Do behavioral-science-backed board games, health passports, and posters positively change girls’ sexual and reproductive health behaviors and attitudes?
| ISRCTN | ISRCTN15387847 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15387847 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 19-0015B |
| Sponsor | International Center for Research on Women |
| Funder | Bill and Melinda Gates Foundation |
- Submission date
- 03/06/2021
- Registration date
- 15/06/2021
- Last edited
- 19/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
Adolescent girls in Burkina Faso face a risk of unintended pregnancy due to a lack of contraceptive use, especially modern methods. The (re)solve project was designed to address contraceptive misperceptions and increase girls’ perceptions of their pregnancy risk through a participatory game and a health passport aimed at easing girls’ access to health facilities. Additional intervention components included posters in schools and health facilities advertising health-related consultations for girls and name tags identifying providers of youth-friendly health services. The aim of this study is to evaluate (re)solve’s impact on girls’ intentions to use contraception, among other outcomes.
Who could participate?
Girls aged 14 to 18 years old at participating schools in Ouagadougou and Bobo-Dialasso, and staff aged 18 years and older who implemented the intervention
What did the study involve?
Participating schools are randomly allocated to the intervention group or the control group. 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. The evaluation includes surveys and interviews with girls in the intervention group at the start and end of the intervention and with implementation staff and experts at the end of the study.
What were the possible benefits and risks of participation?
The intervention may increase girls' intention to use contraception and positively change other contraceptive attitudes. The only risk was that sensitive questions on the survey may make a participant feel uncomfortable, but the participant could withdrawal at any time, or skip a question. At the end of the study, due to the COVID-19 pandemic, the researchers conducted interviews over the phone. There were additional risks to young girls with this new method - for example, a parent might overhear her conversation during the survey - but extra training and adjustments were made to mitigate these potential issues.
Where was the study run from?
32 schools in Ouagadougou and Bobo-Dialasso (Burkina Faso)
When did the study start and stop?
January 2019 to September 2020
Who funded the study?
The Bill and Melinda Gates Foundation (USA)
Who is the main contact?
Laura Hinson
lhinson@icrw.org
Contact information
Scientific
2550 17th Street NW Unit 613
Washington
20009
United States of America
 ORCID ID |
0000-0001-7860-9359 |
|---|---|
| Phone | +1 (0)9195649996 |
| lhinson@icrw.org |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Mixed-methods cluster-randomized control trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| 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 |
| Study objectives | Does a behavior-change intervention targeting girls in 4eme and 3eme (equivalent of U.S. 9th and 10th grade) increase girls' intention to use contraception and positively change other contraceptive attitudes, as compared to girls who did not participate in the intervention? |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | Prevention of unintended pregnancy |
| Intervention | 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. |
| Intervention type | Behavioural |
| Primary outcome measure(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. |
| Key secondary outcome measure(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). |
| Completion date | 30/09/2020 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 14 Years |
| Sex | All |
| Target sample size at registration | 2490 |
| Total final enrolment | 2072 |
| Key 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 |
| Key exclusion criteria | 1. Unwilling to participate or consent 2. Parental consent not obtained |
| Date of first enrolment | 01/11/2019 |
| Date of final enrolment | 01/08/2020 |
Locations
Countries of recruitment
- Burkina Faso
Study participating centres
-
Burkina Faso
-
Burkina Faso
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Laura Hinson (lhinson@icrw.org). Type of data that will be shared: quantitative (Stata) and qualitative (verbatim transcribed and translated from French Word documents). When the data will become available and for how long: upon publication (or around October 2021), 5 years. By what access criteria data will be shared including with whom, for what types of analyses, and by what mechanism: the researchers are open to share the data with individuals who have a research plan. Whether consent from participants was obtained: Yes Comments on data anonymisation: All data is de-identified and anonymous Any ethical or legal restrictions: None Any other comments: None |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 11/12/2023 | 19/12/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/12/2023: Publication reference added.
14/06/2021: Trial's existence confirmed by the ICRW Institutional Review Board.
