OA15.04
Background: In VOICE,≥50% of women assigned to daily active oral tablets or vaginal gel had undetectable drug in all plasma samples tested. MTN-003D is an ancillary study using in-depth interviews (IDI) and focus group discussions (FGD), together with disclosure of PK results, to explore participants' adherence challenges during VOICE.
Methods: We systematically recruited VOICE participants, with plasma samples tested (median=6 samples), and PK results defined as low (0%; N=85), inconsistent (>0% to<75%; N=26) or high (≥75%; N=20) based on frequency of drug detection. The PK results were disclosed one-on-one and initial reactions captured by interviewers. 72 IDI and 12 FGD were conducted and summarized in debriefing reports for rapid review of key findings. IDI participants also ranked 20 theme cards listing adherence challenges.
Results: There were 131 participants (32 South Africa, 48 Zimbabwe, 51 Uganda). The most common reaction to disclosed PK results, by group was: surprise (40%; low), acceptance (42%; inconsistent) and happiness (65%; high). While the majority accepted their PK results in Zimbabwe and South Africa, the opposite happened in Uganda. Nevertheless, even those disagreeing with results discussed adherence challenges. Those in the low/inconsistent groups described how they disposed of unused products. Preliminary findings indicate that most reported initiating use; however, low adherers later discontinued or poorly executed product use. Experienced/worried about side effects and products may be harmful were among the 3 top ranked adherence challenges in both the low and high PK groups. Not receiving enough support was ranked third in the low group; but much lower (11th) in the high group.
Conclusions: Provision of PK results seemingly promoted candid discussions around poor adherence and experience with products in VOICE. Detailed analyses of transcripts should clarify the meaning behind site differences in PK results' reactions, and adherence challenges reported by each PK groups.
