Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care
Point-of-care Viral Load Testing to Enable Streamlined Care and Task Shifting for Chronic HIV Care
Effective management of patients on antiretroviral therapy (ART) is essential to improve
 clinical outcomes and prevent HIV transmission, but monitoring life-long ART for over 15
 million HIV-infected people has become a challenge, particularly in low- and middle-income
 countries (LMICs). As programs continue to focus on identifying HIV-infected people and
 starting ART at higher CD4 thresholds, HIV providers have been overburdened, which has
 resulted in falling retention rates. As ART coverage scales up to include millions more
 people, additional strain will be placed on HIV clinicians and laboratories to manage stable
 patients on chronic ART. Implementing point-of-care HIV VL testing to enable task shifting to
 nurses for chronic HIV care may help mitigate these burdens. Point-of-care Viral Load (VL)
 testing is intended to differentiate patients who are potentially failing on their ART, so
 that they can be referred to the next level of care for possible ART regiment change, from
 patients who are virally suppressed on ART and can be managed by nurses. The investigator's
 scientific objective is to test the clinical equivalence and reduced cost of implementing a
 model for chronic HIV care that uses a point-of-care HIV VL assay to enable streamlined care
 and task shifting among healthcare workers at an urban clinic in South Africa. The central
 hypothesis is that rapid HIV VL testing, implemented by nurses, is an effective and
 cost-efficient strategy for management of chronic HIV infection in the majority of patients,
 thereby allowing more resources to be directed at the minority of patients who need greater
 attention. This work is innovative because it uses a randomized evaluation of an
 implementation model that combines a novel diagnostic point-of-care test with streamlined
 care and task shifting among healthcare workers compared to standard of care for chronic HIV
 care in a resource-limited setting. This randomized trial will then form the basis of a
 larger, multicountry proposal to demonstrate the clinical equivalence and cost-effectiveness
 of implementing an integrated point-of-care HIV VL testing and streamlined care model for
 chronic HIV care in LMICs. If nurses using clinic-based HIV VL testing are cost-effective for
 achieving both viral suppression and retention in care among patients on ART, then
 implementation of this chronic HIV care model would alleviate the strain on existing HIV
 providers and laboratories in LMICs.
The study design will be an open-label, randomized, non-inferiority implementation trial with
 2 study arms. Patients will be enrolled when due their 6 month VL since initiating ART.

 Standard of Care Arm:

 Participants in the Standard-of-Care (SOC) control arm will receive the standard-of-care for
 the clinic consisting of visits with a professional clinician (Physician or Professional
 Nurse) and once stable, community pharmacy ART collection through CCMDD. Viral load
 monitoring will be lab-based. Participants will be assessed for clinical symptoms/signs of
 tuberculosis, other opportunistic infections, and ART side effects at each clinical
 encounter. Participants 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 2 months for repeat
 HIV VL testing. If the HIV VL remains high (≥1,000 copies/mL) after the 2 months of intensive
 adherence counseling, then the patient will be switched to a second-line ART regimen by a
 physician.

 Intervention Arm:

 Participants in the Intervention Group will receive chronic ART management from a
 Professional Nurse and/or Enrolled Nurse every 2 months, and if stable after 6 months,
 community pharmacy ART collection through CCMDD. Viral load monitoring will be POC. Enrolled
 Nurse visits will consist of a clinical symptom and ART side effect checklists, and an ART
 adherence questionnaire, which trigger up-referral to a Professional Nurse/MO where
 appropriate. Point-of-care Xpert® HIV-1 VL testing will be performed while the participant is
 in the clinic to ensure that participants receive the VL results on the same day.
 Participants who have a high HIV VL (≥1,000 copies/mL) will be referred to a Professional
 Nurse. As with the standard-of-care arm, they will receive intensive adherence counseling and
 be asked to return to the clinic in 2 months for repeat point-of-care Xpert® HIV-1 VL
 testing. Participants who continue to have a high HIV VL (≥1,000 copies/mL) after 2 months of
 intensive adherence counseling will be switched to second-line ART by a physician.

 Participants will also be followed for a 12-month study period to assess the study outcome
 measures. This study will follow all aspects of South Africa's ART guidelines, except stable
 patients randomized to the intervention arm will receive Nurse-based care and Xpert® VL
 monitoring, as a comparison to the standard of care.

 At the end of the 12-month study period, all participants will have a repeat CD4 count and
 lab-based HIV VL testing by Roche Taqman v.2.0 assay. The lab-based HIV VL testing will be
 important to use the same HIV VL assay to compare the primary outcomes measures. In addition,
 the research team will evaluate the outcome of "retention in care", which will be defined as
 collecting ART refills at the study exit visit.

 Cost-Effectiveness Component:

 The investigators will use an activity-based micro-costing approach, including time and
 motion studies, to estimate the costs incurred and averted, along with the primary study
 outcomes (viral suppression and retention in care) to estimate the cost per HIV-positive
 person virally suppressed and retained in care in the Intervention Group, as compared to the
 Standard-of-Care Group.

 Time and motion studies will determine the nurse time necessary to conduct the point-of-care
 HIV VL testing and the clinical visit with a stable HIV-infected patient. Time and motion
 studies will be conducted during study initiation and again when the intervention is running
 at full capacity. An experienced research assistant will collect data on the time required to
 complete each step of the chronic care visit (VL testing, clinical assessment, counseling)
 for both study arms. Initial results will be shared with the teams to implement strategies
 for improved efficiency. Observing multiple visits will allow estimation of the average time
 taken for each step; the time taken for research purposes (e.g. data collection) will be
 noted separately from the estimated time needed for monitoring. Multiple staff will be
 observed to capture the range of time required for a successful real-time chronic HIV care.
 Interviews with study staff will also quantify the effort required for each step of visit.
 Through time and motion studies the number of participants who could be supported by a clinic
 will be estimated. The staff time taken for the intervention captures the opportunity cost of
 the chronic care intervention, i.e. staff time that could be spent on a different program.
 The micro-costing data, time and motion studies, and clinical outcomes will be used to
 estimate the average cost per HIV-positive client achieving viral suppression and retained in
 care in the chronic care model compared to the standard of care.
Inclusion Criteria:

 -  HIV-infected and receiving antiretroviral therapy (ART)

 -  Receiving care at Prince Cyril Zulu Clinic in Durban

 -  Stable on Current ART Regimen and due the 6 month follow-up visit post ART initiation

 -  Willing/able to provide written informed consent to participate in the stud

 Exclusion Criteria:

 -  Have significant signs/symptoms of illness that requires active medical care by a
 clinic doctor.

 -  Does not plan to receive HIV care at the Prince Cyril Zulu Communicable Diseases
 Clinic for the following 12 months.

 -  Currently pregnant