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      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

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          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.

          Electronic supplementary material

          The online version of this article (10.1186/s12905-018-0546-8) contains supplementary material, which is available to authorized users.

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          Most cited references5

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          Use of qualitative methods alongside randomised controlled trials of complex healthcare interventions: methodological study

          Objective To examine the use of qualitative approaches alongside randomised trials of complex healthcare interventions. Design Review of randomised controlled trials of interventions to change professional practice or the organisation of care. Data sources Systematic sample of 100 trials published in English from the register of the Cochrane Effective Practice and Organisation of Care Review Group. Methods Published and unpublished qualitative studies linked to the randomised controlled trials were identified through database searches and contact with authors. Data were extracted from each study by two reviewers using a standard form. We extracted data describing the randomised controlled trials and qualitative studies, the quality of these studies, and how, if at all, the qualitative and quantitative findings were combined. A narrative synthesis of the findings was done. Results 30 of the 100 trials had associated qualitative work and 19 of these were published studies. 14 qualitative studies were done before the trial, nine during the trial, and four after the trial. 13 studies reported an explicit theoretical basis and 11 specified their methodological approach. Approaches to sampling and data analysis were poorly described. For most cases (n=20) we found no indication of integration of qualitative and quantitative findings at the level of either analysis or interpretation. The quality of the qualitative studies was highly variable. Conclusions Qualitative studies alongside randomised controlled trials remain uncommon, even where relatively complex interventions are being evaluated. Most of the qualitative studies were carried out before or during the trials with few studies used to explain trial results. The findings of the qualitative studies seemed to be poorly integrated with those of the trials and often had major methodological shortcomings.
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            Effect of a structural intervention for the prevention of intimate-partner violence and HIV in rural South Africa: a cluster randomised trial.

            HIV infection and intimate-partner violence share a common risk environment in much of southern Africa. The aim of the Intervention with Microfinance for AIDS and Gender Equity (IMAGE) study was to assess a structural intervention that combined a microfinance programme with a gender and HIV training curriculum. Villages in the rural Limpopo province of South Africa were pair-matched and randomly allocated to receive the intervention at study onset (intervention group, n=4) or 3 years later (comparison group, n=4). Loans were provided to poor women who enrolled in the intervention group. A participatory learning and action curriculum was integrated into loan meetings, which took place every 2 weeks. Both arms of the trial were divided into three groups: direct programme participants or matched controls (cohort one), randomly selected 14-35-year-old household co-residents (cohort two), and randomly selected community members (cohort three). Primary outcomes were experience of intimate-partner violence--either physical or sexual--in the past 12 months by a spouse or other sexual intimate (cohort one), unprotected sexual intercourse at last occurrence with a non-spousal partner in the past 12 months (cohorts two and three), and HIV incidence (cohort three). Analyses were done on a per-protocol basis. This trial is registered with ClinicalTrials.gov, number NCT00242957. In cohort one, experience of intimate-partner violence was reduced by 55% (adjusted risk ratio [aRR] 0.45, 95% CI 0.23-0.91; adjusted risk difference -7.3%, -16.2 to 1.5). The intervention did not affect the rate of unprotected sexual intercourse with a non-spousal partner in cohort two (aRR 1.02, 0.85-1.23), and there was no effect on the rate of unprotected sexual intercourse at last occurrence with a non-spousal partner (0.89, 0.66-1.19) or HIV incidence (1.06, 0.66-1.69) in cohort three. A combined microfinance and training intervention can lead to reductions in levels of intimate-partner violence in programme participants. Social and economic development interventions have the potential to alter risk environments for HIV and intimate-partner violence in southern Africa.
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              Prevalence of intimate partner violence and abuse and associated factors among women enrolled into a cluster randomised trial in northwestern Tanzania

              Background Intimate partner violence (IPV) is recognised as an important public health and social problem, with far reaching consequences for women’s physical and emotional health and social well-being. Furthermore, controlling behaviour by a partner has a similar impact on women’s well-being, yet little is known about the prevalence of this type of behaviour and other related abuses in Tanzania and in other sub-Saharan African countries. Methods We conducted a cross-sectional study to determine the lifetime and past 12-month prevalence of physical and sexual IPV, economic abuse, emotional abuse and controlling behaviour among ever-partnered women in Mwanza, Tanzania. Women (N = 1049) were enrolled in an ongoing trial (Maisha study) to assess the impact of microfinance combined with gender training on participants’ experience IPV, and other related outcomes. Interviews were conducted by same sex interviewers to collect information about socio-demographic characteristics, experiences of specific acts of IPV and abuse, and symptoms of poor mental health status. Results Overall, about 61% of women reported ever experiencing physical and/or sexual IPV (95% CI: 58–64%) and 27% (95% CI: 24–29%) experienced it in the past 12 months. Partner controlling behaviour was the most prevalent type of abuse with 82% experiencing it in their lifetime and 63% during the past 12 months. Other types of abuses were also common, with 34% of women reporting economic abuse and 39% reporting emotional abuse during the past 12 months. The prevalence of IPV and abuses varied by socio-demographic characteristics, showing much higher prevalence rates among younger women, women with young partners and less educated women. After we adjusted for age and socio-economic status, physical violence (OR = 1.8; 95% CI: 1.3–2.7) and sexual violence (OR = 2.8; 95% CI: 1.9–4.1) were associated with increased reporting of symptoms of poor mental health. Similarly, experience of abuse during the past 12 months was associated with increased reporting of symptoms of poor mental health. Conclusions The high prevalence of IPV and abuses and its strong links with symptoms of poor mental health underline the urgent need for developing and testing appropriate interventions in settings like Tanzania to tackle both violence and abusive behaviours among intimate partners. Trial registration ClinicalTrials.gov – ID NCT02592252, registered retrospectively on 13 August 2015.
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                Author and article information

                Contributors
                sheila.harvey@lshtm.ac.uk
                shelley.lees@lshtm.ac.uk
                gerrymshana@hotmail.com
                Daniel.pilger@lshtm.ac.uk
                christian.hansen@lshtm.ac.uk
                saidi.kapiga@lshtm.ac.uk
                charlotte.watts@lshtm.ac.uk
                Journal
                BMC Womens Health
                BMC Womens Health
                BMC Women's Health
                BioMed Central (London )
                1472-6874
                2 April 2018
                2 April 2018
                2018
                : 18
                : 55
                Affiliations
                [1 ]ISNI 0000 0004 0425 469X, GRID grid.8991.9, Department of Global Health and Development, , London School of Hygiene & Tropical Medicine, ; 15-17 Tavistock Place, London, WC1H 9SH UK
                [2 ]GRID grid.452630.6, Mwanza Intervention Trials Unit, ; PO Box 11936, Mwanza, Tanzania
                [3 ]ISNI 0000 0004 0367 5636, GRID grid.416716.3, National Institute for Medical Research, ; PO Box 1462, Mwanza, Tanzania
                [4 ]ISNI 0000 0004 0425 469X, GRID grid.8991.9, Department of Infectious Disease Epidemiology, , London School of Hygiene & Tropical Medicine, ; Keppel Street, London, WC1E 7HT UK
                Author information
                http://orcid.org/0000-0001-7604-8607
                Article
                546
                10.1186/s12905-018-0546-8
                5879641
                29609568
                7833369b-995b-415a-bd04-c560a4375228
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 8 November 2016
                : 19 March 2018
                Funding
                Funded by: Anonymous donor
                Funded by: UK Aid
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Obstetrics & Gynecology
                maisha,intimate partner violence,cluster randomized controlled trial,qualitative,microfinance,gender training,violence prevention,tanzania,africa

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