Point-of-care Viral Load Testing Among HIV-infected Adolescents in Haiti
Condition: HIV
Study type: Interventional

Summary: 
      This study is designed as an individual randomized trial among 150 HIV-infected adolescents
      aged 10-24 years who have been on ART for >6 months and will be randomized in a 1:1 fashion
      to one of two arms: 1) the intervention arm (POC) will receive a POC VL test with adherence
      counseling informed by the VL result the same day as testing vs. 2) the standard-of-care arm
      (SOC) will receive a standard laboratory-based test with adherence counseling informed by the
      VL result 1 month later. The study tests an intervention, POC VL testing, which reduces the
      time between sample collection and participant receipt of results, thus decreasing the number
      of steps in the HIV treatment cascade. This intervention was developed to addresses health
      systems-based barriers which delay clinic, laboratory, and data management processes for VL
      monitoring for HIV-infected adolescents. Our results will contribute to research on whether
      POC VL testing is a feasible testing method which could be incorporated into health systems
      in similar resource-limited settings and whether it can improve outcomes among HIV-infected
      adolescents.
    

Detailed description: 
      This study is designed as an individual randomized trial among 150 HIV-infected adolescents
      aged 10-24 years who have been on ART for >6 months and will be randomized in a 1:1 fashion
      to one of two arms: 1) the intervention arm (POC) - receiving a POC VL test with adherence
      counseling informed by the VL result the same day as testing vs. 2) the standard-of-care arm
      (SOC) - receiving a standard laboratory-based test with adherence counseling informed by the
      VL result 1 month later. The study tests an intervention, POC VL testing, which reduces the
      time between sample collection and participant receipt of results, thus decreasing the number
      of steps in the HIV treatment cascade. This intervention was developed to addresses health
      systems-based barriers which delay clinic, laboratory, and data management processes for VL
      monitoring for HIV-infected adolescents. The results will contribute to research on whether
      POC VL testing is a feasible testing method which could be incorporated into health systems
      in similar resource-limited settings and whether it can improve outcomes among HIV-infected
      adolescents. The two study arms are described below.

      Standard-of-care (SOC): At the first visit after enrollment and randomization, participants
      in the SOC arm receive a standard laboratory-based VL test. Steps in the standard
      laboratory-based VL testing process include: sample collection at a phlebotomy clinic
      adjacent to the adolescent HIV clinic, labeling and daily storage, transportation (1 hr
      drive) to the central laboratory, arrival and intake at the laboratory, processing in the
      fully automated Abbott system, manual entry of the printed results into an excel spreadsheet
      by laboratory staff, and manual entry of results on the spreadsheet into the EMR by data
      management staff. This process - from sample collection to patient return of results - varies
      depending on the volume of samples collected each day and on laboratory and data management
      staffing. Average time from blood collection to availability of the result in the EMR is 2-3
      weeks. Per standard clinical care at the adolescent HIV clinic, adolescents return for
      monthly visits, and the patient receives the VL result and adherence counseling which is
      informed by the VL result 1 month after providing the blood sample. The primary endpoint is
      return of the VL result within 6 weeks of sample collection to allow for a short time buffer
      for appointments that are not scheduled exactly 1 month from the previous visit for reasons
      related to school, work, family obligations, or holidays.

      These standard laboratory procedures were developed to meet the high demand for VL testing
      when the Haitian national guidelines switched from recommending routine CD4 testing to
      routine VL testing. Since the Abbott systems are fully automated and can batch large
      quantities of samples together, this approach is appropriate for a routine nation-wide health
      system testing protocol. However, the need for transportation, cold-chain storage, and manual
      entry of thousands of results every year may not be the optimal structure for HIV-infected
      adolescents who are more likely to have high VL results and are more likely to be lost from
      care in between visits. This study will test the POC VL test vs. this standard
      laboratory-based test to determine if reducing the time between sample collection and patient
      receipt of results (removing a step in the HIV treatment cascade), can increase the impact of
      VL testing on clinical management and adolescent patient outcomes. The study will test if
      implementation of the POC VL test, in collaboration with clinicians and laboratory staff, and
      accompanied by patient education, can address many of the logistical barriers to
      laboratory-based VL testing in a resource-limited setting such as Haiti.
    

Intervention name(s): point-of-care viral load test
Intervention type(s): Diagnostic Test
Intervention description(s): A point-of-care viral load test returns viral load test results within 90 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: adolescent; HIV; point-of-care; viral load