P42.06
Background: Randomised controlled trials rely on effective preservation of the random allocation of interventions when tested against placebo for a robust outcome. Product sharing among participants can compromise the trial outcome. In resource poor settings, many participants attend study visits together, travel together and often are neighbours or live in the same household. In such circumstances product sharing poses a real concern. We describe incidents of product sharing across 7 clinical research sites in Durban conducting the VOICE trial and strategies implemented to avert such occurrences.
Methods: The Durban sites enrolled 2750 women with 1647 and 1103 participants randomised to the oral and gel arms respectively. Product use assessments were conducted at monthly visits. Product labels with unique identifiers and product codes were checked to verify return of correct products. Discrepancies prompted discussions with participants and strategies were developed by pharmacists. Monthly product use counselling with product sharing messaging was provided to participants.
Results: Thirty-two incidents of product sharing were identified: 18 incidents involved participants returning products not assigned to them and 14 incidents included product count discrepancies. Discussions with participants suggested that the main source of product sharing involved women residing in the same household with participants, 20/32 incidents (62.5%). Four participants also reported that visitors had access to their product. Topical gels were more commonly shared than oral tablets (72 % vs. 28 %). Investigations were done to rule out pharmacy dispensing errors. Counselling, tailored messaging and unique identifiers were used to address product use challenges.
Conclusions: In this trial, product sharing was common among women residing in the same household. Unique labelling of products helped avert repeat incidents of product sharing. For future trials, targeted counselling and unique product identification is recommended.
