McLellan-Lemal Eleanor, Gvetadze Roman, Desai Mitesh A, Makanga Esther M, Pan Yi, Haaland Richard E, Holder Angela N, Mudhune Victor, Williams Tiffany, Samandari Taraz
Centers for Disease Control and Prevention, Office of Infectious Diseases, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Division of HIV/AIDS Prevention, Atlanta, Georgia, USA.
Kenya Medical Research Institute, Center for Global Health Research, Kisumu, Kenya.
J Glob Health Rep. 2018;2. doi: 10.29392/joghr.2.e2018032.
Given future potential use of vaginal rings to prevent HIV infection, we examined the association of contraceptive vaginal ring (CVR) non-adherence with user dissatisfaction, tolerability, demographic, and behavioral factors.
In an open-label single-group study, sexually active women aged 18-34 years using oral or injectable hormonal contraception, conveniently sampled from general population, were assigned to 6-month use of a commercial CVR currently not licensed for use in Kenya. Non-adherence in any CVR cycle completed was assessed from: (1) self-report (not used for at least 1 day), and (2) pharmacy record (failure to timely receive a new CVR or return a used one). Additionally, non-adherence was assessed in a subset of participants by residual progestin and estrogen levels measured in returned CVRs.
Of 202 participants who underwent CVR insertion by a study clinician, 142 completed all 6 visits, 172 responded to questions about ring use, and 43 provided used CVRs from months 1, 3, and 6 for residual hormone analysis. Non-adherence was 14.0% (24/172) by self-report and 54.5% (110/202) by pharmacy record. Non-adherence by pharmacy record was significantly reduced among women with a salary-based income (prevalence ratio (PR) 0.71, 95% confidence interval (CI) (0.55-0.91)] compared to women with income not salary-based or no income. Participants dissatisfied with CVR on ≥4 aspects (ambiguity of instructions, inconvenience of use, sensation, sexual discomfort, etc.) were more likely to report non-adherence (PR 2.69, 95% CI=(1.31-5.52)] compared to those dissatisfied with ≤3 aspects. Non-adherence by residual hormone levels was identified in 46.5% (20/43) participants. Over time, this subset of participants showed increasing non-adherence (=0.004). We found lack of agreement among the various measures of non-adherence.
Economic empowerment interventions, especially those emphasizing partner-independent income options, and expanded education on CVR features may alleviate non-adherence. Addressing CVR dissatisfaction preemptively may also help mitigate non-adherence.
考虑到阴道环在未来预防艾滋病毒感染方面的潜在用途，我们研究了避孕阴道环（CVR）使用不依从与使用者不满、耐受性、人口统计学和行为因素之间的关联。
在一项开放标签单组研究中，从普通人群中方便抽样选取年龄在18 - 34岁、使用口服或注射激素避孕的性活跃女性，分配其使用一种目前在肯尼亚未获许可使用的商用CVR，为期6个月。对于任何完成的CVR周期中的不依从情况，通过以下方式进行评估：（1）自我报告（至少1天未使用），以及（2）药房记录（未及时领取新的CVR或归还已使用的CVR）。此外，在一部分参与者中，通过测量归还的CVR中的孕激素和雌激素残留水平来评估不依从情况。
在202名由研究临床医生进行CVR插入的参与者中，142人完成了全部6次随访，172人回答了关于环使用情况的问题，43人提供了第1、3和6个月使用过的CVR用于残留激素分析。自我报告的不依从率为14.0%（24/172），药房记录的不依从率为54.5%（110/202）。与无薪资收入或非薪资收入的女性相比，有薪资收入的女性药房记录的不依从率显著降低（患病率比（PR）0.71，95%置信区间（CI）（0.55 - 0.91））。对CVR在≥4个方面（说明不明确、使用不便、感觉、性不适等）不满意的参与者比那些对≤3个方面不满意的参与者更有可能报告不依从（PR 2.69，95% CI =（1.31 - 5.52））。46.5%（20/43）的参与者通过残留激素水平被确定为不依从。随着时间推移，这部分参与者的不依从情况有所增加（P = 0.004）。我们发现不同的不依从测量方法之间缺乏一致性。
经济赋权干预措施，特别是那些强调独立于伴侣的收入选择的措施，以及扩大对CVR特征的教育，可能会减轻不依从情况。预先解决对CVR的不满也可能有助于减少不依从。
