6.0 INTRODUCTION
In this chapter, findings from the main phase of the study are presented. The main phase of the study was aimed at assessing participants’ understanding of the study procedures of
randomisation, double-blinding and placebo use as well as the participants’ attitudes to these procedures. This phase was followed by the development and implementation of an
intervention aimed at improving understanding. The development and implementation of the intervention is reported in the Chapter 8.0.
This chapter is divided into two main sections. The first section presents findings related to the disclosure of information to the trial participants. Data for this section was mainly derived from document review and in-depth interviews with study staff involved in obtaining informed consent at the two sites. The second section deals with findings on participants’ levels of understanding. The second section is divided into sub-sections which include: general issues about the study, findings on understanding of randomisation, double-blinding and placebo use, and findings on understanding of personal implications of participation. For each of the three concepts under study, basic frequencies are presented. These are followed by cross-tabulations with some independent variables such as study site, age and level of education of the
respondents.
6.1 FINDINGS FROM DOCUMENT REVIEW
The following documents were reviewed at each site after obtaining permission from the site investigators:
• Study Protocol
• Informed consent forms
• Enrolment Informed Consent assessment Checklist
• Ongoing informed consent assessment checklist
• Informed consent Booklet
In the following sections, the review of each of the documents is provided. Each document was reviewed for purpose, area of strength and areas of inadequacy as related to the subject under study.
6.1.1 Study Protocol
The microbicide study protocol stated that written informed consent was to be obtained from each study participant prior to both screening and enrolment. Written informed consent was also to be obtained for long term specimen storage and possible future testing; however,
consent for specimen storage was not required for study participation. Study staff were required to document the informed consent process in accordance with the Standard Operating
Procedure (SOP) for Source Documentation. Participants were required to be provided with copies of the informed consent forms if they were willing to receive them. Each study site was responsible for translating template forms into local languages based on the templates that were provided by the study sponsor. Each site was also required to verify the accuracy of the
translation by performing an independent back-translation. At both sites, therefore, there were informed consent documents in both English and ChiChewa, and study participants were free to choose which they preferred.
The informed consent form for enrolment was supposed to describe the purpose of the study, the procedures to be followed, and the risks and benefits of participation, in accordance with US regulations 45 CFR 46 (US Department of Health and Human Services, 2009) since the study fell under the jurisdiction of the Food and Drugs Administration (FDA). In addition to the informed consent forms, local investigators were required to work with study staff and community representatives to develop locally-appropriate information materials about the study and a standardised approach to the informed consent process to be implemented at the study site. The process and materials were required to be pilot tested prior to study start-up to ensure cultural appropriateness at each site.
6.1.2 Informed Consent Forms
The informed consent document for both screening and enrolment covered all elements of informed consent required by US regulations according to 45 CFR 46 (US Department of Health and Human Services, 2009), including the following topics that were deemed to be important to this study:
• The unknown safety and unproven efficacy of the study products.
• The need to practice safer sex behaviours regardless of study treatment group.
• The importance of participants in all four study groups to the success of the study.
• The importance of adherence to the study visit and procedures schedule.
• The potential medical risks of study participation (and what do if such risks are experienced).
• The potential social harms associated with study participation (and what do if such harms are experienced).
• The real, yet limited, benefits of study participation.
• The distinction between research and clinical care.
• The right to withdraw from the study at any time.
The informed consent forms also included the following statements, some of which included some important parts that were emphasised in bold:
About benefits the informed consent forms stated:
You may get no direct benefit from being in this study. We do not know if BufferGel or PRO 2000 Gel work to protect against HIV.
About double-blinding, the informed consent forms stated:
You may be placed in a group that gets Buffergel, or PRO 2000 Gel or placebo gel. If you are placed in one of the gel groups, you will not know which gel you are getting.
Because of this, study staff will remind you of the importance of using condoms to protect against HIV.
About alternatives to participation, the forms stated:
There are no gels known to protect against HIV during sex. The only known way to protect against HIV during sex is to use a condom every time you have sex.
About risks of the study gels the form stated:
If you are in one of the study groups that will be using a gel, the gel could cause some bad effects. We do not yet know all the effects of the gels, but some women who used the gels in other studies have had:
• redness, itching, burning, dryness, or other irritation of the genital area and vagina
• genital soreness or pain
• genital blisters or sores
• genital bleeding
• increased vaginal fluids or discharge
• difficulty or pain when urinating
• abdominal pain
• nausea or feeling sick to your stomach
• diarrhea
You could have these effects or other effects that we do not know about. It is unlikely that the study gels will be absorbed from your vagina into your blood. If this happens, we do not know if it might cause bad effects.
If the study gels cause genital sores, this could increase your risk of getting HIV and other infections passed during sex. Because of this, study staff will remind you of the importance of using condoms to protect against HIV.