Trial participants' understanding of randomization, double-blinding, and placebo use in low literacy populations: findings from a study conducted within a microbicide trial in Malawi.
Concerns have been raised about the limits of understanding of consent by clinical trial participants in developing countries. Consequently, this empirical study was conducted in Malawi to assess microbicide trial participants' understanding of randomization, double-blinding, and placebo use. The study used a combination of quantitative and qualitative methods, including structured questionnaire interviews with a random sample of 203 individual participants, four in-depth interviews with research nurses, and two focus group discussions with 18 study participants. Most respondents earned high scores on questions related to randomization (85%) and placebo use (72%), while a greater proportion of the same respondents obtained low scores on questions related to double-blinding (68%) and personal implications of the study procedures (63%). Overall, most respondents (61%; n = 124) obtained low scores on combined understanding of all the three concepts under study.
Medical Research Council of Zimbabwe, Harare, Zimbabwe pndexas@yahoo.com.
Paul
P
Ndebele
University of KwaZulu-Natal, Durban, South Africa.
Douglas
D
Wassenaar
University of Malawi, College of Medicine, Blantyre, Malawi.
Francis
F
Masiye
University of Zambia, Lusaka, Zambia.
Esther
E
Munalula-Nkandu
D000328:Adult; D000890:Anti-Infective Agents / Q000627:therapeutic use; D032882:Comprehension; D003906:Developing Countries; D004311:Double-Blind Method; D032984:Ethics, Research; D005260:Female; D015658:HIV Infections / Q000517:prevention & control; D006801:Humans; D007258:Informed Consent; D000067010:Literacy; D008295:Malawi; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000941:ethics*; D012107:Research Design; D012108:Research Personnel; D035842:Research Subjects; D011795:Surveys and Questionnaires; D035862:Vulnerable Populations; D055815:Young Adult
D000890:Anti-Infective Agents; D010919:Placebos
HIV prevention research; consent; developing countries; understanding