- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02905526
An Intervention Delivered by App Instant Messaging to Increase Use of Effective Contraception Among Young Women in Bolivia
February 6, 2018 updated by: London School of Hygiene and Tropical Medicine
A Randomised Controlled Trial of an Intervention Delivered by App Instant Messaging to Increase Use of Effective Contraception Among Young Women in Bolivia
This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on use of effective contraception in Bolivia.
Woman aged 16-24 will be randomised to have access to Centro de Investigacion, Educacion y Servicios's sexual and reproductive health app (control) or the app plus 0-3 instant messages a day for 4 months (intervention).
Participants will complete a questionnaire at baseline and 4 month follow-up.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
645
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
La Paz, Bolivia
- Centro de Investigacion, Educacion y Servicios
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Aged 16-24
- Own a personal Android mobile phone
- Live in El Alto or La Paz Bolivia
- Sexually active
- Not using the pill, implant, injection, intrauterine device or patch
- Want to avoid a pregnancy
Exclusion Criteria:
- Cannot read Spanish
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
App plus the contraceptive instant messages
|
Contraceptive Instant messages
Mobile phone app
|
Placebo Comparator: Control
App only
|
Mobile phone app
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Use of effective contraception
Time Frame: 4 months
|
The proportion reporting current use of effective contraception (pill, intrauterine device, injection, implant, patch)
|
4 months
|
Acceptability of at least one method of effective contraception
Time Frame: 4 months
|
The proportion reporting that at least one method of effective contraception is acceptable (pill, intrauterine device, injection, implant, patch)
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of individual effective contraceptive methods
Time Frame: 4 months
|
The proportion reporting that individual methods of effective contraception are acceptable (pill, intrauterine device, injection, implant, patch)
|
4 months
|
Discontinuation of effective contraception
Time Frame: 4 months
|
The proportion reporting use of effective contraception at any time during the 4 months (pill, intrauterine device, injection, implant, patch)
|
4 months
|
Service uptake
Time Frame: 4 months
|
The proportion reporting attending a sexual health service during the 4 months
|
4 months
|
Unintended pregnancy
Time Frame: 4 months
|
The proportion reporting that they became pregnant and did not want to become pregnant during the study
|
4 months
|
Induced abortion
Time Frame: 4 months
|
The proportion reporting having an abortion during the study
|
4 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge of effective contraception
Time Frame: 4 months
|
Score on the knowledge measure
|
4 months
|
Perceived norms in relation to using and communicating with partners about contraception
Time Frame: 4 months
|
Responses to the perceived norms scales
|
4 months
|
Personal agency in using and communicating with partners about contraception
Time Frame: 4 months
|
Responses to the personal agency scales
|
4 months
|
Intention to use effective contraception
Time Frame: 4 months
|
Response to the intention scale
|
4 months
|
Intervention 'dose' received
Time Frame: 4 months
|
If participants read all, some, most or none of the messages and if they stopped the messages
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Caroline Free, PhD, London School of Hygiene and Tropical Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- McCarthy OL, Aliaga C, Torrico Palacios ME, Lopez Gallardo J, Huaynoca S, Leurent B, Edwards P, Palmer M, Ahamed I, Free C. An Intervention Delivered by Mobile Phone Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Randomized Controlled Trial. J Med Internet Res. 2020 Jun 22;22(6):e14073. doi: 10.2196/14073.
- McCarthy OL, Osorio Calderon V, Makleff S, Huaynoca S, Leurent B, Edwards P, Lopez Gallardo J, Free C. An Intervention Delivered by App Instant Messaging to Increase Acceptability and Use of Effective Contraception Among Young Women in Bolivia: Protocol of a Randomized Controlled Trial. JMIR Res Protoc. 2017 Dec 18;6(12):e252. doi: 10.2196/resprot.8679.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2017
Primary Completion (Actual)
January 31, 2018
Study Completion (Actual)
January 31, 2018
Study Registration Dates
First Submitted
September 14, 2016
First Submitted That Met QC Criteria
September 16, 2016
First Posted (Estimate)
September 19, 2016
Study Record Updates
Last Update Posted (Actual)
February 7, 2018
Last Update Submitted That Met QC Criteria
February 6, 2018
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10999
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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