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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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28 June 2021 |
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Main ID: |
ISRCTN15387847 |
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Date of registration:
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15/06/2021 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Do behavioral-science-backed board games, health passports, and posters positively change girls’ sexual and reproductive health behaviors and attitudes?
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Scientific title:
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(re)solve in Burkina Faso: mixed-methods cluster-randomized trial to see if a school-based behavior change intervention positively changes girls' sexual and reproductive health behaviors and attitudes |
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Date of first enrolment:
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01/11/2019 |
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Target sample size:
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2490 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN15387847 |
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Study type:
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Interventional |
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Study design:
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Mixed-methods cluster-randomized control trial (Prevention)
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Phase:
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Not Applicable
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Countries of recruitment
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Burkina Faso
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Laura
Hinson |
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Address:
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2550 17th Street NW Unit 613
20009
Washington
United States of America |
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Telephone:
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+1 (0)9195649996 |
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Email:
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lhinson@icrw.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: For girls in the quantitative study and qualitative study: 1. At baseline: 1.1. Is in 4eme and 3eme grade at a participating school 1.2. Is between 14 and 18 years old 1.3. Is unmarried 2. At mid or endline: participated in baseline
For the qualitative study with adults: 1. Implemented (re)solve activities or was trained to implement (re)solve activities (facilitator and PYY facility staff) or has some knowledge, expertise or authority on girls sexual and reproductive health and/or has been involved with intervention 2. 18 years of age or older
Exclusion criteria: 1. Unwilling to participate or consent 2. Parental consent not obtained
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prevention of unintended pregnancy Pregnancy and Childbirth
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Intervention(s)
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From a list of eligible schools with similar characteristics in Ouagadougou and Bobo-Dialasso, the researchers randomly allocate the intervention to 16 of 32 schools - 8 in one city, 8 in another. The remaining schools are control schools. All girls in intervention schools are invited to participate in the intervention and the study; a subset of girls are randomly selected to be in the study.
The interventions are a package of activities including a facilitated board game, a health passport, and exposure to nametags and posters at schools and health facilities.
The control group do not receive any intervention.
The study lasts from October 2019 - July 2020, with intervention-school girls participating at baseline (before intervention), midline (right after exposure to intervention) and endline (several months after intervention). Control-school girls participated at baseline and endline, quantitative only.
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Primary Outcome(s)
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Percentage of girls with an intention to use contraception in the next 3 months, originally measured using a four-point Likert scale (1=Yes, definitely; 2=Yes, probably; 3=No, probably not; and 4=No, definitely not). The researchers collapsed this to a binary variable (No/Yes) and included the 12 girls at endline who responded that they preferred not to answer in the “No” category. Measured at baseline and endline.
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Secondary Outcome(s)
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Measured with quantitative surveys at baseline, midline and endline for the intervention group and baseline and endline for the control group: 1. Percentage of girls who have gone to a health facility for sexual and reproductive health (SRH) services or information (“Have you ever visited a health facility recently for puberty or menstruation information?”) 2. Percentage of girls who strongly agree or agree that contraception causes infertility (“Modern contraception can cause infertility”) 3. Percentage of girls who strongly agree or agree that contraception is the best option (“If I am having sex and want to avoid pregnancy modern contraception is best option”) 4. Percentage of girls who strongly agree or agree that they have the confidence to both get and use contraception (“I feel confident in my ability to get a contraceptive method, if I wanted to avoid pregnancy” and “I feel confident in my ability to use a contraceptive method, if I wanted to avoid pregnancy”) 5. Percentage of girls who strongly agree or agree that health care workers do not like to give contraceptive advice to unmarried girls (“Health care workers do not like to give advice to young unmarried girls about family planning”) 6. Percentage of girls who strongly agree or agree that unmarried girls should not and do not use contraception and that those around them do not use contraception (a combination of three questions: “Most unmarried girls my age do not use modern contraception to avoid or delay pregnancy,” “Most girls think that unmarried girls should not use modern contraception,” and “The people most important to me do not think I should use a modern contraception method”).
The researchers collapsed those that had a “Yes“, “No“, “Don’t know“, and “Prefer not to answer“ response into a binary variable with cases responding “Don’t know“ or “prefer not to answer“ classified as “No“. They collapsed variables that were originally collected using a four-point Likert scale (1=Strongly agree; 2=Agree; 3=Disagree; and 4=Strongly disagree) into a binary variable (0=Disagree and 1=Agree).
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Secondary ID(s)
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19-0015B
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Nil known
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Source(s) of Monetary Support
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Bill and Melinda Gates Foundation
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Ethics review
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Status:
Approval date:
Contact:
Approved 14/10/2019, ICRW Institutional Review Board (1120 20th Street NW STE 500, Washington DC 20036, USA; +1 (0)202 797 0007); kreitz@icrw.org), ref: 19-0015B
Approved 23/09/2019, Comite D’Ethique Institutionnel Pour la Recherche en Sciences de la Sante (CEIRSS, BP 7192 Ouagadougou, Burkina Faso; +226 (0)20 98 18 80; Rouamba_noelw@yahoo.fr), ref: A014-2019
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Results
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Results available:
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Date Posted:
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Date Completed:
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30/09/2020 |
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URL:
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