Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program

Breast Feeding Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03069235
• Other study ID #: NA_00050616
• Status: Completed
• Phase: N/A
• First received: February 27, 2017
• Last updated: March 1, 2017
• Start date: February 8, 2012
• Est. completion date: November 30, 2013

Study information

• Verified date: March 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: November 30, 2013
• Est. primary completion date: November 30, 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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:

Related Conditions & MeSH terms

• Breast Feeding
• HIV Infections
• HIV-infection/Aids

Intervention

Behavioral:
• Family member / peer support
supplemental individualized counselling
• Enhanced intervention with counselor support
"hands on" EBF demonstrations
• standard of care
one on one and in-group counselling

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	MU-JHU CARE

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exclusive breastfeeding	proportion of women who report exclusive breastfeeding to six months	six months