Evaluation of an mHealth SMS Dialogue Strategy to Meet Women's & Couples'

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02781714
Study type	Interventional
Source	University of Washington
Contact
Status	Completed
Phase	N/A
Start date	July 2016
Completion date	September 2017

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02577601` - Impact of Combined Hormonal Contraceptives on UPA	Phase 4
Completed	`NCT03153644` - Improving Contraceptive Care for Women With Medical Conditions
Completed	`NCT04112095` - Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use	Phase 3
Recruiting	`NCT05521646` - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative	N/A
Active, not recruiting	`NCT04291001` - Ovarian Function With ENG Implant and UPA Use	Early Phase 1
Completed	`NCT04568980` - Assessment of Contraceptive Safety and Effectiveness in Cystic Fibrosis
Completed	`NCT03438682` - Real World Effectiveness and Safety of Hysteroscopic (Essure®) Compared to Laparoscopic Sterilization
Active, not recruiting	`NCT01948882` - Evaluation of Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women	N/A
Enrolling by invitation	`NCT04997499` - Adolescent Subcutaneous (SQ) Injection Video Validation	N/A
Recruiting	`NCT03589040` - Darunavir and Rilpivirine Interactions With Etonogestrel Contraceptive Implant	Phase 2
Completed	`NCT04463680` - Rifampin and the Contraceptive Implant	Phase 4
Completed	`NCT03154125` - Sayana® Press Extension Study	Phase 3
Withdrawn	`NCT03725358` - A Cluster-RCT to Increase the Uptake of LARCs Among Adolescent Females and Young Women in Cameroon.	N/A
Completed	`NCT02957630` - "E4/DRSP Endocrine Function, Metabolic Control and Hemostasis Study"	Phase 1/Phase 2
Completed	`NCT02456584` - Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods	Phase 1
Completed	`NCT02718222` - Impact and Performance of Institutionalizing Immediate Post-partum IUD Services	N/A
Recruiting	`NCT02121067` - LNG-IUS at 2 Weeks Postpartum	Phase 4
Terminated	`NCT02169869` - Immediate Postplacental IUD Insertion	N/A
Recruiting	`NCT02292056` - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions	N/A
Withdrawn	`NCT01930994` - Kenya Sino-implant (II) PK Study	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms