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

Not Applicable

Completed

• Conditions: Contraception Behavior
• Interventions: Other: digital family planning screening and referral service

• Registration Number: NCT03224390
• Lead Sponsor: Duke University

Brief Summary

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.

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 Timeline

• Study Start: 2017-07-12
• Study First Submitted: 2017-07-18
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Primary Completion: 2018-03-13
• Study Completion: 2018-03-13
• Results First Submitted: 2018-07-29
• Results First Submitted QC: 2019-05-14
• Results First Posted: 2019-07-19
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 112

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Encouragement Arm	digital family planning screening and referral service	Women randomized to the encouragement arm will receive an invitation via SMS to try the new digital family planning screening and referral service.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Uptake of Long-acting Contraception	1-month post-encouragement	Woman reports starting any long-acting method of contraception since the start of the study

Trial Locations

Locations (1)

Bungoma County; 🇰🇪 Bungoma, Kenya