Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Feeding, HIV-infection/Aids

Intervention / Treatment
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* Behavioral: Family member / peer support
* Behavioral: Enhanced intervention with counselor support
* Behavioral: standard of care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>group/individual counselling. | Behavioral: standard of care<br>* one on one and in-group counselling<br>|
| Experimental: Family member / peer support<br>Structured family member / peer support. | Behavioral: Family member / peer support<br>* supplemental individualized counselling<br>|
| Experimental: Special infant feeding counselor support<br>Enhanced intervention with counselor support | Behavioral: Family member / peer support<br>* supplemental individualized counselling<br>Behavioral: Enhanced intervention with counselor support<br>* hands on EBF demonstrations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exclusive breastfeeding | proportion of women who report exclusive breastfeeding to six months | six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Breast Feeding