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临床试验/NCT03995043
NCT03995043尚未招募不适用

Project for Reproductive Equity Through Volunteers and Entrepreneurship, Networks and Technology: The PREVENT Project Protocol

Dr. Karen Yeates2 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2027年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
198
试验地点
2
主要终点
Change in unmet need for contraceptives at 6 months

研究概览

简要总结

The PREVENT Project is a multifaceted, adolescent friendly, culturally competent program aimed to address the issues surrounding unplanned pregnancies and lack of access and uptake of contraceptive services among adolescent girls. The intervention uses a mobile platform that provides educational SMS (Short Message Service) messaging, interactive voice response, and connects adolescent girls to community based AFSRH (Adolescent Friendly Sexual Reproductive Health) counselling services, as well as discreet contraceptive access points headed by female entrepreneurs. The program will be piloted for 12 months in various wards and villages in rural and urban Kilimanjaro, Tanzania.The acceptability and practicality of the intervention will be assessed using mixed methods. Questionnaires and focus groups will be conducted with the study participants, as well as the medical and non-medical volunteers at the start and end of the pilot. The study will be heavily supported by all-female non-medical social entrepreneurs and sexual reproductive health community mentors (volunteers), and, all-female medical reproductive health team. Recruitment will also take place in hair saloons (local hair braiding and styling establishments) and other female run business such as tailors and female clothing stores that have enlisted to become contraceptive access points in the study. There will be 2 intervention groups, control and case group. Both groups will receive educational SMS (text) messages on SRH (Sexual Reproductive Health) and access individually tailored educational resources through interactive voice response (IVR) services/system via PREVENT mobile platform. In addition to personal support to be able to contact with a SRH community peer mentor in the community for AFSRH counselling and support. The case group will then have access to contraception provided with detailed and discreet information on accessing PREVENT contraceptive access points in all communities included in the study.

详细描述

The PREVENT study seeks to impact knowledge, perceptions, and behavioural changes regarding SRH among adolescent girls. As a result, the data collected in the PREVENT study will be grouped into two main themes: SRH knowledge and attitudes, as well as family planning (pregnancy avoidance) and contraceptive services uptake and outcomes. All data collected during the study will be directly entered and stored into the secure PREVENT mobile platform and related secure storage functions within the platform.

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
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants are blinded through the study arm and the outcomes assessor and investigator are blinded to participant group assignment for the intervention.

入排标准

年龄范围
15 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Women 15-19 years of age
  • Reside within the study area for the duration of the study
  • Have a personal mobile phone and be willing to provide the phone number to the researchers to receive the intervention messages
  • Report being SMS literate (ie. able to read text messages in English or Swahili)
  • Be able and willing to return for follow-up after 12 months
  • Be able and willing to give written informed consent for enrollment in the study

排除标准

  • Be pregnant or planning pregnancy within 12 months (assessed when obtaining consent using HCG (human chorionic gonadotropin) urine dipstick).
  • Participation in another study or intervention that may affect the outcome of this study
  • Already utilizing a long-term form of contraception such as intra-uterine device, or implantable or inject-able contraception
  • Having a non-medical condition detected through screening that hinders study participation such as developmental or cognitive delay

研究组 & 干预措施

Control Intervention

Experimental
  1. Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH.
  2. Personal Support from community peer mentor to access counselling services through SRH

干预措施: Education (Behavioral)

Control Intervention

Experimental
  1. Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH.
  2. Personal Support from community peer mentor to access counselling services through SRH

干预措施: Personal Support (Behavioral)

Case Intervention

Experimental
  1. Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH.
  2. Personal Support from community peer mentor to access counselling services through SRH
  3. Access to Contraception and counselling and service provision will be provided by the mobile reproductive health team at contraceptive access points.

干预措施: Education (Behavioral)

Case Intervention

Experimental
  1. Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH.
  2. Personal Support from community peer mentor to access counselling services through SRH
  3. Access to Contraception and counselling and service provision will be provided by the mobile reproductive health team at contraceptive access points.

干预措施: Personal Support (Behavioral)

Case Intervention

Experimental
  1. Education about contraceptive use, reproductive health and family planning services through SMS messages on SRH.
  2. Personal Support from community peer mentor to access counselling services through SRH
  3. Access to Contraception and counselling and service provision will be provided by the mobile reproductive health team at contraceptive access points.

干预措施: Access to contraception (Behavioral)

结局指标

主要结局

Change in unmet need for contraceptives at 6 months

时间窗: 6 month

Percent change in unmet need for contraceptives among study participants using Tanzania Demographic and health survey.

Change in unmet need for contraceptives at 12 months

时间窗: 12 month

Percent change in unmet need for contraceptives among study participants using Tanzania Demographic and health survey.

次要结局

  • Change in the number of pregnancies among women at 12 months(12 month post randomization)
  • Change in the number of pregnancies among women at 6 months(6 month post randomization)
  • Questionnaire to test knowledge regarding sexual and reproductive health(12 month post randomization)

研究者

发起方
Dr. Karen Yeates
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Karen Yeates

Principal Investigator

Queen's University

研究点 (2)

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