Clinical trial NCT03224390: A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use
Official title: A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception Behavior
Keywords: Contraception
Family Planning
Digital Health
Kenya
Unmet Need
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Moi University
First posted: 2017-07-21
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study
timeFrame: 4-months post-encouragement
Secondary outcomes:
measure: Uptake of Long-acting Contraception
timeFrame: 1-month post-encouragement
Other outcomes:
Locations:
city: Bungoma
country: Kenya
facility: Bungoma County
Study officials:
affiliation: Duke University
name: Eric Green, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.
citation: Green EP, Augustine A, Naanyu V, Hess AK, Kiwinda L. Developing a Digital Marketplace for Family Planning: Pilot Randomized Encouragement Trial. J Med Internet Res. 2018 Jul 31;20(7):e10756. doi: 10.2196/10756.