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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception Behavior

Intervention / Treatment
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* Other: digital family planning screening and referral service


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The service (intervention) is available to anyone living in the catchment area, so it is not possible to randomly assign access to the service and estimate impact through a traditional randomized controlled trial (RCT). Likewise, at this early stage it is not be feasible to randomize access at a higher level, such as counties or subcounties. In situations like this, a variation on the traditional randomized controlled trial called a randomized encouragement design can be very effective. In a randomized encouragement design (RED), participants are randomized to receive an invitation or special encouragement to receive a treatment. Not everyone who is encouraged will take up the service, but as long as those randomly selected to receive the encouragement (the treatment group) use the service at a higher rate than the control group, the impact of the service can be estimated. For more details, see http://bit.ly/RED17protocol (linked in this record).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Encouragement Arm<br>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<br>* 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.<br>|
| No Intervention: Control Arm<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Family Planning, Digital Health, Kenya, Unmet Need