ContraceptionNCT02905526
An Intervention Delivered by App Instant Messaging to Increase Use of Effective Contraception Among Young Women in Bolivia
A study testing Contraceptive instant messages and Mobile phone app in people with Contraception, run by London School of Hygiene and Tropical Medicine at 1 site in Bolivia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Contraceptive instant messages and Mobile phone app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 645 participants
- Where
- 1 siteBolivia
- Study dates
- 1 Mar 2017to 31 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 24 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Cannot read Spanish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Contraception
- Being tested
- Contraceptive instant messages, Mobile phone app
- Keywords
- Reproductive health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contraceptive instant messagesBehavioural
Contraceptive Instant messages
Mobile phone appOther
Mobile phone app
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | App plus the contraceptive instant messages Receives: Behavioral: Contraceptive instant messages; Other: Mobile phone app |
| Control | Placebo comparator | App only Receives: Other: Mobile phone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of effective contraception
The proportion reporting current use of effective contraception (pill, intrauterine device, injection, implant, patch)
Measured: 4 months
Acceptability of at least one method of effective contraception
The proportion reporting that at least one method of effective contraception is acceptable (pill, intrauterine device, injection, implant, patch)
Measured: 4 months
Secondary outcomes (5)
Acceptability of individual effective contraceptive methods
The proportion reporting that individual methods of effective contraception are acceptable (pill, intrauterine device, injection, implant, patch)
Measured: 4 months
Discontinuation of effective contraception
The proportion reporting use of effective contraception at any time during the 4 months (pill, intrauterine device, injection, implant, patch)
Measured: 4 months
Service uptake
The proportion reporting attending a sexual health service during the 4 months
Measured: 4 months
Unintended pregnancy
The proportion reporting that they became pregnant and did not want to become pregnant during the study
Measured: 4 months
Induced abortion
The proportion reporting having an abortion during the study
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start1 Mar 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 645 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- International Planned Parenthood Federation, Centro de Investigacion, Educacion y Servicios
- Responsible party
- Sponsor
- Investigators
- Caroline Free, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905526
- Sponsor's protocol ID
- 10999
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2016
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 32568092McCarthy 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.
PubMed 29254910
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of an Intervention Delivered by App Instant Messaging to Increase Use of Effective Contraception Among Young Women in Bolivia
- ClinicalTrials.gov ID
- NCT02905526
- Acronym / sponsor ID
- 10999
- Conditions
- Contraception
- Keywords
- Reproductive health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 645 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- International Planned Parenthood Federation, Centro de Investigacion, Educacion y Servicios
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Contraceptive instant messages, Other: Mobile phone appApp plus the contraceptive instant messages |
| Control | Placebo comparator | Other: Mobile phone appApp only |
Who may qualify
- Ages
- 16 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Cannot read Spanish
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 |
|---|---|---|
| Contraceptive instant messagesContraceptive Instant messages | Behavioural | Intervention |
| Mobile phone appMobile phone app | Other | Control, Intervention |
Primary outcome
Use of effective contraception
Time frame: 4 months
The proportion reporting current use of effective contraception (pill, intrauterine device, injection, implant, patch)
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)
5 secondary outcomes
Acceptability of individual effective contraceptive methods
Time frame: 4 months
Discontinuation of effective contraception
Time frame: 4 months
Service uptake
Time frame: 4 months
Unintended pregnancy
Time frame: 4 months
Induced abortion
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Derived from this study: PubMed 32568092McCarthy 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.
- Derived from this study: PubMed 29254910McCarthy 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.
- Individual participant dataSharing planned: Undecided
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Contraception
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.
Caroline Free, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contraceptive instant messages and Mobile phone app in people with Contraception, run by London School of Hygiene and Tropical Medicine at 1 site in Bolivia.
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 6 inclusion and 1 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 7 Feb 2018. 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 Bolivia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Use of effective contraception (time frame: 4 months). The study lists 2 primary outcomes in all. 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 NCT02905526, 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 7 Feb 2018.