Evaluation of an mHealth SMS Dialogue Strategy to Meet Women's and Couples' Postpartum Contraceptive Needs in Kenya (Mobile WACh XY)

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.

Study Overview

• Status: Completed
• Conditions: Contraception; Postpartum Period
• Intervention / Treatment: Behavioral: Two-way SMS

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Kisumu County
    • Ahero, Kisumu County, Kenya
      • Ahero sub-County Hospital
  • Siaya County
    • Bondo, Siaya County, Kenya
      • Bondo County Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 50 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Male partner invited to enroll/enrolled; Male partner not invited to enroll; Unpartnered
NO_INTERVENTION: Control; The control arm will receive standard education and counseling provided in antenatal care and in postnatal care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Highly-effective contraceptive use	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.	6 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to contraceptive use	Time postpartum at which contraceptive use was initiated	Through study completion (6 months postpartum)
Dual contraceptive use	Percentage of sexual acts in which a condom was used among contraceptive users	6 weeks, 14 weeks, and 6 months postpartum
Any contraceptive use	Proportion of participants self-reporting use of any contraceptive method will be compared between arms. This outcome will be assessed with a questionnaire.	6 weeks, 14 weeks, and 6 months postpartum
Family planning satisfaction questionnaire	Satisfaction with chosen contraceptive method	6 weeks, 14 weeks, and 6 months postpartum
Exclusive breastfeeding questionnaire	Self-reported exclusive breastfeeding	6 weeks, 14 weeks, and 6 months postpartum

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: University of Nairobi; Kenyatta National Hospital

Publications and helpful links

General Publications

• Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.
• Harrington EK, Drake AL, Matemo D, Ronen K, Osoti AO, John-Stewart G, Kinuthia J, Unger JA. An mHealth SMS intervention on Postpartum Contraceptive Use Among Women and Couples in Kenya: A Randomized Controlled Trial. Am J Public Health. 2019 Jun;109(6):934-941. doi: 10.2105/AJPH.2019.305051.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ACTUAL): September 1, 2017
• Study Completion (ACTUAL): September 1, 2017

Study Registration Dates

• First Submitted: May 14, 2016
• First Submitted That Met QC Criteria: May 23, 2016
• First Posted (ESTIMATE): May 24, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: mobile health; Kenya; contraception; mHealth; couples; postpartum period
• Other Study ID Numbers: 51125

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO