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临床试验/NCT04023799
NCT04023799已完成不适用

Dual Purpose Prevention (DPP) Product Preferences Among Couples

Microbicide Trials Network2 个研究点 分布在 2 个国家目标入组 400 人开始时间: 2020年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
2
主要终点
Attributes of a DPP product that influence preferences among heterosexual couples

研究概览

简要总结

MTN-045 is a cross-sectional study that will utilize questionnaires, including Discrete-Choice Experiments (DCE) and joint decision tasks, to assess couples' preferences related to dual purpose prevention (DPP) products that could be used to prevent unintended pregnancies and HIV infection. Post-survey explanatory in-depth interviews (IDIs) will be conducted with a subset of participants to explore DPP product-related decisions..

详细描述

MTN-045 is a cross-sectional study that will utilize questionnaires, including DCEs and joint decision tasks, and IDIs to assess heterosexual couples' preferences related to DPP products that could be used to prevent unintended pregnancies and HIV infection. One main goal of the study is to determine heterosexual couples' preferences for a DPP product to inform product delivery and future product design to maximize uptake and willingness to use among sub-Saharan African heterosexual couples. Another main goal of the study is to assess the level of influence of the male partner on a woman's preferences for a DPP product and on her decision-making process regarding product preferences and use.

The MTN-045 study population will consist of approximately 400 heterosexual sub-Saharan African couples of reproductive age who have been in a relationship for ≥ 3 months and are interested in contraception and/or HIV prevention. Women who are currently using contraceptives as well as those not using contraceptives will be eligible. Couples who are living together as well as those not living together will be eligible. All participants will complete survey questionnaires, first separately from their partner, then followed by a joint couples' decision task. Up to 80 participants, i.e., one or both partners from a subset of up to 40 couples, will be selected to complete an IDI.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Each member of the couple must meet all of the following criteria to be eligible for inclusion in the study, and both members of the couple must be willing and eligible for the couple to enroll:
  • Able and willing to provide written informed consent in one of the study languages.
  • Able and willing to complete the required study procedures.
  • Currently in a heterosexual relationship (living together or not) for at least 3 months (by self-report) with the other member of the couple.
  • At time of Enrollment, expressed interest in contraception and/or HIV prevention (by self-report).
  • For female partner:
  • Between the ages of 18 to 40 years (inclusive) at Enrollment, verified per site standard operating procedures (SOPs).
  • HIV negative (by self-report).
  • For male partner:
  • Aged 18 years or older at Enrollment, verified per site SOPs.

排除标准

  • Potential participants who meet the following criteria will be excluded from the study along with their partner:
  • Has any significant medical condition or other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe (including risk for IPV as a result of study participation), complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

结局指标

主要结局

Attributes of a DPP product that influence preferences among heterosexual couples

时间窗: 12-15 months during Q2 2019/Q4 2020

Survey questionnaires

Differences in DPP product attribute preferences when comparing individual to couples' choices (e.g., woman's individual preferences vs. preferences indicated through the joint couples decision task)

时间窗: 12-15 months during Q2 2019/Q4 2020

Discrete-Choice Experiments (DCE)

次要结局

  • Salient relationship-based and decision-making factors that influence DPP product interest and preferences(12-15 months during Q2 2019/Q4 2020)
  • Differences in attributes salient to preferences by sociodemographic factors such as age and parity that may reflect lifecourse stage(12-15 months during Q2 2019/Q4 2020)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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