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*Kabeho is the word in Kinyarwanda for wishing someone a long life

The Kabeho Study*: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV. *Kabeho is the word in Kinyarwanda for wishing someone a long life.

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*Kabeho is the word in Kinyarwanda for wishing someone a long life

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  1. The Kabeho Study*: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV *Kabeho is the word in Kinyarwanda for wishing someone a long life

  2. Presentation byMichelle Gill, MPHSenior Research Associate at EGPAF Co-investigator on the Kabeho StudyCo-PIs:Emily A. Bobrow, PhD, MPH Anita Asiimwe, MD, MPHPlacidie Mugwaneza, MD Kabeho Team of Investigators: Jeanine Condo, Sabin Nsanzimana, Muhayimpundu Ribakare, Jean Claude Uwimbabazi, Linda Adair, Laura A. Guay, Gilles F. Ndayisaba, Michelle Gill, Heather J. Hoffman, Eric Remera, Dieudonne Ndatimana, John Rusine, Jeff Safrit, & Cyprien Baribwira

  3. Primary Objective To determine the 18-month HIV-free survivalin a cohort of children born to HIV-positive pregnant women in selected high volume antenatal clinic sites in Kigali, Rwanda, who are participating in the Rwanda National PMTCT program that includes universal lifelong ART (PMTCT Option B+) and comprehensive infant feeding counseling and support

  4. Secondary Objective 1 To determine the individual and facility level factors associated with healthy infant nutritional outcomes (as defined by lack of stunting, underweight, or wasting) among the cohort of HIV-exposed children at 18 months of age

  5. Secondary Objective 2 To determine the individual and facility level factors associated with adherence to the universal ARV regimen among pregnant and postpartum women (Option B+) and their HIV-exposed children in the first 18 months postpartum

  6. Secondary Objective 3 To document selected birth outcomes, including stillbirths, prematurity, low birth weight, and gross congenital anomalies in the cohort HIV-exposed study infants

  7. Research Methods • Study design • Observational prospective cohort of HIV-positive pregnant/early postpartum women and their infants enrolled from antenatal clinics • Monthly structured interviews • 24-hour dietary recall allowing for identification of specific food and quantities fed every 2-3 months • Subset of women will also participate in in-depth qualitative interviews • Focus group discussions with Kabeho study nurses • Semi-structured interviews with health providers • Yearly facility assessment

  8. Research Methods • Population and sample size • 608 HIV-positive pregnant/early postpartum women and their infants enrolled from PMTCT from 14 high volume health facilities in Kigali • Enrollment period: April 2013 – January 2014 • Research Ethics • Written informed consent obtained • IRB approvals from US and Rwanda

  9. Data Collection and Management • Data collected during routine monthly clinic visits • MS Excel for 24-hour dietary recall data • Audio recordings and transcripts created as MS Word files for qualitative data

  10. Women recruited/screened (n=998) Enrollment and Screening Flow Diagram Women ineligible (n=277) Women or their guardian declined to provide consent (n=113) Women enrolled (n=608) Women currently in follow-up(n=550) Infant deaths (n=30) Consent withdraw (n=29) Total termination (n=58)

  11. Preliminary Findings: Background on Kabeho Study Women(N=608)

  12. Preliminary Findings: Background on Kabeho Study Women(N=608)

  13. Preliminary Findings: Background on Kabeho Study Women(N=608) • Side effects reported in the previous month 17.3% • 95% adherence, based on 3-day ART recall 90.9% • Viral Load (RNA-PCR) (n=606) • Undetectable (<20 copies/mL) 52.1% (316) • <400 copies/ml 79.3% (481)

  14. Preliminary Findings: Birth Visit (n=608)

  15. Preliminary Findings: Infant Feeding Results from Birth Visit • 93.6% (569) reported exclusive breastfeeding • 94.6% (574) reported infant receipt of any breast milk • 72.9% (443) reported initiating breastfeeding within the first hour of life • 7.1% (42) reported difficulties with infant feeding • Not enough breast milk most common challenge

  16. Preliminary Findings: ARV Results from Birth Visit • 93.6% (569) of infants were initiated on NVP prophylaxis • 74.7% (454) received NVP immediately after birth • Another 14.5% (88) received the NVP on day 1 of life • Dried blood spot (DBS) specimens were taken from 545 infants for HIV diagnosis

  17. Preliminary Findings: Infant Infections • Two HIV-infected infants • One confirmed at 6 weeks • One confirmed at 9 months • Maternal ARV regimen: TDF/3TC/EFV • Infant ARV regimen: ABC/3TC/Kaletra • Both children breastfeeding

  18. Preliminary Conclusions • To date, 2/608 (0.3%) of infants are HIV-infected • High rates of uptake and adherence to ART can be achieved with the implementation of Option B+, particularly in a setting with high rates of partner disclosure

  19. Next Steps • Continued data collection and ongoing analysis • ART Resistance sub-study • Testing of birth DBS specimens for children that test HIV-positive at any point after birth • Tentative plan to follow the cohort to 24 months of age (beyond the originally planned duration of 18 months) • HIV-positive women in the national PMTCT program are advised to stop breastfeeding at 18 months • Would allow assessment of adherence patterns after breastfeeding cessation, when ARVs may not be perceived as being protective to prevent HIV transmission to the child • Could examine stunting and diet to determine nutritional adequacy after breastfeeding cessation

  20. Thank you!

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