ContraceptionMOTIFNCT01823861
Mobile Technology for Improved Family Planning
A study testing Mobile phone-based intervention in people with Contraception and Post-abortion Family Planning, run by Marie Stopes International at 1 site in Cambodia.
Trial summary
An individual randomised controlled trial (RCT) to evaluate the effectiveness of a voice-based mobile phone health (mHealth) intervention to support post-abortion family planning (PAFP) at four Marie Stopes International clinics in Cambodia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Contraception, Post-abortion Family Planning, mHealth
- What is being tested?
- Mobile phone-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCambodia
- Study dates
- May 2013to Dec 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Client attending for abortion
- Client does not want to have a child at the current time
- Client aged 18 or over
- Client owns a mobile phone
- Client willing to receive simple voice messages relating to contraception from Marie Stopes in Khmer language
Who cannot join
- Not meeting inclusion criteria
- Declined to participate
Trial locations and contacts
1 site in 1 country.
About this study
An individual randomised controlled trial (RCT) to evaluate the effectiveness of a voice-based mobile phone health (mHealth) intervention to support post-abortion family planning (PAFP) at four Marie Stopes International clinics in Cambodia.
The study seeks to address the research question: does a PAFP mHealth intervention increase use of contraception in Cambodia? STUDY RESULTS: http://www.who.int/bulletin/online_first/en/
- Conditions
- Contraception, Post-abortion Family Planning, mHealth
- Being tested
- Mobile phone-based intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile phone-based interventionBehavioural
Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message.
| Study group | Role | What they receive |
|---|---|---|
| Mobile phone-based intervention | Experimental | Standard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message. Receives: Behavioral: Mobile phone-based intervention |
| Standard care | No intervention | Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of a Effective Contraceptive Method at Four-months Post-abortion
Self-reported use of pill, coil, implant or injection for all participants. Objective measurement of contraceptive use for participants from one clinic.
Measured: 4 months
Secondary outcomes (3)
Pregnancy
Measured: 4 months
Repeat Abortion
Measured: 4 months
Contraceptive Discontinuation
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 posted4 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2014
- Study completionDec 2014
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 (6)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marie Stopes International
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01823861
- Sponsor's protocol ID
- MarieStopes
- Acronym
- MOTIF
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2013
- Last updated
- 16 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Smith C, Ngo TD, Gold J, Edwards P, Vannak U, Sokhey L, Machiyama K, Slaymaker E, Warnock R, McCarthy O, Free C. Effect of a mobile phone-based intervention on post-abortion contraception: a randomized controlled trial in Cambodia. Bull World Health Organ. 2015 Dec 1;93(12):842-50A. doi: 10.2471/BLT.15.160267. Epub 2015 Oct 15.
PubMed 26668436Hill J, McGinn J, Cairns J, Free C, Smith C. A Mobile Phone-Based Support Intervention to Increase Use of Postabortion Family Planning in Cambodia: Cost-Effectiveness Evaluation. JMIR Mhealth Uhealth. 2020 Feb 25;8(2):e16276. doi: 10.2196/16276.
PubMed 32130166Smith C, Edwards P, Free C. Assessing the validity and reliability of self-report data on contraception use in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial. Reprod Health. 2018 Mar 15;15(1):50. doi: 10.1186/s12978-018-0494-7.
PubMed 29544520Smith C, Jarvis C, Free C. Assessing loss to follow-up in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial. Trials. 2017 Dec 1;18(1):577. doi: 10.1186/s13063-017-2316-6.
PubMed 29191231Smith C, Ngo TD, Edwards P, Free C. MObile Technology for Improved Family Planning: update to randomised controlled trial protocol. Trials. 2014 Nov 12;15:440. doi: 10.1186/1745-6215-15-440.
PubMed 25388660Smith C, Vannak U, Sokhey L, Ngo TD, Gold J, Khut K, Edwards P, Rathavy T, Free C. MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial. Trials. 2013 Dec 12;14:427. doi: 10.1186/1745-6215-14-427.
PubMed 24330763
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Technology for Improved Family Planning
- ClinicalTrials.gov ID
- NCT01823861
- Acronym / sponsor ID
- MOTIF / MarieStopes
- Conditions
- Contraception, Post-abortion Family Planning, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Marie Stopes InternationalUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine
- Study start
- May 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 16 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An individual randomised controlled trial (RCT) to evaluate the effectiveness of a voice-based mobile phone health (mHealth) intervention to support post-abortion family planning (PAFP) at four Marie Stopes International clinics in Cambodia.
The study seeks to address the research question: does a PAFP mHealth intervention increase use of contraception in Cambodia? STUDY RESULTS: http://www.who.int/bulletin/online_first/en/
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile phone-based intervention | Experimental | Behavioral: Mobile phone-based interventionStandard care plus automated voice message to support post-abortion contraception use every two weeks for total of three months and direct follow up phone call by family planning counsellor depending on response to voice message. |
| Standard care | No intervention | –Face-to-face post-abortion family planning (PAFP) counselling, follow-up at one or two weeks, clinic phone number, existing 'Hotline' phone number. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Client attending for abortion
- Client does not want to have a child at the current time
- Client aged 18 or over
- Client owns a mobile phone
- Client willing to receive simple voice messages relating to contraception from Marie Stopes in Khmer language
Key exclusion criteria (2 listed)
- Not meeting inclusion criteria
- Declined to participate
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 |
|---|---|---|
| Mobile phone-based interventionAutomated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message. | Behavioural | Mobile phone-based intervention |
Primary outcome
Use of a Effective Contraceptive Method at Four-months Post-abortion
Time frame: 4 months
Self-reported use of pill, coil, implant or injection for all participants. Objective measurement of contraceptive use for participants from one clinic.
3 secondary outcomes
Pregnancy
Time frame: 4 months
Repeat Abortion
Time frame: 4 months
Contraceptive Discontinuation
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26668436Smith C, Ngo TD, Gold J, Edwards P, Vannak U, Sokhey L, Machiyama K, Slaymaker E, Warnock R, McCarthy O, Free C. Effect of a mobile phone-based intervention on post-abortion contraception: a randomized controlled trial in Cambodia. Bull World Health Organ. 2015 Dec 1;93(12):842-50A. doi: 10.2471/BLT.15.160267. Epub 2015 Oct 15.
- Derived from this study: PubMed 32130166Hill J, McGinn J, Cairns J, Free C, Smith C. A Mobile Phone-Based Support Intervention to Increase Use of Postabortion Family Planning in Cambodia: Cost-Effectiveness Evaluation. JMIR Mhealth Uhealth. 2020 Feb 25;8(2):e16276. doi: 10.2196/16276.
- Derived from this study: PubMed 29544520Smith C, Edwards P, Free C. Assessing the validity and reliability of self-report data on contraception use in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial. Reprod Health. 2018 Mar 15;15(1):50. doi: 10.1186/s12978-018-0494-7.
- Derived from this study: PubMed 29191231Smith C, Jarvis C, Free C. Assessing loss to follow-up in the MObile Technology for Improved Family Planning (MOTIF) randomised controlled trial. Trials. 2017 Dec 1;18(1):577. doi: 10.1186/s13063-017-2316-6.
- Derived from this study: PubMed 25388660Smith C, Ngo TD, Edwards P, Free C. MObile Technology for Improved Family Planning: update to randomised controlled trial protocol. Trials. 2014 Nov 12;15:440. doi: 10.1186/1745-6215-15-440.
- Derived from this study: PubMed 24330763Smith C, Vannak U, Sokhey L, Ngo TD, Gold J, Khut K, Edwards P, Rathavy T, Free C. MObile Technology for Improved Family Planning Services (MOTIF): study protocol for a randomised controlled trial. Trials. 2013 Dec 12;14:427. doi: 10.1186/1745-6215-14-427.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile phone-based intervention in people with Contraception and Post-abortion Family Planning, run by Marie Stopes International at 1 site in Cambodia.
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 5 inclusion and 2 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 16 Mar 2020. 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 Cambodia. 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 16 Mar 2020). 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?
Use of a Effective Contraceptive Method at Four-months Post-abortion (time frame: 4 months). 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 NCT01823861, which also lists 6 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 16 Mar 2020.