Reproductive HealthSMARTNCT02031575
Study on Mhealth and Reproductive Health in Teens
A study testing Interactive Treatment and Basic Treatment in people with Reproductive Health, run by Harvard University at 1 site in Ghana.
Trial summary
The purpose of the Study on Mhealth and Reproductive Health in Teens (SMART) is to evaluate the effectiveness of using text messages to improve the knowledge, communication, and attitudes about reproductive health among female adolescents in Greater Accra senior high schools. Read more about this study
- Who is it for?
- Ages 14 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Reproductive Health
- What is being tested?
- Interactive Treatment and Basic Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,419 participants
- Where
- 1 siteGhana
- Study dates
- Jan 2014to Jul 2015
- 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 14 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- female
- aged 14-24
- secondary school student at day school
- aged 14-24
- secondary school student at day school
Who cannot join
- male
- secondary school student at boarding school
- secondary school student at boarding school
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the Study on Mhealth and Reproductive Health in Teens (SMART) is to evaluate the effectiveness of using text messages to improve the knowledge, communication, and attitudes about reproductive health among female adolescents in Greater Accra senior high schools. Previous research as well as qualitative work conducted by the Investigators shows that there are significant gaps in knowledge about reproductive health including on topics of pregnancy, sexually transmitted diseases, and contraception among secondary school students in Greater Accra. These gaps contribute to unwanted pregnancy and spread of sexually transmitted diseases. At the same time, phone ownership and use among young people has spread rapidly, especially in urban areas such as Accra. The Study on Mhealth and Reproductive Health (SMART) will seek to use mobile phone messages to increase awareness of these reproductive health issues among female adolescents in Accra. The objectives of SMART are to evaluate whether the messages can increase knowledge, increase communication, and improve attitudes towards reproductive health among adolescents in Greater Accra. By conducting a randomized controlled trial, we will be able to statistically evaluate if the messages have had any effect on improving outcomes for adolescents in the areas of knowledge, communication, and attitudes. This work can help guide future programs that can scale up this intervention and ultimately improve the health and wellbeing of adolescents across Ghana.
- Conditions
- Reproductive Health
- Being tested
- Interactive Treatment, Basic Treatment, Control, comparator arm
- Keywords
- Reproductive Health, Contraception, Public Health, Sexual Health, Adolescents, Mobile Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive TreatmentBehavioural
Mobile phone text messaging service about reproductive health
Basic TreatmentBehavioural
Mobile phone text messaging service about reproductive health
Control, comparator armOther
| Study group | Role | What they receive |
|---|---|---|
| Basic Treatment | Experimental | Sends messages to participants about reproductive health. Receives: Behavioral: Basic Treatment |
| Interactive Treatment | Experimental | Sends multiple choice questions and receives texts message responses from participants with incentive for responding correctly Receives: Behavioral: Interactive Treatment |
| Control | Placebo comparator | Sends messages to students about malaria prevention and control. Receives: Other: Control, comparator arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Reproductive Health True/False Quiz of 20 questions
Measured: 5-6 months after baseline and then again 14-16 months after baseline
Sexual behavior
Assessed via a number of items: age at sexual debut, sex without a condom in the past year, pregnancy in the past year, ever had sex, use of condom at sexual debut, sex in the past year, used any contraception in the past year, used contraception at last sex, had an abortion
Measured: 14-16 months after baseline
Secondary outcomes (2)
Communication about reproductive health with family, friends, professional, and boyfriend
Communication is assessed via questionnaire items that ask the participant how often the participant has communicated with family, friends, professional, and boyfriend over the past 3 months.
Measured: 3 months (asked 5-6 months after baseline and again 12-14 months after baseline)
Attitudes about reproductive health as measured by 5-point Likert type scale
Attitudes about reproductive health are measured via questionnaire items that ask participants about their attitudes about reproductive health. They respond via a 5-point Likert type scale.
Measured: 5-6 months after baseline and asked again 12-14 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reproductive HealthStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Collaborators
- Weiss Family Program Fund for Research in Development Economics, Harvard Lab for Economic Applications and Policy
- Responsible party
- Principal investigator, Slawa Rokicki, Harvard University
- Investigators
- Slawa Rokicki, MS, BS, Principal investigator, Harvard UniversityGunther Fink, PhD, Study chair, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031575
- Sponsor's protocol ID
- IRB13-1647
- Acronym
- SMART
- Status last verified
- Aug 2016
- First submitted
- 7 Jan 2014
- Last updated
- 18 Aug 2016
- Results posted
- No
Publications
Rokicki S, Fink G. Assessing the reach and effectiveness of mHealth: evidence from a reproductive health program for adolescent girls in Ghana. BMC Public Health. 2017 Dec 20;17(1):969. doi: 10.1186/s12889-017-4939-7.
PubMed 29262823
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Mhealth and Reproductive Health in Teens
- ClinicalTrials.gov ID
- NCT02031575
- Acronym / sponsor ID
- SMART / IRB13-1647
- Conditions
- Reproductive Health
- Keywords
- Reproductive Health, Contraception, Public Health, Sexual Health, Adolescents, Mobile Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,419 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Collaborators
- Weiss Family Program Fund for Research in Development Economics, Harvard Lab for Economic Applications and Policy
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 9 Jan 2014 (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.
The purpose of the Study on Mhealth and Reproductive Health in Teens (SMART) is to evaluate the effectiveness of using text messages to improve the knowledge, communication, and attitudes about reproductive health among female adolescents in Greater Accra senior high schools. Previous research as well as qualitative work conducted by the Investigators shows that there are significant gaps in knowledge about reproductive health including on topics of pregnancy, sexually transmitted diseases, and contraception among secondary school students in Greater Accra. These gaps contribute to unwanted pregnancy and spread of sexually transmitted diseases. At the same time, phone ownership and use among young people has spread rapidly, especially in urban areas such as Accra. The Study on Mhealth and Reproductive Health (SMART) will seek to use mobile phone messages to increase awareness of these reproductive health issues among female adolescents in Accra. The objectives of SMART are to evaluate whether the messages can increase knowledge, increase communication, and improve attitudes towards reproductive health among adolescents in Greater Accra. By conducting a randomized controlled trial, we will be able to statistically evaluate if the messages have had any effect on improving outcomes for adolescents in the areas of knowledge, communication, and attitudes. This work can help guide future programs that can scale up this intervention and ultimately improve the health and wellbeing of adolescents across Ghana.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Basic Treatment | Experimental | Behavioral: Basic TreatmentSends messages to participants about reproductive health. |
| Interactive Treatment | Experimental | Behavioral: Interactive TreatmentSends multiple choice questions and receives texts message responses from participants with incentive for responding correctly |
| Control | Placebo comparator | Other: Control, comparator armSends messages to students about malaria prevention and control. |
Who may qualify
- Ages
- 14 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- female
- aged 14-24
- secondary school student at day school
- aged 14-24
- secondary school student at day school
Key exclusion criteria (3 listed)
- male
- secondary school student at boarding school
- secondary school student at boarding school
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 |
|---|---|---|
| Interactive TreatmentMobile phone text messaging service about reproductive health | Behavioural | Interactive Treatment |
| Basic TreatmentMobile phone text messaging service about reproductive health | Behavioural | Basic Treatment |
| Control, comparator arm | Other | Control |
Primary outcome
Knowledge of Reproductive Health True/False Quiz of 20 questions
Time frame: 5-6 months after baseline and then again 14-16 months after baseline
Sexual behavior
Time frame: 14-16 months after baseline
Assessed via a number of items: age at sexual debut, sex without a condom in the past year, pregnancy in the past year, ever had sex, use of condom at sexual debut, sex in the past year, used any contraception in the past year, used contraception at last sex, had an abortion
2 secondary outcomes
Communication about reproductive health with family, friends, professional, and boyfriend
Time frame: 3 months (asked 5-6 months after baseline and again 12-14 months after baseline)
Attitudes about reproductive health as measured by 5-point Likert type scale
Time frame: 5-6 months after baseline and asked again 12-14 months after baseline
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 18 Aug 2016.
- Derived from this study: PubMed 29262823Rokicki S, Fink G. Assessing the reach and effectiveness of mHealth: evidence from a reproductive health program for adolescent girls in Ghana. BMC Public Health. 2017 Dec 20;17(1):969. doi: 10.1186/s12889-017-4939-7.
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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.
Slawa Rokicki, MS, BS principal investigator
Harvard University
Gunther Fink, PhD study chair
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Treatment and Basic Treatment in people with Reproductive Health, run by Harvard University at 1 site in Ghana.
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 3 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 18 Aug 2016. 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 Ghana. 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?
Knowledge of Reproductive Health True/False Quiz of 20 questions (time frame: 5-6 months after baseline and then again 14-16 months after baseline). 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 NCT02031575, which also lists 1 linked publication.
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 18 Aug 2016.