A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use

The specific aim of this pilot study is to estimate the impact of a new digital health service on the uptake of family planning among Kenyan women with an unmet need for contraception. Enrolled women will be randomized to a control arm or an encouragement arm that will receive a special invitation to try the new service.

Study Overview

• Status: Completed
• Conditions: Contraception Behavior
• Intervention / Treatment: Other: digital family planning screening and referral service

Detailed Description

Based on global projections, meeting the unmet demand for contraceptives would prevent more than two-thirds of unintended pregnancies and more than two-thirds of maternal deaths. Voluntary family planning has also been shown to improve newborn health outcomes, advance women's empowerment, and bring socioeconomic benefits through reductions in fertility and population growth. Yet among the populations that would benefit the most from family planning, uptake remains too low.

The specific aim of this pilot study is to estimate the impact of a new digital health service on the uptake of family planning among Kenyan women with an unmet need for contraception. This service promotes uptake by offering free screening and referral. Women text the service for free, complete a short automated screening over the phone, and receive a list of recommended methods and a referral to local family planning providers offering those methods. The main hypothesis is that the service will increase the uptake of family planning among these users.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Bungoma, Kenya
    • Bungoma County

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. be between the ages of 18 and 35 (inclusive);
2. have an unmet need for family planning;
3. live in the service catchment area;
4. demonstrate phone ownership;
5. opt-in to receiving calls and/or SMS messages from the study team;
6. demonstrate basic ability to operate study tablet; and
7. consent to participate in the study.

Exclusion Criteria:

1. outside of the age range;
2. no unmet need for family planning;
3. live outside the service catchment area;
4. not able to demonstrate ownership of basic phone capable of receiving/making phone calls and receiving/sending SMS messages;
5. does not agree to receive calls and/or SMS messages from the study team;
6. does not demonstrate basic ability to operate study tablet; or
7. does not consent to participate in the study
8. not pregnant or <4 months postpartum

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Encouragement Arm; Women randomized to the encouragement arm will receive an invitation via SMS to try the new digital family planning screening and referral service.	Other: digital family planning screening and referral service; Clients text the service and receive a free call back to complete an automated family planning counseling session that results in a set of recommended methods that fit the client's preferences. The client is matched to family planning providers that offer these methods, and the service sends a referral code that the client can redeem at a facility. When someone receives a referral code, the service tracks them through their encounter with a provider to learn about their experience with the service, the provider, and their choice in contraception. The service also follows-up with clients who do not act on referrals to better understand their reasons and tries different behavioral nudges to promote uptake of contraception. The service does not pay costs the client may incur at a facility.
No Intervention: Control Arm; Women randomized to the control arm will receive a different set of SMS messages that do NOT include a special encouragement try the new digital family planning screening and referral service.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study	Woman reports starting any modern method of contraception since the start of the study	4-months post-encouragement

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake of Long-acting Contraception	Woman reports starting any long-acting method of contraception since the start of the study	1-month post-encouragement

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Moi University
• Investigators: Principal Investigator: Eric Green, PhD, Duke University

Publications and helpful links

General Publications

• Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
• Green EP, Augustine A, Naanyu V, Hess AK, Kiwinda L. Developing a Digital Marketplace for Family Planning: Pilot Randomized Encouragement Trial. J Med Internet Res. 2018 Jul 31;20(7):e10756. doi: 10.2196/10756.

Helpful Links

• Research design and analysis protocol
• Green et al. (2018). Developing a digital marketplace for family planning: Pilot randomized encouragement trial. Journal of Medical Internet Research, 20(7), e10756.

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Actual): March 13, 2018
• Study Completion (Actual): March 13, 2018

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 22, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Contraception; Kenya; Digital Health; Family Planning; Unmet Need
• Other Study ID Numbers: E0108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No