HIVNCT02162498
Study to Determine Impact of Feeding Buddies on Adherence to WHO PMTCT Guidelines in South Africa
A study testing Feeding buddies in people with HIV and PMTCT, run by PATH at 1 site in South Africa.
Trial summary
The 2010 revised WHO recommendations to provide antiretroviral (ARV) prophylaxis or treatment to mothers or infants during the breastfeeding period indicate a paradigm shift in prevention of mother-to-child transmission (PMTCT); care; and treatment programming. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Feeding buddies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 932 participants
- Where
- 1 siteSouth Africa
- Study dates
- Aug 2013to Aug 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women 18 years of age or older and attending one of the study clinics and enrolled in the national PMTCT program
- Women must be least 14 but not more than 28 weeks pregnant (defined using the date of the last menstrual period and clinical examination)
- They must have a documented HIV infection
- Have indicated their intention to deliver and remain within the study area for at least 6 months following the birth of their infant
- Committed to exclusively breastfeed
- Provide written informed consent
Show all 9Show fewer
- Intervention mothers only: Must have agreed to participate in the WinOp feeding buddies program, and identified and disclosed to a feeding buddy
- Participants will include people of any gender who are 18 years of age or older, who the mother has selected - HIV status will not be an inclusion criteria for this feeding buddy.
- Provide written informed consent
Who cannot join
- Women will be excluded from the study if they do not attend a study clinic
- If they are more than 28 weeks pregnant before enrollment
- If they indicate their intention to deliver or have postnatal visits outside the study area
- Intend to formula or mixed feed their infant
- Any participant that is seriously ill will be excluded from the study and referred for services and support
- Intervention mothers only: Not participating in the WinOp feeding buddies program
Show all 14Show fewer
- Potential participants will be excluded who are under the age of 18. HIV status is not an exclusion criteria for the feeding buddy.
- Any participant that is seriously ill will be excluded from the study and referred for services and support
- Inclusion criteria for community care givers and PMTCT counselors (in-depth interviews only)
- Participants will include people of any gender who are 18 years of age or older, who serve as a community care giver or PMTCT counselor in the study sites.
- Provide written informed consent
- Exclusion criteria for community care givers and PMTCT counselors (in-depth interviews only)
- Potential participants will be excluded who are under the age of 18 and who do not serve as a community care giver or PMTCT counselor in a study site.
- Any participant that is seriously ill will be excluded from the study and referred for services and support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Feeding Buddies on Adherence to WHO PMTCT Guidelines in South Africa
The 2010 revised WHO recommendations to provide antiretroviral (ARV) prophylaxis or treatment to mothers or infants during the breastfeeding period indicate a paradigm shift in prevention of mother-to-child transmission (PMTCT); care; and treatment programming. Yet despite South Africa's adoption of this guidance, myriad challenges currently exist. Confusion in the public health care system related to mixed messaging around safe infant feeding and the provision of-and now withdrawal of-free formula milk have made adherence to exclusive breastfeeding a challenge in South Africa. Cultural, social, and psychological factors influence the ability of women to follow PMTCT guidelines, which include exclusive breastfeeding for six months, adherence to ARV prophylaxis or treatment, and early infant diagnosis. Facility-based interventions alone are often inadequate to effect sustained behavioral changes in the face of multiple contextual factors. Community- and home-based support are needed, yet cost and systems constraints make these infeasible in many PMTCT programs. Some preliminary pilot data suggests that a feeding buddy strategy could fill this gap and provide a home-based support system for the mother. The feeding buddy, who is selected by an HIV-positive pregnant woman to support her in overcoming sociocultural challenges to adhering to various aspects of PMTCT programs, is not an employed health care worker, but rather an individual known to the mother, making the intervention extremely cost-effective, and requiring minimal resources to implement. In the Uthungulu District of KZN the Programme for Appropriate Technologies in Health (PATH) is implementing a programme (Window of Opportunity-WinOp) of improving health of mothers and infants, and the feeding buddy strategy is one of the strategies included in this overall package of care. While this strategy has been encouraged by the South African Department of Health, it has not previously been implemented nor obviously evaluated. In order to scale-up such a programme and justify the human resource costs, it is vital that such a programme be evaluated.
The goal of this proposed research study is therefore to evaluate the effect of the feeding buddy strategy to support mothers to adhere to PMTCT recommendations.
Read more
The investigators hypothesize that mothers who choose a feeding buddy will have increased rates of exclusive breastfeeding and adherence to ARV prophylaxis or treatment, as well as improved rates of early infant diagnosis and stigma reduction.
This evaluation will provide valuable information to the Department of Health in terms of choosing best practice models for promoting HIV-free infant survival and optimum health of infants in resource limited settings. The project plans to employ a cluster randomized intervention design and will include 300 mothers and their infants as well as the 300 buddies in the intervention group, as well as 300 mothers in the control group. All participants will be part of the WinOp feeding buddy intervention programme.
- Being tested
- Feeding buddies
- Keywords
- Peer support, Adherence, Exclusive breastfeeding, Early infant diagnosis, Stigma and disclosure
- Medical subject headings
- Breast Feeding, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding buddiesBehavioural
The Window of Opportunity program is implementing feeding buddies within their comprehensive programming. Their feeding buddies intervention targets all mothers at ANC for promoting health behaviors, especially exclusive breastfeeding.
The NIH study is an implementation science award to evaluate the feeding buddies intervention, specifically among HIV positive recipients and evaluating the outcome of adherence to PMTCT recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Feeding buddies intervention | Experimental | Sites receiving a comprehensive feeding buddy program implemented by the Window of Opportunity program. Receives: Behavioral: Feeding buddies |
| Standard of care | No intervention | Sites from Window of Opportunity program who are not yet receiving the comprehensive feeding buddies program and are only receiving standard of care PMTCT support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of a feeding buddy on adherence to exclusive breastfeeding.
We hypothesize that mothers who choose a feeding buddy to provide enhanced support will have increased rates of initiation and duration of exclusive breastfeeding.
Exclusive breastfeeding: Defined as no other food or drink, not even water, apart from breast milk (including expressed breast milk) with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines (WHO/UNICEF. Infant and young child feeding counselling: an integrated course. Geneva: World Health Organization; 2006), measured by recall prior to each visit; from this aggregate data number of months engaged in EBF will be calculated.
Measured: 6 months postpartum
To determine the effect of a feeding buddy on adherence to ARV prophylaxis or ART regimens.
We hypothesize that mothers who choose a feeding buddy to provide enhanced support will have increased rates of adherence to ARV prophylaxis or ART regimens.
Adherence to ARV: Three separate outcomes will be examined, including adherence to:
- ARV prophylaxis to prevent MTCT among HIV+ mothers who do not have indications for ARV treatment
- ARV treatment of HIV+ mothers when indicated for their own health
- ARV prophylaxis of infant
Adherence to ARV in each case defined as taking more than 95% of prescribed doses.71 Adherence will be assessed through:
- Medical records at each clinic visit (e.g., pill counts) \&
- Self-report at study visits Dose adherence is measured as number of prescribed doses per drug per day divided by the self-reported number of missed doses on each of the past four days. In addition, an adherence index 71 is based on dosing, timing and special instructions questions.
Measured: 6 months postpartum
Secondary outcomes (2)
To determine the effect of a feeding buddy on adherence to infant HIV testing at 6 weeks.
We hypothesize that mothers who choose a feeding buddy to provide enhanced support will have increased rates of having their infant tested for HIV at 6 weeks.
Early infant HIV diagnosis: This will be examined through date of infant HIV PCR test as indicated through recall and medical record.
Measured: 6 weeks postpartum
To determine the effect of a feeding buddy on disclosure and stigma.
We hypothesize that mothers who choose a feeding buddy will have increased rates of disclosure and decreased effect from stigma around HIV status.
Impact on stigma and disclosure: This will be measured through descriptive analysis of perceived and enacted stigma associated with being HIV.
Exposure: The exposure of interest is choosing a feeding buddy and level of exposure to the feeding buddy, the latter providing a dose-response measure of support. Exposure will be measured as having selected a buddy who has attended an orientation session (yes/no); number of visits to antenatal and postnatal visits accompanied by the feeding buddy; and the number, frequency, and type (in-person, telephone) of contacts between mother and buddy.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 932 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- University of KwaZulu
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162498
- Sponsor's protocol ID
- 5R01HD075090-02
- Status last verified
- Aug 2015
- First submitted
- 10 Jun 2014
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Gavine A, Shinwell SC, Buchanan P, Farre A, Wade A, Lynn F, Marshall J, Cumming SE, Dare S, McFadden A. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2022 Oct 25;10(10):CD001141. doi: 10.1002/14651858.CD001141.pub6.
PubMed 36282618
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Feeding Buddies on Adherence to WHO PMTCT Guidelines in South Africa
- ClinicalTrials.gov ID
- NCT02162498
- Acronym / sponsor ID
- 5R01HD075090-02
- Keywords
- Peer support, Adherence, Exclusive breastfeeding, Early infant diagnosis, Stigma and disclosure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 932 participants (estimated)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- University of KwaZulu
- Study start
- Aug 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 12 Jun 2014 (estimated)
- 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.
The 2010 revised WHO recommendations to provide antiretroviral (ARV) prophylaxis or treatment to mothers or infants during the breastfeeding period indicate a paradigm shift in prevention of mother-to-child transmission (PMTCT); care; and treatment programming. Yet despite South Africa's adoption of this guidance, myriad challenges currently exist. Confusion in the public health care system related to mixed messaging around safe infant feeding and the provision of-and now withdrawal of-free formula milk have made adherence to exclusive breastfeeding a challenge in South Africa. Cultural, social, and psychological factors influence the ability of women to follow PMTCT guidelines, which include exclusive breastfeeding for six months, adherence to ARV prophylaxis or treatment, and early infant diagnosis. Facility-based interventions alone are often inadequate to effect sustained behavioral changes in the face of multiple contextual factors. Community- and home-based support are needed, yet cost and systems constraints make these infeasible in many PMTCT programs. Some preliminary pilot data suggests that a feeding buddy strategy could fill this gap and provide a home-based support system for the mother. The feeding buddy, who is selected by an HIV-positive pregnant woman to support her in overcoming sociocultural challenges to adhering to various aspects of PMTCT programs, is not an employed health care worker, but rather an individual known to the mother, making the intervention extremely cost-effective, and requiring minimal resources to implement. In the Uthungulu District of KZN the Programme for Appropriate Technologies in Health (PATH) is implementing a programme (Window of Opportunity-WinOp) of improving health of mothers and infants, and the feeding buddy strategy is one of the strategies included in this overall package of care. While this strategy has been encouraged by the South African Department of Health, it has not previously been implemented nor obviously evaluated. In order to scale-up such a programme and justify the human resource costs, it is vital that such a programme be evaluated.
The goal of this proposed research study is therefore to evaluate the effect of the feeding buddy strategy to support mothers to adhere to PMTCT recommendations.
The investigators hypothesize that mothers who choose a feeding buddy will have increased rates of exclusive breastfeeding and adherence to ARV prophylaxis or treatment, as well as improved rates of early infant diagnosis and stigma reduction.
This evaluation will provide valuable information to the Department of Health in terms of choosing best practice models for promoting HIV-free infant survival and optimum health of infants in resource limited settings. The project plans to employ a cluster randomized intervention design and will include 300 mothers and their infants as well as the 300 buddies in the intervention group, as well as 300 mothers in the control group. All participants will be part of the WinOp feeding buddy intervention programme.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feeding buddies intervention | Experimental | Behavioral: Feeding buddiesSites receiving a comprehensive feeding buddy program implemented by the Window of Opportunity program. |
| Standard of care | No intervention | –Sites from Window of Opportunity program who are not yet receiving the comprehensive feeding buddies program and are only receiving standard of care PMTCT support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pregnant women 18 years of age or older and attending one of the study clinics and enrolled in the national PMTCT program
- Women must be least 14 but not more than 28 weeks pregnant (defined using the date of the last menstrual period and clinical examination)
- They must have a documented HIV infection
- Have indicated their intention to deliver and remain within the study area for at least 6 months following the birth of their infant
- Committed to exclusively breastfeed
Key exclusion criteria (14 listed)
- Women will be excluded from the study if they do not attend a study clinic
- If they are more than 28 weeks pregnant before enrollment
- If they indicate their intention to deliver or have postnatal visits outside the study area
- Intend to formula or mixed feed their infant
- Any participant that is seriously ill will be excluded from the study and referred for services and support
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 |
|---|---|---|
| Feeding buddiesThe Window of Opportunity program is implementing feeding buddies within their comprehensive programming. Their feeding buddies intervention targets all mothers at ANC for promoting health behaviors, especially exclusive breastfeeding. The NIH study is an implementation science award to evaluate the feeding buddies intervention, specifically among HIV positive recipients and evaluating the outcome of adherence to PMTCT recommendations. | Behavioural | Feeding buddies intervention |
Primary outcome
To determine the effect of a feeding buddy on adherence to exclusive breastfeeding.
Time frame: 6 months postpartum
We hypothesize that mothers who choose a feeding buddy to provide enhanced support will have increased rates of initiation and duration of exclusive breastfeeding. Exclusive breastfeeding: Defined as no other food or drink, not even water, apart from breast milk (including expressed breast milk) with the exception of drops or syrups consisting of vitamins, mineral supplements or medicines (WHO/UNICEF. Infant and young child feeding counselling: an integrated course. Geneva: World Health Organization; 2006), measured by recall prior to each visit; from this aggregate data number of months engaged in EBF will be calculated.
To determine the effect of a feeding buddy on adherence to ARV prophylaxis or ART regimens.
Time frame: 6 months postpartum
We hypothesize that mothers who choose a feeding buddy to provide enhanced support will have increased rates of adherence to ARV prophylaxis or ART regimens. Adherence to ARV: Three separate outcomes will be examined, including adherence to: 1. ARV prophylaxis to prevent MTCT among HIV+ mothers who do not have indications for ARV treatment 2. ARV treatment of HIV+ mothers when indicated for their own health 3. ARV prophylaxis of infant Adherence to ARV in each case defined as taking more than 95% of prescribed doses.71 Adherence will be assessed through: 1. Medical records at each clinic visit (e.g., pill counts) \& 2. Self-report at study visits Dose adherence is measured as number of prescribed doses per drug per day divided by the self-reported number of missed doses on each of the past four days. In addition, an adherence index 71 is based on dosing, timing and special instructions questions.
2 secondary outcomes
To determine the effect of a feeding buddy on adherence to infant HIV testing at 6 weeks.
Time frame: 6 weeks postpartum
To determine the effect of a feeding buddy on disclosure and stigma.
Time frame: 6 months postpartum
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 21 Oct 2015.
- Derived from this study: PubMed 36282618Gavine A, Shinwell SC, Buchanan P, Farre A, Wade A, Lynn F, Marshall J, Cumming SE, Dare S, McFadden A. Support for healthy breastfeeding mothers with healthy term babies. Cochrane Database Syst Rev. 2022 Oct 25;10(10):CD001141. doi: 10.1002/14651858.CD001141.pub6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding buddies in people with HIV and PMTCT, run by PATH at 1 site in South Africa.
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 9 inclusion and 14 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 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
To determine the effect of a feeding buddy on adherence to exclusive breastfeeding. (time frame: 6 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02162498, which also lists 1 linked publication.
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 21 Oct 2015; AzTrials last refreshed its copy on 7 Nov 2026.