B positive_A population based evaluation of expanded ART access in pregnancy

B 阳性_基于人群的妊娠期扩大 ART 获取的评估

• 批准号: 9764401
• 负责人: Emma Kate Kalk
• 金额: $ 79.92万
• 依托单位: UNIVERSITY OF CAPE TOWN
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-01 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9764401
• 关键词: AIDS/HIV problem; Address; Adherence; Adult; Africa South of the Sahara; Anti-Retroviral Agents; Breast Feeding; CD4 Lymphocyte Count; Caring; Characteristics; Child; Child Health; Clinical; Cohort Analysis; Cohort Studies; Communicable Diseases; Complex; Conceptions; Congenital Abnormality; Country; Data; Data Set; Diagnosis; Disease; Early treatment; Effectiveness; Ensure; Environment; Epidemic; Evaluation; Event; Exposure to; Family; Future; Government; Guidelines; HIV; HIV Infections; HIV therapy; HIV-exposed uninfected infant; Health; Health Information System; Hospitalization; Infant; Information Systems; Intervention; Knowledge; Laboratories; Life; Link; Longterm Follow-up; Low Birth Weight Infant; Maternal Health; Maternal and Child Health; Measures; Mental Health; Modeling; Monitor; Mother-to-child HIV transmission; Mothers; Outcome; Patients; Perinatal; Pharmaceutical Preparations; Policies; Population; Positioning Attribute; Postpartum Period; Postpartum Women; Pregnancy; Pregnancy Outcome; Pregnant Women; Prevention; Prevention Guidelines; Preventive; Program Effectiveness; Province; Public Sector; Recording of previous events; Regimen; Reporting; Research; Research Infrastructure; Risk; Safety; Sentinel; Serious Adverse Event; Seroprevalences; Service delivery model; Services; Severities; Site; South Africa; System; Testing; Vertical Disease Transmission; Viral Load result; Vital Status; Woman; adverse pregnancy outcome; antenatal; antiretroviral therapy; base; cohort; congenital anomaly; cost; electronic data; feeding; health care delivery; improved; innovation; insight; mathematical model; mortality; novel; perinatal health; perinatal outcomes; perinatal period; population based; pregnant; prenatal exposure; prevent; programs; public health relevance; sexual HIV transmission; stillbirth; transmission process; treatment program; trend

DESCRIPTION (provided by applicant): Universal three-drug antiretroviral therapy (ART) for HIV-infected women offers many advantages in terms of preventing HIV transmission to children, safer breastfeeding, improved maternal health, reduced sexual transmission of HIV, and simplified treatment programs. Safety of increased ART exposure during pregnancy and conception for mothers and their children is not fully established, and there are concerns about maternal adherence and program effectiveness. Investigating the impact of these changes is complex due to weak clinical and information systems in many settings, rapidly changing guidelines and service realities, and difficulty ensuring long term follow-up of sufficient numbers of children to exclude potential harmful effects. The current HIV antenatal seroprevalence in the Western Cape province of South Africa is 19% with vertical transmission of HIV estimated at 2%. Providing maternity care to 100,000 mothers a year, the province has a long history of innovation in PMTCT programs; recently introducing life-long universal ART for HIV- infected pregnant or breast-feeding women. The province is uniquely placed to comprehensively evaluate this guideline change due to the availability of electronic data on the ART program, and the ability to link via a unique health identifier to a range of other datasets to improve follow-u, ascertainment of pregnancy and ART exposure, laboratory values, vital status data and other outcomes. This proposal seeks to evaluate the impact of the guideline change on: 1) the effectiveness of PMTCT and ART programs for participating women based; 2) the impact of increased ART exposure antenatally and around conception on maternal and perinatal health outcomes; 3) the impact on child health outcomes for children exposed in utero to ART; and finally 4) the impact on the governmental ART program and on the epidemic itself. At each level of evaluation, a population-based province-wide activity is paired with a sentinel site activity which probes clinical and operational issues in greater depth. All of the sentinel site activities are located in the same sites to improve operational efficiency, while all of the province-wide data activities will be undertaken by a single team. Program effectiveness will be assessed both through cohort analyses of the entire provincial ART cohort of 35,000 adult patients starting ART each year, and a detailed cohort study of 900 women in the sentinel site. Maternal and perinatal health outcomes will be assessed through provincial mortality reporting and perinatal audits which both have high levels of completeness, complimented by participation at the sentinel site in the national pregnancy exposure (PER) register and birth defects surveillance register. Post-neonatal child health outcomes will be tracked through hospital admissions, which for children from the PER, will be reviewed to verify discharge diagnoses. Program and epidemic impact will be explored through mathematical modeling based on a new country level HIV and demographic model.

描述（由申请人提供）：针对感染艾滋病毒的妇女的通用三种药物抗逆转录病毒疗法（ART）在预防艾滋病毒传播给儿童、更安全的母乳喂养、改善孕产妇健康、减少艾滋病毒的性传播和简化治疗方案方面具有许多优势。妊娠和受孕期间增加抗逆转录病毒治疗对母亲及其子女的安全性尚未完全确定，而且对孕产妇依从性和规划有效性存在担忧。调查这些变化的影响是复杂的，因为在许多情况下临床和信息系统薄弱，指南和服务现实迅速变化，以及难以确保足够数量的长期随访

项目成果

Preterm birth and severe morbidity in hospitalized neonates who are HIV exposed and uninfected compared with HIV unexposed.

• DOI: 10.1097/qad.0000000000002856
• 发表时间: 2021-05-01
• 期刊: AIDS (London, England)
• 作者: Anderson K;Kalk E;Madlala HP;Nyemba DC;Jacob N;Slogrove A;Smith M;Kroon M;Harrison MC;Eley BS;Boulle A;Myer L;Davies MA
• 通讯作者: Davies MA

Pharmacovigilance: A public health priority for South Africa.

药物警戒：南非的公共卫生优先事项。

• 发表时间: 2017
• 期刊: South African health review
• 作者: Mehta,Ushma;Kalk,Emma;Boulle,Andrew;Nkambule,Portia;Gouws,Joey;Rees,Helen;Cohen,Karen
• 通讯作者: Cohen,Karen

Association between food intake and obesity in pregnant women living with and without HIV in Cape Town, South Africa: a prospective cohort study.

• DOI: 10.1186/s12889-021-11566-2
• 发表时间: 2021-08-04
• 期刊: BMC public health
• 影响因子: 4.5
• 作者: Madlala HP;Steyn NP;Kalk E;Davies MA;Nyemba D;Malaba TR;Mehta U;Petro G;Boulle A;Myer L
• 通讯作者: Myer L

Maternal weight trajectories and associations with infant growth in South African women.

• DOI: 10.1186/s12889-023-16963-3
• 发表时间: 2023-10-20
• 期刊: BMC PUBLIC HEALTH
• 影响因子: 4.5
• 作者: Madlala, Hlengiwe P.;Bengtson, Angela M.;Hannan, Luke;Malaba, Thokozile R.;Kalk, Emma;Nyemba, Dorothy;Boulle, Andrew;Myer, Landon
• 通讯作者: Myer, Landon

Trends in maternal and neonatal mortality in South Africa: a systematic review protocol.

南非孕产妇和新生儿死亡率趋势：系统评价方案。

• DOI: 10.1186/s13643-017-0560-1
• 发表时间: 2017
• 期刊: Systematic reviews
• 影响因子: 3.7
• 作者: Damian,DamianJ;Njau,Bernard;Lisasi,Ester;Msuya,SiaE;Boulle,Andrew
• 通讯作者: Boulle,Andrew