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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.
Register: ISRCTN
Last refreshed on: 28 June 2021
Main ID:  ISRCTN15387847
Date of registration: 15/06/2021
Prospective Registration: No
Primary sponsor: International Center for Research on Women
Public title: Do behavioral-science-backed board games, health passports, and posters positively change girls’ sexual and reproductive health behaviors and attitudes?
Scientific title: (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
Date of first enrolment: 01/11/2019
Target sample size: 2490
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN15387847
Study type:  Interventional
Study design:  Mixed-methods cluster-randomized control trial (Prevention)  
Phase:  Not Applicable
Countries of recruitment
Burkina Faso
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Laura    Hinson
Address:  2550 17th Street NW Unit 613 20009 Washington United States of America
Telephone: +1 (0)9195649996
Email: lhinson@icrw.org
Affiliation: 
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Prevention of unintended pregnancy
Pregnancy and Childbirth
Intervention(s)

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.
Primary Outcome(s)
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.
Secondary Outcome(s)

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).
Secondary ID(s)
19-0015B
Nil known
Source(s) of Monetary Support
Bill and Melinda Gates Foundation
Secondary Sponsor(s)
Ethics review
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
Results
Results available:
Date Posted:
Date Completed: 30/09/2020
URL:
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