Optimizing the Delivery of Maternal and Child Health Services to Strengthen the Primary Health Care System in Rural South Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,172
- 试验地点
- 2
- 主要终点
- Proportion of HIV-infected pregnant women who are on ART and have received an HIV VL test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Single (Care Provider)
盲法说明
Masking was only until randomisation status identified at the start of each intervention step.
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Currently postpartum: immediately post delivery OR 3-6 days postpartum OR 6 weeks postpartum; AND
- •Lives in Africa Centre Demographic Surveillance Area (DSA); AND/OR
- •Attended antenatal care (ANC) or postnatal care (PNC) in study intervention clinics
排除标准
- •Below 18 years of age;
- •Not postpartum;
- •Does not live within Africa Centre DSA; AND
- •Did not attend ANC or PNC at study intervention clinics
研究组 & 干预措施
Receiving/ received QI intervention
A clinic which is presently receiving the Intensive Phase of the QI intervention, or is in the Maintenance Phase
干预措施: Quality Improvement (Other)
Not yet received QI intervention
A clinic which has not yet received the QI intervention
干预措施: Baseline data collection (active comparator) (Other)
结局指标
主要结局
Proportion of HIV-infected pregnant women who are on ART and have received an HIV VL test
时间窗: At study mid-point and study end (approximately 20 months)
Proportion of women who are HIV-uninfected at first ANC HIV test with a repeat antenatal HIV test
时间窗: At study mid-point and study end (approximately 20 months)
次要结局
- Proportion of HEI receiving nevirapine prophylaxis(At study mid-point and study end (approximately 20 months))
- Uptake of exclusive breastfeeding(At study mid-point and study end (approximately 20 months))
- Uptake of contraception(At study mid-point and study end (approximately 20 months))
- Proportion of HIV-infected women initiated on ART during pregnancy/breastfeeding (PMTCT)(At study mid-point and study end (approximately 20 months))
- Number of participants with knowledge of HIV(At study mid-point and study end (approximately 20 months))
- Proportion of infant HIV PCR positivity among HIV-exposed infants (HEI)(At study mid-point and study end (approximately 20 months))
- Proportion of HIV-infected pregnant women who have HIV virologic suppression(At study mid-point and study end (approximately 20 months))
- Number of participants with knowledge of early infant feeding(At study mid-point and study end (approximately 20 months))
- Number of participants with knowledge of available contraception(At study mid-point and study end (approximately 20 months))
- Subjective experience: provider job satisfaction and motivation(At study mid-point and study end (approximately 20 months))
- Subjective experience: patient satisfaction with services(At study mid-point and study end (approximately 20 months))
- Proportion of participants enrolled at delivery attending 6-week postnatal visit(At study mid-point and study end (approximately 20 months))
