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临床试验/NCT04915885
NCT04915885撤回不适用

Strengthening Contraceptive Counseling Services to Empower Clients and Meet Their Needs: Protocol for a Multi-phase Complex Intervention in Pakistan

Nguyen-Toan Tran0 个研究点开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Change in clients' decision-making autonomy

研究概览

简要总结

High-quality contraceptive counseling can strengthen global efforts to reduce the unmet need for and suboptimal use of modern contraceptives. This study aims to identify a package of contraceptive counseling interventions designed to strengthen existing contraceptive services and determine its effectiveness in increasing clients' level of decision-making autonomy and meeting their contraceptive needs.

详细描述

Methods The five-phase complex intervention design starts with a pre-formative phase aimed at mapping potential study sites to establish the sampling frame. The two-part formative phase first uses participatory approaches to identify the perspectives of clients, including young people and providers, to ensure research contextualization and address each interest group's needs and priorities; clinical observations of client-provider encounters to document routine care form the second part. The design workshop of the third phase will result in the development of a package of contraceptive counseling interventions. In the fourth and experimental phase, a multi-intervention, three-arm, single-blinded, parallel cluster randomized-controlled trial will compare routine care (arm 1) with the contraceptive counseling package (arm 2) and the same package combined with wider method availability (arm 3). The fifth and reflective phase aims to analyze the package's cost-effectiveness and identify implementation barriers and enablers. The primary outcomes are clients' level of decision-making autonomy and met need for modern contraceptives.

Discussion Applying participatory action research principles in designing, testing, and scaling up effective, affordable, and sustainable counseling interventions could help optimize clients' decision-making autonomy and meet their needs for modern contraceptives in low-resource settings. Recognizing the socio-cultural and health service complexities surrounding contraception, including client-provider power dynamics, the study assumes that engaging key stakeholders, including adolescents, women, men, service providers, and policymakers would be more effective. A set of low-technology interventions will likely affect, at the individual level and in a sustainable way, the knowledge, attitudes, and behaviors of women and couples toward contraceptive counseling and provision. At the health service delivery level, the trial implementation would necessitate a shift in providers' attitudes and accountability toward a systematic integration into their clinical practice of must-have and person-centered counseling components, as well as improved health service organization to ensure the availability of competent staff and diversity of contraceptive choices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
15 Years 至 49 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • she comes to the family planning clinic with the intention to 1.a. use contraception for the first time in her life (new user), or 1.b. switch from a contraceptive method to another one (switching user), or 1.c. resume a method after not using any in the prior three months (lapse user), or 1.d. discontinue a modern method (discontinuing user);
  • she is not coming for the resupply of a currently used method, such as pills or injectables;
  • she has the intention to continue her follow-up at the health center during the 12-month study follow-up;
  • she does not participate in another study; and
  • she provides informed consent.

排除标准

  • 未提供

结局指标

主要结局

Change in clients' decision-making autonomy

时间窗: Through study completion, an average of 1 year

Person-Centered Contraceptive Counseling scale (PCCC), developed and tested by Dehlendorf et al. (2021)

Change in clients' met need for family planning

时间窗: Through study completion, an average of 1 year

number of participants who want to avoid a pregnancy and are using a contraceptive method / all participants

次要结局

  • Change in modern contraceptive prevalence(6 months and 12 months post enrollment)

研究者

发起方
Nguyen-Toan Tran
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nguyen-Toan Tran

World Health Organization consultant

University of Geneva, Switzerland

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