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临床试验/NCT02781714
NCT02781714已完成不适用

Evaluation of an mHealth SMS Dialogue Strategy to Meet Women's and Couples' Postpartum Contraceptive Needs in Kenya

University of Washington2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2016年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
260
试验地点
2
主要终点
Highly-effective contraceptive use

研究概览

简要总结

Meeting women's need for postpartum family planning is has been acknowledged as a global priority in maternal and child health. The prevention of unintended pregnancies in sub-Saharan African countries, which carry the highest global burdens of maternal mortality and HIV infection, is projected to substantially decrease maternal and neonatal morbidity and mortality. Many barriers to contraceptive uptake exist, both within and outside of the postpartum time period, and include socio-cultural, economic, and supply-side factors. Furthermore, while the importance of engaging men in family planning programs has been acknowledged for decades, few interventions have succeeded in increasing male involvement in family planning while maintaining a focus on women's empowerment. Innovative approaches to meeting the family planning needs of women and couples are urgently needed.

Public health interventions are increasingly incorporating mobile health (mHealth) approaches using short message service (SMS) technology in low-income countries, approaches that have demonstrated benefit among various reproductive health outcomes. The investigators hypothesize that personalized, bidirectional SMS dialogue with individual women and couples will increase postpartum contraceptive uptake, thereby decreasing unmet need for family planning in Kenya. The investigators have collaborated with the University of Washington (UW) Department of Computer Science and Engineering (CSE) along with Kenyan telecommunication providers to develop a hybrid messaging system that allows for innovative bidirectional SMS messaging. This system has been used successfully in maternal child health (MCH) clinics in Kenya. In qualitative research, women in Kenya have expressed a strong desire for mHealth support to provide additional education, counseling and reminders to supplement counseling by health workers.

The investigators propose a randomized controlled trial (RCT) comparing the effects of bidirectional SMS dialogue vs. control on highly effective contraceptive use at 6 months postpartum among HIV negative women and couples in Nyanza Province, Kenya. Data from this RCT and accompanying qualitative study will contribute to innovative, scale-able strategies to address unmet need for contraception and increase male involvement in family planning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
14 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant; at least 28 weeks gestation
  • HIV negative
  • Daily access to a mobile phone
  • Planning to stay in area for 6 months postpartum
  • Able to read/write or has trusted person to help

排除标准

  • Does not meet above criteria

研究组 & 干预措施

Two-way SMS

Experimental

Pre-programmed SMS messages by partner track will be delivered twice weekly to participants in participants' preferred languages from enrollment to 6 months postpartum. They will include a question soliciting a response from the participant(s). Interactive SMS communication will be responded to and managed by the study nurse at each site. Content themes will include: general support/encouragement, postpartum visit reminders, postpartum pregnancy risk and benefits of birth spacing, postpartum contraceptive options and side effects, family planning misconceptions, and couple communication.

干预措施: Two-way SMS (Behavioral)

Control

No Intervention

The control arm will receive standard education and counseling provided in antenatal care and in postnatal care.

结局指标

主要结局

Highly-effective contraceptive use

时间窗: 6 months postpartum

Proportion of participants self-reporting use of oral contraceptive pills, injectable contraception, contraceptive implant, intrauterine device, or male/female sterilization at 6 months postpartum will be compared between arms. Questionnaires will be used to assess this outcome.

次要结局

  • Time to contraceptive use(Through study completion (6 months postpartum))
  • Dual contraceptive use(6 weeks, 14 weeks, and 6 months postpartum)
  • Any contraceptive use(6 weeks, 14 weeks, and 6 months postpartum)
  • Family planning satisfaction questionnaire(6 weeks, 14 weeks, and 6 months postpartum)
  • Exclusive breastfeeding questionnaire(6 weeks, 14 weeks, and 6 months postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Harrington

Acting Instructor / Family Planning Fellow

University of Washington

研究点 (2)

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