Cervical CancerNCT02509702
Use of SMSs to Improve Attendance to Cervical Cancer Follow-up Screening
A study testing Connected to Care in people with Cervical Cancer, run by Marianne Andersen at 3 sites in Tanzania.
Trial summary
This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Connected to Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 705 participants
- Where
- 3 sitesTanzania
- Study dates
- 17 Aug 2015to 6 Oct 2019
- 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 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Informed consent
- HPV positive
- Age 25 - 60 years
- Private mobile phone
Who cannot join
- Pregnant on day of enrolment
- Menstruating on day of enrolment
- Hysterectomy
- Diagnosed with cervical pre-cancer within past 12 months
- Diagnosed with cervical cancer
- Invalid mobile phone number
- Unreachable when trying to convey HPV positive result
Trial locations and contacts
3 sites in 1 country.
Tanzania3 sites
Ocean Road Cancer Institute (ORCI)
Dar es Salaam, 3592
Mawenzi Regional Referral Hospital
Moshi, Kilimanjaro
Kilimanjaro Christian Medical Centre (KCMC)
Moshi, 3010
About this study
Official title: Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)
This study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.
Read the detailed description
Connected2Care is a non-blinded, multicentre, parallel-group, randomised controlled trial. Tanzanian Women testing positive to HR HPV at inclusion are randomly assigned in an allocation ratio of 1:1 to the SMS intervention or the control group (standard care). In a period of 10 months, the intervention group will receive 15 one-directional health educative text messages and SMS-reminders for their appointment. The total sample size will be 700 with 350 women in each study arm. Primary outcome is attendance rate for follow-up. Secondary objectives are cost-effectiveness measured through incremental ratios and knowledge of cervical cancer by a 16-item true/false scale questionnaire at baseline and follow-up.
- Conditions
- Cervical Cancer
- Being tested
- Connected to Care
- Keywords
- Mobile health, Screening, Early detection of cancer, HPV, SMS intervention, RCT, Tanzania
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Connected to CareBehavioural
10 health educative SMSs' sent once a month 5 SMS-reminders for follow-up appointment sent on days -14, -7, -1 pre- follow-up appointment, and +1, +7 post follow-up appointment
| Study group | Role | What they receive |
|---|---|---|
| Connected to Care | Experimental | The SMS intervention will consist of 15 text messages that will be sent to the intervention group over a period of 10 months. There will be two types of text messages: (1) educational text messages; and (2) SMS reminders for the follow-up appointment. Receives: Behavioral: Connected to Care |
| Control | No intervention | The control group will receive standard care, which is a follow-up appointment at 14 months written on an appointment card. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of SMS intervention on attendance rate to follow-up screening appointment
The effect measure of the intervention is the 14-month follow-up attendance rate for HPV positive women. The number of women in the intervention group that attend follow-up screening will be compared to the the number of women that attend follow-up screening in the control group.
Measured: up to 14 months
Secondary outcomes (2)
Acceptability of text message intervention
6-point Likert scale (1: I do not like it at all - 6: I like it very much)
Measured: Baseline + 2 years Follow-up (likert scale)
Acceptability of text message intervention
Qualitative interviews. Open-ended
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study start17 Aug 2015
- Primary completion6 Oct 2019
- Study completion6 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marianne Andersen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marianne Andersen, Odense University Hospital
- Investigators
- Vibeke Rasch, MD, Study chair, University of Southern DenmarkJulius Mwaiselage, MD, Study chair, Ocean Road Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509702
- Sponsor's protocol ID
- Connected2Care
- Status last verified
- Dec 2021
- First submitted
- 15 Jun 2015
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Linde DS, Andersen MS, Mwaiselage JD, Manongi R, Kjaer SK, Rasch V. Text messages to increase attendance to follow-up cervical cancer screening appointments among HPV-positive Tanzanian women (Connected2Care): study protocol for a randomised controlled trial. Trials. 2017 Nov 21;18(1):555. doi: 10.1186/s13063-017-2215-x.
PubMed 29162148Lokke KF, Rasch V, Mwaiselage J, Gammeltoft T, Linde DS. Acceptability of text messages and knowledge change for cervical cancer screening: a Tanzanian mixed methods study. BMJ Open. 2022 Sep 19;12(9):e058450. doi: 10.1136/bmjopen-2021-058450.
PubMed 36123109Palmer 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 32779730Linde DS, Andersen MS, Mwaiselage J, Manongi R, Kjaer SK, Rasch V. Effectiveness of One-Way Text Messaging on Attendance to Follow-Up Cervical Cancer Screening Among Human Papillomavirus-Positive Tanzanian Women (Connected2Care): Parallel-Group Randomized Controlled Trial. J Med Internet Res. 2020 Apr 2;22(4):e15863. doi: 10.2196/15863.
PubMed 32238335Linde DS, Rasch V, Mwaiselage JD, Gammeltoft TM. Competing needs: a qualitative study of cervical cancer screening attendance among HPV-positive women in Tanzania. BMJ Open. 2019 Feb 27;9(2):e024011. doi: 10.1136/bmjopen-2018-024011.
PubMed 30819704
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messages to Increase Attendance to Follow-up Cervical Cancer Screening Appointments Among HPV Positive Tanzanian Women (Connected2Care)
- ClinicalTrials.gov ID
- NCT02509702
- Acronym / sponsor ID
- Connected2Care
- Conditions
- Cervical Cancer
- Keywords
- Mobile health, Screening, Early detection of cancer, HPV, SMS intervention, RCT, Tanzania
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- Marianne AndersenUniversity, hospital or other
- Study start
- 17 Aug 2015 (actual)
- Primary completion
- 6 Oct 2019 (actual)
- Study completion
- 6 Oct 2019 (actual)
- First posted
- 28 Jul 2015 (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 study evaluates the effect of the SMS intervention 'Connected2Care' on the attendance rate to cervical cancer screening follow-up appointments.
Detailed description
Connected2Care is a non-blinded, multicentre, parallel-group, randomised controlled trial. Tanzanian Women testing positive to HR HPV at inclusion are randomly assigned in an allocation ratio of 1:1 to the SMS intervention or the control group (standard care). In a period of 10 months, the intervention group will receive 15 one-directional health educative text messages and SMS-reminders for their appointment. The total sample size will be 700 with 350 women in each study arm. Primary outcome is attendance rate for follow-up. Secondary objectives are cost-effectiveness measured through incremental ratios and knowledge of cervical cancer by a 16-item true/false scale questionnaire at baseline and follow-up.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connected to Care | Experimental | Behavioral: Connected to CareThe SMS intervention will consist of 15 text messages that will be sent to the intervention group over a period of 10 months. There will be two types of text messages: (1) educational text messages; and (2) SMS reminders for the follow-up appointment. |
| Control | No intervention | –The control group will receive standard care, which is a follow-up appointment at 14 months written on an appointment card. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Informed consent
- HPV positive
- Age 25 - 60 years
- Private mobile phone
Key exclusion criteria (7 listed)
- Pregnant on day of enrolment
- Menstruating on day of enrolment
- Hysterectomy
- Diagnosed with cervical pre-cancer within past 12 months
- Diagnosed with cervical cancer
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 |
|---|---|---|
| Connected to Care10 health educative SMSs' sent once a month 5 SMS-reminders for follow-up appointment sent on days -14, -7, -1 pre- follow-up appointment, and +1, +7 post follow-up appointment | Behavioural | Connected to Care |
Primary outcome
Effect of SMS intervention on attendance rate to follow-up screening appointment
Time frame: up to 14 months
The effect measure of the intervention is the 14-month follow-up attendance rate for HPV positive women. The number of women in the intervention group that attend follow-up screening will be compared to the the number of women that attend follow-up screening in the control group.
2 secondary outcomes
Acceptability of text message intervention
Time frame: Baseline + 2 years Follow-up (likert scale)
Acceptability of text message intervention
Time frame: 2 years
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 29 Dec 2021.
- Background: PubMed 29162148Linde DS, Andersen MS, Mwaiselage JD, Manongi R, Kjaer SK, Rasch V. Text messages to increase attendance to follow-up cervical cancer screening appointments among HPV-positive Tanzanian women (Connected2Care): study protocol for a randomised controlled trial. Trials. 2017 Nov 21;18(1):555. doi: 10.1186/s13063-017-2215-x.
- Derived from this study: PubMed 36123109Lokke KF, Rasch V, Mwaiselage J, Gammeltoft T, Linde DS. Acceptability of text messages and knowledge change for cervical cancer screening: a Tanzanian mixed methods study. BMJ Open. 2022 Sep 19;12(9):e058450. doi: 10.1136/bmjopen-2021-058450.
- 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 32238335Linde DS, Andersen MS, Mwaiselage J, Manongi R, Kjaer SK, Rasch V. Effectiveness of One-Way Text Messaging on Attendance to Follow-Up Cervical Cancer Screening Among Human Papillomavirus-Positive Tanzanian Women (Connected2Care): Parallel-Group Randomized Controlled Trial. J Med Internet Res. 2020 Apr 2;22(4):e15863. doi: 10.2196/15863.
- Derived from this study: PubMed 30819704Linde DS, Rasch V, Mwaiselage JD, Gammeltoft TM. Competing needs: a qualitative study of cervical cancer screening attendance among HPV-positive women in Tanzania. BMJ Open. 2019 Feb 27;9(2):e024011. doi: 10.1136/bmjopen-2018-024011.
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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.
Vibeke Rasch, MD study chair
University of Southern Denmark
Julius Mwaiselage, MD study chair
Ocean Road Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Connected to Care in people with Cervical Cancer, run by Marianne Andersen at 3 sites in Tanzania.
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 4 inclusion and 7 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 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Tanzania. 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?
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?
Effect of SMS intervention on attendance rate to follow-up screening appointment (time frame: up to 14 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 NCT02509702, which also lists 5 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 29 Dec 2021.