HIV Clinical Trial
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.
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.
Status | Completed |
Enrollment | 932 |
Est. completion date | August 2015 |
Est. primary completion date | August 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | University of KwaZulu-Natal | Durban | KwaZulu-Natal |
Lead Sponsor | Collaborator |
---|---|
PATH | University of KwaZulu |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
6 months postpartum | No |
Primary | 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. |
6 months postpartum | No |
Secondary | 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. |
6 weeks postpartum | No |
Secondary | 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. |
6 months postpartum | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06162897 -
Case Management Dyad
|
N/A | |
Completed |
NCT03999411 -
Smartphone Intervention for Smoking Cessation and Improving Adherence to Treatment Among HIV Patients
|
Phase 4 | |
Completed |
NCT02528773 -
Efficacy of ART to Interrupt HIV Transmission Networks
|
||
Active, not recruiting |
NCT05454839 -
Preferences for Services in a Patient's First Six Months on Antiretroviral Therapy for HIV in South Africa
|
||
Recruiting |
NCT05322629 -
Stepped Care to Optimize PrEP Effectiveness in Pregnant and Postpartum Women
|
N/A | |
Completed |
NCT02579135 -
Reducing HIV Risk Among Adolescents: Evaluating Project HEART
|
N/A | |
Active, not recruiting |
NCT01790373 -
Evaluating a Youth-Focused Economic Empowerment Approach to HIV Treatment Adherence
|
N/A | |
Not yet recruiting |
NCT06044792 -
The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH
|
||
Completed |
NCT04039217 -
Antiretroviral Therapy (ART) Persistence in Different Body Compartments in HIV Negative MSM
|
Phase 4 | |
Active, not recruiting |
NCT04519970 -
Clinical Opportunities and Management to Exploit Biktarvy as Asynchronous Connection Key (COMEBACK)
|
N/A | |
Completed |
NCT04124536 -
Combination Partner HIV Testing Strategies for HIV-positive and HIV-negative Pregnant Women
|
N/A | |
Recruiting |
NCT05599581 -
Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health
|
N/A | |
Active, not recruiting |
NCT04588883 -
Strengthening Families Living With HIV in Kenya
|
N/A | |
Completed |
NCT02758093 -
Speed of Processing Training in Adults With HIV
|
N/A | |
Completed |
NCT02500446 -
Dolutegravir Impact on Residual Replication
|
Phase 4 | |
Completed |
NCT03805451 -
Life Steps for PrEP for Youth
|
N/A | |
Active, not recruiting |
NCT03902431 -
Translating the ABCS Into HIV Care
|
N/A | |
Completed |
NCT00729391 -
Women-Focused HIV Prevention in the Western Cape
|
Phase 2/Phase 3 | |
Recruiting |
NCT05736588 -
Elimisha HPV (Human Papillomavirus)
|
N/A | |
Recruiting |
NCT03589040 -
Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant
|
Phase 2 |