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

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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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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