NCT03069235

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
218

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
Last Updated

March 3, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

February 27, 2017

Last Update Submit

March 1, 2017

Conditions

HIV-infection/AidsBreast Feeding

Keywords

HIVBreast Feeding

Outcome Measures

Primary Outcomes (1)

  • Exclusive breastfeeding

    proportion of women who report exclusive breastfeeding to six months

    six months

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

group/individual counselling.

Behavioral: standard of care

Family member / peer support

EXPERIMENTAL

Structured family member / peer support.

Behavioral: Family member / peer support

Special infant feeding counselor support

EXPERIMENTAL

Enhanced intervention with counselor support

Behavioral: Family member / peer supportBehavioral: Enhanced intervention with counselor support

Interventions

Family member / peer supportBEHAVIORAL

supplemental individualized counselling

Family member / peer supportSpecial infant feeding counselor support
Enhanced intervention with counselor supportBEHAVIORAL

"hands on" EBF demonstrations

Special infant feeding counselor support
standard of careBEHAVIORAL

one on one and in-group counselling

Standard of Care

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeBreast Feeding

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Joyce Matovu, MA

    MU-JHU CARE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 3, 2017

Study Start

February 8, 2012

Primary Completion

November 30, 2013

Study Completion

November 30, 2013

Last Updated

March 3, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share