Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program

NCT ID: NCT03069235

Last Updated: 2017-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-08

Study Completion Date

2013-11-30

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.

Conditions

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HIV-infection/Aids Breast Feeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard of Care

group/individual counselling.

Group Type ACTIVE_COMPARATOR

standard of care

Intervention Type BEHAVIORAL

one on one and in-group counselling

Family member / peer support

Structured family member / peer support.

Group Type EXPERIMENTAL

Family member / peer support

Intervention Type BEHAVIORAL

supplemental individualized counselling

Special infant feeding counselor support

Enhanced intervention with counselor support

Group Type EXPERIMENTAL

Family member / peer support

Intervention Type BEHAVIORAL

supplemental individualized counselling

Enhanced intervention with counselor support

Intervention Type BEHAVIORAL

"hands on" EBF demonstrations

Interventions

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Family member / peer support

supplemental individualized counselling

Intervention Type BEHAVIORAL

Enhanced intervention with counselor support

"hands on" EBF demonstrations

Intervention Type BEHAVIORAL

standard of care

one on one and in-group counselling

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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MU-JHU CARE

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joyce Matovu, MA

Role: PRINCIPAL_INVESTIGATOR

MU-JHU CARE

Other Identifiers

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NA_00050616

Identifier Type: -

Identifier Source: org_study_id

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