NCT03280680

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
Last Updated

September 12, 2017

Status Verified

July 1, 2017

Enrollment Period

3.6 years

First QC Date

August 22, 2017

Last Update Submit

September 10, 2017

Conditions

Keywords

Violence against young women and girlsSexual and reproductive health and rightsConsentHealth servicesLegal servicesAwareness raisingCommunity mobilization

Outcome Measures

Primary Outcomes (4)

  • Knowledge of sexual and reproductive health

    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.

    4 months post intervention

  • Sexual and reproductive health practice

    To asses this Questions were asked about use of family planning methods, use of condom for preventing sexually transmitted infections, MR.

    4 months post intervention

  • Sexual and reproductive health service utilization

    Questions were asked about utilization of antenatal care, postnatal care, facility delivery and service seeking for sexually transmitted infections.

    4 months post intervention

  • Violence against women and girls

    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.

    4 months post intervention

Study Arms (3)

Female+male group sessions

EXPERIMENTAL
Other: Female+male group sessionsOther: Female group sessionsOther: No group sessions

Female group sessions

EXPERIMENTAL
Other: Female group sessionsOther: No group sessions

No group sessions

OTHER
Other: No group sessions

Interventions

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.

Female+male 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.

Female group sessionsFemale+male group sessions

Community mobilization and service provision for sexual and reproductive and violence against women were also provided.

Female group sessionsFemale+male group sessionsNo group sessions

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (22)

  • Bates LM, Schuler SR, Islam F, Islam K. Socioeconomic factors and processes associated with domestic violence in rural Bangladesh. Int Fam Plan Perspect. 2004 Dec;30(4):190-9. doi: 10.1363/3019004.

    PMID: 15590385BACKGROUND
  • 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

    BACKGROUND
  • Naved RT, Persson LA. Factors associated with spousal physical violence against women in Bangladesh. Stud Fam Plann. 2005 Dec;36(4):289-300. doi: 10.1111/j.1728-4465.2005.00071.x.

    PMID: 16395946BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • Schuler SR, Hashemi SM, Riley AP, Akhter S. Credit programs, patriarchy and men's violence against women in rural Bangladesh. Soc Sci Med. 1996 Dec;43(12):1729-42. doi: 10.1016/s0277-9536(96)00068-8.

    PMID: 8961417BACKGROUND
  • Jewkes R. Intimate partner violence: causes and prevention. Lancet. 2002 Apr 20;359(9315):1423-9. doi: 10.1016/S0140-6736(02)08357-5.

    PMID: 11978358BACKGROUND
  • 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

    BACKGROUND
  • Gage AJ. Women's experience of intimate partner violence in Haiti. Soc Sci Med. 2005 Jul;61(2):343-64. doi: 10.1016/j.socscimed.2004.11.078. Epub 2005 Feb 17.

    PMID: 15893051BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • Naved RT, Azim S, Bhuiya A, Persson LA. Physical violence by husbands: magnitude, disclosure and help-seeking behavior of women in Bangladesh. Soc Sci Med. 2006 Jun;62(12):2917-29. doi: 10.1016/j.socscimed.2005.12.001. Epub 2006 Jan 19.

    PMID: 16426717BACKGROUND
  • International guidelines for ethical review of epidemiological studies. Law Med Health Care. 1991 Fall-Winter;19(3-4):247-58. No abstract available.

    PMID: 1779694BACKGROUND
  • 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

    BACKGROUND
  • Parker B, Ulrich Y. A protocol of safety: research on abuse of women. Nursing Research Consortium on Violence and Abuse. Nurs Res. 1990 Jul-Aug;39(4):248-50. No abstract available.

    PMID: 2367208BACKGROUND

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2017

First Posted

September 12, 2017

Study Start

November 1, 2010

Primary Completion

May 31, 2014

Study Completion

December 31, 2014

Last Updated

September 12, 2017

Record last verified: 2017-07