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

NCT02781714 | Completed

• 1 other identifier: 51125
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 2

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.

Conditions

Contraception; Postpartum Period

Keywords

contraception; postpartum period; mobile health; mHealth; Kenya; couples

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (2)

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.

Behavioral: Two-way SMS

Control

NO INTERVENTION

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

Interventions

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: 1. Male partner invited to enroll/enrolled 2. Male partner not invited to enroll 3. Unpartnered

Two-way SMS

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Does not meet above criteria

Sponsors & Collaborators

• University of Washington: lead
• Kenyatta National Hospital: collaborator
• University of Nairobi: collaborator

Study Sites (2)

Ahero sub-County Hospital

Ahero, Kisumu County, Kenya

Location

Bondo County Hospital

Bondo, Siaya County, Kenya

Location

Related Publications (2)

• 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.

  PMID: 32813276 DERIVED

• 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.

  PMID: 31067089 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Instructor / Family Planning Fellow

Study Record Dates

• First Submitted: May 14, 2016
• First Posted: May 24, 2016
• Study Start: July 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 3, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KE (2)