Strengthening Informed Consent for Authentic Participation in Perinatal HIV Research

The overall goal of the study is to inform efforts to improve meaningful consent into clinical trials. The investigators are evaluating whether substituting a visual informed consent form (ICF) for the usual text-only ICF will increase potential participants' understanding of the risks and benefits of research and contribute to more informed participation.

This study is nested within a larger clinical trial of a nutrition intervention for infants underway in South Africa. For this larger trial, a visual ICF was developed that covers the identical content of a standard text-only ICF. For this sub-study (n=40), women who are considering enrollment into this larger study who agree to enroll in the sub-study, will be randomized to either receive the visual ICF or to receive the text-only ICF. Following the decision to either participate or not in the larger trial, women will be interviewed about their knowledge recall of the content of the ICF including concerning the trial goal, the voluntary nature of participation, potential benefits, potential risks, and randomization measured using a mix of true/false/uncertain and likert-type response options. Questions will also be asked about decision conflict, self-rated understanding, self-efficacy, and satisfaction with the informed consent process. Eight weeks later, at one of the follow-up visits in the larger trial, these questions will be repeated to determine knowledge retention and decision regret and trust in the study team. The evaluation includes both quantitative and qualitative data which will be analyzed using standard mixed methods analysis techniques.

In addition, an independent population of women from the same area with infants of the same age but who are not eligible for the larger trial will be enrolled (n=20). For this population, participating in the trial is a hypothetical situation and thus respondents have no direct connection with the study team and thus are less prone to positive bias in responses. Questions will be asked concerning opinions about the visual ICF using a semi-structured, qualitative, think-aloud approach.

Inclusion criteria

• Women ages 18-45 years of age
• Pregnant women or women that have recently given birth within the past 2-6 weeks

Exclusion criteria

• Unwilling to provide consent
• Severe maternal or infant illness (e.g. tuberculosis, major psychiatric or neurological conditions)
• Inability to communicate in one of the three languages (English, isiXhosa, or Afrikaans)