Author Contributions: Dr Essex had full access to all of the data in the study and takes responsibility for the integrity and the accuracy of the data analysis.
Study concept and design: Thior, Lockman, Smeaton, Shapiro, Wester, Heymann, Gilbert, Stevens, Kim, Kebaabetswe, Mazonde, McIntosh, Lee, Marlink, Lagakos, Essex.
Acquisition of data: Thior, Wester, Stevens, Peter, van Widenfelt, Moffat, Ndase, Arimi, Makhema.
Analysis and interpretation of data: Thior, Lockman, Smeaton, Shapiro, Wester, Heymann, Gilbert, Stevens, Kim, van Widenfelt, Moffat, McIntosh, Novitsky, Lee, Marlink, Lagakos, Essex.
Drafting of the manuscript: Thior, Lockman, Smeaton, Shapiro, Heymann, Gilbert, Kim, Lagakos, Essex.
Critical revision of the manuscript for important intellectual content: Thior, Lockman, Smeaton, Shapiro, Wester, Heymann, Gilbert, Stevens, Peter, Kim, van Widenfelt, Moffat, Ndase, Arimi, Kebaabetswe, Mazonde, Makhema, McIntosh, Novitsky, Lee, Marlink, Lagakos, Essex.
Statistical analysis: Smeaton, Gilbert, Kim, Lagakos.
Obtaining funding: Thior, Lockman, Shapiro, Lagakos, Essex.
Administrative, technical, or material support: Thior, Lockman, Smeaton, Shapiro, Wester, Heymann, Gilbert, Stevens, Peter, Kim, van Widenfelt, Moffat, Ndase, Arimi, Kebaabetswe, Mazonde, Makhema, McIntosh, Novitsky, Lee, Marlink, Lagakos, Essex.
Study supervision: Thior, Lockman, Shapiro, Wester, Heymann, Stevens, Makhema, Essex.
Financial Disclosures: None reported.
Funding/Support: This work was supported by a grant from the National Institutes of Health, NICHD (R01 HD37793); a grant from the Oak Foundation; Boehringer Ingelheim (which provided nevirapine); and by GlaxoSmithKline (which provided zidovudine); and the United Nations Children's Fund, which provided funds to assist with ongoing monitoring of the study participants. The Fogarty International Center grant TW00004 supported several of the trainees who were involved in this study.
Mashi Study Team: Drs C. Anude and J. Chanda, study physicians; L. Makori, nursing diploma, study nurse; J. B. Moorad, T. A. Modise, T. Moyo, and M. Malamba, nursing and midwifery diplomas, study nurses; D. Arbi and K. Koloi, nursing diplomas, nurse recruiters; L. Dube and T. Mmolotsi, health education diplomas, health educators and recruiters; S. Babitseng and D. Mere, nursing diplomas, recruiters (Molepolole site); Dr J. Boyle, study physician; J. Magetse, V. Modikwa, and M. Tsuro, nursing and midwifery diplomas, study nurses; T. Sekoto, family nurse practitioner diploma, study nurse; L. Garebatho, nursing diploma, study nurse; M. Sesinyi and K. Kelebalekgosi, health educator diplomas, health educators and recruiters (Mochudi site); Dr Z. Tedla, study physician; G. Mayondi, K. Sebinang, J. Setswalo, nursing and midwifery diplomas, study nurses; N. Makubate, community health nursing and midwifery diploma, study nurse; L. Tsalaile, MSc nursing education, study nurse; B. Tsule, nursing diploma, study nurse; I. Thebeetsile, nursing diploma, nurse recruiter; I. Leteane and O. Makgabana, health education diplomas, health educators and recruiters (Lobatse Site); Drs. M. Mogodi, A. Owor, I. Hove, and A. Asmelash, study physicians; T. Kakhu, P. Ramalepa, and J. Lubinda, nursing and midwifery diplomas, study nurses; S. Ndebele, F. Modise, C. Bohule, K. Motshabi, and M. Ntshimane, nursing diplomas, nurse recruiters; (Gaborone site). The Mashi Study Team refers to the clinical staff hired to conduct the research study. Those named in the acknowledgment with affiliations at Harvard School of Public Health or the Botswana-Harvard Partnership are also employees of these institutions. The only compensation received by employees was their regular salary. All other named individuals or organizations were collaborators and did not receive any compensation.
Data Safety and Monitoring Board: Justice U. Dow, Lobatse High Court, Botswana; R. Gelber, PhD, Dana Farber Cancer Institute and Children's Hospital, Boston, Mass; D. Katzenstein, MD, Stanford University Medical Center, Menlo Park, Calif; B. Lo, MD, University of California at San Francisco; A. Mushi, MD, Gaborone, Botswana; C. Mwangi, MD, Nyangabgwe Hospital, Francistown, Botswana; C. Tharakan, PhD, Department of Statistics, University of Botswana, Gaborone, Botswana; and R. Whitley, MD, University of Alabama at Birmingham Children's Hospital.
Role of the Sponsors: The sponsors of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.
Previous Presentations: Material presented as an abstract at the 12th Conference on Retroviruses and Opportunistic Infections, February 22-25, 2005, Boston, Mass, abstract No. 75LB.14. Breastfeeding with 6 months of infant zidovudine prophylaxis vs formula feeding for reducing HIV-1 transmission and infant mortality: a randomized trial in southern Africa.
Acknowledgment: We are indebted to the patients who participated in the Mashi Study. We also wish to thank M. F. McLane (Harvard School of Public Health), M. Montano, PhD (Boston University), and S. Y. Chang, PhD (Harvard School of Public Health) for laboratory coordination and training; S. Gaseitsiwe, E. Sepako, G. Sebetso, Y. Wu, T. Nkoane, F. Chand, A. M. Reich, and B. N. Bome, MSc (Botswana-Harvard HIV Reference Laboratory) for their work in the laboratory; T. Masoloko, K. Onyait, S. Yates, and M. Mmelesi, MPH (Botswana-Harvard School of Public Health AIDS Initiative Partnership), and K. Phiri (Harvard School of Public Health), for data management; C. Suckow, RN (Frontier Science) for training in data management; A. Patterson, PharmD, and R. Anzaldi (Children's Hospital, Boston), D. Kekwaletse and R. Leepo, MSc (Botswana-Harvard School of Public Health AIDS Initiative Partnership), as study pharmacists; M. Pretorius Holme, MS, and Lendsey Melton, MA (Harvard School of Public Health) for editorial coordination; R. Madison, O. Ntogwa, R. Molefe, T. Maotwe, B. Mafoko, A. Sanders, K. Maswere, and J. Setimela (Botswana-Harvard School of Public Health AIDS Initiative Partnership), for administration; and Drs L. Mofenson, A. Willoughby, R. Nugent, and J. Moye (National Institutes of Health), and Drs M. Lallemant and G. Jourdain (Institut de Recherche pour le Développement), for guidance. There was no compensation from a funding sponsor for any contributions by individuals named in the Acknowledgment section. We thank the Botswana Ministry of Health for providing nursing and driver support, infant formula, and the antiretrovirals and monitoring for women and infants on HAART; the administration, the maternity ward and MCH staff at the Scottish Livingstone Hospital, Deborah Retief Memorial Hospital, Athlone Hospital, and Princess Marina Hospital. We thank the District Health Teams and Clinics in Molepolole, Mochudi, Lobatse, and Gaborone. We also thank the Central Medical Store and Medswana.