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Completed

NCT Number: NCT03224390

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.

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Key information

Conditions

Contraception Behavior Behavior Reproductive Behavior

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bungoma County

Bungoma, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

digital family planning screening and referral service

Other

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.

Primary outcomes

  1. Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study

    Time frame: 4-months post-encouragement

    Woman reports starting any modern method of contraception since the start of the study

Secondary outcomes

  1. Uptake of Long-acting Contraception

    Time frame: 1-month post-encouragement

    Woman reports starting any long-acting method of contraception since the start of the study

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Moi University

Registry information

Acronym: E0108

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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