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

NCT ID: NCT02295800

Last Updated: 2018-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1216 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mother-to-child HIV Transmission

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mothers

HIV Infected mothers

Standard of care

Intervention Type OTHER

Semi-structured interviews

Intervention Type OTHER

Infants

HIV exposed infants

Standard of care

Intervention Type OTHER

Healthcare workers

Facility based healthcare workers

Semi-structured interviews

Intervention Type OTHER

Interventions

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Standard of care

Intervention Type OTHER

Semi-structured interviews

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Rwanda

OTHER_GOV

Sponsor Role collaborator

University of Rwanda

OTHER

Sponsor Role collaborator

Elizabeth Glaser Pediatric AIDS Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily A. Bobrow, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Elizabeth Glaser Pediatric AIDS Foundation

Locations

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Elizabeth Glaser Pediatric AIDS Foundation

Kigali, , Rwanda

Site Status

Countries

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Rwanda

Other Identifiers

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EGPAF0098

Identifier Type: -

Identifier Source: org_study_id

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