ClinicalTrials.gg
CompletedNCT02295800KabehoUpdated Sep 10, 2026

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

An observational study in Mother-to-child HIV Transmission, sponsored by Elizabeth Glaser Pediatric AIDS Foundation. Completed at 1 site in Rwanda. Open to female participants. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Elizabeth Glaser Pediatric AIDS Foundation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,216
Sex
Female
01

Study 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.

02

Conditions studied

  • Mother-to-child HIV Transmission

Keywords

  • HIV
  • PMTCT
  • Antenatal Care
03

In context

Lead sponsor

Elizabeth Glaser Pediatric AIDS Foundation is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Documented 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 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

Exclusion Criteria:

  • Women not willing to provide to participate
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,216 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

Interventions

  • OtherStandard of care
  • OtherSemi-structured interviews
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What researchers measure

Primary outcomes

  1. 18 - 24 month HIV-free survival of children born to HIV-positive pregnant women

    Time frame: 18 - 24 months

Secondary outcomes

  1. 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

  2. Infants and young children breastfed (exclusive or any breastfeeding) at various ages

    Time frame: 18 - 24 months

  3. 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

07

Study locations

1 site
  • Elizabeth Glaser Pediatric AIDS Foundation
    Kigali, BP 2788, Rwanda
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2013 to primary completion in May 2016, 37 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 15, 2014
First posted
Nov 20, 2014
StartActual
Apr 2013
Primary completionActual
May 2016
CompletionActual
Dec 2016
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02295800
Lead sponsor
Elizabeth Glaser Pediatric AIDS Foundation
Collaborators
Ministry of Health, Rwanda, University of Rwanda
Responsible party
Sponsor
First posted
Nov 20, 2014
Start date
Apr 2013
Primary completion
May 2016
Completion
Dec 2016
Last update
Sep 10, 2026

Study contacts

Emily A. Bobrow, PhD, MPH
principal investigator · Elizabeth Glaser Pediatric AIDS Foundation

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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