Drawing blood from young children: lessons learned from a trial in Ghana
Sam Newton1, Victor Doku, Wenzel Geissler
1Kintampo Health Research Centre, P.O. Box 200, Kintampo, Ghana. samkofinewton@yahoo.com
Insights
Vitamin A supplementation trials in Ghana faced higher-than-expected participant dropouts due to blood draw concerns. Community engagement strategies helped reduce these losses, improving trial validity.
Area of Science:
- Clinical Trials
- Pediatric Health
- Immunology
Background:
- Assessing vitamin A supplementation's impact on pediatric immune responses to vaccines.
- Identifying challenges in conducting longitudinal studies involving blood draws in young children.
Purpose of the Study:
- To report on lessons learned from a trial in Ghana regarding participant retention.
- To analyze factors contributing to loss to follow-up in a pediatric vitamin A supplementation study.
Main Methods:
- A randomized trial in Ghana involving vitamin A supplementation and vaccine response assessment.
- Monitoring participant attrition rates at various study visits, distinguishing between visits with and without blood draws.
- Implementing community engagement strategies to address participant concerns.
Main Results:
- Higher losses to follow-up occurred during visits involving blood draws compared to those without.
- Initial recruitment targets were exceeded due to anticipated attrition, extending the recruitment period.
- Community meetings and allowing mothers to observe blood draws helped mitigate participant anxiety.
Conclusions:
- Participant concerns about blood draws significantly impacted retention in the Ghana trial.
- Proactive community engagement and transparent procedures are crucial for improving participant adherence in pediatric clinical trials.
- Addressing misconceptions surrounding study procedures is vital for ensuring trial validity and data integrity.
Abstract:
This paper reflects on lessons learned from a trial in Ghana assessing the impact of vitamin A supplementation on children's immune responses to tetanus and polio vaccines. There were more losses to follow-up than was anticipated at visits during which blood was drawn, owing to concerns or misconceptions about blood draw. The trial initially planned to recruit 960 children but had to recruit more because the proportion of infants lost to follow-up was greater than the anticipated 15%, resulting in a longer recruitment period. Of 1085 infants who were randomised into the trial, 767 (71%) completed follow-up at 6 months of age. It was notable that at the first (6 weeks) and fourth (6 months) visits at which blood was drawn, losses to follow-up were greater than at the second (10 weeks) and third (14 weeks) visits during which blood was not drawn. Losses to follow-up pose a threat to the validity of trials as there is a chance that those lost to follow-up may differ from those who remain in the trial. Monitoring losses to follow-up as they emerged and allowing mothers to witness the blood draw, as well as holding community meetings, helped to allay anxieties in the community.
