Improving participant understanding of informed consent in an HIV-prevention clinical trial: a comparison of methods.

Empirical research on informed consent has shown that study participants often do not fully understand consent information. This study assessed participant understanding of three mock consent approaches describing an HIV-prevention clinical trial in Lilongwe, Malawi prior to trial implementation. Pregnant women (n = 297) were systematically selected from antenatal-care waiting lines and sequentially allocated to receive an enhanced standard consent form (group 1), a context-specific consent form (group 2), or context-specific counseling cards (group 3).

Using formative research to develop a context-specific approach to informed consent for clinical trials.

PARTICIPANT UNDERSTANDING is of particular concern when obtaining informed consent. Recommendations for improving understanding include disclosing information using culturallyappropriate and innovative approaches. To increase the effectiveness of the consent process for a clinical trial in Malawi on interventions to prevent mother-tochild transmission of HIV during breastfeeding, formative research was conducted to explore the community's understanding of medical research as well as how to explain research through local terms and meanings.

Development of an interactive computer-assisted instruction (ICAI) program for patient prenatal genetic screening and carrier testing for use in clinical settings.

Educating patients on prenatal genetic screening and carrier testing in a timely and effective manner is faced with barriers including, providers' limited knowledge, and little time available to spend discussing screening and testing during a visit. This paper describes the use of cognitive response interviews (CRI) and usability testing (UT) in the development of an interactive computer assisted instruction (ICAI) program for use by prenatal patients in clinical settings. Lessons learned during the program development process included simplification of content and adaptation of navigational features in response to observations and interviews of a sample of patients representing the intended population.

Assessment of an interactive computer-based patient prenatal genetic screening and testing education tool.

The Enhancing Patient Prenatal Education study tested the feasibility and educational impact of an interactive program for patient prenatal genetic screening and testing education. Patients at two private practices and one public health clinic participated (N = 207). The program collected knowledge and measures of anxiety before and after use of the tool.

Racial differences in enrolment in a cancer genetics registry.

Background: Lower enrolment of minorities into research studies has been reported frequently. Most studies have little information about nonparticipants, making it difficult to identify characteristics associated with enrolment and how they might vary by race.

Methods: Women who had previously participated in a population-based, case-control study of breast cancer in North Carolina were invited to enroll in a cancer genetics registry.

Communication about carrier testing within hemophilia A families.

Genetic diseases are family diseases. Although there is considerable research on how individuals decide to have genetic testing and their individual reactions to testing, there is limited research on the familial context of genetic testing. In the present study, we focus on three aspects of the family context of genetic testing for hemophilia A carrier status among women at risk to be carriers.

Gender differences in psychosocial reactions to cystic fibrosis carrier testing.

Gender differences involving genetic testing have become a topic of research as feminist critiques assert that women may be affected differently, and possibly more significantly, than men by genetic carrier testing information. It is possible that men and women differ in their reactions to learning whether they are or are not a carrier of a specific mutation. It is also possible that men and women may differ in their reactions to different methods of genetic testing.