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| Name | Class |
|---|---|
| Moi University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of Long-acting Contraception | Woman reports starting any long-acting method of contraception since the start of the study | 1-month post-encouragement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Green, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bungoma County | Bungoma | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32779730 | Derived | 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. | |
| 30064968 | Derived |
| Label | URL |
|---|---|
| Research design and analysis protocol | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Encouragement Arm | One month after the end of the recruitment period, on October 2, 2017, women randomized to the encouragement arm received an invitation via SMS text message to try the service and complete a free family planning screening (plus bonus phone credit of approximately US $2, not conditional on the use of service). |
| FG001 | Control Arm | Women randomized to the control arm received a different set of messages thanking them for participating in the study; the control messages did not mention the investigational service. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Encouragement Arm | One month after the end of the recruitment period, on October 2, 2017, women randomized to the encouragement arm received an invitation via SMS text message to try the service and complete a free family planning screening (plus bonus phone credit of approximately US $2, not conditional on the use of service). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 4-months post-encouragement |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Encouragement Arm | One month after the end of the recruitment period, on October 2, 2017, women randomized to the encouragement arm received an invitation via SMS text message to try the service and complete a free family planning screening (plus bonus phone credit of approximately US $2, not conditional on the use of service). |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Green | Duke University | 9196817289 | eric.green@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2017 | Jan 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003268 | Contraception Behavior |
| ID | Term |
|---|---|
| D043762 | Reproductive Behavior |
| D001519 | Behavior |
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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).
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|
| 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. |
| Green et al. (2018). Developing a digital marketplace for family planning: Pilot randomized encouragement trial. Journal of Medical Internet Research, 20(7), e10756. | View source |
| Control Arm |
Women randomized to the control arm received a different set of messages thanking them for participating in the study; the control messages did not mention the investigational service. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Secondary | Uptake of Long-acting Contraception | Woman reports starting any long-acting method of contraception since the start of the study | data were not collected | Posted | 1-month post-encouragement |
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 0 |
| 56 |
| EG001 | Control Arm | Women randomized to the control arm received a different set of messages thanking them for participating in the study; the control messages did not mention the investigational service. | 0 | 56 | 0 | 56 | 0 | 56 |
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