Mother-to-child HIV TransmissionKabehoNCT02295800
The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV
An observational study of Mother-to-child HIV Transmission, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Rwanda.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Mother-to-child HIV Transmission
- What is being tested?
- Semi-structured interviews
- How many people
- 1,216 participants
- Where
- 1 siteRwanda
- Study dates
- Apr 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Women not willing to provide informed consent to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Mother-to-child HIV Transmission
- Being tested
- Standard of care, Semi-structured interviews
- Keywords
- HIV, PMTCT, Antenatal Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of careOther
Semi-structured interviewsOther
| Study group | Role | What they receive |
|---|---|---|
| Mothers | HIV Infected mothers Receives: Other: Standard of care; Other: Semi-structured interviews | |
| Infants | HIV exposed infants Receives: Other: Standard of care | |
| Healthcare workers | Facility based healthcare workers Receives: Other: Semi-structured interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
18 - 24 month HIV-free survival of children born to HIV-positive pregnant women
Measured: 18 - 24 months
Secondary outcomes (3)
HIV-exposed infants with stunting, underweight, or wasting Infants and young children breastfed (exclusive or any breastfeeding) at various ages
Measured: 18 - 24 months
Infants and young children breastfed (exclusive or any breastfeeding) at various ages
Measured: 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
Measured: 18 - 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study startApr 2013
- Primary completionMay 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mother-to-child HIV TransmissionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Rwanda, University of Rwanda
- Responsible party
- Sponsor
- Investigators
- Emily A. Bobrow, PhD, MPH, Principal investigator, Elizabeth Glaser Pediatric AIDS Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02295800
- Sponsor's protocol ID
- EG0098
- Acronym
- Kabeho
- Status last verified
- Sep 2026
- First submitted
- 15 Oct 2014
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV
- ClinicalTrials.gov ID
- NCT02295800
- Acronym / sponsor ID
- Kabeho / EG0098
- Conditions
- Mother-to-child HIV Transmission
- Keywords
- HIV, PMTCT, Antenatal Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,216 participants (actual)
- Lead sponsor
- Elizabeth Glaser Pediatric AIDS FoundationUniversity, hospital or other
- Collaborators
- Ministry of Health, Rwanda, University of Rwanda
- Study start
- Apr 2013 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mothers | – | Other: Standard of care, Other: Semi-structured interviewsHIV Infected mothers |
| Infants | – | Other: Standard of careHIV exposed infants |
| Healthcare workers | – | Other: Semi-structured interviewsFacility based healthcare workers |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (1 listed)
- Women not willing to provide informed consent to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care | Other | Infants, Mothers |
| Semi-structured interviews | Other | Healthcare workers, Mothers |
Primary outcome
18 - 24 month HIV-free survival of children born to HIV-positive pregnant women
Time frame: 18 - 24 months
3 secondary outcomes
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
Infants and young children breastfed (exclusive or any breastfeeding) at various ages
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily A. Bobrow, PhD, MPH principal investigator
Elizabeth Glaser Pediatric AIDS Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mother-to-child HIV Transmission, run by Elizabeth Glaser Pediatric AIDS Foundation at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18 - 24 month HIV-free survival of children born to HIV-positive pregnant women (time frame: 18 - 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.