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

NCT ID: NCT02781714

Last Updated: 2018-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Two-way SMS

Intervention Type: 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

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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:

1. Male partner invited to enroll/enrolled

2. Male partner not invited to enroll

3. Unpartnered

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kenyatta National Hospital

OTHER_GOV

Sponsor Role: collaborator

University of Nairobi

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Harrington

Acting Instructor / Family Planning Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahero sub-County Hospital

Ahero, Kisumu County, Kenya

Bondo County Hospital

Bondo, Siaya County, Kenya

Countries

Kenya

References

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.

Reference Type: DERIVED

PMID: 32813276 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31067089 (View on PubMed)

Other Identifiers

51125

Identifier Type: -

Identifier Source: org_study_id