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-12-00024.
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-12-00024.
Presentation byMichelle Gill, MPH
Senior Research Associate at EGPAF Co-investigator on the Kabeho Study
Co-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
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 DiagramWomen 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 age 29 years (IQR 25-34)
Married or co-habitating 79.1% (481)
Median time women knew their HIV-positive status
38.0 months (IQR 4.7 – 83.5)
Disclosure to partner 81.7% (497)
HIV-positive father of the baby 50.3% (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 regimen 35.2% (214)Due to PMTCT during an earlier pregnancy
60.7% (130/214)
Median time on ART 13.4 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 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)
The Kabeho Study: Kigali Breastfeeding and Antiretroviral Assessment for the Elimination of HIV
Preliminary Findings: Birth Visit (n=608)
Stillbirth, or died immediately after birth 2.1% (13)
Live births 97.9% (595) Female 51.8% (308)Mature birth 98.0% (583)Mean infant birth weight (SD) 3230 grams (529)Congenital anomalies
Hydrocephalus-1Congenital Heart Disease-1Musculoskeletal anomaly-3 (all extra digits)Lingual frenulum-3 Imperforate anus -1
1.5% (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