A cluster randomized controlled trial to assess the impact on intimate partner violence of a 10-session participatory gender training curriculum delivered to women taking part in a group-based microfinance loan scheme in Tanzania (MAISHA CRT01): study protocol

Sheila Harvey, Shelley Lees, Gerry Mshana, Daniel Pilger, Christian Hansen, Saidi Kapiga, Charlotte Watts, Sheila Harvey, Shelley Lees, Gerry Mshana, Daniel Pilger, Christian Hansen, Saidi Kapiga, Charlotte Watts

Abstract

Background: Worldwide, almost one third (30%) of women who have been in a relationship have experienced physical and/or sexual violence from an intimate partner. Given the considerable negative impacts of intimate partner violence (IPV) on women's physical health and well-being, there is an urgent need for rigorous evidence on violence prevention interventions.

Methods: The study, comprising a cluster randomized controlled trial (RCT) and in-depth qualitative study, will assess the impact on women's past year experience of physical and/or sexual IPV of a participatory gender training curriculum (MAISHA curriculum) delivered to women participating in group-based microfinance in Tanzania. More broadly, the study aims to learn more about the factors that contribute to women's vulnerability to violence and understand how the intervention impacts on the lives of women and their families. Sixty-six eligible microfinance loan groups are enrolled and randomly allocated to: the 10-session MAISHA curriculum, delivered over 20 weeks (n = 33); or, to no intervention (n = 33). Study participants are interviewed at baseline and at 24 months post-intervention about their: household; partner; income; health; attitudes and social norms; relationship (including experiences of different forms of violence); childhood; and community. For the qualitative study and process evaluation, focus group discussions are being conducted with study participants and MAISHA curriculum facilitators. In-depth interviews are being conducted with a purposive sample of 18 participants. The primary outcome, assessed at 24 months post-intervention, is a composite of women's reported experience of physical and/or sexual IPV during the past 12 months. Secondary outcomes include: reported experience of physical, sexual and emotional/psychological IPV during the past 12 months, attitudes towards IPV and reported disclosure of IPV to others.

Discussion: The study forms part of a wider programme of research (MAISHA) that includes: a complementary cluster RCT evaluating the impact of delivering the MAISHA curriculum to women not receiving formal group-based microfinance; an economic evaluation; and a cross-sectional survey of men to explore male risk factors associated with IPV. MAISHA will generate rigorous evidence on violence prevention interventions, as well as further insights into the different forms and consequences of violence and drivers of violence perpetration.

Trial registration: ClinicalTrials.gov ID: NCT02592252 , registered retrospectively on 13 August 2015.

Keywords: Africa; Cluster randomized controlled trial; Gender training; Intimate partner violence; Maisha; Microfinance; Qualitative; Tanzania; Violence prevention.

Conflict of interest statement

Ethics approval and consent to participate

The MAISHA study is being conducted following WHO recommendations on researching violence against women [15]. It has been approved by the Tanzanian National Health Research Ethics Committee of the National Institute for Medical Research (Ref: NIMR/HQ/R.8a/Vol. IX/1512), and the ethics committee of the London School of Hygiene & Tropical Medicine (Ref: 11642). The study is implemented in close collaboration with local leaders and a community liaison system has been set up to facilitate the study team working with the communities where the study operates.

Written informed consent (witnessed by an independent witness for illiterate participants) is obtained from all participants before administering any study procedures.

The study sponsor is the London School of Hygiene & Tropical Medicine (Sponsor reference: QA430).

Consent for publication

Not applicable.

Competing interests

Following initiation of the study, Professor Watts has been seconded to DFID as their chief scientific advisor. Her ongoing role in this study is in her academic capacity at LSHTM.

No other interests declared.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

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Fig. 1
Theory of change model
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Overview of participant flow

References

    1. United Nations Sustainable Development Goals. . Accessed 22 Feb 2018.
    1. World Health Organization, London School of Hygiene & Tropical Medicine, South African Medical Research Council. Global and regional estimates of violence against women: prevalence and health effects of intimate partner violence and non-partner sexual violence. Geneva, World Health Organization 2013. . Accessed 22 Feb 2018.
    1. Wathen CN, Macmillan HL. Children’s exposure to intimate partner violence: impacts and interventions. Paediatr Child Health. 2013;18(8):419–422.
    1. World Health Organization and London School of Hygiene and Tropical Medicine. Preventing intimate partner and sexual violence against women: taking action and generating evidence. Geneva, World Health Organization 2010. . Accessed 22 Feb 2018.
    1. Elsberg M, Arango DJ, Morton M, Gennari F, Kiplesund S, Contreras M, Watts C. Prevention of violence against women and girls: what does the evidence say? Lancet. 2015;385(9977):1555–1566. doi: 10.1016/S0140-6736(14)61703-7.
    1. Pronyk PM, Hargreaves JR, Kim JC, Morison LA, Phetla G, Watts C, Busza J, Porter JD. Effect of a structural intervention for the prevention of intimate-partner violence and HIV in rural South Africa: a cluster randomised trial. Lancet. 2006;368(9551):1973–1983. doi: 10.1016/S0140-6736(06)69744-4.
    1. Kim J, Ferrari G, Abramsky T, Watts C, Hargreaves J, Morison L, et al. Assessing the incremental effects of combining economic and health interventions: the IMAGE study in South Africa. Bull World Health Organ. 2009;87(11):824–832. doi: 10.2471/BLT.08.056580.
    1. Garcia-Moreno C, Jansen H, Ellsberg M, Heise L, Watts C. Prevalence of intimate partner violence: findings from the WHO multi-country study on women's health and domestic violence. Lancet. 2006;368(9543):1260–1269. doi: 10.1016/S0140-6736(06)69523-8.
    1. The ACQUIRE Project, EngenderHealth, Promudo. Engaging boys and men in gender transformation: the group education manual. New York, 2008. . Accessed 22 Feb 2018.
    1. EngenderHealth. CoupleConnect: a gender-transformative HIV prevention curriculum for Tanzanian couples. CHAMPION Brief No 3, 2014. . Accessed 22 Feb 2018.
    1. Levack A, Rolleri L, DeAtley J. Gen.M: a gender transformative teenage pregnancy prevention curriculum. New York: EngenderHealth; 2014.
    1. Raising Voices. SASA!. . Accessed 22 Feb 2018.
    1. Population Council. It’s All One Curriculum: Guidelines and Activities for Unified Approach to Sexuality, Gender, HIV, and Human Rights Education -. Accessed 09 Jan 2018 .
    1. Chan AW, Tetzlaff JM, Gotzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Ellsberg M, Heise L. Researching violence against women: a practical guide for researchers and activists. Washington DC: World Health Organization, PATH; 2005.
    1. Lewin S, Glenton C, Ozman AD. Use of qualitative methods alongside randomized controlled trials of complex healthcare interventions: methodological study. BMJ. 2009;339:b3496. doi: 10.1136/bmj.b3496.
    1. Kapiga S, Harvey SE, Muhammad AK, Stoeckl H, Mshana G, Hashim R, Hansen C, Lees S, Watts C. Prevalence of intimate partner violence and abuse and associated factors among women enrolled into a cluster randomized controlled trial in northwestern Tanzania. BMC Public Health. 2017;17:190. doi: 10.1186/s12889-017-4119-9.

Source: PubMed

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