Study on Mhealth and Reproductive Health in Teens

Reproductive Health Clinical Trial

— SMART  

Official title:

Study on Mhealth and Reproductive Health in Teens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031575
• Other study ID #: IRB13-1647
• Status: Completed
• Phase: N/A
• First received: January 7, 2014
• Last updated: August 17, 2016
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: August 2016
• Source: Harvard University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1419
• Est. completion date: July 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 14 Years to 24 Years

Eligibility

Inclusion Criteria (for treated and control subjects):

• female

• aged 14-24

• secondary school student at day school

Exclusion Criteria (for treated and control subjects):

• male

• secondary school student at boarding school

Inclusion criteria (for spillover subjects):

• aged 14-24

• secondary school student at day school

Exclusion Criteria (for spillover subjects):

• secondary school student at boarding school

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Reproductive Health

Intervention

Behavioral:
• Interactive Treatment
Mobile phone text messaging service about reproductive health
• Basic Treatment
Mobile phone text messaging service about reproductive health

Other:
• Control, comparator arm

Locations

Country	Name	City	State
Ghana	Innovations for Poverty Action	Accra	Greater Accra

Sponsors (3)

Lead Sponsor	Collaborator
Harvard University	Harvard Lab for Economic Applications and Policy, Weiss Family Program Fund for Research in Development Economics

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spillover effect	Assess how much knowledge, communication, and attitudes spilled over to students in same school but not receiving any intervention	3-6 months	No
Other	Process Measures	Assess whether students liked the intervention, whether they used it, and other questions designed to understand whether the mobile service was useful from students' perspectives	3-6 months	No
Other	Heterogeneous effects	Assess whether treatment effects are heterogeneous along a number of dimensions: age (younger/older), category of school, and community connectedness.	3-6 months	No
Other	Cost effectiveness	Assess whether the interactive treatment arm was cost effective compared to the basic treatment arm.	3-6 months	No
Primary	Knowledge of Reproductive Health True/False Quiz of 20 questions		5-6 months after baseline and then again 14-16 months after baseline	No
Primary	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	14-16 months after baseline	No
Secondary	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.	3 months (asked 5-6 months after baseline and again 12-14 months after baseline)	No
Secondary	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.	5-6 months after baseline and asked again 12-14 months after baseline	No