Chronic HIV InfectionOpt4KidsNCT03820323
Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy
A study testing POC VL and targeted DRM testing. and SOC VL testing in people with Chronic HIV Infection, run by University of Alabama at Birmingham at 1 site in Kenya.
Trial summary
Among nearly 1 million HIV-infected children receiving antiretroviral treatment (ART), as many as 40% of those living in resource limited settings have not achieved virologic suppression. Kenya, a The Joint United Nations Programme on HIV/AIDS (UNAIDS) fast-track and The U.S. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Chronic HIV Infection
- What is being tested?
- POC VL and targeted DRM testing. and SOC VL testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 704 participants
- Where
- 1 siteKenya
- Study dates
- 7 Mar 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 1-14 years living with HIV (documented HIV positive)
- On first-line ART per Kenyan National Guideline or
- Newly initiating ART
Who cannot join
- On second-line, third-line, or non-standard first-line ART
Trial locations and contacts
1 site in 1 country.
About this study
Among nearly 1 million HIV-infected children receiving antiretroviral treatment (ART), as many as 40% of those living in resource limited settings have not achieved virologic suppression. Kenya, a The Joint United Nations Programme on HIV/AIDS (UNAIDS) fast-track and The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) priority country, has an estimated 98,000 children aged 0-14 years living with HIV. Virologic suppression is achieved by only 65% of Kenyan children on ART translating to only 38% of the final UNAIDS 90-90-90 goal for population-level viral suppression. Feasible, scalable and cost-effective approaches to maximizing durability of first-line ART and ensuring viral load (VL) suppression in HIV-infected children are urgently needed. This pilot study will evaluate two critical components related to viral suppression in children via: 1) Point-of-care (POC) VL testing (Aim 1) and 2) targeted drug resistance mutation (DRM) testing (Aim 2) among children on first-line ART at three facilities within a PEPFAR-funded HIV care and treatment program in Kenya. The hypotheses are: 1) viral suppression rates will be higher among children with access to POC VL testing and time to suppression shorter compared to children with standard VL testing and 2) DRM testing will shorten time to viral suppression and that the investigators will observe high levels of 1st line antiretroviral DRMs among children on ART without viral suppression. This proposal directly addresses the urgent need to find interventions to maximize viral suppression among children on ART and achieve the UNAIDS 90-90-90 goals.
Read the detailed description
The study design will be a randomized, controlled study to pilot the use of POC VL and DRM testing in children aged 1-14 years on first-line ART. Children enrolling at each site will be randomized 1:1 to two study arms.
Standard of Care Arm:
Participants in the Standard-of-Care (SOC) control arm will receive the standard-of-care VL and DRM testing based on the existing Kenyan national guidelines. VL testing will be 6 months after ART initiation (then every 3 months if unsuppressed, otherwise every 12 months) with DRM testing only if failing second-line ART. Children who have a high lab-based HIV VL (≥1,000 copies/mL) will receive intensive adherence counseling and be asked to return to the clinic in 3 months for repeat HIV VL testing. If the HIV VL remains high (≥1,000 copies/mL), the children will be managed per Kenya national guidelines.
Intervention Arm:
Children in the intervention arm will undergo POC VL testing every 3 months for a total of 12 months. "Targeted" DRM testing will include DRM testing for each child on the first detection of lack of viral suppression (VL > 1000 copies/mL) and in children newly initiating ART.
The investigators will follow the viral outcomes 12 months after the implementation of POC VL testing and compare VL suppression rates, defined as VL <1000 copies/mL by the Kenyan national guidelines, among intervention vs. control arms, accounting for pre-intervention VL suppression rates.
The primary outcome for Aim 1 is rates of viral suppression (defined as VL <1000 copies/mL) at 12 months after POC VL testing implementation at the three facilities. The secondary outcome for Aim 1 is time to viral suppression among those children without viral suppression at their 1st POC VL testing or newly initiating ART after POC VL testing implementation. In Aim 2, the investigators intend to evaluate the impact of targeted HIV DRM testing on viral suppression in the intervention arm only. The investigators will also explore how sociodemographic, behavioral, clinical, and facility factors may be contributing to the DRM patterns they observe.
- Conditions
- Chronic HIV Infection
- Being tested
- POC VL and targeted DRM testing., SOC VL testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC VL and targeted DRM testing.Diagnostic test
Point-of-care Viral Load Testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of ART and when viremia (VL>1000 copies/mL) is detected.
SOC VL testingDiagnostic test
Also called Kenyan National guidelines for viral load testing
SOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Participants in the Standard-of-Care control arm will receive laboratory based VL testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). DRM testing is usually done if there is a failing 2nd line ART regimen based on the current Kenyan guideline. Receives: Diagnostic Test: SOC VL testing |
| Intervention | Experimental | POC VL and targeted DRM testing. Receives: Diagnostic Test: POC VL and targeted DRM testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Viral Suppression
Viral Load <1000 copies/mL at 12 months after enrollment
Measured: 12 months after enrollment
Secondary outcomes (4)
Virological Suppression at 12 Months Among Children Newly Initiating ART or Initially Virologically Unsuppressed
Among children newly initiating ART or initially virologically unsuppressed, we then evaluated the virological suppression status at 12 months post-enrollment.
Measured: 12 months post enrollment
Number of Participants Who Underwent POC VL Testing
The number of children undergoing VL testing within each group (POC VL testing or SOC VL testing) at the scheduled intervals.
Measured: Every 3 months within the 12 months study period
Turn-around Time for the VL Testing Results
The time it takes for viral load results to be received by health care providers and participants.
Measured: Every 3 months within the 12 months study period
Number of Children With Any or Major Drug Resistance Mutations (DRMs)
The number of children tested for DRMs with any or major mutations within each class of HIV drugs.
Measured: 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start7 Mar 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic HIV InfectionStudies 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
- Model description
- Randomized control trial of two study arms
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 704 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kenya Medical Research Institute, University of Colorado, Denver, University of Washington
- Responsible party
- Principal investigator, Rena Patel, University of Alabama at Birmingham
- Investigators
- Rena Patel, MD, MPH, Principal investigator, University of Alabama at BirminghamLisa L Abuogi, MD, MSc, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820323
- Sponsor's protocol ID
- STUDY000004861
- Other IDs
- R34MH115769
- Acronym
- Opt4Kids
- Status last verified
- Apr 2024
- First submitted
- 23 Jan 2019
- Last updated
- 10 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all outcome measures will be made available after study completion
Publications
Scallon AJ, Hassan SA, Qian SR, Gao Y, Oyaro P, Brown E, Wagude J, Mukui I, Kinywa E, Oluoch F, Odhiambo F, Oyaro B, Kingwara L, Yongo N, Karauki E, Otieno L, John-Stewart GC, Abuogi LL, Patel RC. "I feel drug resistance testing allowed us to make an informed decision": qualitative insights on the role of HIV drug resistance mutation testing among children and pregnant women living with HIV in western Kenya. BMC Health Serv Res. 2023 Aug 24;23(1):908. doi: 10.1186/s12913-023-09804-x.
PubMed 37620855Qian SRW, Hassan SA, Scallon AJ, Oyaro P, Brown E, Wagude J, Mukui I, Kinywa E, Oluoch F, Odhiambo F, Oyaro B, Kingwara L, Yongo N, Karauki E, Gao J, Otieno L, John-Stewart GC, Abuogi LL, Patel RC. "After viral load testing, I get my results so I get to know which path my life is taking me": qualitative insights on routine centralized and point-of-care viral load testing in western Kenya from the Opt4Kids and Opt4Mamas studies. BMC Health Serv Res. 2022 Dec 17;22(1):1540. doi: 10.1186/s12913-022-08593-z.
PubMed 36528677Patel RC, Oyaro P, Thomas KK, Wagude J, Mukui I, Brown E, Hassan SA, Kinywa E, Oluoch F, Odhiambo F, Oyaro B, Kingwara L, Karauki E, Yongo N, Otieno L, John-Stewart GC, Abuogi LL. Point-of-care HIV viral load and targeted drug resistance mutation testing versus standard care for Kenyan children on antiretroviral therapy (Opt4Kids): an open-label, randomised controlled trial. Lancet Child Adolesc Health. 2022 Oct;6(10):681-691. doi: 10.1016/S2352-4642(22)00191-2. Epub 2022 Aug 18.
PubMed 35987208Patel RC, Oyaro P, Odeny B, Mukui I, Thomas KK, Sharma M, Wagude J, Kinywa E, Oluoch F, Odhiambo F, Oyaro B, John-Stewart GC, Abuogi LL. Optimizing viral load suppression in Kenyan children on antiretroviral therapy (Opt4Kids). Contemp Clin Trials Commun. 2020 Oct 27;20:100673. doi: 10.1016/j.conctc.2020.100673. eCollection 2020 Dec.
PubMed 33195874
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT03820323
- Acronym / sponsor ID
- Opt4Kids / STUDY000004861
- Conditions
- Chronic HIV Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Kenya Medical Research Institute, University of Colorado, Denver, University of Washington
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 29 Jan 2019 (actual)
- Results
- Posted 27 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Among nearly 1 million HIV-infected children receiving antiretroviral treatment (ART), as many as 40% of those living in resource limited settings have not achieved virologic suppression. Kenya, a The Joint United Nations Programme on HIV/AIDS (UNAIDS) fast-track and The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) priority country, has an estimated 98,000 children aged 0-14 years living with HIV. Virologic suppression is achieved by only 65% of Kenyan children on ART translating to only 38% of the final UNAIDS 90-90-90 goal for population-level viral suppression. Feasible, scalable and cost-effective approaches to maximizing durability of first-line ART and ensuring viral load (VL) suppression in HIV-infected children are urgently needed. This pilot study will evaluate two critical components related to viral suppression in children via: 1) Point-of-care (POC) VL testing (Aim 1) and 2) targeted drug resistance mutation (DRM) testing (Aim 2) among children on first-line ART at three facilities within a PEPFAR-funded HIV care and treatment program in Kenya. The hypotheses are: 1) viral suppression rates will be higher among children with access to POC VL testing and time to suppression shorter compared to children with standard VL testing and 2) DRM testing will shorten time to viral suppression and that the investigators will observe high levels of 1st line antiretroviral DRMs among children on ART without viral suppression. This proposal directly addresses the urgent need to find interventions to maximize viral suppression among children on ART and achieve the UNAIDS 90-90-90 goals.
Detailed description
The study design will be a randomized, controlled study to pilot the use of POC VL and DRM testing in children aged 1-14 years on first-line ART. Children enrolling at each site will be randomized 1:1 to two study arms.
Standard of Care Arm:
Participants in the Standard-of-Care (SOC) control arm will receive the standard-of-care VL and DRM testing based on the existing Kenyan national guidelines. VL testing will be 6 months after ART initiation (then every 3 months if unsuppressed, otherwise every 12 months) with DRM testing only if failing second-line ART. Children who have a high lab-based HIV VL (≥1,000 copies/mL) will receive intensive adherence counseling and be asked to return to the clinic in 3 months for repeat HIV VL testing. If the HIV VL remains high (≥1,000 copies/mL), the children will be managed per Kenya national guidelines.
Intervention Arm:
Children in the intervention arm will undergo POC VL testing every 3 months for a total of 12 months. "Targeted" DRM testing will include DRM testing for each child on the first detection of lack of viral suppression (VL > 1000 copies/mL) and in children newly initiating ART.
The investigators will follow the viral outcomes 12 months after the implementation of POC VL testing and compare VL suppression rates, defined as VL <1000 copies/mL by the Kenyan national guidelines, among intervention vs. control arms, accounting for pre-intervention VL suppression rates.
The primary outcome for Aim 1 is rates of viral suppression (defined as VL <1000 copies/mL) at 12 months after POC VL testing implementation at the three facilities. The secondary outcome for Aim 1 is time to viral suppression among those children without viral suppression at their 1st POC VL testing or newly initiating ART after POC VL testing implementation. In Aim 2, the investigators intend to evaluate the impact of targeted HIV DRM testing on viral suppression in the intervention arm only. The investigators will also explore how sociodemographic, behavioral, clinical, and facility factors may be contributing to the DRM patterns they observe.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial of two study arms
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Diagnostic Test: SOC VL testingParticipants in the Standard-of-Care control arm will receive laboratory based VL testing based on the existing Kenyan national guidelines by routine clinical staff (not study staff). DRM testing is usually done if there is a failing 2nd line ART regimen based on the current Kenyan guideline. |
| Intervention | Experimental | Diagnostic Test: POC VL and targeted DRM testing.POC VL and targeted DRM testing. |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 1-14 years living with HIV (documented HIV positive)
- On first-line ART per Kenyan National Guideline or
- Newly initiating ART
Key exclusion criteria (1 listed)
- On second-line, third-line, or non-standard first-line ART
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 |
|---|---|---|
| POC VL and targeted DRM testing.Point-of-care Viral Load Testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of ART and when viremia (VL>1000 copies/mL) is detected. | Diagnostic test | Intervention |
| SOC VL testingAlso: Kenyan National guidelines for viral load testingSOC VL testing is done at 6 months after ART initiation then every 3 months if unsuppressed, otherwise every 12 months. DRM testing is conducted only if failing 2nd line ART. | Diagnostic test | Standard of Care |
Primary outcome
Number of Participants With Viral Suppression
Time frame: 12 months after enrollment
Viral Load <1000 copies/mL at 12 months after enrollment
4 secondary outcomes
Virological Suppression at 12 Months Among Children Newly Initiating ART or Initially Virologically Unsuppressed
Time frame: 12 months post enrollment
Number of Participants Who Underwent POC VL Testing
Time frame: Every 3 months within the 12 months study period
Turn-around Time for the VL Testing Results
Time frame: Every 3 months within the 12 months study period
Number of Children With Any or Major Drug Resistance Mutations (DRMs)
Time frame: 12 months post enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37620855Scallon AJ, Hassan SA, Qian SR, Gao Y, Oyaro P, Brown E, Wagude J, Mukui I, Kinywa E, Oluoch F, Odhiambo F, Oyaro B, Kingwara L, Yongo N, Karauki E, Otieno L, John-Stewart GC, Abuogi LL, Patel RC. "I feel drug resistance testing allowed us to make an informed decision": qualitative insights on the role of HIV drug resistance mutation testing among children and pregnant women living with HIV in western Kenya. BMC Health Serv Res. 2023 Aug 24;23(1):908. doi: 10.1186/s12913-023-09804-x.
- Derived from this study: PubMed 36528677Qian SRW, Hassan SA, Scallon AJ, Oyaro P, Brown E, Wagude J, Mukui I, Kinywa E, Oluoch F, Odhiambo F, Oyaro B, Kingwara L, Yongo N, Karauki E, Gao J, Otieno L, John-Stewart GC, Abuogi LL, Patel RC. "After viral load testing, I get my results so I get to know which path my life is taking me": qualitative insights on routine centralized and point-of-care viral load testing in western Kenya from the Opt4Kids and Opt4Mamas studies. BMC Health Serv Res. 2022 Dec 17;22(1):1540. doi: 10.1186/s12913-022-08593-z.
- Derived from this study: PubMed 35987208Patel RC, Oyaro P, Thomas KK, Wagude J, Mukui I, Brown E, Hassan SA, Kinywa E, Oluoch F, Odhiambo F, Oyaro B, Kingwara L, Karauki E, Yongo N, Otieno L, John-Stewart GC, Abuogi LL. Point-of-care HIV viral load and targeted drug resistance mutation testing versus standard care for Kenyan children on antiretroviral therapy (Opt4Kids): an open-label, randomised controlled trial. Lancet Child Adolesc Health. 2022 Oct;6(10):681-691. doi: 10.1016/S2352-4642(22)00191-2. Epub 2022 Aug 18.
- Derived from this study: PubMed 33195874Patel RC, Oyaro P, Odeny B, Mukui I, Thomas KK, Sharma M, Wagude J, Kinywa E, Oluoch F, Odhiambo F, Oyaro B, John-Stewart GC, Abuogi LL. Optimizing viral load suppression in Kenyan children on antiretroviral therapy (Opt4Kids). Contemp Clin Trials Commun. 2020 Oct 27;20:100673. doi: 10.1016/j.conctc.2020.100673. eCollection 2020 Dec.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all outcome measures will be made available after study completion
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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.
Rena Patel, MD, MPH principal investigator
University of Alabama at Birmingham
Lisa L Abuogi, MD, MSc principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POC VL and targeted DRM testing. and SOC VL testing in people with Chronic HIV Infection, run by University of Alabama at Birmingham at 1 site in Kenya.
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 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 10 Apr 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 Kenya. 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?
Yes. Results are posted in the registry (first posted 27 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Viral Suppression (time frame: 12 months after enrollment). 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 NCT03820323, which also lists 4 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 10 Apr 2024.