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Right to Health and Freedom From Violence (SAFE)

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ClinicalTrials.gov Identifier: NCT03280680
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Collaborators:
Population Council
Bangladesh Legal Aid and Services Trust (BLAST)
We Can Campaign
Marie Stopes International
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:

Bangladesh has the earliest patterns of marriage in the current developing world, high adolescent fertility and high rates of spousal violence against women and girls. Women and girls are often denied the right to choice or consent with respect to marriage, sex, contraceptive use and childbearing. However, the denial of these rights and its consequences, have not been adequately recognized and addressed in the context of the existing discourse or interventions in Bangladesh on sexual and reproductive health or violence against women. It is envisaged that the focus on realizing the right to choice and consent will bring about change in attitudes and behaviors that could not be achieved through a single intervention.

A multi-sectoral action research-based intervention is proposed, involving access to information about rights, available remedies and related referrals. Information will be coupled with access to legal and health services. This action research project aims to create a body of evidence. This multi-sectoral intervention in urban Bangladesh will highlight the critical element of expressing or refusing consent and choice, through a strong network between legal services, reproductive and sexual health service providers, human rights advocates, and research organizations.

This project proposes to implement an integrated intervention with both primary preventions and curative components based on the findings of the formative research. This project will document the program implementation and impact through detailed quantitative and qualitative evidence gathering, and carrying out an advocacy program to disseminate the results and bring about change. It includes:

  • designing culturally sensitive intervention activities with a joined up approach.
  • a strong community mobilization campaign for creating an enabling environment for women to live violence free lives.
  • individual access to reproductive and sexual health services provided through health clinics and legal services, with legal clinics providing information, advice and support access to judicial remedies for redress in cases of serious violence.
  • broader advocacy activities involving key stakeholders to reflect upon the findings and understandings geneated by the study and their relevance for the administration of justice delivery mechanisms.

Community engagement in the project will occur at multiple levels. At the local level the project will engage through community mobilisation and service delivery with adolescent girls, women and men living in urban slums of Dhaka city. It will also undertake targeted advocacy programmes with the frontlines of the justice delivery system relevant to these areas. Finally, it will engage at a national level with policymakers, researchers and key stakeholders in the justice system and health through its advocacy related interventions, drawing directly upon its findings.


Condition or disease Intervention/treatment Phase
Sexual and Reproductive Health and Rights Violence Against Women and Girls Other: Female+male group sessions Other: Female group sessions Other: No group sessions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Growing up Safe and Healthy( SAFE): Addressing Sexual and Reproductive Health and Rights and Violence Against Women and Girls in Urban Bangladesh
Actual Study Start Date : November 1, 2010
Actual Primary Completion Date : May 31, 2014
Actual Study Completion Date : December 31, 2014

Arm Intervention/treatment
Experimental: Female+male group sessions Other: Female+male group sessions
Female and male group member received separate group session on sexual and reproductive health and rights, gender, violence against women and girls, consent and choice, conflict resolution etc. Each group received 13 sessions of 2 hours over 20 months. Community mobilization and service provision for sexual and reproductive and violence against women were also provided.

Other: Female group sessions
Only female group member received separate group session on sexual and reproductive health and rights, gender, violence against women and girls, consent and choice, conflict resolution etc. Each group received 13 sessions of 2 hours over 20 months. Community mobilization and service provision for sexual and reproductive and violence against women were also provided.

Other: No group sessions
Community mobilization and service provision for sexual and reproductive and violence against women were also provided.

Experimental: Female group sessions Other: Female group sessions
Only female group member received separate group session on sexual and reproductive health and rights, gender, violence against women and girls, consent and choice, conflict resolution etc. Each group received 13 sessions of 2 hours over 20 months. Community mobilization and service provision for sexual and reproductive and violence against women were also provided.

Other: No group sessions
Community mobilization and service provision for sexual and reproductive and violence against women were also provided.

No group sessions Other: No group sessions
Community mobilization and service provision for sexual and reproductive and violence against women were also provided.




Primary Outcome Measures :
  1. Knowledge of sexual and reproductive health [ Time Frame: 4 months post intervention ]
    Questions were asked about knowledge of adverse effect of teen pregnancy, knowledge about MR, family planning methods and sexually transmitted infections. Positive responses to these were considered a person as knowing about sexual and reproductive health.

  2. Sexual and reproductive health practice [ Time Frame: 4 months post intervention ]
    To asses this Questions were asked about use of family planning methods, use of condom for preventing sexually transmitted infections, MR.

  3. Sexual and reproductive health service utilization [ Time Frame: 4 months post intervention ]
    Questions were asked about utilization of antenatal care, postnatal care, facility delivery and service seeking for sexually transmitted infections.

  4. Violence against women and girls [ Time Frame: 4 months post intervention ]
    Violence against women and girls was measured using the modified version of the Conflict Tactics Scale. The questionnaire explored physical, sexual, and economic violence perpetrated by husband.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female aged 10-29 years from the studied slums
  • Male aged 18-35 years from the studied slums

Exclusion Criteria:

  • Female aged below 10 and above 29 years
  • Male aged below 18 and above 35 years
  • Female and males who are living outside the studied slums
Publications:
National Institute of Population Research and Training (NIPORT), MEASURE Evaluation, ICDDR,B, Association for Community and Population Research (ACPR). (2008). 2006 Bangladesh Urban Health Survey. Dhaka. https://www.measureevaluation.org/resources/publications/tr-08-68
Naved, R. T., Persson, L. A. (2005). Factors associated with physical violence by husbands in Bangladesh. Studies in Family Planning, 36(4): 289-300. http://login.research4life.org/tacsgr0onlinelibrary_wiley_com/doi/10.1111/j.1728-4465.2005.00071.x/epdf
Naved, R. T. (2008). Violence against women, in 2006 Bangladesh Urban Health Survey. Vol. II, pp. 287-311. https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0ahUKEwjZ2pnw7trVAhVKv48KHbsgBAoQFgglMAA&url=https%3A%2F%2Fwww.measureevaluation.org%2Fresources%2Fpublications%2Ftr-08-68%2Fat_download%2Fdocument&usg=AFQjCNGsStPuzepZeC2BirkTln9LrjemJA
Sethuraman, K., Gujarappa, L., Kapadia-Kundu, N., Naved, R. T., Barua, A., Khoche, P., Parveen, S. (2007). "Delaying the first pregnancy: A survey in Maharashtra, Rajasthan and Bangladesh". Economic and Political Weekly, Nov 3, pp. 79-89. https://www.jstor.org/tc/accept?origin=/stable/pdf/40276749.pdf?refreqid=excelsior%3Aaa1fd2fa65e1471ff64a4e86c84c77b0
García-Moreno, C., Jansen, H.A.F.M., Ellsberg, M., Heise, L., Watts, C. (2005). WHO Multi-country Study on Women's Health and Domestic Violence against Women: Initial Results on Prevalence, Health Outcomes and Women's Responses. Geneva, World Health Organization. http://www.who.int/gender/violence/who_multicountry_study/Introduction-Chapter1-Chapter2.pdf
Amin, S., Selim, N., Waiz, N. K. (2006). Causes and consequences of early marriage in Bangladesh: Background report for workshop on programs and policies to prevent early marriage. Dhaka: Population Council.
Amin, S., and Das, M. (2008). Marriage Continuity and Change in Bangladesh. In Ravinder Kaur, Shalini Grover and Rajni Palriwala (edited) Marriage in South Asia: Shifting Concepts, Changing Practices in a Globalising World, New Delhi: Orient Blackswan. https://www.researchgate.net/publication/283732805_Marriage_Continuity_and_Change_in_Bangladesh
Siddiqi, D. (2005). Of Consent and Contradiction: Forced Marriage in Bangladesh. In Welchman and Hossain (Eds) "Honour" Crimes, Paradigms and Violence against Women, Zed, London. https://books.google.com.bd/books?id=ujwLunL_rrQC&printsec=frontcover&source=gbs_ge_summary_r&cad=0#v=onepage&q&f=false
Bryant, S.A., Spencer, G.A. (2003). University students' attitudes about attributing blame in domestic violence. Journal of Family Violence, 18(6): 369 - 376. https://link.springer.com/content/pdf/10.1023%2FA%3A1026205817132.pdf
Gage, A. (2005). Women's experience of intimate partner violence in Haiti. Social Science and Medicine, 61, 343-364. doi:10.1016/j.socscimed.2004.11.078. http://ac.els-cdn.com/S0277953604006422/1-s2.0-S0277953604006422-main.pdf?_tid=a573f61a-8238-11e7-a826-00000aab0f02&acdnat=1502856726_acab257dc04f9747396689bc587577d1
Rashid, S.F. (2006) Small Powers, Little Choice: Contextualising Reproductive and Sexual Rights in Slums in Bangladesh, IDS Bulletin 37(5). http://onlinelibrary.wiley.com/doi/10.1111/j.1759-5436.2006.tb00305.x/epdf
Morrison, A., M. Ellsberg, S. Bott. (2007). Addressing gender-based violence: A critical review of evaluations. World Bank Economic Review, 22:25-51. http://documents.worldbank.org/curated/en/733971468331173114/Addressing-gender-based-violence-a-critical-review-of-interventions
Bhuiya, I., Rahman, M., Rob, U., Khan, M. E and Zahiduzzaman. (2009). Increasing Dual Protection among Rickshaw Pullers in Bangladesh. Population Council and USAID. http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.175.7587&rep=rep1&type=pdf
Burket, M. K., Alauddin, M., Malek, A., & Rahman, M. (2006). Raising the age of marriage for young girls in Bangladesh. Pathfinder International, Bangladesh. http://www2.pathfinder.org/site/DocServer/PF_Bangladesh_FINAL.pdf?docID=6601%3Cfont%20size%3D
Amin, S. (2005). Kishori Abhijan: A Pilot Project to Empower Adolescent Girls. Transitions to Adulthood, 13. New York, NY: Population Council. http://www.popcouncil.org/uploads/pdfs/TABriefs/13_KishoriAbhijan.pdf
CIOMS (1991). International guidelines for ethical review of epidemiological studies. Geneva. http://onlinelibrary.wiley.com/doi/10.1111/j.1748-720X.1991.tb01822.x/abstract
World Health Organization (2001). Putting women first: Ethical and safety recommendations for research on domestic violence against women (WHO/FCH/GWH/01.1). Geneva, Switzerland: https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0ahUKEwj5-qvv9drVAhUhSo8KHbtrAJQQFgglMAA&url=http%3A%2F%2Fwww.who.int%2Fgender%2Fviolence%2Fwomenfirtseng.pdf&usg=AFQjCNGubsx25jT8EMYw7QM6WLo5w6AnSw

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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03280680    
Other Study ID Numbers: PR-10007
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Violence against young women and girls
Sexual and reproductive health and rights
Consent
Health services
Legal services
Awareness raising
Community mobilization