Evaluation of an mHealth SMS Dialogue Strategy to Meet Women's and Couples' Postpartum Contraceptive Needs in Kenya (Mobile WACh XY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02781714|
Recruitment Status : Completed
First Posted : May 24, 2016
Last Update Posted : May 3, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Contraception Postpartum Period||Behavioral: Two-way SMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of an mHealth SMS Dialogue Strategy to Meet Women's and Couples' Postpartum Contraceptive Needs in Kenya|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Experimental: Two-way SMS
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.
Behavioral: Two-way SMS
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:
No Intervention: Control
The control arm will receive standard education and counseling provided in antenatal care and in postnatal care.
- 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.
- Time to contraceptive use [ Time Frame: Through study completion (6 months postpartum) ]Time postpartum at which contraceptive use was initiated
- 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
- 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.
- Family planning satisfaction questionnaire [ Time Frame: 6 weeks, 14 weeks, and 6 months postpartum ]Satisfaction with chosen contraceptive method
- Exclusive breastfeeding questionnaire [ Time Frame: 6 weeks, 14 weeks, and 6 months postpartum ]Self-reported exclusive breastfeeding
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781714
|Ahero sub-County Hospital|
|Ahero, Kisumu County, Kenya|
|Bondo County Hospital|
|Bondo, Siaya County, Kenya|