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Study on mhealth and Reproductive Health in Teens (SMART)
Last registered on August 23, 2015

Pre-Trial

Trial Information
General Information
Title
Study on mhealth and Reproductive Health in Teens (SMART)
RCT ID
AEARCTR-0000180
Initial registration date
February 01, 2014
Last updated
August 23, 2015 10:12 AM EDT
Location(s)
Region
Primary Investigator
Affiliation
Harvard University
Other Primary Investigator(s)
Additional Trial Information
Status
Completed
Start date
2014-01-13
End date
2015-07-31
Secondary IDs
Abstract
Despite the fact that 76% of females in Ghana have heard of at least one modern contraceptive method and 96% have heard of HIV/AIDS, this awareness has not translated into use of contraception. Recent studies show that use of modern contraception among female adolescents is very low: only about one-third of sexually experienced female adolescents used a condom the first time they had sex. The burden of sexually transmitted infections is high, with up to 20% of sexually active 15-19 year old girls reporting ever having symptoms. The Study on mhealth and Reproductive Health in Teens (SMART) is a randomized controlled trial that will evaluate the effectiveness of an interactive text-messaging program on improvement in reproductive health knowledge, communication, and attitudes among female adolescents in Accra, Ghana. Research will begin in January 2014 and conclude in June 2015.
External Link(s)
Registration Citation
Citation
Rokicki, Slawa. 2015. "Study on mhealth and Reproductive Health in Teens (SMART)." AEA RCT Registry. August 23. https://doi.org/10.1257/rct.180-4.0.
Former Citation
Rokicki, Slawa. 2015. "Study on mhealth and Reproductive Health in Teens (SMART)." AEA RCT Registry. August 23. https://www.socialscienceregistry.org/trials/180/history/5099.
Sponsors & Partners

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Experimental Details
Interventions
Intervention(s)
Text-messaging program over 12 weeks that includes information on female anatomy, sex, pregnancy, sexually transmitted diseases, and contraception including male and female condoms, the birth control pill, and emergency contraception.
Intervention Start Date
2014-02-15
Intervention End Date
2014-05-10
Primary Outcomes
Primary Outcomes (end points)
Knowledge, Communication, and Attitudes about reproductive health

Sexual behavior including age of sexual debut, sex without a condom in the past year, pregnancy in the past year
Primary Outcomes (explanation)
Knowledge of reproductive health is the percentage correct of a 25 question true/false quiz;
Amount of communication about reproductive health is a 5-point scale about how much the respondent talks about reproductive health with friends, family, boyfriend, and professional (nurse/teacher);
Attitudes about reproductive health include 5-point Likert-type scales about agreeing or disagreeing with statements about using, buying, and talking about sex and contraception, and peer/family support of contraception or delaying sex.
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
The experiment is randomized at the school-level. One intervention classroom and one spillover classroom in each school will be given the baseline survey. The intervention classroom will be assigned to treatment or control and receive messages for 12 weeks. The participants will be encouraged to talk with their classmates about the messages. Both the intervention and spillover classrooms will be given a follow-up survey after the intervention is complete.
Experimental Design Details
The study will be conducted in senior high public or private day schools in Greater Accra, Ghana that are either mixed gender or girls schools. The sampling frame was drawn from the 2012 Register of Secondary Schools from the Ghana Education Service. From this list, there were originally 46 public and private day schools in Greater Accra. However, 8 schools from that register had either become boarding schools or were no longer functional so they were dropped from the sampling frame. This yielded a total of 38 schools. In each school we will recruit the second year Home Economics class wherever possible. This class is at least 95-100% female. Any males in the class will not be asked to participate. The typical class size of a Home Economics class ranges from 10-50 students. Of the 38 schools, 9 do not have a Home Economics class. In these schools, another class will be chosen and the boys will be asked not to participate. In addition, one other classroom in each school will be recruited as a spillover classroom. This class will usually be the Science class. Typical class sizes of Science classes are 15-40 students. The spillover class will take both questionnaires, but will not receive the intervention. Consent will be given by the student if they are 18 and over, and by the student's parents if they are under 18.
Randomization Method
Randomization done in office by a computer
Randomization Unit
School
Was the treatment clustered?
Yes
Experiment Characteristics
Sample size: planned number of clusters
38 Schools
Sample size: planned number of observations
1140 students
Sample size (or number of clusters) by treatment arms
14 schools control, 12 schools basic treatment, 12 schools interactive treatment
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
15 percentage points in knowledge score, power 0.9, alpha 0.05, intraclass correlation of 0.05, 30 students per cluster.
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Harvard University-Area Committee on the Use of Human Subjects
IRB Approval Date
2013-10-21
IRB Approval Number
IRB13-1647
IRB Name
Ghana Health Service Ethical Review Committee
IRB Approval Date
2013-11-25
IRB Approval Number
GHS-ERC:05/09/13
Analysis Plan
Analysis Plan Documents
Protocol and Statistical Analysis Plan

MD5: 1c947597295ab347ab5965e66a7b2e14

SHA1: f332bd2449325c14fc9f6c6511efa934b30d50f0

Uploaded At: February 01, 2014

SMART Protocol and Statistical Analysis Plan - addendum for behavioral outcomes

MD5: 5cdc89727e9e47529876f9155e4283f5

SHA1: 9d69c6306cb91f005931696e4c79e9f0fc4e694d

Uploaded At: April 14, 2015

Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
No
Is data collection complete?
Data Publication
Data Publication
Is public data available?
No
Program Files
Program Files
Reports and Papers
Preliminary Reports
Relevant Papers