Background
In 2011, South Africa changed infant feeding guidelines for women with HIV from government-supplied formula feeding to exclusive breastfeeding for six months and continued breastfeeding for two years or longer. With only 8% of infants under 6 months of age being breastfed, interventions are required to improve breastfeeding rates. We assessed whether an appropriately powered randomized trial was feasible regarding i) recruitment and retention, and ii) protocol adherence. We explored the potential effects of the intervention on sustaining exclusive breastfeeding at 24 weeks postpartum.
Methods
We conducted a randomized parallel, two arm feasibility trial. Women were included if they initiated breastfeeding within 24 hours of giving birth at the Worcester midwife obstetric unit, on antiretroviral treatment, and aged ≥18 years. We randomly assigned mother-infant pairs to receive weekly text messaging encouraging exclusive breastfeeding plus in-person individual motivational interviews postpartum at weeks 2, 6, and 10 at Family Clinical Research with Ubuntu or standard infant feeding counselling during routine postnatal clinic visits.
Results
Of 123 mothers consented for screening, 52 eligible participants consented for study participation. We recruited an average of five participants per month over 11 months. Most participants were unemployed (75%), had some high school education (84%), and disclosed their HIV status to someone close (88%). About 65% participants completed outcome evaluation at week 10, decreasing to 35% at week 24. Twenty participants had the week 24 visit planned between 20 March and August 2020, during COVID-19 lockdown. Of these, four completed the visit telephonically, 16 were lost to follow up. Exclusive breastfeeding rate remained relatively high across both groups through week 24. Although the intervention group had higher rates of exclusive breastfeeding at week 24 than the control group this difference was minimal; rate difference 22.2% [95% confidence interval (CI) -20.1% to 64.5%].
Conclusions
With a large enough eligible target population recruitment targets could be achieved for the large randomized trial. Strategies to retain participants, such as remote monitoring in addition to in-person follow-up visits, will be essential.
Trial registration: The trial was registered on ClinicalTrials.gov on 31/10/2016; NCT02949713 and on Pan African Clinical Trial Registry on 08/11/2016; PACTR201611001855404.