Clinical trial NCT02162498: Study to Determine Impact of Feeding Buddies on Adherence to WHO PMTCT Guidelines in South Africa
Official title: Effect of Feeding Buddies on Adherence to WHO PMTCT Guidelines in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
PMTCT
Keywords: Peer support
Adherence
Exclusive breastfeeding
Early infant diagnosis
Stigma and disclosure
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: University of KwaZulu
First posted: 2014-06-12
Enrollment: 932
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: Inclusion criteria for pregnant women

* 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
* Intervention mothers only: Must have agreed to participate in the WinOp feeding buddies program, and identified and disclosed to a feeding buddy

Exclusion criteria for pregnant women

* 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

Inclusion criteria for buddies

* 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

Exclusion criteria for buddies

* 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

Primary outcomes:
measure: To determine the effect of a feeding buddy on adherence to exclusive breastfeeding.
timeFrame: 6 months postpartum
measure: To determine the effect of a feeding buddy on adherence to ARV prophylaxis or ART regimens.
timeFrame: 6 months postpartum
Secondary outcomes:
measure: To determine the effect of a feeding buddy on adherence to infant HIV testing at 6 weeks.
timeFrame: 6 weeks postpartum
measure: To determine the effect of a feeding buddy on disclosure and stigma.
timeFrame: 6 months postpartum
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: University of KwaZulu-Natal
state: KwaZulu-Natal
Study officials:
References:
citation: 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.