Friedland Barbara A, Gundacker Holly, Achilles Sharon L, Chen Beatrice A, Hoesley Craig, Richardson Barbra A, Kelly Clifton W, Piper Jeanna, Johnson Sherri, Devlin Brid, Steytler John, Kleinbeck Kyle, Dangi Bindi, Friend Chantél, Song Mei, Mensch Barbara, van der Straten Ariane, Jacobson Cindy, Hendrix Craig W, Brown Jill, Blithe Diana, Hiller Sharon L
Center for Biomedical Research, Population Council, New York, NY, United States of America.
Statistical Center for HIV/AIDS Research and Prevention (SCHARP), Fred Hutchinson Cancer Center, Seattle, Washington, United States of America.
PLoS One. 2025 Jan 14;20(1):e0312957. doi: 10.1371/journal.pone.0312957. eCollection 2025.
End-user feedback early in product development is important for optimizing multipurpose prevention technologies for HIV and pregnancy prevention. We evaluated the acceptability of the 90-day dapivirine levonorgestrel ring (DPV-LNG ring) used for 14 days compared to a dapivirine-only ring (DVR-200mg) in MTN-030/IPM 041 (n = 23), and when used for 90 days cyclically or continuously in MTN-044/IPM 053/CCN019 (n = 25). We enrolled healthy, non-pregnant, HIV-negative women aged 18-45 in Pittsburgh, PA and Birmingham, AL (MTN-030 only). Self-reports of vaginal bleeding and adherence (ring removals, expulsions) were collected via daily short message service. Acceptability data were recorded in face-to-face interviews at study exit. We assessed differences in acceptability by product characteristics and adherence; and associations between baseline characteristics/demographics, number of bleeding days, adherence, and overall acceptability. Most (21/23) women in the 14-day MTN-030 study and about half (13/25) in the 90-day MTN-044 study liked their assigned rings. In MTN-030 there were no significant associations between any variables and overall acceptability of either ring. In MTN-044, women who disliked the DPV-LNG ring had a significantly higher incidence of unanticipated vaginal bleeding, and reporting that vaginal bleeding changes were unacceptable than those who liked it. Although we found no overall association between adherence and acceptability, significantly more women who disliked (versus liked) the DPV-LNG ring reported expulsions during toileting. The DPV-LNG ring could meet the needs of women seeking simultaneous protection from HIV and unintended pregnancy. Addressing issues related to vaginal bleeding and expulsions early in product development will likely enhance acceptability of the DPV-LNG ring. Trial registration: Clinical Trial Registration: MTN-030/IPM 041: ClinicalTrials.gov NCT02855346; MTN-044/IPM 053/CCN019: ClinicalTrials.gov NCT03467347.
在产品开发早期收集终端用户反馈对于优化用于预防艾滋病毒和意外怀孕的多用途预防技术至关重要。在MTN - 030/IPM 041（n = 23）研究中，我们评估了使用14天的90天达匹韦林左炔诺孕酮环（DPV - LNG环）与仅含达匹韦林的环（DVR - 200mg）相比的可接受性；在MTN - 044/IPM 053/CCN019（n = 25）研究中，评估了其循环或连续使用90天的可接受性。我们在宾夕法尼亚州匹兹堡市和阿拉巴马州伯明翰市招募了年龄在18 - 45岁的健康、未怀孕、艾滋病毒阴性的女性（仅MTN - 030研究）。通过每日短信服务收集阴道出血和依从性（取环、环排出）的自我报告。在研究结束时通过面对面访谈记录可接受性数据。我们按产品特性和依从性评估可接受性的差异；以及基线特征/人口统计学、出血天数、依从性和总体可接受性之间的关联。在为期14天的MTN - 030研究中，大多数（21/23）女性喜欢她们分配到的环，在为期90天的MTN - 044研究中约一半（13/25）女性喜欢。在MTN - 030中，任何变量与两种环的总体可接受性之间均无显著关联。在MTN - 044中，不喜欢DPV - LNG环的女性意外阴道出血的发生率显著更高，并且报告阴道出血变化不可接受的比例高于喜欢该环的女性。尽管我们发现依从性与可接受性之间没有总体关联，但报告在排尿时环排出的不喜欢（与喜欢相比）DPV - LNG环的女性明显更多。DPV - LNG环可以满足寻求同时预防艾滋病毒和意外怀孕的女性的需求。在产品开发早期解决与阴道出血和环排出相关的问题可能会提高DPV - LNG环的可接受性。试验注册：临床试验注册：MTN - 030/IPM 041：ClinicalTrials.gov NCT02855346；MTN - 044/IPM 053/CCN019：ClinicalTrials.gov NCT03467347。
