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

Contraception Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03224390
• Other study ID #: E0108
• Status: Completed
• Phase: N/A
• Start date: July 12, 2017
• Est. completion date: March 13, 2018

Study information

• Verified date: October 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: March 13, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception Behavior

Intervention

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.

Locations

Country	Name	City	State
Kenya	Bungoma County	Bungoma

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Moi University

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Uptake of Long-acting Contraception	Woman reports starting any long-acting method of contraception since the start of the study	1-month post-encouragement

External Links

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