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Completed

NCT Number: NCT03069235

Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program

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.

Completed

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family member / peer support

Behavioral

supplemental individualized counselling

Enhanced intervention with counselor support

Behavioral

"hands on" EBF demonstrations

Standard of Care

Behavioral

one on one and in-group counselling

Primary outcomes

  1. Exclusive breastfeeding

    Time frame: six months

    proportion of women who report exclusive breastfeeding to six months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • MU-JHU CARE

Registry information

Official study 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

Acronym: EBF

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 3, 2017
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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