Botswana Birth Outcomes Surveillance Extension

博茨瓦纳出生结果监测扩展

• 批准号: 10434695
• 负责人: Roger L Shapiro
• 金额: $ 57.78万
• 依托单位: HARVARD SCHOOL OF PUBLIC HEALTH
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-03 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10434695
• 关键词: Adult; Africa; African; Birth; Botswana; Childhood Acute Lymphocytic Leukemia; Conceptions; Congenital Abnormality; Country; Data; Data Set; Developed Countries; Exposure to; Government; Guidelines; HIV; HIV Infections; Hospitals; Incidence; Individual; Infant; Lead; Lopinavir/Ritonavir; Neural Tube Defects; Nevirapine; Outcome; Policies; Pregnancy; Pregnant Women; Premature Birth; Randomized Clinical Trials; Regimen; Reporting; Research; Risk; Risk Estimate; Safety; Signal Transduction; Site; Small for Gestational Age Infant; System; Tenofovir; Time; Treatment Protocols; United States National Institutes of Health; Update; Woman; World Health Organization; adverse birth outcomes; adverse outcome; antiretroviral therapy; base; design; early pregnancy; efavirenz; emtricitabine; infant outcome; neonatal death; novel; pregnant; programs; randomized trial; stillbirth; surveillance data; treatment guidelines; treatment program

Abstract Antiretroviral treatment (ART) guidelines depend upon safety data in pregnancy. Although developed countries have moved to dolutegravir (DTG)-based first-line ART for non-pregnant adults, the World Health Organization (WHO) still recommends efavirenz (EFV)/emtricitabine (FTC)/tenofovir (TDF) while awaiting safety data for DTG that may harmonize guidelines for pregnant and non-pregnant adults. In June 2016, Botswana became the first country in Africa to switch to DTG/TDF/FTC as first-line ART for adults, including pregnant women. This change occurred in the setting of ongoing NIH-supported birth outcomes surveillance at 8 sites throughout Botswana (R01HD080471), which was designed to evaluate adverse birth outcomes by ART regimen and neural tube defects by EFV exposure status. This surveillance system has already provided initial safety data for the DTG roll-out, and has raised concerns about the safety of specific nevirapine- and lopinavir/ritonavir- based “legacy” ART regimens in pregnancy. Botswana's change to DTG/TDF/FTC, combined with the government's plan to switch women off “legacy” ART starting in 2018, opens new scientific opportunities for this surveillance system. We are therefore applying for a new R01 to continue (and enhance) birth outcomes surveillance in Botswana. Our proposal has the following primary aims: 1) to perform the first large analysis of adverse birth outcomes and congenital abnormalities following DTG exposure from the time of conception, and 2) to evaluate birth outcomes among women who either continue “legacy” ART or switch to DTG/TDF/FTC prior to (or during) pregnancy. These novel aims take advantage of the unique ART landscape in Botswana (including an upcoming plan to switch women off legacy ART regimens), and build on the emerging scientific findings from our highly productive surveillance system. Data generated from this study will be critical for updating WHO (and US) guidelines for the use of ART among pregnant women, and for women who may become pregnant.

摘要

项目成果

Prevalence and outcomes of twin pregnancies in Botswana: a national birth outcomes surveillance study.

• DOI: 10.1136/bmjopen-2020-047553
• 发表时间: 2021-10-21
• 期刊: BMJ open
• 影响因子: 2.9
• 作者: Isaacson A;Diseko M;Mayondi G;Mabuta J;Davey S;Mmalane M;Makhema J;Jacobson DL;Luckett R;Shapiro RL;Zash R
• 通讯作者: Zash R

Anti-hypertensive use for non-severe gestational hypertension in Botswana: A case-control study.

• DOI: 10.1002/ijgo.13809
• 发表时间: 2022-03
• 期刊: International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics
• 作者: Johnson KM;Zash R;Modest AM;Luckett R;Diseko M;Mmalane M;Makhema J;Ramogola-Masire D;Wylie BJ;Shapiro R
• 通讯作者: Shapiro R

The impact of free antiretroviral therapy for pregnant non-citizens and their infants in Botswana.

• DOI: 10.1002/jia2.26161
• 发表时间: 2023-10
• 期刊: Journal of the International AIDS Society
• 影响因子: 6

Modest reduction in adverse birth outcomes following the COVID-19 lockdown.

• DOI: 10.1016/j.ajog.2020.12.1198
• 发表时间: 2021-06
• 期刊: American journal of obstetrics and gynecology
• 影响因子: 9.8
• 作者: Caniglia EC;Magosi LE;Zash R;Diseko M;Mayondi G;Mabuta J;Powis K;Dryden-Peterson S;Mosepele M;Luckett R;Makhema J;Mmalane M;Lockman S;Shapiro R
• 通讯作者: Shapiro R

Weight gain during pregnancy among women initiating dolutegravir in Botswana.

• DOI: 10.1016/j.eclinm.2020.100615
• 发表时间: 2020-12
• 期刊: EClinicalMedicine
• 影响因子: 15.1
• 作者: Caniglia EC;Shapiro R;Diseko M;Wylie BJ;Zera C;Davey S;Isaacson A;Mayondi G;Mabuta J;Luckett R;Makhema J;Mmalane M;Lockman S;Zash R
• 通讯作者: Zash R