Abaasa Andrew, Gafos Mitzy, Anywaine Zacchaeus, Nunn Andrew, Crook Angela, Levin Jonathan, McCormack Sheena, Kamali Anatoli
MRC/UVRI Uganda Research Unit on AIDS, P.O Box 49, Entebbe, Uganda.
MRC Clinical Trials Unit at UCL, London, UK.
Reprod Health. 2017 Mar 11;14(1):36. doi: 10.1186/s12978-017-0296-3.
Use of a reliable contraception method has become an inclusion criterion in prevention trials to minimize time off product. We report on hormonal contraceptive prevalence, uptake, sustained use and correlates of use in the Microbicides Development Programme (MDP 301) trial at the Masaka Centre in Uganda.
HIV negative women in sero-discordant relationships were enrolled and followed-up for 52 to 104 weeks from 2005 to 2009. Contraceptive use data was collected through self-report at baseline and dispensing records during follow-up. Hormonal contraceptives were promoted and provided to women that were not using a reliable method at enrolment. Baseline contraceptive prevalence, uptake and sustained use were calculated. Uptake was defined as a participant who reported not using a reliable method at enrolment and started using a hormonal method at any time after. Logistic regression models were fitted to investigate predictors of hormonal contraceptive uptake.
A total of 840 women were enrolled of whom 21 aged ≥50 years and 12 without follow-up data were excluded; leaving 807 (median age 31 IQR 26-38) in this analysis. At baseline, 228 (28%) reported using a reliable contraceptive; 197 hormonal, 28 female-sterilisation, two IUCD and one hysterectomy. As such 579 were not using a reliable contraceptive at enrolment, of whom 296 (51%) subsequently started using a hormonal contraceptive method; 253 DMPA, four oral pills, and two norplant. Overall 193 (98%) existing users and 262 (88%) new users sustained use throughout follow-up. Independent correlates of hormonal contraceptive uptake were: younger women ≤30 years, aOR = 2.5, 95% CI: 1.7-3.6 and reporting not using contraceptives at baseline due to lack of access or money, breastfeeding or other reasons, in comparison to women who reported using unreliable method.
Promotion and provision of hormonal contraception doubled the proportion of women using a reliable method of contraception. Uptake was pronounced among younger women and those not previously using a reliable method because of lack of access or money, and breastfeeding. Promotion and provision of hormonal contraceptives in trials that require the interruption or discontinuation of investigational products during pregnancy is important to reduce the time off product.
Protocol Number ISRCTN64716212 .
在预防试验中，采用可靠的避孕方法已成为纳入标准，以尽量减少脱离产品的时间。我们报告了乌干达马萨卡中心微生物杀灭剂开发计划（MDP 301）试验中激素避孕的患病率、使用率、持续使用率及其相关因素。
招募处于血清学不一致关系中的HIV阴性女性，并于2005年至2009年对其进行52至104周的随访。避孕使用数据通过基线时的自我报告和随访期间的发放记录收集。向入组时未采用可靠避孕方法的女性推广并提供激素避孕措施。计算基线避孕患病率、使用率和持续使用率。使用率定义为入组时报告未采用可靠避孕方法且在之后任何时间开始使用激素避孕方法的参与者。采用逻辑回归模型研究激素避孕使用的预测因素。
总共招募了840名女性，其中21名年龄≥50岁以及12名无随访数据的女性被排除；本分析中剩余807名女性（中位年龄31岁，四分位间距26 - 38岁）。基线时，228名（28%）报告采用可靠避孕方法；197名使用激素避孕，28名采用女性绝育术，2名使用宫内节育器，1名进行了子宫切除术。因此，579名女性入组时未采用可靠避孕方法，其中296名（51%）随后开始使用激素避孕方法；253名使用醋酸甲羟孕酮，4名使用口服避孕药，2名使用皮下埋植剂。总体而言，193名（98%）现有使用者和262名（88%）新使用者在整个随访期间持续使用。激素避孕使用的独立相关因素为：年龄≤30岁的年轻女性，调整后比值比（aOR）= 2.5，95%置信区间（CI）：1.7 - 3.6；与报告采用不可靠避孕方法的女性相比，因无法获取或资金不足、母乳喂养或其他原因在基线时报告未使用避孕措施的女性。
推广并提供激素避孕措施使采用可靠避孕方法的女性比例增加了一倍。年轻女性以及因无法获取或资金不足和母乳喂养而此前未采用可靠避孕方法的女性中使用率较高。在需要在孕期中断或停用研究产品的试验中推广并提供激素避孕措施对于减少脱离产品的时间很重要。
协议编号ISRCTN64716212 。
