HIV-infection/AidsEBFNCT03069235
Promoting Exclusive Breastfeeding Among HIV Infected Women in a PMTCT Program
A study testing Family member / peer support and Enhanced intervention with counselor support in people with HIV-infection/Aids and Breast Feeding, run by Johns Hopkins University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- HIV-infection/Aids, Breast Feeding
- What is being tested?
- Family member / peer support and Enhanced intervention with counselor support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- 8 Feb 2012to 30 Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- none
About this study
Official title: Operational Research to Promote Breastfeeding Among HIV Infected Women Attending the Prevention of Mother to Child Transmission (PMTCT) Program in Mulago Hospital, Kampala, Uganda
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.
Read the 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.
- Conditions
- HIV-infection/Aids, Breast Feeding
- Being tested
- Family member / peer support, Enhanced intervention with counselor support, standard of care
- Keywords
- HIV, Breast Feeding
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family member / peer supportBehavioural
supplemental individualized counselling
Enhanced intervention with counselor supportBehavioural
"hands on" EBF demonstrations
standard of careBehavioural
one on one and in-group counselling
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | group/individual counselling. Receives: Behavioral: standard of care |
| Family member / peer support | Experimental | Structured family member / peer support. Receives: Behavioral: Family member / peer support |
| Special infant feeding counselor support | Experimental | Enhanced intervention with counselor support Receives: Behavioral: Family member / peer support; Behavioral: Enhanced intervention with counselor support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive breastfeeding
proportion of women who report exclusive breastfeeding to six months
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start8 Feb 2012
- Primary completion30 Nov 2013
- Study completion30 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infection/AidsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- MU-JHU CARE
- Responsible party
- Sponsor
- Investigators
- Joyce Matovu, MA, Principal investigator, MU-JHU CARE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069235
- Sponsor's protocol ID
- NA_00050616
- Acronym
- EBF
- Status last verified
- Mar 2017
- First submitted
- 27 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operational Research to Promote Breastfeeding Among HIV Infected Women Attending the Prevention of Mother to Child Transmission (PMTCT) Program in Mulago Hospital, Kampala, Uganda
- ClinicalTrials.gov ID
- NCT03069235
- Acronym / sponsor ID
- EBF / NA_00050616
- Conditions
- HIV-infection/Aids, Breast Feeding
- Keywords
- HIV, Breast Feeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- MU-JHU CARE
- Study start
- 8 Feb 2012 (actual)
- Primary completion
- 30 Nov 2013 (actual)
- Study completion
- 30 Nov 2013 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Behavioral: standard of caregroup/individual counselling. |
| Family member / peer support | Experimental | Behavioral: Family member / peer supportStructured family member / peer support. |
| Special infant feeding counselor support | Experimental | Behavioral: Family member / peer support, Behavioral: Enhanced intervention with counselor supportEnhanced intervention with counselor support |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family member / peer supportsupplemental individualized counselling | Behavioural | Family member / peer support, Special infant feeding counselor support |
| Enhanced intervention with counselor support"hands on" EBF demonstrations | Behavioural | Special infant feeding counselor support |
| standard of careone on one and in-group counselling | Behavioural | Standard of Care |
Primary outcome
Exclusive breastfeeding
Time frame: six months
proportion of women who report exclusive breastfeeding to six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Matovu, MA principal investigator
MU-JHU CARE
Questions about this trial
What is this clinical trial studying?
A study testing Family member / peer support and Enhanced intervention with counselor support in people with HIV-infection/Aids and Breast Feeding, run by Johns Hopkins University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exclusive breastfeeding (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017.