Department of Community and Global Health, School of International Health, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan.
Department of Community Health, Mbarara University of Science and Technology, P.O BOX 1410, Mbarara, Uganda.
Trials. 2020 Mar 17;21(1):270. doi: 10.1186/s13063-020-4192-8.
Dual-method use is known as the most reliable protection against unintended pregnancies and sexually transmitted infections, including HIV. However, it is not commonly used in sub-Sharan Africa, especially among women using highly effective contraceptives. This article describes a protocol to evaluate the effect of an intervention formulated under the positive deviance approach for promoting dual-method use in Uganda.
A total of 150 women will be interviewed using a structured questionnaire to find those practicing dual-method use. In-depth interviews will then be conducted with all women using the dual method and 10 women using only highly effective contraceptives to identify their unique practice. Then, a cluster randomized controlled trial will be conducted to examine the effect of an intervention formulated under the positive deviance approach on dual-method uptake and adherence. Twenty health facilities will be randomized to an intervention or control arm and 480 women will be enrolled in each group. The participants will be followed up for 8 months.
This trial focuses on women who already adapted dual-method use and identifies their unique solutions to promote dual-method use. This trial could tackle barriers for dual-method use, which expert outsiders may fail to recognize, by analyzing and promulgating their unique behaviors. This study could provide evidence that the positive deviance approach can address unintended pregnancies and sexually transmitted infections as well as other health problems which usual approaches have failed to address.
UMIN-CTR Clinical Trial, UMIN000037065. Registered on 14 June 2019.
双方法使用被认为是预防意外怀孕和性传播感染（包括 HIV）的最可靠方法。然而，在撒哈拉以南非洲地区，这种方法并不常见，尤其是在使用高效避孕方法的女性中。本文描述了一项在积极偏差方法下制定的干预措施，以评估其在乌干达促进双方法使用的效果的研究方案。
将使用结构化问卷对 150 名女性进行访谈，以发现那些采用双方法的女性。然后，将对所有使用双方法的女性和 10 名仅使用高效避孕方法的女性进行深入访谈，以确定他们独特的做法。然后，将进行一项基于积极偏差方法制定的干预措施对双方法使用的效果的集群随机对照试验。将 20 个卫生机构随机分为干预组或对照组，每组将招募 480 名女性。参与者将随访 8 个月。
本试验侧重于已经采用双方法的女性，并确定她们独特的解决方案来促进双方法的使用。本试验可以通过分析和宣传他们独特的行为来解决双方法使用的障碍，而这些障碍可能是专家们无法识别的。本研究可以提供证据表明，积极偏差方法可以解决意外怀孕和性传播感染以及其他通常方法未能解决的健康问题。
UMIN-CTR 临床试验，UMIN000037065。于 2019 年 6 月 14 日注册。
