跳至主要内容
临床试验/NCT04307849
NCT04307849已完成不适用

Engaging Providers, Community Members, and Young Women to Adapt and Pilot a Youth-friendly Sexual and Reproductive Health Package in Low-income Communities in India

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年9月15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
100
试验地点
1
主要终点
Change in Sexual and Reproductive Health and Rights Knowledge Survey Score

研究概览

简要总结

This study will systematically adapt, pilot test, and evaluate an integrated community/facility intervention to improve the uptake of adolescent-friendly services for married and unmarried adolescent girls and young women (AGYW; ages 15-25) in a low-income area with a population of approximately 700,000 in Mumbai, India

详细描述

Aim 1: Adapt the health club curriculum and provider/staff sensitization training using Assessment, Decision, Administration, Production, discussion with Topical experts, Integration, Training, and Testing (ADAPT-ITT) Formative mixed methods data will be collected from stakeholders to assess the landscape of adolescent-friendly care and gaps to adapt the intervention. Intervention sessions will be presented to groups of stakeholders to elicit feedback on adaptations.

The formative research entails a mixed methods assessment of the adolescent sexual reproductive health landscape in the study area, and adaptation of the intervention components through interactive sessions, consistent with ADAPT-ITT.

ADAPT-ITT Assessment Phase

Key informant interviews (KIIs) - Qualitative key informant interviews (N=35) will be conducted with both public and private community-based health providers, NGO workers, community health workers (CHWs), and parents of young women. Interviews will also be conducted with government officials at the community and M Ward levels (wards are the smallest administrative unit of governmental ministries). These interviews will focus on qualitative mapping of adolescent health and treatment-seeking pathways and providers in the study area, and factors in the family, community, and elsewhere that influence adolescent girls' and young women's health. The KIIs will also provide insight into aspects of the intervention and evaluation tools requiring modification. KIIs will also be invited to join a community advisory board (CAB) for the duration of the project. This CAB will provide a forum for AGYW to present their learnings from the adolescent club, and serve as a resource should community members have questions or concerns about the intervention.

In-depth interviews with adolescent girls and young women (IDIs) - Qualitative in-depth interviews will be conducted with 20 AGYW (aged 15-25 years old) to understand their experiences with healthcare in the study area, treatment-seeking patterns, and factors in the family, community and elsewhere that influence their health. Young women will also be asked to comment on the proposed intervention's feasibility and acceptability, and provide input on aspects of the intervention and evaluation tools that need modification. Roughly equal numbers of married and unmarried young women will be recruited for participation. Young women will be recruited with assistance from NGO programs, CHWs, and referrals from other participants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • AGYW between the ages of 15-25 years old
  • Provide consent or assent,
  • Living in the study area for one year or more,
  • If unmarried and under the age of 18, have parental consent to participate. Married AGYW and/or those age 18 or over will be recruited if they meet inclusion criteria and provide informed consent.

排除标准

  • AGYW who are unable to give consent due to psychological or mental limitations,
  • If unmarried and under the age of 18 do not have parental consent to participate.

结局指标

主要结局

Change in Sexual and Reproductive Health and Rights Knowledge Survey Score

时间窗: Pre-Test (Baseline), Week 10 Post-Initiation of Intervention

Change from baseline to end of intervention (\~10 weeks) will be measured using the subscale "Sexual and Reproductive Health Knowledge" subscale of the "Illustrative Questionnaire for Interview-Surveys with Young People" \[Cleland, et al. 2001(1)\], which has been validated and used to assess adolescent and young adult knowledge about sexual and reproductive health and rights. The survey consists of a subset of 22 questions, and takes approximately 20 minutes to complete. Each correct answer receives 1 point, while wrong answers and "I don't know" responses receive 0 points. The total score is the sum of responses and ranges from 0-22. Higher scores suggest better sexual and reproductive health and rights knowledge.

次要结局

  • Change in Clinic Service Uptake/Use: Change in Number of Requests for Contraception(Pre-Test (Baseline), Week 10 Post-Initiation of Intervention)
  • Change in Clinic Service Uptake/Use: Change in Number of Requests for Menstrual Health Materials/Support (MHM/S)(Pre-Test (Baseline), Week 10 Post-Initiation of Intervention)
  • Change in Clinic Service Uptake/Use: Change in Number of Requests for STI/HIV Tests(Pre-Test (Baseline), Week 10 Post-Initiation of Intervention)
  • Change in Personal and Community Safety(Pre-Test (Baseline), Week 10 Post-Initiation of Intervention)
  • Change in Gender Norms(Pre-Test (Baseline), Week 10 Post-Initiation of Intervention)
  • Change in Perceived Self-efficacy and Agency(Pre-Test (Baseline), Week 10 Post-Initiation of Intervention)
  • Change in Mental Health as Measured Using GAD-7(Pre-Test (Baseline), Week 10 Post-Initiation of Intervention)
  • Change in Mental Health as Measured Using PHQ-8(Pre-Test (Baseline), Week 10 Post-Initiation of Intervention)
  • Intervention Acceptability as Rated by AGYW(Week 10 Post-Initiation of Intervention)
  • Satisfaction With Intervention/Services as Rated by AGYW(Week 10 Post-Initiation of Intervention)
  • Intervention Feasibility as Rated by AGYW(Week 10 Post-Initiation of Intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Youth-friendly Sexual and Reproductive Healthcare... | 临床试验