HIV/AIDSPOCNCT03533868
Reaching 90% HIV Suppression: The Role of POC Viral Load Monitoring in Nigeria
A study testing Point-of-care viral load monitoring test in people with HIV/AIDS, run by Harvard School of Public Health (HSPH) at 2 sites in Nigeria.
Trial summary
The UNAIDS 90-90-90 goals represents an ambitious strategy to end the acquired immunodeficiency syndrome (AIDS) epidemic by 2020 [UNAIDS, 2015]. While viral load (VL) quantification is the gold standard of HIV treatment monitoring, it is only routinely available and employed in resource-rich countries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Point-of-care viral load monitoring test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 543 participants
- Where
- 2 sitesNigeria
- Study dates
- 9 Apr 2018to 28 Feb 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -All HIV-infected patients newly initiating ART
Who cannot join
- Previous ARV experience
- Pregnant
Trial locations and contacts
2 sites in 1 country.
Nigeria2 sites
Jos University Teaching Hospital
Jos, Plateau State
Comprehensive Health Care Centre, Zamko
Zamko, Plateau State
About this study
Official title: Reaching 90% Target of HIV Viral Suppression: The Role of Point-of-Care Viral Load Monitoring in Resource-Constrained Settings in Nigeria
The UNAIDS 90-90-90 goals represents an ambitious strategy to end the acquired immunodeficiency syndrome (AIDS) epidemic by 2020 [UNAIDS, 2015]. While viral load (VL) quantification is the gold standard of HIV treatment monitoring, it is only routinely available and employed in resource-rich countries. The use of an affordable, reliable, point-of-care (POC) VL assay has been considered a "game-changer", where increased access, minimal lab worker training, and same day results could be addressed in a single solution. To date, POC VL assays have been evaluated by their manufacturers with reference panels of samples with some in-country laboratory evaluations. While these are appropriate and critical first steps, it is also important to evaluate the impact of this new technology against the standard of care (SOC) method of VL monitoring in an actual resource-limited setting.
Nigeria has the second highest burden of HIV in the world, with an estimated 3.2 million infected and serves as a relevant setting for testing feasibility and efficacy of POC VL monitoring [UNAIDS, 2016]. In order to present the case for implementing the use of POC VL testing across Nigeria, data on the acceptability, feasibility and efficacy of using POC testing for VL monitoring are needed. To address this need, the investigators have designed a randomized controlled trial comparing POC VL to monitoring to the SOC, which follows the Nigerian National Guidelines, to provide operational evidence for implementation of POC VL testing in Nigeria. This trial is aimed at testing the hypothesis that using POC versus SOC VL monitoring in HIV-infected patients newly initiating ART will improve overall ART outcomes, increase ART adherence and program retention rates, and result in faster switches to second-line treatment of patients failing first-line ART.
Read the detailed description
The investigators will conduct an un-blinded randomized implementation trial comparing POC VL monitoring, using the Cepheid Gene Xpert HIV-1 VL®, to SOC VL monitoring, using the Roche AmpliPrep/COBAS Taqman system. The trial will be conducted at two sites in Plateau State, Nigeria.
ART-naïve patients initiating ART will be randomized on a 1:1 basis to the SOC VL monitoring control arm or the POC VL monitoring arm. VL monitoring will occur according to the current Nigerian ART guidelines-recommended algorithm, with the addition of a baseline VL test. For the month 6 and 12 visits, patients that are enrolled in the POC VL monitoring arm will be provided their VL results. Participants in the SOC arm will receive their Roche VL test results after the results become available per SOC protocol. All other aspects of their HIV care and treatment will be identical to services that they would normally receive at these treatment centers.
The investigators will follow all patients up through their Month 12 follow-up visit. At trial exit, the investigators will ask patients, caregivers of patients under the age of 18 years, and providers for their participation in surveys on the operational performance and acceptability of the POC versus SOC VL monitoring. Following that time point, the patients will continue receiving HIV care and treatment utilizing the SOC procedures for the clinic.
- Conditions
- HIV/AIDS
- Being tested
- Point-of-care viral load monitoring test
- Keywords
- Point-of-care, Viral load monitoring, Nigeria
- 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.
Point-of-care viral load monitoring testDiagnostic test
For enumerating viral load for patients in the POC arm, we will use the Cepheid Xpert® HIV-1 Viral Load test, a quantitative assay with a quantification range of 40 to 10,000,000 copies/mL. Based on the GeneXpert® technology, Xpert HIV-1 VL automates the test process, including RNA extraction, purification, reverse transcription and cDNA real-time quantitation in one fully integrated cartridge. The pre-loaded disposable single-use cartridges provide a visual read-out within 90 minutes. The assay requires 1 mL of plasma using a precision pipette (1.2 mL using a transfer pipette).
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | No intervention | Patients in this arm will have their viral load monitored using the standard of care method, using the Roche Cobas TaqMan HIV-1® v2 (Roche) assay. |
| Point-of-care (POC) | Experimental | Patients in this arm will have their follow-up viral loads (after baseline) monitored using a Point-of-care viral load monitoring test, the Cepheid Xpert HIV-1 Viral Load assay. Receives: Diagnostic Test: Point-of-care viral load monitoring test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with VL<1000 copies/mL at month 12 post-initiation of ART (range 11-15 months) in SOC VL versus POC VL
Proportion of patients that have undetectable viral load at the end of observation (month 12) will be compared by treatment arm
Measured: 12 months (range 11-15 months)
Secondary outcomes (11)
Difference in ART adherence patterns in patients in the SOC versus POC VL arms
Average percent adherence will be computed using patient refill data that are stored electronically. The average will be calculated as number of days supplied over total days in the given time interval, adjusting for amount of medication that should remain since last refill, computed based on amount supplied during the previous visit minus the number of days since the last visit.
Measured: From ART initiation to month 12
Difference in loss to follow-up rates by 12 months post-initiation of ART between patients monitored with SOC versus POC VL arms
LTFU at month 12 is defined as not having made any refill pick-ups or clinical visits since 9-month post-initiation of ART.
Measured: Month 12
Impact of trial site on differences in virologic suppression rates within patients receiving SOC VL monitoring
Comparison of data from two different trial sites
Measured: Month 12
Difference in time from ART initiation to the confirmation of virologic failure in SOC versus POC VL monitoring arms
Subset analysis in those that experienced virologic failure (confirmed)
Measured: ART Initiation to Month 12
Difference in time from ART initiation to switch to 2L treatment in patients in VF in SOC versus POC VL monitoring arms
Subset analysis in those that experienced virologic failure (confirmed)
Measured: ART Initiation to Month 12
Difference in time from specimen collection to availability of VL results in patient charts in SOC versus POC VL monitoring arms
Comparison of time from specimen collection to the time the result is entered into the patient chart by treatment arm
Measured: All follow-up visits at which VL monitored up to Month 12
Difference in time from specimen collection to delivery of VL results to patient in SOC versus POC VL monitoring arms
Comparison of time from specimen collection to the time the result is verbally conveyed to the patient by their clinician by treatment arm
Measured: All follow-up visits at which VL monitored up to Month 12
Difference in time from lab confirmation of first unsuppressed VL to adherence counseling provided and switch to 2L in SOC versus POC VL monitoring arms
Subset analysis in those that experienced virologic failure (confirmed)
Measured: All follow-up visits at which VL monitored up to Month 12
Difference in HIV DRM patterns in patients failing 1L ART in the SOC versus POC VL monitoring arm
Subset analysis in those that experienced virologic failure (confirmed)
Measured: Month 12
Health care worker (HCW) satisfaction level with POC versus SOC VL monitoring
Health care workers will complete a standardized survey querying about their satisfaction with the POC assay. The survey uses a scale measuring agreement level. The scale ranges from 0 to 5 where 0=not applicable, 1=strongly disagree and 5=strongly agree
Measured: Month 12
POC VL arm patient satisfaction with POC vs SOC VL testing
POC VL arm patients will be queried using a standardized survey about their satisfaction with the POC VL assay. The survey uses a scale measuring agreement level. The scale ranges from 0 to 5 where 0=not applicable, 1=strongly disagree and 5=strongly agree.
Measured: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start9 Apr 2018
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to have their viral load monitored by either the standard of care or point-of-care method at their follow-up clinical visits up to 12 months.
- Masking
- None (open label)
- Enrolment
- 543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Jos University Teaching Hospital, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Phyllis Kanki, Harvard School of Public Health (HSPH)
- Investigators
- Phyllis Kanki, DVM, DSc, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533868
- Sponsor's protocol ID
- CDC-CGH-2018-059
- Acronym
- POC
- Status last verified
- Mar 2021
- First submitted
- 11 May 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data set from the proposed trial, stripped of all identifying information and anonymized to protect patient confidentiality, will be available upon request within 30 months of the end of data collection.
Publications
Fonjungo PN, Boeras DI, Zeh C, Alexander H, Parekh BS, Nkengasong JN. Access and Quality of HIV-Related Point-of-Care Diagnostic Testing in Global Health Programs. Clin Infect Dis. 2016 Feb 1;62(3):369-374. doi: 10.1093/cid/civ866. Epub 2015 Sep 30.
PubMed 26423384Fonjungo PN, Osmanov S, Kuritsky J, Ndihokubwayo JB, Bachanas P, Peeling RW, Timperi R, Fine G, Stevens W, Habiyambere V, Nkengasong JN. Ensuring quality: a key consideration in scaling-up HIV-related point-of-care testing programs. AIDS. 2016 May 15;30(8):1317-23. doi: 10.1097/QAD.0000000000001031.
PubMed 26807969Chaplin B, Agbaji O, Reyes Nieva H, Olatunde B, Chang C, Mitruka K, Sule H, Dajel T, Zee A, Ahmed ML, Ahmed I, Okonkwo P, Rawizza H, Kanki P. Timeliness of Point-of-Care Viral Load Results Improves Human Immunodeficiency Virus Monitoring in Nigeria. Clin Infect Dis. 2023 Feb 8;76(3):e671-e680. doi: 10.1093/cid/ciac609.
PubMed 35872644Chang C, Agbaji O, Mitruka K, Olatunde B, Sule H, Dajel T, Zee A, Ahmed ML, Ahmed I, Okonkwo P, Chaplin B, Kanki P. Clinical Outcomes in a Randomized Controlled Trial Comparing Point-of-Care With Standard Human Immunodeficiency Virus (HIV) Viral Load Monitoring in Nigeria. Clin Infect Dis. 2023 Feb 8;76(3):e681-e691. doi: 10.1093/cid/ciac605.
PubMed 35867672Meloni ST, Agbaji O, Chang CA, Agaba P, Imade G, Oguche S, Mukhtar A, Mitruka K, Cox MH, Zee A, Kanki P. The role of point-of-care viral load monitoring in achieving the target of 90% suppression in HIV-infected patients in Nigeria: study protocol for a randomized controlled trial. BMC Infect Dis. 2019 May 2;19(1):368. doi: 10.1186/s12879-019-3983-6.
PubMed 31046695
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching 90% Target of HIV Viral Suppression: The Role of Point-of-Care Viral Load Monitoring in Resource-Constrained Settings in Nigeria
- ClinicalTrials.gov ID
- NCT03533868
- Acronym / sponsor ID
- POC / CDC-CGH-2018-059
- Conditions
- HIV/AIDS
- Keywords
- Point-of-care, Viral load monitoring, Nigeria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 543 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Jos University Teaching Hospital, Centers for Disease Control and Prevention
- Study start
- 9 Apr 2018 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 23 May 2018 (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 UNAIDS 90-90-90 goals represents an ambitious strategy to end the acquired immunodeficiency syndrome (AIDS) epidemic by 2020 [UNAIDS, 2015]. While viral load (VL) quantification is the gold standard of HIV treatment monitoring, it is only routinely available and employed in resource-rich countries. The use of an affordable, reliable, point-of-care (POC) VL assay has been considered a "game-changer", where increased access, minimal lab worker training, and same day results could be addressed in a single solution. To date, POC VL assays have been evaluated by their manufacturers with reference panels of samples with some in-country laboratory evaluations. While these are appropriate and critical first steps, it is also important to evaluate the impact of this new technology against the standard of care (SOC) method of VL monitoring in an actual resource-limited setting.
Nigeria has the second highest burden of HIV in the world, with an estimated 3.2 million infected and serves as a relevant setting for testing feasibility and efficacy of POC VL monitoring [UNAIDS, 2016]. In order to present the case for implementing the use of POC VL testing across Nigeria, data on the acceptability, feasibility and efficacy of using POC testing for VL monitoring are needed. To address this need, the investigators have designed a randomized controlled trial comparing POC VL to monitoring to the SOC, which follows the Nigerian National Guidelines, to provide operational evidence for implementation of POC VL testing in Nigeria. This trial is aimed at testing the hypothesis that using POC versus SOC VL monitoring in HIV-infected patients newly initiating ART will improve overall ART outcomes, increase ART adherence and program retention rates, and result in faster switches to second-line treatment of patients failing first-line ART.
Detailed description
The investigators will conduct an un-blinded randomized implementation trial comparing POC VL monitoring, using the Cepheid Gene Xpert HIV-1 VL®, to SOC VL monitoring, using the Roche AmpliPrep/COBAS Taqman system. The trial will be conducted at two sites in Plateau State, Nigeria.
ART-naïve patients initiating ART will be randomized on a 1:1 basis to the SOC VL monitoring control arm or the POC VL monitoring arm. VL monitoring will occur according to the current Nigerian ART guidelines-recommended algorithm, with the addition of a baseline VL test. For the month 6 and 12 visits, patients that are enrolled in the POC VL monitoring arm will be provided their VL results. Participants in the SOC arm will receive their Roche VL test results after the results become available per SOC protocol. All other aspects of their HIV care and treatment will be identical to services that they would normally receive at these treatment centers.
The investigators will follow all patients up through their Month 12 follow-up visit. At trial exit, the investigators will ask patients, caregivers of patients under the age of 18 years, and providers for their participation in surveys on the operational performance and acceptability of the POC versus SOC VL monitoring. Following that time point, the patients will continue receiving HIV care and treatment utilizing the SOC procedures for the clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to have their viral load monitored by either the standard of care or point-of-care method at their follow-up clinical visits up to 12 months.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | No intervention | –Patients in this arm will have their viral load monitored using the standard of care method, using the Roche Cobas TaqMan HIV-1® v2 (Roche) assay. |
| Point-of-care (POC) | Experimental | Diagnostic Test: Point-of-care viral load monitoring testPatients in this arm will have their follow-up viral loads (after baseline) monitored using a Point-of-care viral load monitoring test, the Cepheid Xpert HIV-1 Viral Load assay. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -All HIV-infected patients newly initiating ART
Key exclusion criteria (2 listed)
- Previous ARV experience
- Pregnant
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 |
|---|---|---|
| Point-of-care viral load monitoring testFor enumerating viral load for patients in the POC arm, we will use the Cepheid Xpert® HIV-1 Viral Load test, a quantitative assay with a quantification range of 40 to 10,000,000 copies/mL. Based on the GeneXpert® technology, Xpert HIV-1 VL automates the test process, including RNA extraction, purification, reverse transcription and cDNA real-time quantitation in one fully integrated cartridge. The pre-loaded disposable single-use cartridges provide a visual read-out within 90 minutes. The assay requires 1 mL of plasma using a precision pipette (1.2 mL using a transfer pipette). | Diagnostic test | Point-of-care (POC) |
Primary outcome
Proportion of patients with VL<1000 copies/mL at month 12 post-initiation of ART (range 11-15 months) in SOC VL versus POC VL
Time frame: 12 months (range 11-15 months)
Proportion of patients that have undetectable viral load at the end of observation (month 12) will be compared by treatment arm
11 secondary outcomes
Difference in ART adherence patterns in patients in the SOC versus POC VL arms
Time frame: From ART initiation to month 12
Difference in loss to follow-up rates by 12 months post-initiation of ART between patients monitored with SOC versus POC VL arms
Time frame: Month 12
Impact of trial site on differences in virologic suppression rates within patients receiving SOC VL monitoring
Time frame: Month 12
Difference in time from ART initiation to the confirmation of virologic failure in SOC versus POC VL monitoring arms
Time frame: ART Initiation to Month 12
Difference in time from ART initiation to switch to 2L treatment in patients in VF in SOC versus POC VL monitoring arms
Time frame: ART Initiation to Month 12
Difference in time from specimen collection to availability of VL results in patient charts in SOC versus POC VL monitoring arms
Time frame: All follow-up visits at which VL monitored up to Month 12
Difference in time from specimen collection to delivery of VL results to patient in SOC versus POC VL monitoring arms
Time frame: All follow-up visits at which VL monitored up to Month 12
Difference in time from lab confirmation of first unsuppressed VL to adherence counseling provided and switch to 2L in SOC versus POC VL monitoring arms
Time frame: All follow-up visits at which VL monitored up to Month 12
Difference in HIV DRM patterns in patients failing 1L ART in the SOC versus POC VL monitoring arm
Time frame: Month 12
Health care worker (HCW) satisfaction level with POC versus SOC VL monitoring
Time frame: Month 12
POC VL arm patient satisfaction with POC vs SOC VL testing
Time frame: Month 12
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 1 Apr 2021.
- Background: PubMed 26423384Fonjungo PN, Boeras DI, Zeh C, Alexander H, Parekh BS, Nkengasong JN. Access and Quality of HIV-Related Point-of-Care Diagnostic Testing in Global Health Programs. Clin Infect Dis. 2016 Feb 1;62(3):369-374. doi: 10.1093/cid/civ866. Epub 2015 Sep 30.
- Background: PubMed 26807969Fonjungo PN, Osmanov S, Kuritsky J, Ndihokubwayo JB, Bachanas P, Peeling RW, Timperi R, Fine G, Stevens W, Habiyambere V, Nkengasong JN. Ensuring quality: a key consideration in scaling-up HIV-related point-of-care testing programs. AIDS. 2016 May 15;30(8):1317-23. doi: 10.1097/QAD.0000000000001031.
- Derived from this study: PubMed 35872644Chaplin B, Agbaji O, Reyes Nieva H, Olatunde B, Chang C, Mitruka K, Sule H, Dajel T, Zee A, Ahmed ML, Ahmed I, Okonkwo P, Rawizza H, Kanki P. Timeliness of Point-of-Care Viral Load Results Improves Human Immunodeficiency Virus Monitoring in Nigeria. Clin Infect Dis. 2023 Feb 8;76(3):e671-e680. doi: 10.1093/cid/ciac609.
- Derived from this study: PubMed 35867672Chang C, Agbaji O, Mitruka K, Olatunde B, Sule H, Dajel T, Zee A, Ahmed ML, Ahmed I, Okonkwo P, Chaplin B, Kanki P. Clinical Outcomes in a Randomized Controlled Trial Comparing Point-of-Care With Standard Human Immunodeficiency Virus (HIV) Viral Load Monitoring in Nigeria. Clin Infect Dis. 2023 Feb 8;76(3):e681-e691. doi: 10.1093/cid/ciac605.
- Derived from this study: PubMed 31046695Meloni ST, Agbaji O, Chang CA, Agaba P, Imade G, Oguche S, Mukhtar A, Mitruka K, Cox MH, Zee A, Kanki P. The role of point-of-care viral load monitoring in achieving the target of 90% suppression in HIV-infected patients in Nigeria: study protocol for a randomized controlled trial. BMC Infect Dis. 2019 May 2;19(1):368. doi: 10.1186/s12879-019-3983-6.
- UNAIDS. Ambitious treatment targets: writing the final chapter of the AIDS epidemic. 2015.Link provided by the sponsor.
- WHO. The Availability and Use of HIV Diagnostics: A 2012/2013 WHO Survey in Low- and Middle-Income Countries. Geneva. 2014.Link provided by the sponsor.
- UNAIDS. Country factsheets: Nigeria, 2016.Link provided by the sponsor.
- FMOH Nigeria. National Guidelines for Prevention Treatment and Care. 2016.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study data set from the proposed trial, stripped of all identifying information and anonymized to protect patient confidentiality, will be available upon request within 30 months of the end of data collection.
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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.
Phyllis Kanki, DVM, DSc principal investigator
Harvard School of Public Health (HSPH)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care viral load monitoring test in people with HIV/AIDS, run by Harvard School of Public Health (HSPH) at 2 sites in Nigeria.
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 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 1 Apr 2021. 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 Nigeria. 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?
Proportion of patients with VL<1000 copies/mL at month 12 post-initiation of ART (range 11-15 months) in SOC VL versus POC VL (time frame: 12 months (range 11-15 months)). 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 NCT03533868, which also lists 5 linked publications.
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 1 Apr 2021.