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Table 1 Comparison of the volunteer responses in the two case studies

From: Volunteer experiences and perceptions of the informed consent process: Lessons from two HIV clinical trials in Uganda

Findings

Trial One responses

Trial Two responses

Perceptions of trial objectives

Investigating how the body would react to the study vaccines and whether it would cause harm

What would happen to their health if they stopped taking septrin

Side effects reported

Only 3 of 13 reported side effects which were: a swollen hand, dizzy feeling on first day of vaccination, heart palpitation but not related to high blood pressure

Only one volunteer reported that she became frequently sick since joining the trial

Reasons for joining the trial

Hope to protect from HIV

Hope to get improved quality of life, help others in future to take less drugs

Reasons for continuing in trial

Avoid catching HIV which information is reinforced by the research team at the scheduled follow up visits

It is a strategy to cope with HIV

Why a volunteer would drop out of the trial

Loss of interest, no time to attend follow-up visits, difficult with finding money to travel to research clinic

Failure to get money to travel for clinic visit, discouragement from other members in the community

aWho was involved in decision making

The female volunteers had to inform and sometimes seek permission from spouses. A few female volunteers made their own decisions. The male volunteers only make their own decisions and informed spouses but were not obliged to.

Both male and female volunteers made their own decisions and usually they would not share with their partners

  1. aTrial One procedures required that a sexual partner was known and also tested for HIV; Trial Two volunteers were not obliged to bring their partners to the research clinic for HIV testing