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Clinical Trials/NCT03224390
NCT03224390
Completed
Not Applicable

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

Duke University1 site in 1 country112 target enrollmentJuly 12, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Contraception Behavior
Sponsor
Duke University
Enrollment
112
Locations
1
Primary Endpoint
Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 12, 2017
End Date
March 13, 2018
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Uptake of Long-acting Contraception(1-month post-encouragement)

Study Sites (1)

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