Impact of Partner-Related Social Harms on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III Trial

作者：Thesla Palanee‐Phillips, Sarah T. Roberts, Krishnaveni Reddy, Vaneshree Govender, Logashvari Naidoo, Samantha Siva, Zakir Gafoor, Arendevi Pather, Flavia Matovu Kiweewa, Kudzai Hlahla, Bonus Makanani, Gonasagrie Nair, Katie Schwartz, Kristine Torjesen, Elizabeth R. Brown, Lydia Soto‐Torres, Jared M. Baeten, Elizabeth Montgomery, on behalf of the MTN-020/ASPIRE Team · 发表于：JAIDS Journal of Acquired Immune Deficiency Syndromes · 年份：2018 · DOI：10.1097/qai.0000000000001866 · 被引用次数：44 · 研究领域：HIV/AIDS Research and Interventions、Adolescent Sexual and Reproductive Health、HIV, Drug Use, Sexual Risk

BACKGROUND: Long-acting female-initiated methods such as the dapivirine ring may give women greater agency in HIV-1 prevention. However, social harms, defined as nonmedical adverse consequences of study participation or dapivirine ring use, may reduce product adherence and consequently HIV-1 protection. METHODS: We assessed whether experiencing social harms from male partners was associated with lower adherence to the dapivirine ring in the MTN-020/ASPIRE trial. Reports of social harms were solicited quarterly. Low adherence was defined by plasma dapivirine levels ≤95 pg/mL or residual dapivirine levels in returned rings >23.5 mg. RESULTS: Among 2629 women enrolled in ASPIRE, 85 (3.2%) reported 87 social harms during a median follow-up of 1.6 years. Women were significantly more likely to have low adherence, measured by plasma dapivirine levels, at visits with a social harm in the past month than at visits where no social harm was reported (adjusted risk ratio 2.53, 95% confidence interval: 1.37 to 4.66, P = 0.003). There was no association for social harms reported ≥1 month prior, suggesting an acute, short-term effect. Women were significantly more likely to not return a ring at visits with a social harm reported (adjusted risk ratio 24.70, 95% confidence interval: 18.57 to 32.85, P < 0.001). In rings that were returned, social harms were not associated with residual dapivirine levels. CONCLUSIONS: Although social harms were uncommon (<5% of women with >1 year of use), part...