How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania

Table 1 Comprehension and retention of key informed consent messages at 4, 24 and 52 weeks follow-up, MDP301 Trial, Mwanza¹

Message	N (%) of participants with accurate message retention at each visit				Chi square test for linear trend, 4 to 52 weeks (p-value)
	Wk 4 (n = 99)	Wk 24 (n = 83)	Wk 52 (n = 74)	All wks combined (N = 256)
Key message 1: Gel may not protect her from HIV	76 (76.8%)	59 (71.1%)	62 (83.8%)	197 (77.0%)	0.90 (p = 0.341)
Key message 2: Condoms will protect her from HIV	82 (82.8%)	69 (83.1%)	59 (79.7%)	210 (82.0%)	0.25 (p = 0.619)
Key message 3: She will have to stop using gel if she becomes pregnant	92 (92.9%)	78 (94.0%)	69 (93.3%) ^§	239 (93.3%)	0.19 (p = 0.665)

¹A single researcher made an assessment of message retention at each time point; it was therefore not possible to calculate a Kappa statistic for concordance
^§ There was one missing value at wk 52

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