Abstract

Reimbursement of participants in clinical trials is extensively debated. Guidance recommends that compensation should reflect time, inconvenience and reimbursement of expenses. This study describes how participants spend their reimbursement and perceptions of appropriate reimbursement amounts. This was a sub-study of the evidence for contraceptive options and HIV outcomes (ECHO) trial. Participants were from two sites in KwaZulu-Natal, South Africa. A mixed methods approach was used. 500 participants completed a questionnaire, and 32 participated in one of four focus group discussions (FGD). The majority (81%) used reimbursement for transport to the research site, followed by toiletry purchases (64%). Many described how reimbursement supplemented income, used to cover basic living costs. Some used money to buy luxury items and takeaway foods. The ideal reimbursement amount per visit ranged: ZAR150-ZAR340 (US$10–24). Reimbursement spending and perceptions are in line with local guidance. Reimbursement should consider risk minimization together with ensuring informed, voluntary decision making.

Highlights

  • The purpose of reimbursement in research and clinical trials is to compensate participants for their inconvenience and time as well as any expenses incurred, such as transport costs [1,2,3,4,5,6]

  • This research was a sub-study of the multi-center, openlabel, randomized clinical trial, comparing HIV incidence and contraceptive benefits in women using depot medroxyprogesterone acetate (DMPA-IM), levonorgestrel (LNG) implant, and copper intrauterine devices (IUDs), the evidence for contraceptive options and HIV outcomes (ECHO) trial [26]

  • Women aged 16–35 years were invited to enroll into the ECHO trial if they desired effective contraception and were willing to be randomised to any one of the three trial contraceptive methods approved for use in South Africa (DMPA-IM, LNG or IUD)

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Summary

Introduction

The purpose of reimbursement in research and clinical trials is to compensate participants for their inconvenience and time as well as any expenses incurred, such as transport costs [1,2,3,4,5,6]. Guidelines exist for reimbursement of trial participants [5, 7,8,9,10,11,12], acceptable reimbursement rates are under researched. There is a paucity of literature on how participants spend their reimbursement money. Reimbursement of participants in research and clinical trials is an extensively debated issue worldwide [3, 4, 6, 13,14,15,16]. Substantial reimbursement offers may be especially enticing to vulnerable groups who may disregard risks to their safety for

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