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Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program (EBF)

Primary Purpose

HIV-infection/Aids, Breast Feeding

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Family member / peer support
Enhanced intervention with counselor support
standard of care
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for HIV-infection/Aids focused on measuring HIV, Breast Feeding

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • HIV-positive pregnant women in their late second or third trimester
  • On antiretroviral therapy (ARVs) for PMTCT or meets MOH guidelines for ARV therapy
  • Intention to breast feed
  • Willingness to deliver at Mulago Hospital
  • Living within Kampala and planning to stay within Kampala district for months after delivery
  • Willingness to participate during post partum period
  • Willingness to be home visited
  • Willingness and ability to bring a close family member of choice to the clinic, who is ≥ 18 years, who will be able to be in touch with the at least three times a week and to give support on EBF

Exclusion Criteria:

  • none

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Standard of Care

    Family member / peer support

    Special infant feeding counselor support

    Arm Description

    group/individual counselling.

    Structured family member / peer support.

    Enhanced intervention with counselor support

    Outcomes

    Primary Outcome Measures

    Exclusive breastfeeding
    proportion of women who report exclusive breastfeeding to six months

    Secondary Outcome Measures

    Full Information

    First Posted
    February 27, 2017
    Last Updated
    March 1, 2017
    Sponsor
    Johns Hopkins University
    Collaborators
    MU-JHU CARE
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03069235
    Brief Title
    Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program
    Acronym
    EBF
    Official Title
    Operational Research to Promote Breastfeeding Among HIV Infected Women Attending the Prevention of Mother to Child Transmission (PMTCT) Program in Mulago Hospital, Kampala, Uganda
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 8, 2012 (Actual)
    Primary Completion Date
    November 30, 2013 (Actual)
    Study Completion Date
    November 30, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    MU-JHU CARE

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study evaluates strategies aimed at promoting exclusive breast feeding for 6 months followed by continued breastfeeding for the next 6 months with introduction of complementary foods among HIV infected women in a resource limited setting.
    Detailed Description
    This is a single center, operational research study with two components. A formative component and randomized intervention trial. The study aims are to inform, promote and evaluate strategies aimed at promoting exclusive breast feeding for 6 months followed by continued breastfeeding for the next 6 months with introduction of complementary foods among HIV infected women in a resource limited settings. The primary objective of the qualitative formative research which includes Focus Group Discussions (FGD) and Key Informant Interviews (KII) is to explore factors affecting decisions on EBF and continued breastfeeding among HIV infected women. The primary objective for the Intervention phase is to compare either of two intervention strategies against the standard arm using Ministry of Health (MOH) messages aimed at promoting EBF for 6 month.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV-infection/Aids, Breast Feeding
    Keywords
    HIV, Breast Feeding

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    218 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Arm Description
    group/individual counselling.
    Arm Title
    Family member / peer support
    Arm Type
    Experimental
    Arm Description
    Structured family member / peer support.
    Arm Title
    Special infant feeding counselor support
    Arm Type
    Experimental
    Arm Description
    Enhanced intervention with counselor support
    Intervention Type
    Behavioral
    Intervention Name(s)
    Family member / peer support
    Intervention Description
    supplemental individualized counselling
    Intervention Type
    Behavioral
    Intervention Name(s)
    Enhanced intervention with counselor support
    Intervention Description
    "hands on" EBF demonstrations
    Intervention Type
    Behavioral
    Intervention Name(s)
    standard of care
    Intervention Description
    one on one and in-group counselling
    Primary Outcome Measure Information:
    Title
    Exclusive breastfeeding
    Description
    proportion of women who report exclusive breastfeeding to six months
    Time Frame
    six months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: HIV-positive pregnant women in their late second or third trimester On antiretroviral therapy (ARVs) for PMTCT or meets MOH guidelines for ARV therapy Intention to breast feed Willingness to deliver at Mulago Hospital Living within Kampala and planning to stay within Kampala district for months after delivery Willingness to participate during post partum period Willingness to be home visited Willingness and ability to bring a close family member of choice to the clinic, who is ≥ 18 years, who will be able to be in touch with the at least three times a week and to give support on EBF Exclusion Criteria: none
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joyce Matovu, MA
    Organizational Affiliation
    MU-JHU CARE
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program

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