Browsing by Author "Tierney C"

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    Effect on growth of exposure to maternal antiretroviral therapy in breastmilk versus extended infant nevirapine prophylaxis among HIV-exposed perinatally uninfected infants in the PROMISE randomized trial.
    (2021) Stranix-Chibanda L; Tierney C; Pinilla M; George K; Aizire J; Chipoka G; Mallewa M; Naidoo M; Nematadzira T; Kusakara B; Violari A; Mbengeranwa T; Njau B; Fairlie L; Theron G; Mubiana-Mbewe M; Khadse S; Browning R; Fowler MG; Siberry GK; FHI 360, Durham, NC, United States of America.; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, United States of America.; University of North Carolina Project, Lilongwe, Malawi.; Johns Hopkins University School of Medicine, Baltimore, MD, United States of America.; University of Zimbabwe Clinical Trials Research Centre, Harare, Zimbabwe.; Office of HIV/AIDS, United States Agency for International Development, Washington, DC, United States of America.; Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research in the Department of Biostatistics, Boston, MA, United States of America.; Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa.; Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.; Perinatal HIV Research Unit, Johannesburg, South Africa.; Makerere University-Johns Hopkins University Research Programme, Kampala, Uganda.; University of KwaZulu-Natal, Centre Aids Prevention Research South Africa (CAPRISA), Durban, South Africa.; College of Medicine-Johns Hopkins University Project, Blantyre, Malawi.; University of Zimbabwe Faculty of Medicine and Health Sciences, Child and Adolescent Health Unit, Harare, Zimbabwe.; Department of Obstetrics and Gynaecology, BJ Government Medical College, Pune, India.; Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, MD, United States of America.; Kilimanjaro Christian Medical Center, Moshi, United Republic of Tanzania.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    BACKGROUND: Malnutrition is highly prevalent in HIV-exposed perinatally uninfected infants (HEUs) increasing the risk of morbidity and mortality throughout the life course. We set out to compare the effect of postnatal exposure to maternal antiretroviral therapy (mART) in breastmilk versus infant Nevirapine prophylaxis (iNVP) on somatic growth of HEUs in the randomized PROMISE trial. METHODS AND FINDINGS: We randomized 2431 mothers with HIV and their 2444 HEUs from six African countries and India 6-14 days after delivery to mART or iNVP for prevention of breastmilk HIV transmission. The mART regimen contained tenofovir/emtricitabine (99%) plus lopinavir/ritonavir. Infant growth parameters were compared at postnatal week 10, 26, 74 and 104 using World Health Organization (WHO) z-scores for length-for-age (LAZ), weight-for-age (WAZ), and head circumference-for-age (HCAZ). Week 26 LAZ was the primary endpoint measure. Student T-tests compared mean LAZ, WAZ, and HCAZ; estimated mean and 95% confidence interval (CI) are presented. Maternal and infant baseline characteristics were comparable between study arms. The estimated median breastfeeding duration was 70 weeks. After a mean follow-up of 88 weeks, mean LAZ and WAZ were below the WHO reference population mean at all timepoints, whereas mean HCAZ was not. The mART and iNVP arms did not differ for the primary outcome measure of LAZ at week 26 (p-value = 0.39; estimated mean difference (95%CI) of -0.05 (-0.18, 0.07)) or any of the other secondary growth outcome measures or timepoints (all p-values≥0.16). Secondary analyses of the primary outcome measure adjusting for week 0 LAZ and other covariates did not change these results (all p-values≥0.09). However, infants assigned to mART were more likely to have stunting compared to iNVP infants at week 26 (odds ratio (95% CI): 1.28 (1.05, 1.57)). CONCLUSIONS: In HEUs, growth effects from postnatal exposure to mART compared to iNVP were comparable for measures on length, weight and head circumference with no clinically relevant differences between the groups. Despite breastfeeding into the second year of life, length and weight were below reference population means at all ages in both arms. Further investment is needed to optimize postnatal growth of infants born to women with HIV. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov number NCT01061151.
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    Slow Acceptance of Universal Antiretroviral Therapy (ART) Among Mothers Enrolled in IMPAACT PROMISE Studies Across the Globe.
    (2019-Sep) Stranix-Chibanda L; Brummel S; Pilotto J; Mutambanengwe M; Chanaiwa V; Mhembere T; Kamateeka M; Aizire J; Masheto G; Chamanga R; Maluwa M; Hanley S; Joao E; Theron G; Nevrekar N; Nyati M; Santos B; Aurpibul L; Mubiana-Mbewe M; Oliveira R; Anekthananon T; Mlay P; Angelidou K; Tierney C; Ziemba L; Coletti A; McCarthy K; Basar M; Chakhtoura N; Browning R; Currier J; Fowler MG; Flynn P; Instituto of Pediatrics Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.; Kilimanjaro Christian Medical Centre, Moshi, Tanzania.; Harvard T.H. Chan School of Public Health, Botswana Harvard AIDS Institute Partnership, Gaborone, Botswana.; Centre Aids Prevention Research South Africa (CAPRISA), University of KwaZulu-Natal, Durban, South Africa.; Division of AIDS, National Institute of Allergy and Infectious Diseases, Bethesda, USA.; University of Zimbabwe College of Health Sciences, Paediatrics and Child Health, Harare, Zimbabwe. lstranix@uzchs-ctrc.org.; College of Medicine - Johns Hopkins Research Project, Blantyre, Malawi.; University of North Carolina Project, Lilongwe, Malawi.; University of Zimbabwe College of Health Sciences - Clinical Trials Research Centre, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe.; Department of Infectious Diseases, St Jude Children's Research Hospital, Memphis, TN, USA.; Perinatal HIV Research Unit, Johannesburg, South Africa.; Division of Infectious Diseases, University of California Los Angeles, Los Angeles, USA.; Harvard T.H. Chan School of Public Health, Center for Biostatistics in AIDS Research in the Department of Biostatistics, Boston, USA.; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, USA.; Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.; Department of Obstetrics and Gynaecology, Stellenbosch University, Cape Town, South Africa.; FHI 360, IMPAACT Operations Center, Durham, NC, USA.; University of Zimbabwe College of Health Sciences - Clinical Trials Research Centre, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe. lstranix@uzchs-ctrc.org.; Frontier Science and Technology Research Foundation, Amherst, USA.; Department of Infectious Diseases, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.; Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, USA.; Research Institute for Health Sciences, Chiang Mai University, Chiang Mai, China.; Hospital Nossa Senhora da Conceicao, Porto Alegre, Brazil.; Laboratorio de AIDS e Imunologia Molecular - Fiocruz, Hospital Geral de Nova Iguacu, Rio de Janeiro, Brazil.; Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda.; Department of Obstetrics and Gynaecology, BJ Government Medical College, Pune, India.; Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.; CIDRZ; Centre for Infectious Disease Research in Zambia (CIDRZ)
    The PROMISE trial enrolled asymptomatic HIV-infected pregnant and postpartum women not eligible for antiretroviral treatment (ART) per local guidelines and randomly assigned proven antiretroviral strategies to assess relative efficacy for perinatal prevention plus maternal/infant safety and maternal health. The START study subsequently demonstrated clear benefit in initiating ART regardless of CD4 count. Active PROMISE participants were informed of results and women not receiving ART were strongly recommended to immediately initiate treatment to optimize their own health. We recorded their decision and the primary reason given for accepting or rejecting the universal ART offer after receiving the START information. One-third of participants did not initiate ART after the initial session, wanting more time to consider. Six sessions were required to attain 95% uptake. The slow uptake of universal ART highlights the need to prepare individuals and sensitize communities regarding the personal and population benefits of the "Treat All" strategy.