Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program

Not Applicable

Completed

• Conditions: HIV-infection/Aids; Breast Feeding
• Interventions: Behavioral: Family member / peer support; Behavioral: standard of care; Behavioral: Enhanced intervention with counselor support

• Registration Number: NCT03069235
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2012-02-08
• Primary Completion: 2013-11-30
• Study Completion: 2013-11-30
• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-02-27
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-01
• Study First Posted: 2017-03-03
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 218

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Special infant feeding counselor support	Enhanced intervention with counselor support	Enhanced intervention with counselor support
Family member / peer support	Family member / peer support	Structured family member / peer support.
Standard of Care	standard of care	group/individual counselling.
Special infant feeding counselor support	Family member / peer support	Enhanced intervention with counselor support

Primary Outcome Measures

Name	Time	Method
Exclusive breastfeeding	six months	proportion of women who report exclusive breastfeeding to six months