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

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ClinicalTrials.gov Identifier: NCT03224390
Recruitment Status : Completed
First Posted : July 21, 2017
Results First Posted : July 19, 2019
Last Update Posted : October 22, 2019
Sponsor:
Collaborator:
Moi University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Contraception Behavior Other: digital family planning screening and referral service Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Care Provider, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use
Actual Study Start Date : July 12, 2017
Actual Primary Completion Date : March 13, 2018
Actual Study Completion Date : March 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224390


Locations
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Kenya
Bungoma County
Bungoma, Kenya
Sponsors and Collaborators
Duke University
Moi University
Investigators
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Principal Investigator: Eric Green, PhD Duke University
  Study Documents (Full-Text)

Documents provided by Duke University:
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03224390    
Other Study ID Numbers: E0108
First Posted: July 21, 2017    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: October 22, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
Contraception
Family Planning
Digital Health
Kenya
Unmet Need