P42.04
Background: Results from VOICE revealed that drug was detected in≤30% of plasma samples from women assigned to active arms. Since participants indicated≥90% of doses were taken, do self-reports on challenges to product use provide useful information on adherence? If so, when, during a trial, is it optimal to collect such information?
Methods: We investigate adherence challenges reported during and after VOICE among 72 active arm participants enrolled in MTN-003D, a qualitative study exploring aspects of the trial that affected product use. Responses to questions on challenges to use and reasons for non-use were compared:
1) at the first and last VOICE quarterly visits when participants reported on product adherence (PA);
2) at a Termination Visit interview (TV) conducted about 8 weeks after product use ended among 38 of the 72 participants still enrolled when the questionnaire was designed following early closure of two arms; and
3) during the 003D Stage 2 in-depth interviews (IDI), conducted about 1.5 years after the TV, where participants were informed about their drug detection pattern and classified into adherence groups.
Results: At the first PA 6 of 70 participants and, at the last PA, 4 of 68 indicated reasons they did not use product daily in the prior 4 weeks. At TV, 15 of 38 participants responded that they were not always adherent; on average 1.6 challenges were reported by these 15. During the IDIs after drug results were revealed to participants, 65 of 72 reported challenges; 38 listed 5+challenges. Among the 43 in the low adherence group, 4 reported no challenges; 26 reported 5+. Among the 20 in the high adherence group, 3 reported no challenges; 9 reported 5+.
Conclusions: VOICE participants were reluctant to disclose reasons for non-adherence when on product; after product use ended, willingness to report challenges increased slightly. Only when presented with drug detection patterns denoting whether product was taken, however, were participants forthcoming about the challenges they faced.
