WEPEC494

Title

Provision of residual drug level results from the dapivirine ring open label extension study: Participant reactions and explanations during a qualitative ancillary study (MTN 032)

Presenter

Kalendri Naidoo

Authors

K. Naidoo¹, L.E. Mansoor¹, A.W.K. Katz², M. Garcia³, E.N. Browne², D. Kemigisha⁴, N.S. Morar⁵, C. Zimba⁶, M. Chitukuta⁷, K. Reddy⁸, L. Soto-Torres⁹, S. Naidoo⁵, E.T. Montgomery²

Institutions

¹Centre for the AIDS Programme of Research in South Africa, Durban, South Africa, ²RTI International, San Francisco, United States, ³FHI 360, Durham, United States, ⁴Makerere University - Johns Hopkins University Research Collaboration, Kampala, Uganda, ⁵South African Medical Research Council, Durban, South Africa, ⁶UNC Project Malawi, Lilongwe, Malawi, ⁷University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe, ⁸Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa, ⁹National Institute of Allergy and Infectious Diseases, Rockville, United States

Background: MTN-025/HOPE was an open label study of the dapivirine vaginal ring with 15 sites in sub-Saharan Africa. MTN-032/AHA, an ancillary follow-on study, retrospectively explored ring adherence during HOPE. Participants were presented with their residual drug level (RDL) results and their reactions and adherence challenges in response to these RDLs were discussed during in-depth interviews (IDI).
Methods: AHA randomly selected former HOPE participants at 6 sites. Ten participants per site were stratified by month-1 adherence data (low, middle, high; 1:3:1 ratio). IDIs explored ring experiences and challenges and included presentation of all monthly RDLs categorized from 0 (no use) to 3 (high use). Interviewers discussed the participants'' adherence challenges and responses to their RDLs and assessed whether they believed the RDLs matched their actual use throughout study participation and if they trusted the RDL testing methods. Interviewers quantitatively categorized RDL reactions on forms and summarized experiences in debrief reports. Analysts summarized qualitative data; quantitative data were tabulated using Stata.
Results: Sixty women were enrolled (age 23-48), with a median of 12 (62%; range 1-12) monthly RDL scores per participant. Most women (41/60; 68%) felt their RDLs did not match their ring use. On average, this group had varying RDLs, with majority < 3, but reported using the ring; 61% distrusted the test method. Their explanations for the discrepancy included: delays in monthly ring changes, bodies not absorbing dapivirine, blood type/stress limiting drug release, ring having less drug or not working, ring insertion errors, use of traditional medication, and faulty testing machines. Those who felt RDL matched their use (n=19) predominantly trusted the test method (95%). These participants were generally consistent users (RDLs ≥2), but occasionally described ring non-use because of menses, vaginal itching, pelvic pain, increased vaginal wetness, partner feeling the ring, partner objection, ring cleaning, and community myths.
Conclusions: Women in this study sample, with variable adherence levels, felt they were more consistent ring users than RDL signified. Understanding participants'' reported use beyond RDL scores provides insight into how the ring is understood to work and is incorporated into women''s lives, which will help facilitate successful real-world implementation of the ring.

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