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

Study Overview
=================
Brief Summary
-----------------
The study design includes an observational prospective cohort of HIV-positive pregnant/postpartum women and their infants enrolled during antenatal clinics (or immediately postpartum) from prevention of mother-to-child transmission (PMTCT) programs and followed until the infants reach the age of 18 - 24 months and semi-structure interviews with a sub-set of these women. A second study component involves semi-structured interviews with health care workers (HCW) involved in the PMTCT programs and yearly facility surveys at the selected study facilities.

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

Conditions
-----------------
Mother-to-child HIV Transmission

Intervention / Treatment
-----------------
* Other: Standard of care
* Other: Semi-structured interviews


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented HIV infection Pregnant, in the last trimester of pregnancy or within two weeks post-delivery. Participation in the PMTCT program during antenatal care at one of the study sites Planning on remaining in the Kigali area after delivery Able and willing to give informed consent for study participation for herself and her infant(s). If a pregnant woman is less than 18 years of age and still living with her parents, informed consent will also be required from one of her parents Exclusion Criteria: Women not willing to provide informed consent to participate
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mothers<br>HIV Infected mothers | Other: Standard of care<br> <br> Other: Semi-structured interviews<br> <br> |
| Infants<br>HIV exposed infants | Other: Standard of care<br> <br> |
| Healthcare workers<br>Facility based healthcare workers | Other: Semi-structured interviews<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 18 - 24 month HIV-free survival of children born to HIV-positive pregnant women |  | 18 - 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV-exposed infants with stunting, underweight, or wasting Infants and young children breastfed (exclusive or any breastfeeding) at various ages |  | 18 - 24 months | 
| Infants and young children breastfed (exclusive or any breastfeeding) at various ages |  | 18 - 24 months | 
| Adherence to the universal antiretroviral therapy (ARV) regimen among pregnant and postpartum women (Option B+) and their HIV-exposed children, including the proportion of study women with HIV RNA < 1000 copies/ml or > 2 log10 copies/mL decrease in viral |  | 18 - 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, PMTCT, Antenatal Care