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OpenTrials
Completed

NCT Number: NCT02781714

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

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.

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Key information

Age range

14 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahero sub-County Hospital, Ahero, Kisumu County, Kenya

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Does not meet above criteria

Treatment and study plan

Two-way SMS

Behavioral

SMS messages will provide tailored and actionable education, counseling, and reminders specific to antenatal/postpartum timing and partner track. Messages will include questions and prompts; women and their male partners have the option of writing back to a nurse with questions or concerns, who will provide real-time responses via text and/or make referrals to a clinic. Message content will be tailored to women and couples, and will range from health benefits of child spacing and an emphasis on contraceptive options, to the hierarchy of effectiveness and information on specific methods, to simple reminders about postpartum visits.

Prior to randomization, each enrolled woman will be asked if she has a male partner, and whether she would like to refer her male partner for recruitment and enrollment into the study. The partner tracks are as follows:

  • Male partner invited to enroll/enrolled
  • Male partner not invited to enroll
  • Unpartnered

Primary outcomes

  1. Highly-effective contraceptive use

    Time frame: 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.

Secondary outcomes

  1. Time to contraceptive use

    Time frame: Through study completion (6 months postpartum)

    Time postpartum at which contraceptive use was initiated

  2. Dual contraceptive use

    Time frame: 6 weeks, 14 weeks, and 6 months postpartum

    Percentage of sexual acts in which a condom was used among contraceptive users

  3. Any contraceptive use

    Time frame: 6 weeks, 14 weeks, and 6 months postpartum

    Proportion of participants self-reporting use of any contraceptive method will be compared between arms. This outcome will be assessed with a questionnaire.

  4. Family planning satisfaction questionnaire

    Time frame: 6 weeks, 14 weeks, and 6 months postpartum

    Satisfaction with chosen contraceptive method

  5. Exclusive breastfeeding questionnaire

    Time frame: 6 weeks, 14 weeks, and 6 months postpartum

    Self-reported exclusive breastfeeding

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Kenyatta National Hospital
  • University of Nairobi

Registry information

Acronym: Mobile WACh XY

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 24, 2016
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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