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A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use (E0108)

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Duke University

Status

Completed

Conditions

Contraception Behavior

Treatments

Other: digital family planning screening and referral service

Study type

Interventional

Funder types

Other

Identifiers

NCT03224390
2017-0406

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 patients

Sex

Female

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

112 participants in 2 patient groups

Encouragement Arm
Experimental group
Description:
Women randomized to the encouragement arm will receive an invitation via SMS to try the new digital family planning screening and referral service.
Treatment:
Other: digital family planning screening and referral service
Control Arm
No Intervention group
Description:
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.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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