Objectives: We assessed the feasibility of an appropriately powered randomised trial by evaluating whether participants could be recruited and retained, and sought preliminary information on exclusive breastfeeding rates.
Setting: Primary healthcare facility, serving a rural community.
Participants: Women initiating breast feeding within 24 hours of giving birth, on antiretroviral treatment and aged ≥18 years.
Interventions: We randomised mother-infant pairs to receive weekly text messaging encouraging exclusive breast feeding plus in-person individual motivational interviews post partum at weeks 2, 6 and 10, or standard infant feeding counselling.
Outcome measures: The feasibility endpoints included number of participants who consented to participate and number with complete evaluation of infant feeding practices at study visits. Exploratory endpoints included number of participants who exclusively breast fed at 24 weeks post partum and number of participants adhering to study protocol.
Results: Of 123 mothers screened, 52 participants consented for 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 had 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, 4 completed the visit telephonically, 16 were lost to follow-up. Exclusive breastfeeding rate remained relatively high across both groups through week 24. The difference in exclusive breastfeeding rates between the intervention and control groups was minimal: rate difference 22.2% (95% CI -20.1% to 64.5%).
Conclusions: With a large eligible target population, recruitment targets could be achieved for a large trial. Strategies to retain participants, such as remote monitoring and in-person follow-up visits, will be essential.
Trial registration number: ClinicalTrials.gov Registry (NCT02949713) and Pan African Clinical Trial Registry (PACTR201611001855404).
Keywords: EPIDEMIOLOGY; Feasibility Studies; HIV & AIDS; PAEDIATRICS; PUBLIC HEALTH.
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