherence counseling and regimen change, will not result in significant improvement in clinical outcomes in PLWH.
Read the detailed description
This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda.
In Phase 1, the study team will perform/record the following:
- Administer a basic demographic and health questionnaire
- Record routine clinical parameters during visit to include:
- Current ARV and prophylaxis regimen
- Last CD4 and VL, if available
- Clinical illness since last visit
- Document the amount of time each patient spends in each phase of clinic (i.e. waiting room, provider, phlebotomy, waiting for results, adherence counseling).
- Measure the number of participants requiring HIV-1 VL testing each clinic day, proportion electing to receive results by phone or at next visit.
- Patients having blood drawn for HIV-1 VL testing will complete a semi-structured interview to explore perceptions of the current testing paradigm when results are received.
- Provider and laboratory staff will complete a semi-structured interview to explore perceptions of the current testing paradigm with emphasis on workload
In Phase 2, the study team will perform/record the following:
- Record routine clinical parameters during visit to include:
- Current ARV and prophylaxis regimen
- Last CD4 and VL, if available
- Clinical illness since last visit
- Determine the amount of time each patient spends in each phase of clinic (i.e. waiting room, provider, phlebotomy, waiting for results, adherence counseling).
- Measure the number of Xpert HIV-1 tests performed, the amount of time laboratory staff spends performing the tests and conducting maintenance, the number of tests failures and/or invalid tests, and equipment downtime related problems with software or power supply.
- Measure the number of participants requiring HIV-1 VL testing each clinic day, proportion electing to receive results on same day, by phone, or next visit.
- Patients having blood drawn for HIV-1 VL testing will complete a semi-structured interview to explore perceptions of the current testing paradigm when results are received.
- Provider and laboratory staff will complete a semi-structured interview to explore perceptions of the current testing paradigm with emphasis on workload.
- Conditions
- HIV-1-infection
- Being tested
- Cepheid Xpert HIV-1 Viral Load Assay
- Keywords
- viral load, CD4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cepheid Xpert HIV-1 Viral Load AssayDiagnostic test
Rapid, on-site molecular HIV-1 viral load testing used in accordance with cleared/approved labeling
| Study group | Role | What they receive |
|---|---|---|
| Target Population | HIV positive individuals attending Bugoye ART clinic Receives: Diagnostic Test: Cepheid Xpert HIV-1 Viral Load Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Tests Performed Successfully Each Clinic Day
HIV viral load tests performed at peripheral health center
Measured: Each clinic day for up to six months
Number of Tests Performed Successfully each Month
HIV viral load tests performed at peripheral health center
Measured: Each month for up to six months
Secondary outcomes (6)
Proportion of Eligible Patients Electing to Stay to Receive Results
Acceptability of rapid HIV viral load results
Measured: Each clinic day for up to six months
Proportion of Eligible Patients Electing to Stay to Receive Results
Acceptability of rapid HIV viral load results
Measured: Each month for up to six months
Mean Time Clients Spend in Clinic
Impact on routine ART Clinic flow
Measured: Each clinic day for up to 9 months
Provider Perception of Workload
Perceived time spent conducting on-site testing vs send-out testing
Measured: Pre- and post-intervention (approximately 6 months apart)
Mean and median time-to-result
Mean and median number of days from blood draw to client receiving viral load result either from current standard of care or on-site testing
Measured: Up to 90 days after blood draw, after which considered not returned
Machine Down-Time and Maintenance
Total number of hours spent in maintenance, trouble-shooting, or repair
Measured: Each clinic day (i.e. weekly) during the 6 months of Phase 2 when the Xpert is operational
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start8 Aug 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ross M Boyce, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517825
- Sponsor's protocol ID
- 19-2363
- Other IDs
- P30AI050410
- Status last verified
- May 2022
- First submitted
- 31 Jul 2020
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Boyce RM, Ndizeye R, Ngelese H, Baguma E, Shem B, Rubinstein RJ, Rockwell E, Lotspeich SC, Shook-Sa BE, Ntaro M, Nyehangane D, Wohl DA, Siedner MJ, Mulogo EM. It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda. PLOS Glob Public Health. 2023 Mar 27;3(3):e0001678. doi: 10.1371/journal.pgph.0001678. eCollection 2023.
PubMed 36972208
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGHID 11920 - More Than a Machine: Exploring the Ancillary Systems and Processes Required to Make Point-of-care HIV-1 Viral Load Testing Effective in Rural Western Uganda
- ClinicalTrials.gov ID
- NCT04517825
- Acronym / sponsor ID
- 19-2363
- Conditions
- HIV-1-infection
- Keywords
- viral load, CD4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 8 Aug 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Aug 2020 (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.
This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda.
The central hypothesis is that implementation of PoC HIV-1 testing without accompanying modifications to clinic triage and flow, laboratory processes, and existing protocols guiding adherence counseling and regimen change, will not result in significant improvement in clinical outcomes in PLWH.
Detailed description
This is a two-phase study designed to assess measures of feasibility, sustainability, acceptability, penetration, and fidelity before and after implementation of a rapid molecular HIV-1 viral load testing infrastructure at a level III health center in rural western Uganda.
In Phase 1, the study team will perform/record the following:
- Administer a basic demographic and health questionnaire
- Record routine clinical parameters during visit to include:
- Current ARV and prophylaxis regimen
- Last CD4 and VL, if available
- Clinical illness since last visit
- Document the amount of time each patient spends in each phase of clinic (i.e. waiting room, provider, phlebotomy, waiting for results, adherence counseling).
- Measure the number of participants requiring HIV-1 VL testing each clinic day, proportion electing to receive results by phone or at next visit.
- Patients having blood drawn for HIV-1 VL testing will complete a semi-structured interview to explore perceptions of the current testing paradigm when results are received.
- Provider and laboratory staff will complete a semi-structured interview to explore perceptions of the current testing paradigm with emphasis on workload
In Phase 2, the study team will perform/record the following:
- Record routine clinical parameters during visit to include:
- Current ARV and prophylaxis regimen
- Last CD4 and VL, if available
- Clinical illness since last visit
- Determine the amount of time each patient spends in each phase of clinic (i.e. waiting room, provider, phlebotomy, waiting for results, adherence counseling).
- Measure the number of Xpert HIV-1 tests performed, the amount of time laboratory staff spends performing the tests and conducting maintenance, the number of tests failures and/or invalid tests, and equipment downtime related problems with software or power supply.
- Measure the number of participants requiring HIV-1 VL testing each clinic day, proportion electing to receive results on same day, by phone, or next visit.
- Patients having blood drawn for HIV-1 VL testing will complete a semi-structured interview to explore perceptions of the current testing paradigm when results are received.
- Provider and laboratory staff will complete a semi-structured interview to explore perceptions of the current testing paradigm with emphasis on workload.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Target Population | – | Diagnostic Test: Cepheid Xpert HIV-1 Viral Load AssayHIV positive individuals attending Bugoye ART clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 18 years or older receiving care at the Bugoye Health Center Antiretroviral therapy clinic
Key inclusion criteria (1 listed)
- Adult patients aged 18 years or older receiving care at the Bugoye Health Center Antiretroviral therapy clinic
Key exclusion criteria (1 listed)
- Patients unwilling or unable to provide informed consent
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 |
|---|---|---|
| Cepheid Xpert HIV-1 Viral Load AssayRapid, on-site molecular HIV-1 viral load testing used in accordance with cleared/approved labeling | Diagnostic test | Target Population |
Primary outcome
Number of Tests Performed Successfully Each Clinic Day
Time frame: Each clinic day for up to six months
HIV viral load tests performed at peripheral health center
Number of Tests Performed Successfully each Month
Time frame: Each month for up to six months
HIV viral load tests performed at peripheral health center
6 secondary outcomes
Proportion of Eligible Patients Electing to Stay to Receive Results
Time frame: Each clinic day for up to six months
Proportion of Eligible Patients Electing to Stay to Receive Results
Time frame: Each month for up to six months
Mean Time Clients Spend in Clinic
Time frame: Each clinic day for up to 9 months
Provider Perception of Workload
Time frame: Pre- and post-intervention (approximately 6 months apart)
Mean and median time-to-result
Time frame: Up to 90 days after blood draw, after which considered not returned
Machine Down-Time and Maintenance
Time frame: Each clinic day (i.e. weekly) during the 6 months of Phase 2 when the Xpert is operational
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 23 May 2022.
- Derived from this study: PubMed 36972208Boyce RM, Ndizeye R, Ngelese H, Baguma E, Shem B, Rubinstein RJ, Rockwell E, Lotspeich SC, Shook-Sa BE, Ntaro M, Nyehangane D, Wohl DA, Siedner MJ, Mulogo EM. It takes more than a machine: A pilot feasibility study of point-of-care HIV-1 viral load testing at a lower-level health center in rural western Uganda. PLOS Glob Public Health. 2023 Mar 27;3(3):e0001678. doi: 10.1371/journal.pgph.0001678. eCollection 2023.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Ross M Boyce, MD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1-infection, run by University of North Carolina, Chapel Hill at 2 sites in Uganda.
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 1 inclusion and 1 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 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. 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?
Number of Tests Performed Successfully Each Clinic Day (time frame: Each clinic day for up to six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04517825, which also lists 1 linked publication.
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 23 May 2022.