Operational Research to Promote Breastfeeding Among HIV Infected Women Attending the Prevention of Mother to Child Transmission (PMTCT) Program in Mulago Hospital, Kampala, Uganda
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 218
- Primary Endpoint
- Exclusive breastfeeding
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- Not provided
Arms & Interventions
Standard of Care
group/individual counselling.
Intervention: standard of care (Behavioral)
Family member / peer support
Structured family member / peer support.
Intervention: Family member / peer support (Behavioral)
Special infant feeding counselor support
Enhanced intervention with counselor support
Intervention: Family member / peer support (Behavioral)
Special infant feeding counselor support
Enhanced intervention with counselor support
Intervention: Enhanced intervention with counselor support (Behavioral)
Outcomes
Primary Outcomes
Exclusive breastfeeding
Time Frame: six months
proportion of women who report exclusive breastfeeding to six months
Secondary Outcomes
No secondary outcomes reported