Management and Optimization of Nutrition, Antenatal, Reproductive, Child Health & HIV Care
Condition: Pregnancy; HIV
Study type: Interventional

Summary: 
      This study evaluates the impact of a quality improvement (QI) intervention on maternal and
      child healthcare services in seven primary healthcare (PHC) clinics, in a rural setting of
      KwaZulu-Natal, South Africa.
    

Detailed description: 
      INTRODUCTION TO QUALITY IMPROVEMENT Quality Improvement (QI), defined as "systematic and
      continuous actions that lead to measurable improvement in health care services and the health
      status of targeted patient groups" (IOM 2014) has roots in the consumer industry as far back
      as the 1920s. Data-driven structured process improvements have their origins in the consumer
      industry, particularly motor vehicles, and Avedis Donabedian first described a model for
      healthcare quality improvement in the 1960s which reflects the same process change model
      utilised in the consumer industry: the key elements being structures, processes and outcomes.
      Don Berwick and colleagues founded the Institute for Healthcare Improvement (IHI) in the
      1990s, now a leading institution on QI worldwide. The QI approach or 'form' is structured and
      uses specific QI tools, whereas its application or 'function' is varied depending on selected
      process interventions and local context. Given the move towards rigorously improving quality
      of health care worldwide, QI methodology is increasingly gaining popularity not only in
      high-income settings but also in low- and middle-income countries (LMIC) including South
      Africa through Department of Health (DoH) commitments to improving quality of health care and
      reducing disparities thereof.

      EVIDENCE BASE FOR QI Whereas QI is increasingly used worldwide including resource-rich
      settings and resource-limited settings, there is a paucity of scientific evidence assessing
      causal impact of QI on health outcomes, particularly the gold standard randomized controlled
      trial. Studies in resource-limited settings suggest a beneficial effect of QI on measured
      healthcare outcomes however none assessed QI rigorously as a single intervention.

      GAPS IN THE PMTCT CASCADE AND INFANT NUTRITION Despite worldwide rollout of antiretroviral
      therapy (ART) and efforts to prevent mother-to-child transmission (PMTCT), there are still
      large gaps in coverage with approximately 240,000 infants vertically infected with HIV
      worldwide, 89% of whom were from the WHO Africa region. South Africa has a very high
      prevalence of HIV, with a national average of 30% amongst antenatal care (ANC) clients. In
      the Africa Centre Demographic Surveillance Area (DSA) located within the Hlabisa sub-district
      of uMkhanyakude district, the HIV prevalence amongst females of reproductive age (15-49
      years) ranged from 20-45% in 2011.KwaZulu-Natal province had the highest prevalence of HIV
      amongst ANC clients of 37.4% in 2012. Furthermore, although KwaZulu-Natal (KZN) had the
      highest rate of ART coverage amongst HIV-infected pregnant women eligible for ART, the
      uMkhanyakude district in KZN had ART coverage of only 73% during the same period, far behind
      the national target of 90%.

      Studies have shown inadequate virologic suppression amongst HIV-infected pregnant and
      breastfeeding (PBF) mothers, and inadequate repeat HIV testing of HIV-negative mothers during
      the PBF period. Surveillance of PBF mothers in Kenya, Malawi and South Africa demonstrated an
      HIV seroconversion rate of approximately 4%, illustrating the need to repeat HIV testing
      through pregnancy and breastfeeding in order to minimize risk of MTCT. Moreover the rate of
      virologic suppression amongst HIV-infected PBF women varied from 27% (in Kenya) to 72% in
      Malawi in the same study, and underscores the importance of virologic monitoring to reduce
      MTCT through virologic suppression. A study in Kenya demonstrated a repeat HIV testing rate
      of approximately 23% in HIV negative mothers. Given the risk of seroconversion during PBF,
      the World Health Organisation recommends repeat HIV screening during PBF in high prevalence
      settings. Although SA has achieved a commendable reduction in MTCT to 2.7% in 2011 at 6 weeks
      of age in line with the UNAIDS call for virtual elimination of MTCT by 2015, these gaps in
      PMTCT coverage increase the risk of undetected maternal HIV seroconversion and inadequate
      virologic suppression and therefore PMTCT achievements to date may be reversed without
      adequate intervention. Furthermore, given the fertility rate of the population, an MTCT rate
      of 2.7% with an antenatal HIV prevalence of 30% the number of new infant infections per year
      in South Africa is concerning high. Preliminary data from the Africa Centre suggest that less
      than 40% HIV-negative pregnant women undergo re-testing for HIV during pregnancy, whilst
      approximately 10-20% on lifelong ART (initiated prior to or during the current pregnancy)
      have virologic failure.

      An important component on the agenda for reducing maternal morbidity and mortality is
      preventing unwanted pregnancies through better uptake of family planning methods. However
      limitations to contraceptive uptake include lack of knowledge and lack of access in
      resource-limited settings. According to UNFPA estimates, contraceptive prevalence in South
      Africa is approximately 65% despite free access to most methods.

      Although replacement feeding of HIV-exposed infants might mitigate the risk of MTCT, in
      resource-limited settings with unreliable access to safe drinking water the high risk of
      childhood illnesses such as diarrhoea and pneumonia is associated with high rates of
      mortality. As under 5 childhood mortality in these settings can be reduced significantly by
      exclusive breastfeeding (EBF), the WHO recommends EBF for HIV-infected and HIV-uninfected
      mothers, whilst the importance of ART and virologic suppression are further emphasised. These
      recommendations are endorsed by the South African DoH however stigma associated with EBF by
      HIV-infected mothers often becomes a barrier to uptake of EBF in general. South Africa had
      the lowest rates of EBF in the world in 2012 at just 8%.

      New South African DoH ART guidelines were implemented in January 2015, notably changing PMTCT
      guidance to Option B+ (lifelong ART for all pregnant women regardless of CD4 count). HIV
      screening every 3 months during PBF is also recommended due to the risk of seroconversions
      given the high prevalence of HIV in South Africa. Furthermore, viral load (VL) testing of PBF
      on ART is recommended, immediately for those already on ART prior to pregnancy and every 6
      months thereafter (assuming VL results are <1000 copies/mL); newly diagnosed PBF women should
      receive a VL test 3 months after initiating ART and 6 monthly thereafter (assuming VL results
      are <1000 copies/mL).

      THE CONTEXT OF ANTENATAL AND POSTNATAL CARE SERVICES The Africa Centre for Population Health
      is located in the Hlabisa sub-district of uMkhanyakude district in rural KwaZulu-Natal South
      Africa. The Africa Centre Demographic Surveillance Area (DSA) covers an area of 438 km2 and
      is home to the Africa Centre Household Demographic Surveillance System (HDSS), covering
      approximately 90,000 people from 11,000 households annually. The HDSS is a longitudinal
      cohort from the early 2000s and collects individual and household information on mortality,
      fertility, migration, health status and socio-economic data. This provides a nuanced
      understanding of the study population and enables linking of datasets.

      There are 7 primary healthcare clinic (PHC) facilities which are nurse-led in the DSA,
      providing ANC, PNC and other medical services, and one local district hospital (Hlabisa
      hospital) which offers some tertiary care services including routine and emergency obstetric
      care. The number of deliveries occurring in Hlabisa sub-district is estimated at about 3000
      per annum.

      The local hospital also provides medical doctor support to the PHCs when available. As part
      of the National Strategic Plan to improve quality of healthcare services, the DoH has rolled
      out District Clinical Specialist Teams (DCST) including a family physician, paediatrician,
      anaesthetist, midwife and obstetrician. However the success of staff recruitment to the DCST
      has been varied. Finally, a local scoping study (unpublished data) of healthcare staff
      demonstrated gaps in training, supervision and retention of staff with consequent impact on
      healthcare worker motivation and performance.

      STUDY HYPOTHESIS AND JUSTIFICATION Given the nature of overstretched health services, gaps in
      the PMTCT cascade and infant nutrition illustrated above, a QI intervention is considered
      most appropriate for optimising clinic processes and therefore healthcare outcomes. It is
      anticipated that through a real time data-driven approach, process outcomes can be
      continuously monitored, thereby motivating long term sustainability of changes in clinical
      practice and improving provider and patient satisfaction with services. Furthermore, QI is a
      strategy the South African DoH is committed to, as part of improving quality of health
      services and has worked on several projects with the Centre for Rural Health (CRH),
      University of KwaZulu-Natal.

      The investigators believe this is the first study to causally assess the impact of QI on
      specified health care outcomes, utilizing a randomised controlled trial (stepped-wedge) study
      design.
    

Intervention name(s): Quality Improvement; Baseline data collection (active comparator)
Intervention type(s): Other; Other
Intervention description(s): In a stepped wedge fashion all 7 PHC clinics will receive QI one by one (exception: the two smallest clinics will be rolled into one step). Each step is of 2 months' duration. The study will commence with baseline data collection across all clinics, before the first randomised clinic receives the QI intervention. The QI intervention involves the following activities at each clinic: [1] Situational Analysis: assessment of clinic needs and gaps in processes that influence the specified study endpoints; [2] Intensive Intervention Phase (2 months): the clinic QI team (healthcare facility staff) with support of CRH QI mentors maps clinic processes and establishes priorities for process improvements through identification of bottlenecks, root-causes and commence plan-do-study-act (PDSA) cycles; [3] Maintenance Phase (duration varies for each clinic based on stepped wedge study design): clinic processes are further improved through iterative PDSA cycles; [4] Follow up.; Endpoint data collection only
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Stepped wedge trial: therefore all clusters receive intervention, in randomised sequence.
Masking: Single (Care Provider)
Primary purpose: Health Services Research
Keywords: postnatal