Clinical trial NCT02781714: Evaluation of an mHealth SMS Dialogue Strategy to Meet Women's and Couples' Postpartum Contraceptive Needs in Kenya
Official title: Evaluation of an mHealth SMS Dialogue Strategy to Meet Women's and Couples' Postpartum Contraceptive Needs in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Postpartum Period
Keywords: contraception
postpartum period
mobile health
mHealth
Kenya
couples
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Kenyatta National Hospital
name: University of Nairobi
First posted: 2016-05-24
Enrollment: 260
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Highly-effective contraceptive use
timeFrame: 6 months postpartum
Secondary outcomes:
measure: Time to contraceptive use
timeFrame: Through study completion (6 months postpartum)
measure: Dual contraceptive use
timeFrame: 6 weeks, 14 weeks, and 6 months postpartum
measure: Any contraceptive use
timeFrame: 6 weeks, 14 weeks, and 6 months postpartum
measure: Family planning satisfaction questionnaire
timeFrame: 6 weeks, 14 weeks, and 6 months postpartum
measure: Exclusive breastfeeding questionnaire
timeFrame: 6 weeks, 14 weeks, and 6 months postpartum
Other outcomes:
Locations:
city: Ahero
country: Kenya
facility: Ahero sub-County Hospital
state: Kisumu County
city: Bondo
country: Kenya
facility: Bondo County Hospital
state: Siaya County
Study officials:
References:
citation: 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.
citation: 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.