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

January 2, 2018 updated by: Elizabeth Glaser Pediatric AIDS Foundation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1216

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
      • Kigali, Rwanda, BP 2788
        • Elizabeth Glaser Pediatric AIDS Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women identified as HIV infected during antenatal care and receiving PMTCT services (regardless of ARV regimen received) in the selected antenatal clinics in Kigali, Rwanda are eligible for study enrollment. The infants born to enrolled study women during the study pregnancy will also be study participants up to the age of 18 - 24 months.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Mothers
HIV Infected mothers
Other: Standard of care
Other: Semi-structured interviews
Infants
HIV exposed infants
Other: Standard of care
Healthcare workers
Facility based healthcare workers
Other: Semi-structured interviews

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
HIV-exposed infants with stunting, underweight, or wasting Infants and young children breastfed (exclusive or any breastfeeding) at various ages
Time Frame: 18 - 24 months
18 - 24 months
Infants and young children breastfed (exclusive or any breastfeeding) at various ages
Time Frame: 18 - 24 months
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
Time Frame: 18 - 24 months
18 - 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elizabeth Glaser Pediatric AIDS Foundation

Collaborators

University of Rwanda
Ministry of Health, Rwanda

Investigators

  • Principal Investigator: Emily A. Bobrow, PhD, MPH, Elizabeth Glaser Pediatric AIDS Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

November 17, 2014

First Posted (Estimate)

November 20, 2014

Study Record Updates

Last Update Posted (Actual)

January 4, 2018

Last Update Submitted That Met QC Criteria

January 2, 2018

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EGPAF0098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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