Estimating treatment effects in studies of perinatal transmission of HIV. 2004

Heejung Bang, and Donna Spiegelman
Department of Biostatistics, University of North Carolina, 137E Franklin Street, Suite 400, Chapel Hill, NC 27599-8030, USA. heejung_bang@unc.edu

Fetal loss often precludes the ascertainment of infection status in studies of perinatal transmission of HIV. The standard analysis based on liveborn babies can result in biased estimation and invalid inference in the presence of fetal death. This paper focuses on the problem of estimating treatment effects for mother-to-child transmission when infection status is unknown for some babies. Minimal data structures for identifiability of parameters are given. Methods using full likelihood and the inverse probability of selection-weighted estimators are suggested. Simulation studies are used to show that these estimators perform well in finite samples. Methods are applied to the data from a clinical trial in Dar es Salaam, Tanzania. To validly estimate the treatment effect using likelihood methods, investigators should make sure that the design includes a mini-study among uninfected mothers and that efforts are made to ascertain the infection status of as many babies lost as possible. The inverse probability weighting methods need precise estimation of the probability of observing infection status. We can further apply our methodology to the study of other vertically transmissible infections which are potentially fatal pre- and perinatally.

UI MeSH Term Description Entries
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D011247 Pregnancy The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH. Gestation,Pregnancies
D011251 Pregnancy Complications, Infectious The co-occurrence of pregnancy and an INFECTION. The infection may precede or follow FERTILIZATION. Complications, Infectious Pregnancy,Infectious Pregnancy Complications,Maternal Sepsis,Pregnancy, Infectious Complications,Sepsis during Pregnancy,Sepsis in Pregnancy,Infectious Pregnancy Complication,Pregnancy Complication, Infectious,Sepsis in Pregnancies,Sepsis, Maternal
D005260 Female Females
D005313 Fetal Death Death of the developing young in utero. BIRTH of a dead FETUS is STILLBIRTH. Fetal Mummification,Fetal Demise,Death, Fetal,Deaths, Fetal,Demise, Fetal,Fetal Deaths,Mummification, Fetal
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013636 Tanzania A republic in eastern Africa, south of UGANDA and north of MOZAMBIQUE. Its capital is Dar es Salaam. It was formed in 1964 by a merger of the countries of TANGANYIKA and ZANZIBAR. Tanganyika,Zanzibar,United Republic of Tanzania
D014801 Vitamin A Retinol and derivatives of retinol that play an essential role in metabolic functioning of the retina, the growth of and differentiation of epithelial tissue, the growth of bone, reproduction, and the immune response. Dietary vitamin A is derived from a variety of CAROTENOIDS found in plants. It is enriched in the liver, egg yolks, and the fat component of dairy products. Retinol,11-cis-Retinol,3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8-nonatetraen-1-ol, (all-E)-Isomer,All-Trans-Retinol,Aquasol A,Vitamin A1,All Trans Retinol
D015497 HIV-1 The type species of LENTIVIRUS and the etiologic agent of AIDS. It is characterized by its cytopathic effect and affinity for the T4-lymphocyte. Human immunodeficiency virus 1,HIV-I,Human Immunodeficiency Virus Type 1,Immunodeficiency Virus Type 1, Human
D015658 HIV Infections Includes the spectrum of human immunodeficiency virus infections that range from asymptomatic seropositivity, thru AIDS-related complex (ARC), to acquired immunodeficiency syndrome (AIDS). HTLV-III Infections,HTLV-III-LAV Infections,T-Lymphotropic Virus Type III Infections, Human,HIV Coinfection,Coinfection, HIV,Coinfections, HIV,HIV Coinfections,HIV Infection,HTLV III Infections,HTLV III LAV Infections,HTLV-III Infection,HTLV-III-LAV Infection,Infection, HIV,Infection, HTLV-III,Infection, HTLV-III-LAV,Infections, HIV,Infections, HTLV-III,Infections, HTLV-III-LAV,T Lymphotropic Virus Type III Infections, Human

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