this study was made possible by the united states agency for international development and the...
TRANSCRIPT
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