Optimizing Viral Load Suppression in Kenyan Children on Antiretroviral Therapy
Condition: Chronic HIV Infection
MeSH terms: HIV Infections
Study type: Interventional

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.
    

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.
    

Intervention name(s): POC VL and targeted DRM testing.; SOC VL testing
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): 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 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.
Other intervention name(s): Kenyan National guidelines for viral load testing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized control trial of two study arms
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic