There have been major advances in the prevention of mother-to-child transmission (PMTCT) of HIV in developed countries, but hundreds of thousands of children are newly infected with HIV every year in sub- Saharan Africa. Initiation of antiretroviral therapy (ART) in eligible pregnant women (CD4<350 cells/uL) can play a critical role in PMTCT efforts, as women who are eligible for ART are most likely to transmit HIV to their children and also are at the greatest risk of morbidity and mortality themselves. However it is clear that current approaches and services for ART initiation in pregnancy are suboptimal in South Africa (SA) and other parts of the continent where PEPFAR is active. Many eligible women do not start ART while pregnant, and those who do often begin too late in pregnancy to realize the full benefits. We propose to evaluate a new intervention to promote rapid ART initiation among eligible pregnant women in Cape Town, SA. The Emnonophele Intervention (meaning """"""""taking care of health"""""""" in isiXhosa, the local language) represents a new operational paradigm for """"""""fast tracking"""""""" ART initiation in pregnancy that combines strategies to address the key health systems, clinical, and patient education and adherence issues that currently act as barriers to rapid ART initiation in pregnancy. The intervention features midwife-delivered ART within the antenatal clinic (ANC);using an efavirenz-containing regimen that avoids the delays and toxicities associated with nevirapine;and adapting patient education to be delivered during and immediately after (rather than before) ART initiation. Our team consists of leading researchers in PMTCT, ART and patient education working in partnership with local PEPFAR and public health care services. Pilot work on EI has demonstrated its feasibility and acceptability among HIV-infected pregnant women and health care providers. We propose a pragmatic trial to provide a rigorous evaluation of EI versus the existing standard of care, with HIV viral suppression at the time of delivery as the primary outcome. Secondary aims include the transmission of HIV from mother-to-child and retention in care through 6 months postpartum, as well as the acceptability and cost-effectiveness of this intervention. By recognizing that ART-eligible pregnant women are a vulnerable, high risk group EI shifts the paradigm for implementation of PMTCT and ART services, and addresses well-documented challenges to delivering ART in pregnancy to optimize both maternal and child health outcomes. We propose a rigorous evaluation of the feasibility, implementation, impact and cost-effectiveness of EI. Developed in partnership with SA DOH and local services, EI has the potential to strengthen PEPFAR-supported PMTCT and HIV treatment services locally and nationally. Furthermore, EI will provide a feasible and evidence-based intervention platform to enhance ART use during pregnancy, contributing directly to efforts to eliminate new pediatric HIV infections in Africa.

Public Health Relevance

Using antiretroviral therapy (ART) effectively in pregnancy is a critical part of efforts to reduce the mother-to- child transmission of HIV infection in South Africa and many other countries where PEPFAR is active. However we know there are many problems facing current services to start pregnant women on ART and follow them during pregnancy, so we propose an innovative new approach for ART initiation in pregnancy that emphasizes ART-eligible pregnant women as a high-risk population who need special attention. We will study a new model to revolutionize ART initiation in pregnancy and will make a major contribution to improving maternal and child health in countries like South Africa where HIV is common.

National Institute of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Research Project (R01)
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Special Emphasis Panel (ZAI1)
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Russo, Denise
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Columbia University (N.Y.)
Public Health & Prev Medicine
Schools of Public Health
New York
United States
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Trafford, Zara; Gomba, Yolanda; Colvin, Christopher J et al. (2018) Experiences of HIV-positive postpartum women and health workers involved with community-based antiretroviral therapy adherence clubs in Cape Town, South Africa. BMC Public Health 18:935
Brittain, Kirsty; Mellins, Claude A; Remien, Robert H et al. (2018) Patterns and Predictors of HIV-Status Disclosure Among Pregnant Women in South Africa: Dimensions of Disclosure and Influence of Social and Economic Circumstances. AIDS Behav 22:3933-3944
Langwenya, Nontokozo; Phillips, Tamsin K; Brittain, Kirsty et al. (2018) Same-day antiretroviral therapy (ART) initiation in pregnancy is not associated with viral suppression or engagement in care: A cohort study. J Int AIDS Soc 21:e25133
le Roux, Stanzi M; Donald, Kirsten A; Brittain, Kirsty et al. (2018) Neurodevelopment of breastfed HIV-exposed uninfected and HIV-unexposed children in South Africa. AIDS 32:1781-1791
Brittain, Kirsty; Remien, Robert H; Mellins, Claude A et al. (2018) Determinants of suboptimal adherence and elevated HIV viral load in pregnant women already on antiretroviral therapy when entering antenatal care in Cape Town, South Africa. AIDS Care 30:1517-1523
Phillips, Tamsin K; Wilson, Ira B; Brittain, Kirsty et al. (2018) Decreases in self-reported ART adherence predict HIV viremia among pregnant and postpartum South African women. J Acquir Immune Defic Syndr :
Iyun, Victoria; Brittain, Kirsty; Phillips, Tamsin K et al. (2018) Prevalence and determinants of unplanned pregnancy in HIV-positive and HIV-negative pregnant women in Cape Town, South Africa: a cross-sectional study. BMJ Open 8:e019979
Brittain, Kirsty; Remien, Robert H; Phillips, Tamsin et al. (2017) Factors associated with alcohol use prior to and during pregnancy among HIV-infected pregnant women in Cape Town, South Africa. Drug Alcohol Depend 173:69-77
Phillips, Tamsin; Brittain, Kirsty; Mellins, Claude A et al. (2017) A Self-Reported Adherence Measure to Screen for Elevated HIV Viral Load in Pregnant and Postpartum Women on Antiretroviral Therapy. AIDS Behav 21:450-461
Wong, Marcia; Myer, Landon; Zerbe, Allison et al. (2017) Depression, alcohol use, and stigma in younger versus older HIV-infected pregnant women initiating antiretroviral therapy in Cape Town, South Africa. Arch Womens Ment Health 20:149-159

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