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Maximizing MTCT Prevention & Care Access: The Kesho Bora Study

This study aims to enhance interventions for preventing mother-to-child HIV transmission and improving HIV-infected mothers' health through ARV therapy. By focusing on both prevention and care aspects, it seeks to optimize outcomes and address key policy questions. Detailed design includes categorized treatment based on disease stage, offering appropriate prophylaxis, and regular follow-up. Ethical considerations, like sustainability and justice, are also emphasized, ensuring the study's integrity and long-term impact. With sites in various locations and ongoing approval processes, the study is set to commence in the last quarter of 2003.

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Maximizing MTCT Prevention & Care Access: The Kesho Bora Study

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  1. MTCT-Prevention: The Kesho Bora study Tim Farley Department of Reproductive Health and Research World Health Organization

  2. Background • Majority of MTCT-prevention research focused on saving infant from HIV infection • Care needs of mother (and family) have received relatively little attention • Rapidly increasing access to care in resource-limited settings allows more comprehensive approach to MTCT prevention • Programmes linking MTCT prevention and care are beginning to be implemented

  3. Rationale • Efficacy of interventions to prevent mother-to-child transmission (MTCT) of HIV in resource-constrained settings must be improved • Health of HIV-infected mothers identified in MTCT-prevention programmes needs more attention • Alternatives to replacement feeding for children born to HIV-infected mothers need to be identified

  4. Overall Objective • To optimize use of antiretrovirals to reduce risk of MTCT and provide for mother’s health • Explicit link between MTCT-prevention and care • Address key policy questions in providing ARV therapy based on MTCT-prevention intervention

  5. Design Details • Women stratified on disease stage in late pregnancy • CD4+ count < 200 cells/mm3 or HIV Stage III or IV • Initiate triple ARV-therapy (ZDV+3TC+NVP) • CD4+ count > 500 cells/mm3 • Offered short-course MTCT prophylaxis (1 month ZDV + single dose NVP) • CD4+ count in range 200-500 cells/mm3 • Randomised to receive short-course or extended triple-ARV MTCT prophylaxis (ZDV+3TC+NVP) for max 6 months • Regular follow up of mothers and infants for 2 years

  6. Key Justice Considerations • Women who require treatment for their own HIV disease initiate life-long triple ARV therapy • Women not (yet) requiring care receive MTCT-prevention prophylaxis (short-course or extended regimen) • All women whose health deteriorates during study initiate life-long triple-ARV therapy

  7. Ethical Challenges (1) • Sustainability • Study period up to 2 years following delivery • Care needs during study provided from study resources • Study being conducted in sites where • Care programme currently exists, or • Care programme under development and expected to be operational before end of study • Close partnerships being developed with governments and NGOs to provide long-term care • Study team not able to provide cast-iron guarantee of long-term care

  8. Ethical Challenges (2) • Justice considerations • Priority for initiating triple ARV therapy • Mothers in study who require therapy • Mothers in study whose health deteriorates during study • Mothers in study whose health deteriorates after the study • Under discussion (balance justice vs. resources) • Partners of study volunteers who require therapy • Children of study volunteers who require therapy • Health-care workers involved with study • Community advisory panel to advise (decide?) on who qualifies for long-term care

  9. Ethical Challenges (3) • Coercion • Life-long ARV therapy only offered to women volunteering for study cohort • Compliance • Therapy programmes usually require demonstrated ability to comply with burdensome tablet schedule • Violence • Will priority access to ARV therapy for partners expose women to unwanted pregnancy? • Does volunteering for study confer right to free life-long care?

  10. Current Status (June 2003) • Sites • Bobo Dioulasso, Mombasa, Moshi, Nairobi • Approvals • WHO Ethics Committees • Local (and national) ethical approval underway • Study instruments and procedures (including ARV therapy) • Under development, advanced draft available • Study start date …last quarter 2003

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