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

NCT03224390 | Completed Results

• 1 other identifier: 2017-0406
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception Behavior

Keywords

Contraception; Family Planning; Digital Health; Kenya; Unmet Need

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Uptake of Long-acting Contraception

  1-month post-encouragement

Study Arms (2)

Encouragement Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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.

Interventions

digital family planning screening and referral service OTHER

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.

Encouragement Arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• Moi University: collaborator

Study Sites (1)

Bungoma County

Bungoma, Kenya

Location

Related Publications (2)

• 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.

  PMID: 32779730 DERIVED

• 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.

  PMID: 30064968 DERIVED

Related Links

• Research design and analysis protocol
• Green et al. (2018). Developing a digital marketplace for family planning: Pilot randomized encouragement trial. Journal of Medical Internet Research, 20(7), e10756.

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Limitations and Caveats

The main limitation of this study was attrition. While attrition was not significantly associated with treatment assignment, found and unfound participants at endline differed on a few baseline characteristics.

Results Point of Contact

• Title: Dr. Eric Green
• Organization: Duke University

eric.green@duke.edu

9196817289

Study Officials

• Eric Green, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 18, 2017
• First Posted: July 21, 2017
• Study Start: July 12, 2017
• Primary Completion: March 13, 2018
• Study Completion: March 13, 2018
• Last Updated: June 28, 2024
• Results First Posted: July 19, 2019

Record last verified: 2024-06

Locations

KE (1)