Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program

Operational Research to Promote Breastfeeding Among HIV Infected Women Attending the Prevention of Mother to Child Transmission (PMTCT) Program in Mulago Hospital, Kampala, Uganda

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03069235

Acronym

EBF

Enrollment

218

Registered

2017-03-03

Start date

2012-02-08

Completion date

2013-11-30

Last updated

2017-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Feeding, HIV-infection/Aids

Keywords

HIV, Breast Feeding

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.

Interventions

BEHAVIORALFamily member / peer support

supplemental individualized counselling

BEHAVIORALEnhanced intervention with counselor support

hands on EBF demonstrations

BEHAVIORALstandard of care

one on one and in-group counselling

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Exclusive breastfeeding	six months	proportion of women who report exclusive breastfeeding to six months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026