Contraception BehaviorE0108NCT03224390
A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use
A study testing digital family planning screening and referral service in people with Contraception Behavior, run by Duke University at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception Behavior
- What is being tested?
- digital family planning screening and referral service
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteKenya
- Study dates
- 12 Jul 2017to 13 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Contraception Behavior
- Being tested
- digital family planning screening and referral service
- Keywords
- Contraception, Family Planning, Digital Health, Kenya, Unmet Need
- Medical subject headings
- Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital family planning screening and referral serviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4-months post-encouragement
Secondary outcomes (1)
Uptake of Long-acting Contraception
Woman reports starting any long-acting method of contraception since the start of the study
Measured: 1-month post-encouragement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start12 Jul 2017
- Primary completion13 Mar 2018
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Contraception BehaviorStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Moi University
- Responsible party
- Sponsor
- Investigators
- Eric Green, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224390
- Sponsor's protocol ID
- 2017-0406
- Acronym
- E0108
- Status last verified
- Jun 2024
- First submitted
- 18 Jul 2017
- Last updated
- 28 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32779730Green 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.
PubMed 30064968
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Estimate the Impact of a Screening and Referral Service on Contraceptive Use
- ClinicalTrials.gov ID
- NCT03224390
- Acronym / sponsor ID
- E0108 / 2017-0406
- Conditions
- Contraception Behavior
- Keywords
- Contraception, Family Planning, Digital Health, Kenya, Unmet Need
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Moi University
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 19 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Encouragement Arm | Experimental | Other: digital family planning screening and referral serviceWomen randomized to the encouragement arm will receive an invitation via SMS to try the new 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital family planning screening and referral serviceClients 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. | Other | Encouragement Arm |
Primary outcome
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
1 secondary outcome
Uptake of Long-acting Contraception
Time frame: 1-month post-encouragement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32779730Palmer 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.
- Derived from this study: PubMed 30064968Green 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.
- Research design and analysis protocolLink provided by the sponsor.
- Green et al. (2018). Developing a digital marketplace for family planning: Pilot randomized encouragement trial. Journal of Medical Internet Research, 20(7), e10756.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Green, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital family planning screening and referral service in people with Contraception Behavior, run by Duke University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Report Starting Any Modern Method of Contraception Since the Start of the Study (time frame: 4-months post-encouragement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03224390, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.