Development and Testing of Balika Bodhu (NCT06126770) | Clinical Trial Compass
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Development and Testing of Balika Bodhu
Bangladesh2,918 participantsStarted 2023-11-08
Plain-language summary
The study aims to generate knowledge on barriers experienced by married adolescent girls (MAGs) in demanding, accessing and practicing their rights regarding their sexual and reproductive health (SRH), including family planning (FP) use, conception, and seeking health care relating to SRH. We will also explore the underlying factors influencing such barriers. The study will develop and test a social norms intervention that addresses the gaps in programming and in the literature combining a comprehensive empowerment programme for MAGs with engagement of other stakeholders to increase demand, access and practices of positive behaviours in relation to sexual and reproductive health and rights (SRHR) among these girls. We will collaborate with a local organization, who usually work on empowerment and SRHR of women, for implementing the intervention and will build their capacity as well. The study will employ a mixed-method two-arm cluster randomized controlled trial design. All the information generated will inform the program and policy about the barriers and potential solutions to improve demand, access and practices of SRHR among the MAGs.
Who can participate
Age range
15 Years – 19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria:
For MAGs:
i) Adolescent girls aged 15-19 years; ii) Currently married and living with husband; and iii) Both the girl and her husband have no intention of migrating out within the next 15 months.
For husbands:
i) The husbands of the selected adolescent girls will also be eligible to be included in the study.
For community members:
i) Aged 35-59 years.
Exclusion criteria:
i) MAGs who are physically or mentally unstable; ii) Any couple having plans to migrate out during the next one and a half years.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Instrumental agency of MAGs in decision making regarding SRHR
Timeframe: 15 months
Trial details
NCT IDNCT06126770
SponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh