ContraceptionNCT02905513
An Intervention Delivered by App Instant Messaging to Increase the Acceptability of Effective Contraception Among Young People in Tajikistan
A study testing Contraceptive app instant messages and Mobile phone app in people with Contraception, run by London School of Hygiene and Tropical Medicine at 1 site in Tajikistan.
Trial summary
This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on the acceptability of effective contraception in Tajikistan. Read more about this study
- Who is it for?
- Ages 16 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- Contraceptive app 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
- 580 participants
- Where
- 1 siteTajikistan
- Study dates
- 16 Nov 2016to 30 Nov 2017
- 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
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 16-24
- Own a personal Android mobile phone
- Live in Tajikistan
Who cannot join
- Cannot read Tajik or Russian
Trial locations and contacts
1 site in 1 country.
Tajikistan1 site
Tajik Family Planning Alliance
Dushanbe
About this study
Official title: A Randomised Controlled Trial of an Intervention Delivered by App Instant Messaging to Increase the Acceptability of Effective Contraception Among Young People in Tajikistan
This randomised controlled trial will establish the effect a contraceptive intervention delivered by mobile phone app instant messaging on the acceptability of effective contraception in Tajikistan. Woman and men aged 16-24 will be randomised to have access to the Tajik Family Planning Alliance'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 months.
- Conditions
- Contraception
- Being tested
- Contraceptive app 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 app instant messagesBehavioural
Mobile phone appOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | App plus the contraceptive instant messages Receives: Behavioral: Contraceptive app 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.
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)
Measured: 4 months
Secondary outcomes (6)
Use of effective contraception
The proportion reporting current use of effective contraception (pill, intrauterine device, injection, implant)
Measured: 4 months
Acceptability of individual effective contraceptive methods
The proportion reporting that individual methods of effective contraception are acceptable (pill, intrauterine device, injection, implant)
Measured: 4 months
Discontinuation of effective contraception
The proportion reporting use (or partner's 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 (or partner became pregnant) and did not want to become pregnant during the study
Measured: 4 months
Induced abortion
The proportion reporting having (or partner 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 start16 Nov 2016
- Primary completion31 Jul 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- 580 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, Tajik Family Planning Alliance
- Responsible party
- Sponsor
- Investigators
- Caroline Free, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905513
- Sponsor's protocol ID
- 10998
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2016
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 32779730McCarthy O, Ahamed I, Kulaeva F, Tokhirov R, Saibov S, Vandewiele M, Standaert S, Leurent B, Edwards P, Palmer M, Free C. A randomized controlled trial of an intervention delivered by mobile phone app instant messaging to increase the acceptability of effective contraception among young people in Tajikistan. Reprod Health. 2018 Feb 13;15(1):28. doi: 10.1186/s12978-018-0473-z.
PubMed 29433506McCarthy O, Leurent B, Edwards P, Tokhirov R, Free C. A randomised controlled trial of an intervention delivered by app instant messaging to increase the acceptability of effective contraception among young people in Tajikistan: study protocol. BMJ Open. 2017 Sep 21;7(9):e017606. doi: 10.1136/bmjopen-2017-017606.
PubMed 28939582
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 the Acceptability of Effective Contraception Among Young People in Tajikistan
- ClinicalTrials.gov ID
- NCT02905513
- Acronym / sponsor ID
- 10998
- Conditions
- Contraception
- Keywords
- Reproductive health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 580 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- International Planned Parenthood Federation, Tajik Family Planning Alliance
- Study start
- 16 Nov 2016 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 30 Nov 2017 (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 the acceptability of effective contraception in Tajikistan. Woman and men aged 16-24 will be randomised to have access to the Tajik Family Planning Alliance'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 months.
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 app 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
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 16-24
- Own a personal Android mobile phone
- Live in Tajikistan
Key exclusion criteria (1 listed)
- Cannot read Tajik or Russian
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 app instant messages | Behavioural | Intervention |
| Mobile phone app | Other | Control, Intervention |
Primary outcome
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)
6 secondary outcomes
Use of effective contraception
Time frame: 4 months
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 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 29433506McCarthy O, Ahamed I, Kulaeva F, Tokhirov R, Saibov S, Vandewiele M, Standaert S, Leurent B, Edwards P, Palmer M, Free C. A randomized controlled trial of an intervention delivered by mobile phone app instant messaging to increase the acceptability of effective contraception among young people in Tajikistan. Reprod Health. 2018 Feb 13;15(1):28. doi: 10.1186/s12978-018-0473-z.
- Derived from this study: PubMed 28939582McCarthy O, Leurent B, Edwards P, Tokhirov R, Free C. A randomised controlled trial of an intervention delivered by app instant messaging to increase the acceptability of effective contraception among young people in Tajikistan: study protocol. BMJ Open. 2017 Sep 21;7(9):e017606. doi: 10.1136/bmjopen-2017-017606.
- Individual participant dataSharing planned: Undecided
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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.
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 app instant messages and Mobile phone app in people with Contraception, run by London School of Hygiene and Tropical Medicine at 1 site in Tajikistan.
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 3 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 Tajikistan. 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?
Acceptability of at least one method of effective contraception (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 NCT02905513, which also lists 3 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.