Ignite Creation Date:
2024-05-06 @ 7:45 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06126770
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-10-12
Brief Title:
Development and Testing of Balika Bodhu
Sponsor:
International Centre for Diarrhoeal Disease Research Bangladesh
Organization:
International Centre for Diarrhoeal Disease Research Bangladesh
Study Overview
Official Title:
Development and Testing of Balika Bodhu a Social Norm Intervention to Address Denial of Sexual and Reproductive Health and Rights to Married Adolescent Girls in Rural Bangladesh
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Background Sexual and reproductive health and rights SRHR are vital to ones health and development Over the last few decades Bangladesh known as a patriarchal society has made remarkable progress in improving contraceptive use and maternal health However the progress has not been consistent in different SRHR domains and is not uniform across different groups of reproductive aged females The progress was particularly slow in realising SRH rights of the women Evidence suggests that choice and consent of females are ignored in all spheres of SRHR and that patriarchal gender and social norms and discriminatory laws and practices in Bangladesh perpetuate denial of SRHR to females Due to high prevalence of child marriage in Bangladesh 59 NIPORT ICF 2019 a huge proportion of adolescent girls are married before reaching 18 In a patriarchal setting such as Bangladesh with very strong gender and age hierarchies these child brides typically command the lowest power in the marital home They typically have lower education than those who get married in adulthood They also lack voice and bargaining skills In such a context the husband or mother-in-law may figure prominently in decisions about using contraception and the timing of childbearing In this context denial of SRHR usually becomes part of their lived experiences
Although social norms are recognised as one of the main drivers of denial of SRHR to married adolescent girls MAG social norms theories and approaches to programming are relatively new and there has been little attempt to develop and rigorously test interventions to address such social norms worldwide and in Bangladesh Also a handful of programmes have been implemented worldwide and in Bangladesh to empower partnered female adolescents for promoting SRHR But we argue that conceptualization of empowerment in these initiatives were often not grounded in solid theory and evidence Thus empowerment programmes for women and girls often fail to include a critical component namely movement building and collective agency and critical consciousness without which empowerment cannot take place in its true sense
The current study proposes to develop and test Balika Bodhu a social norm intervention to address 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 practice of positive behaviours in relation to SRHR among these MAGs Balika Bodhu covers married adolescent girls aged 15-19 years
The Balika Bodhu intervention The Balika Bodhu intervention will be developed heavily drawing on CAREs IMAGINE model and on SAFE a project spearheaded by icddrb and aimed at promoting SRHR and addressing violence against women in slums of Dhaka
Balika Bodhu intervention will be implemented by Nari Maitree an NGO working on womens issues The research team will conduct both quantitative and qualitative monitoring for documenting implementation fidelity Effectiveness of the intervention will be assessed in changing social norms endorsing denial of SRHR to MAGS and in empowering them to demand access and practice SRHR The intervention will involve a 12-month gender transformative participatory programming for 1 empowering MAGs and 2 creating an enabling environment in the family and the community for the MAGs to demand access and practice SRHR
The intervention will target Married adolescent girls their spouses and elderlyinfluential community members Thirty-six 2-hour weekly sessions will be conducted with MAGs The session topics will be categorized into two broad headings i Health and life skills sessions covering for example topics such as sex and gender rights marriages SRHR eg first conception birth spacing contraception healthy relationships polygamy divorce gender-based violence GBV communication and negotiation anger and conflict management goal setting household budgeting activism leadership skills and community action planning and ii Business and entrepreneurship sessions which will basically include sessions smart planning of businesses eg market research business planning and adding value
Spouses of the MAGs will receive 20 2-hour bi-weekly sessions The session topics will cover sex and gender rights marriages registration dowry conception and contraception healthy relationships polygamy divorce gender-based violence GBV communication and negotiation anger and conflict management goal setting and household budgeting
A total of three 2-hour couples sessions will be held each to be delivered every two months starting from the 6th month of the intervention The session topics will include teenage pregnancy unwanted pregnancy and action planning Elderly and influential community members will have three 2-hour bi-monthly sessions starting from the 6th month of the intervention covering topics related to teenage pregnancy unwanted pregnancy and action planning
MAGs with leadership qualities will be identified and trained to conduct campaigns and activism They will be put in contact with other girls groups and networks mentored and given access to resources to execute four community-level social norm activities These leaders will also receive training on income generating
Hypothesis Balika Bodhu a social norm intervention on sexual and reproductive health and rights SRHR combining a comprehensive empowerment package for married adolescent girls MAGs and positive engagement of relevant stakeholders will significantly improve demand access and practices regarding SRHR among MAGs in family planning FP use conception and SRH service uptake
Objectives
Primary objective
1 To develop Balika Bodhu a social norm intervention combining empowerment of MAGs and mobilisation of relevant stakeholders to promote demand for access to and practices of SRHR including FP use conception and SRH service uptake
2 To measure the effect of Balika Bodhu in increasing demand for access to and practices of SRHR FP use conception and SRH service uptake of MAGS
Secondary objectives
3 To measure the effect of Balika Bodhu on empowerment of MAGs
4 To measure the effect of Balika Bodhu on social norm regarding SRHR of MAGs
5 To explore how change happens or why change does not occur
Methods Study design Balika Bodhu will involve a mixed-method two-arm intervention and control Cluster Randomized Controlled Trial CRCT design
Study site Balika Bodhu will be implemented in 32 clusters villages primary sampling unit in Rajbari Sadar upazila of Rajbari district
Cluster formation and randomization The villages from Rajbari Sadar upazila will be treated as clusters or the primary sampling units in this study Thirty-two clusters will be formed ensuring sufficient buffer zone around each cluster and then will be randomized to two study arms intervention and control
Household enumeration sampling recruitment of study participants and survey and qualitative data collection Once the clusters have been selected and randomized to intervention and control arms an enumeration of the households in each cluster will be conducted to collect socio-demographic information on the household members eg sex date of birth age and marital status to form the sampling frame for the MAGs their husbands and the community survey
A total of 1120 MAGs will be randomly selected 35 per cluster from the list obtained through household enumeration Their husbands will also be included in the study Upon receiving consent the selected MAGs and their husbands will be enrolled in the study and included in the baseline survey Following the baseline survey interviews MAGs from the intervention villages will be invited to participate in the Balika Bodhu intervention and upon receiving their consent they will be formally enrolled in the intervention All MAGs and their husbands who were interviewed at baseline will also be targeted for follow-up interviews at the endline
For the community survey separate cross-sectional samples will be drawn and interviewed at baseline and endline We will obtain lists of eligible community members females and males aged 35 years or more from household enumeration Nine females and nine males will be randomly selected from each cluster for inclusion in the surveys making the total in each round 576
Qualitative data will be collected at baseline and endline from two intervention clusters using 32 In-depth Interviews with 16 MAGs and 16 husbands of MAGs and 6 Key Informant Interviews with mothers-in-law of MAGs NGO staff CHWs village doctors traditional healers drug sellers and 8 Focus Group Discussions with MAGs their spouses and elderly womeninfluential community members aged 35 years or more
Blinding No one will be blinded during this selection and allocation process in this study
Quantitative data analyses During baseline we will explore the current situation in empowerment and SRHR among MAGs and their correlates while at end line we will measure the impact of the social norms intervention on empowerment on social norm change and promotion of demand access and positive practices in relation to SRHR among the MAGs Descriptive analyses will be performed to report frequencies and percentages of different outcomes of interest Chi-square ANOVA and t-tests will be performed to check whether the study arms are covariate balanced Linear and logistic regression analyses will be performed to identify the underlying factors for current situation in SRHR among MAGs
Intention-to-treat ITT analysis will be used during assessing the impact of the intervention Thus all the MAGs enrolled at baseline and could be successfully interviewed at endline will be included in the analysis irrespective of their actual level of participation in the intervention activities The information on participation of study participants in the intervention activities will come from the programme monitoring data and will also used in the models The impact of the intervention on primary and secondary outcomes will be assed using risk ratiosregression coefficients derived from binarylinear regression analyses for measuring change in outcomes in the intervention arms relative to change in the control arm Significance level will be set at p05 for all analyses The data will be analysed using STATA 16
Qualitative data analyses With the informants permission all interviews and FGDs will be digitally recorded All recorded interviews will be transcribed verbatim Data analysis will be iterative To explore research questions we will combine the intense within-case focus of Narrative Analysis with the across-case approach of Grounded Theory a robust analytic strategy for qualitative data
Ethical considerations This study will be guided by CIOMS International Guidelines for Ethical Review of Epidemiological Studies and the WHO recommendations for ethical considerations in researching violence against The study will seek ethical approval from icddrbs institutional review board This application and all documents related to the protection of human subjects will be reviewed the IRB of icddrb All members of the research team will be trained to meet the highest ethical standards of data collection and analysis
The MAGs who are minor aged below 18 will be considered as mature minors and informed consent will be sought by the interviewer prior to the interview with each study participant Participation in the study will be as entirely voluntary All the participants will be informed orally of the purpose and nature of the study its expected benefits sensitivity confidentiality and voluntary nature of participation
Although social norms are recognised as one of the main drivers of denial of SRHR to married adolescent girls MAG social norms theories and approaches to programming are relatively new and there has been little attempt to develop and rigorously test interventions to address such social norms worldwide and in Bangladesh Also a handful of programmes have been implemented worldwide and in Bangladesh to empower partnered female adolescents for promoting SRHR But we argue that conceptualization of empowerment in these initiatives were often not grounded in solid theory and evidence Thus empowerment programmes for women and girls often fail to include a critical component namely movement building and collective agency and critical consciousness without which empowerment cannot take place in its true sense
The current study proposes to develop and test Balika Bodhu a social norm intervention to address 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 practice of positive behaviours in relation to SRHR among these MAGs Balika Bodhu covers married adolescent girls aged 15-19 years
The Balika Bodhu intervention The Balika Bodhu intervention will be developed heavily drawing on CAREs IMAGINE model and on SAFE a project spearheaded by icddrb and aimed at promoting SRHR and addressing violence against women in slums of Dhaka
Balika Bodhu intervention will be implemented by Nari Maitree an NGO working on womens issues The research team will conduct both quantitative and qualitative monitoring for documenting implementation fidelity Effectiveness of the intervention will be assessed in changing social norms endorsing denial of SRHR to MAGS and in empowering them to demand access and practice SRHR The intervention will involve a 12-month gender transformative participatory programming for 1 empowering MAGs and 2 creating an enabling environment in the family and the community for the MAGs to demand access and practice SRHR
The intervention will target Married adolescent girls their spouses and elderlyinfluential community members Thirty-six 2-hour weekly sessions will be conducted with MAGs The session topics will be categorized into two broad headings i Health and life skills sessions covering for example topics such as sex and gender rights marriages SRHR eg first conception birth spacing contraception healthy relationships polygamy divorce gender-based violence GBV communication and negotiation anger and conflict management goal setting household budgeting activism leadership skills and community action planning and ii Business and entrepreneurship sessions which will basically include sessions smart planning of businesses eg market research business planning and adding value
Spouses of the MAGs will receive 20 2-hour bi-weekly sessions The session topics will cover sex and gender rights marriages registration dowry conception and contraception healthy relationships polygamy divorce gender-based violence GBV communication and negotiation anger and conflict management goal setting and household budgeting
A total of three 2-hour couples sessions will be held each to be delivered every two months starting from the 6th month of the intervention The session topics will include teenage pregnancy unwanted pregnancy and action planning Elderly and influential community members will have three 2-hour bi-monthly sessions starting from the 6th month of the intervention covering topics related to teenage pregnancy unwanted pregnancy and action planning
MAGs with leadership qualities will be identified and trained to conduct campaigns and activism They will be put in contact with other girls groups and networks mentored and given access to resources to execute four community-level social norm activities These leaders will also receive training on income generating
Hypothesis Balika Bodhu a social norm intervention on sexual and reproductive health and rights SRHR combining a comprehensive empowerment package for married adolescent girls MAGs and positive engagement of relevant stakeholders will significantly improve demand access and practices regarding SRHR among MAGs in family planning FP use conception and SRH service uptake
Objectives
Primary objective
1 To develop Balika Bodhu a social norm intervention combining empowerment of MAGs and mobilisation of relevant stakeholders to promote demand for access to and practices of SRHR including FP use conception and SRH service uptake
2 To measure the effect of Balika Bodhu in increasing demand for access to and practices of SRHR FP use conception and SRH service uptake of MAGS
Secondary objectives
3 To measure the effect of Balika Bodhu on empowerment of MAGs
4 To measure the effect of Balika Bodhu on social norm regarding SRHR of MAGs
5 To explore how change happens or why change does not occur
Methods Study design Balika Bodhu will involve a mixed-method two-arm intervention and control Cluster Randomized Controlled Trial CRCT design
Study site Balika Bodhu will be implemented in 32 clusters villages primary sampling unit in Rajbari Sadar upazila of Rajbari district
Cluster formation and randomization The villages from Rajbari Sadar upazila will be treated as clusters or the primary sampling units in this study Thirty-two clusters will be formed ensuring sufficient buffer zone around each cluster and then will be randomized to two study arms intervention and control
Household enumeration sampling recruitment of study participants and survey and qualitative data collection Once the clusters have been selected and randomized to intervention and control arms an enumeration of the households in each cluster will be conducted to collect socio-demographic information on the household members eg sex date of birth age and marital status to form the sampling frame for the MAGs their husbands and the community survey
A total of 1120 MAGs will be randomly selected 35 per cluster from the list obtained through household enumeration Their husbands will also be included in the study Upon receiving consent the selected MAGs and their husbands will be enrolled in the study and included in the baseline survey Following the baseline survey interviews MAGs from the intervention villages will be invited to participate in the Balika Bodhu intervention and upon receiving their consent they will be formally enrolled in the intervention All MAGs and their husbands who were interviewed at baseline will also be targeted for follow-up interviews at the endline
For the community survey separate cross-sectional samples will be drawn and interviewed at baseline and endline We will obtain lists of eligible community members females and males aged 35 years or more from household enumeration Nine females and nine males will be randomly selected from each cluster for inclusion in the surveys making the total in each round 576
Qualitative data will be collected at baseline and endline from two intervention clusters using 32 In-depth Interviews with 16 MAGs and 16 husbands of MAGs and 6 Key Informant Interviews with mothers-in-law of MAGs NGO staff CHWs village doctors traditional healers drug sellers and 8 Focus Group Discussions with MAGs their spouses and elderly womeninfluential community members aged 35 years or more
Blinding No one will be blinded during this selection and allocation process in this study
Quantitative data analyses During baseline we will explore the current situation in empowerment and SRHR among MAGs and their correlates while at end line we will measure the impact of the social norms intervention on empowerment on social norm change and promotion of demand access and positive practices in relation to SRHR among the MAGs Descriptive analyses will be performed to report frequencies and percentages of different outcomes of interest Chi-square ANOVA and t-tests will be performed to check whether the study arms are covariate balanced Linear and logistic regression analyses will be performed to identify the underlying factors for current situation in SRHR among MAGs
Intention-to-treat ITT analysis will be used during assessing the impact of the intervention Thus all the MAGs enrolled at baseline and could be successfully interviewed at endline will be included in the analysis irrespective of their actual level of participation in the intervention activities The information on participation of study participants in the intervention activities will come from the programme monitoring data and will also used in the models The impact of the intervention on primary and secondary outcomes will be assed using risk ratiosregression coefficients derived from binarylinear regression analyses for measuring change in outcomes in the intervention arms relative to change in the control arm Significance level will be set at p05 for all analyses The data will be analysed using STATA 16
Qualitative data analyses With the informants permission all interviews and FGDs will be digitally recorded All recorded interviews will be transcribed verbatim Data analysis will be iterative To explore research questions we will combine the intense within-case focus of Narrative Analysis with the across-case approach of Grounded Theory a robust analytic strategy for qualitative data
Ethical considerations This study will be guided by CIOMS International Guidelines for Ethical Review of Epidemiological Studies and the WHO recommendations for ethical considerations in researching violence against The study will seek ethical approval from icddrbs institutional review board This application and all documents related to the protection of human subjects will be reviewed the IRB of icddrb All members of the research team will be trained to meet the highest ethical standards of data collection and analysis
The MAGs who are minor aged below 18 will be considered as mature minors and informed consent will be sought by the interviewer prior to the interview with each study participant Participation in the study will be as entirely voluntary All the participants will be informed orally of the purpose and nature of the study its expected benefits sensitivity confidentiality and voluntary nature of participation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None