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

Sponsor

University of Washington (Other)

Overall Status

Completed

CT.gov ID

NCT02781714

Collaborator

Kenyatta National Hospital (Other), University of Nairobi (Other)

260

Enrollment

Locations

Arms

Actual Duration (Months)

130

Patients Per Site

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Highly-effective contraceptive use [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 Outcome Measures

Time to contraceptive use [Through study completion (6 months postpartum)]
Time postpartum at which contraceptive use was initiated
Dual contraceptive use [6 weeks, 14 weeks, and 6 months postpartum]
Percentage of sexual acts in which a condom was used among contraceptive users
Any contraceptive use [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 [6 weeks, 14 weeks, and 6 months postpartum]
Satisfaction with chosen contraceptive method
Exclusive breastfeeding questionnaire [6 weeks, 14 weeks, and 6 months postpartum]
Self-reported exclusive breastfeeding

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahero sub-County Hospital	Ahero	Kisumu County	Kenya
2	Bondo County Hospital	Bondo	Siaya County	Kenya

Sponsors and Collaborators

University of Washington
Kenyatta National Hospital
University of Nairobi

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elizabeth Harrington, Acting Instructor / Family Planning Fellow, University of Washington

ClinicalTrials.gov Identifier:

NCT02781714

Other Study ID Numbers:

51125

First Posted:

May 24, 2016

Last Update Posted:

May 3, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Elizabeth Harrington, Acting Instructor / Family Planning Fellow, University of Washington

Study Results

No Results Posted as of May 3, 2018