Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program

Johns Hopkins University218 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

218

Conditions

HIV-infection/Aids Breast Feeding

Interventions

Family member / peer supportBEHAVIORAL

supplemental individualized counselling

Enhanced intervention with counselor supportBEHAVIORAL

"hands on" EBF demonstrations

standard of careBEHAVIORAL

one on one and in-group counselling

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Exclusive breastfeeding

proportion of women who report exclusive breastfeeding to six months

Time frame: six months

Data from ClinicalTrials.gov

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