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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Johns Hopkins University

Collaborator
MU-JHU CARE

Information provided by (Responsible Party)
Johns Hopkins University
ClinicalTrials.gov Identifier
NCT03069235

First received: February 27, 2017
Last updated: March 1, 2017
Last Verified: March 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention
HIV-infection/Aids
Breast Feeding

Behavioral : Family member / peer support
Behavioral : Enhanced intervention with counselor support
Behavioral : standard of care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures

  • Exclusive breastfeeding [ Time Frame: six months ]
    proportion of women who report exclusive breastfeeding to six months

Enrollment: 218
Study Start Date: February 8, 2012
Study Completion Date: November 30, 2013
Primary Completion Date: November 30, 2013 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Standard of Care
group/individual counselling.
Behavioral: standard of care

one on one and in-group counselling

Experimental: Family member / peer support
Structured family member / peer support.
Behavioral: Family member / peer support

supplemental individualized counselling

Experimental: Special infant feeding counselor support
Enhanced intervention with counselor support
Behavioral: Family member / peer support

supplemental individualized counselling

Behavioral: Enhanced intervention with counselor support

"hands on" EBF demonstrations

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.

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 50 Years  
Sexes Eligible for Study: Female  
Accepts Healthy Volunteers: No  

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:

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03069235

Sponsors and Collaborators

Johns Hopkins University
MU-JHU CARE

Investigators

Principal Investigator: Joyce Matovu, MA MU-JHU CARE
More Information

More Information


Responsible Party: Johns Hopkins University  
ClinicalTrials.gov Identifier: NCT03069235   History of Changes  
Other Study ID Numbers: NA_00050616  
Study First Received: February 27, 2017  
Last Updated: March 1, 2017  
Individual Participant Data    
Plan to Share IPD: No  

Studies a U.S. FDA-regulated Drug Product: No  
Studies a U.S. FDA-regulated Device Product: No  

Keywords provided by Johns Hopkins University:

HIV
Breast Feeding

Additional relevant MeSH terms:
HIV Infections

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.