*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.

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


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


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



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



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


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


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


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


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)


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)



(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)



(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)


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)


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


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


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


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


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


Thank you!

*kabeho is the word in kinyarwanda for wishing someone a long life

Documents

antiretroviral assessment

breastfeeding assessment

kigali antiretroviral

kigali breastfeeding

kabeho study copis

hivexposed children

cyprien baribwirathis

hivpositive pregnant