Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program (EBF)

Johns Hopkins University

Status: Completed

Conditions: Breast Feeding; HIV-infection/Aids

Treatments: Behavioral: standard of care; Behavioral: Family member / peer support; Behavioral: Enhanced intervention with counselor support

Study type: Interventional

Funder types: Other

Identifiers

NCT03069235

NA_00050616

Details and patient eligibility

About

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.

Full 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.

Enrollment: 218 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 3 patient groups

Standard of Care

Active Comparator group

Description:

group/individual counselling.

Treatment:

Behavioral: standard of care

Family member / peer support

Experimental group

Description:

Structured family member / peer support.

Treatment:

Behavioral: Family member / peer support

Special infant feeding counselor support

Experimental group

Description:

Enhanced intervention with counselor support

Treatment:

Behavioral: Enhanced intervention with counselor support

Behavioral: Family member / peer support