Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy

Chronic HIV Infection Clinical Trial

— Opt4Kids  

Official title:

Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820323
• Other study ID #: STUDY000004861
• Secondary ID: R34MH115769
• Status: Completed
• Phase: N/A
• Start date: March 7, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 704
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 14 Years

Eligibility

Inclusion Criteria:

• Children aged 1-14 years living with HIV (documented HIV positive)

• On first-line ART per Kenyan National Guideline or

• Newly initiating ART

Exclusion Criteria:

• On second-line, third-line, or non-standard first-line ART

Related Conditions & MeSH terms

• Chronic HIV Infection
• HIV Infections

Intervention

Diagnostic Test:
• 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.
• SOC VL 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.

Locations

Country	Name	City	State
Kenya	Rtcp-Faces	Kisumu

Sponsors (5)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Kenya Medical Research Institute, National Institute of Mental Health (NIMH), University of Colorado, Denver, University of Washington

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Viral Suppression	Viral Load <1000 copies/mL at 12 months after enrollment	12 months after enrollment
Secondary	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.	12 months post enrollment
Secondary	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.	Every 3 months within the 12 months study period
Secondary	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.	Every 3 months within the 12 months study period
Secondary	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.	12 months post enrollment