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MTCT-Prevention: The Kesho Bora study

MTCT-Prevention: The Kesho Bora study. Tim Farley Department of Reproductive Health and Research World Health Organization. Background. Majority of MTCT-prevention research focused on saving infant from HIV infection

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MTCT-Prevention: 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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