This study was made possible by the United States Agency for International Development and the generous support of the American people through USAID Cooperative Agreement No.AID-OAA-A 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

This study was made possible by the United States Agency for International Development and the generous support of the American people through USAID Cooperative Agreement No.AID-OAA-A Presentation by Michelle Gill, MPH Senior Research Associate at EGPAF Co-investigator on the Kabeho Study Co-PIs: Emily A. Bobrow, PhD, MPH Anita Asiimwe, MD, MPH Placidie 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

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV Primary Objective To determine the 18-month HIV-free survival in 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

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV 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

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV 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

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV 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

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV 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

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV 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

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV 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

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV Enrollment and Screening Flow Diagram Women recruited/screened (n=998) Women enrolled (n=608) Women currently in follow-up (n=550) Women ineligible (n=277) Women or their guardian declined to provide consent (n=113) Infant deaths (n=30) Consent withdraw (n=29) Total termination (n=58)

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV Preliminary Findings: Background on Kabeho Study Women (N=608) Median age29 years (IQR 25-34) Married or co-habitating79.1% (481) Median time women knew their HIV-positive status 38.0 months (IQR 4.7 – 83.5) Disclosure to partner81.7% (497) HIV-positive father of the baby50.3% (306)

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV Preliminary Findings: Background on Kabeho Study Women (N=608) Most common ARV regimen (TDF/3TC/EFV) 56.6% (344) Took previous ARV regimen35.2% (214) Due to PMTCT during an earlier pregnancy 60.7% (130/214) Median time on ART13.4 months (IQR 2.96 – 48.8) Median time on current ART regimen 9.2 months (IQR 2.3 – 34.8)

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV Preliminary Findings: Background on Kabeho Study Women (N=608) Side effects reported in the previous month17.3% 95% adherence, based on 3-day ART recall90.9% Viral Load (RNA-PCR) (n=606)  Undetectable (<20 copies/mL)52.1% (316)  <400 copies/ml79.3% (481)

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV Preliminary Findings: Birth Visit (n=608) Stillbirth, or died immediately after birth2.1% (13) Live births97.9% (595) Female51.8% (308) Mature birth98.0% (583) Mean infant birth weight (SD)3230 grams (529) Congenital anomalies Hydrocephalus-1 Congenital Heart Disease-1 Musculoskeletal anomaly-3 (all extra digits) Lingual frenulum-3 Imperforate anus % (9)

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV 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

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV 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

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV 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

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV 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

The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV 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

This study was made possible by the United States Agency for International Development and the generous support of the American people through USAID Cooperative Agreement No.AID-OAA-A Thank you!