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

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. This is a mixed methods study comprising a cluster RCT with a complementary in-depth qualitative study and an integrated process evaluation. The study is being conducted in Mwanza city, in northwestern Tanzania. In collaboration with BRAC, established microfinance loan groups in Mwanza city are being identified and assessed for eligibility to take part. Each member of a microfinance loan group is required to pay a deposit before receiving their first loan. They are also required to contribute a small payment each week as a social security deposit. The interest rate is fixed at 25%. The group meets every week to repay part of the loan with a maximum loan repayment time of six months. If an individual member of the group is unable to contribute her share of the loan repayment, the other members of the group must cover this. Established microfinance loan groups that meet the following criteria are eligible for inclusion in the study: For each microfinance loan group enrolled, only women within the group who consent to take part, undergo study procedures. The group-based microfinance loans are delivered by BRAC with no involvement from the MAISHA study team. Microfinance groups allocated to the control arm continue to meet every week for loan repayments following BRAC procedures. Although the MAISHA team continues to keep in regular contact with the groups (to minimize losses to follow-up), there is no further intervention. Microfinance groups allocated to the intervention arm also continue to meet every week for loan repayments. In addition, on alternate weeks, either before or after the loan group meeting, they receive the MAISHA curriculum – Wanawake na Maisha (which means “women and life” in Swahili). The curriculum comprises 10 sessions and was developed for the MAISHA study, by EngenderHealth (an international non-profit organisation focussing on family planning, maternal health, HIV and AIDS and gender equity) in collaboration with LSHTM and MITU. Some of the curriculum activities for Wanawake na Maisha were adapted from other curricula [6, 9–13], including the Sisters for Life curriculum developed for IMAGE in South Africa [6]. The overall aim of the MAISHA curriculum is that, after completing the 10 sessions, participants will have developed skills to help them minimize, and potentially prevent, IPV within intimate relationships, as well as having increased capacity to defend themselves against IPV and the negative consequences resulting from IPV. The specific objectives of the curriculum are detailed in Table 1. Objectives of The MAISHA curriculum (Wanawake Na Maisha) The MAISHA curriculum is delivered over 20 weeks. Each of the 10 sessions (outlined in Fig. ​Fig.1)1) is approximately an hour and a half to two hours giving a total time of approximately 20 h. Each session is participatory and comprises: giving information to participants, small group activities and group discussions, and ending with a take home assignment designed to encourage participants to practice the skills covered during the session. The MAISHA curriculum is delivered by trained facilitators following the MAISHA curriculum manual, which provides detailed guidance for each session. The manual includes tips and notes for the facilitators, including examples of group ice-breakers and energisers. The facilitators have been trained by EngenderHealth to facilitate the MAISHA curriculum which included: gender equitable behavior and attitudes; managing group dynamics (including emotional reactions and disclosure of sensitive information); establishing a safe and comfortable learning environment; and encouraging all participants to take part in discussions. In addition, the training also included discussions around beliefs, including: the belief that intimate relationships should never be coercive, exploitative or abusive; belief in the importance of gender equity and women’s rights; and belief that inequitable gender norms can be changed. Ongoing training of the MAISHA curriculum facilitators, including practicing facilitation skills through role play, is supported by MITU and LSHTM. The MAISHA curriculum facilitators are not involved in collection of baseline data or any outcome assessments for the study. The primary outcome is a composite of women’s reported experience of physical and/or sexual IPV during the past 12 months and is assessed via a face-to-face interview at 24 months post-intervention (29 months post-randomization). The secondary outcomes, also assessed at 24 months post intervention, are women’s reported experience of specific forms of IPV during the past 12 months, as follows: Other secondary outcomes are: Table 2 details the questions asked to assess the different forms of IPV, which have been adapted from the WHO Violence Against Women instrument [8]. Questions used to assess different forms of intimate partner violence experienced by women taking part in the MAISHA study (taken from the WHO Violence Against Women instrument [8]) For each type of violence/abuse, if a woman answers yes to one of more of the questions, then she is recorded has having experienced that form of violence/abuse A woman is recorded as having experienced physical and/or sexual violence (primary outcome) if she answers yes to one or more of the six questions relating to physical violence and/or one or more of the three questions relating to sexual violence Following enrolment into the study, baseline data are collected from women who have consented to take part. Randomization occurs once all women in a block of six microfinance loan groups have completed the baseline interview. The intervention is delivered over 20 weeks (five months) and women in the both study arms are then followed up 24 months later, i.e. 29 months post-randomization (Fig. 2). Overview of participant flow The sample size calculation assumes an estimated prevalence of IPV during the past 12 months of 30% in the comparison arm, based on data from the WHO multi-country study in Tanzania [8]. A sample size of 33 microfinance loan groups per study arm with an average of 20 participants per group (allowing for 10% loss to follow-up) will provide 80% power to detect a reduction of 30% in physical and/or sexual IPV during the past 12 months, and 90% power to detect a reduction of 34%, assuming an intra-cluster correlation of 0.02. Even with an intra-cluster correlation of 0.04, the study will have 80% power to detect a reduction in IPV during the past 12 months of 33%. The study team, in collaboration with BRAC, has identified three neighborhood BRAC branches, out of the seven branches operating across Mwanza city, in which to recruit established microfinance loan groups. Within these three neighborhoods, there are 220 established microfinance loan groups. The study team works closely with BRAC to select groups to approach and invite to take part in the study. Selection of groups to approach is based on factors such as the length of time the group has been established (at least one year), the size of the group (between 15 and 30 active members), and good attendance at the weekly loan meetings, with a good record of loan repayments. Randomization occurs in blocks of six microfinance loan groups. To ensure transparency of the process to the communities, randomization and allocation is a participatory process involving the study team and a representative from each of the six microfinance loan groups to be randomized. Groups are allocated to either intervention or control by tossing a coin. First, representatives from each of the six microfinance groups are randomly divided into two sets (A and B) of three groups. This is done by each representative drawing a folded sheet of paper (with A or B written on it) from a box. One of the representative is asked to call, heads or tails, for her set of three groups to be allocated to the intervention. A study team member then tosses the coin. Given the nature of the intervention, it is not possible to blind participants, or the study team involved in day-to-day operations and delivery of the MAISHA curriculum, after assignment of the intervention. Data analysts will be blinded to allocation. The MAISHA study schedule is outlined in Table ​Table33 (adapted from the SPIRIT template [14]). Data are collected at the following time points: MAISHA study schedule (based on SPIRIT template [14]) PGT-participatory gender training; IPV-intimate partner violence; a Reported experience during past 12 months b Participants are a purposive sample of women from control and intervention arms – the same women will participate at three time-points c immediately following completion of the MAISHA curriculum 1. Baseline (prior to randomization) – following informed consent procedures, a face-to-face interview is conducted using a structured questionnaire adapted from the WHO Violence Against Women instrument [8]. The MAISHA questionnaire has seven sections which ask the woman about her: household; partner; income; health; attitudes and social norms; relationship (including experiences of violence); childhood; and about her community. The questionnaire has been translated into Swahili (the national language) and interviews are conducted in private by female interviewers trained in interviewing techniques, gender issues, violence and ethical issues related to research on IPV [15]. 2. Intervention – during the 20-week intervention period, the following data are collected: attendance, or not, at the MAISHA curriculum sessions – to understand the “dose” of intervention received; and reasons for non-attendance at the MAISHA curriculum sessions – to understand the potential barriers to attendance. 3. 29 months post-randomization – a face-to-face interview is conducted using a structured questionnaire similar to that used at baseline and following the same procedures. A total of 54 in-depth interviews (IDIs) are being conducted with participants. Eighteen women are being purposefully selected from the two study arms to represent women who do and do not report IPV at baseline. A separate team of trained interviewers conduct the IDIs and are blinded as to whether, or not, a woman has reported IPV. Each woman is invited to attend three IDIs – pre-intervention, immediately post-intervention and 24 months post-intervention. The IDIs explore the participants’ life stories and experiences of microfinance, the socio-cultural and structural factors associated with IPV and personal experiences of IPV and its impact on both themselves and their children. For women in the intervention arm, the post-intervention IDIs also explore their views and experiences of the MAISHA curriculum and its impact on their experiences of IPV. Five trial participants from the intervention arm who drop out of the MAISHA curriculum after attending two sessions will be invited to participate in an IDI to explore their reasons for withdrawal from the MAISHA curriculum. Up to 10 key informant interviews are being conducted with local government and non-government organization officials, police, influential community leaders (e.g. religious leaders) and health care professionals. Interviews are conducted pre-intervention and 24 months post-intervention and explore the wider social and political context for IPV. Twenty-seven focus group discussions (FGDs) are being conducted – comprising nine FGDs at three time points (pre-intervention, immediately post-intervention and 24 months post-intervention). Six FGDs are being conducted with women in the intervention arm and three with women in the control arm. Where possible the same women (approximately 10 per focus group) are asked to attend at all three time points. The FGDs explore experiences of microfinance and the socio-cultural and structural factors associated with IPV. The post-intervention FGDs with women in the intervention arm also explore their views and experiences of the MAISHA curriculum and its impact on their views of IPV. FGDs are being conducted with the MAISHA curriculum facilitators to explore their views on the curriculum as a whole and on specific modules, the challenges they have experienced when delivering the sessions, and their perspectives on the impact of the MAISHA curriculum. The photo voices method is being used to enhance understanding of IPV and intimate relationships. A total of nine women (six from the intervention arm and three from the control arm) are invited to take part immediately post-intervention. Participants receive two days training on using a camera and the ethics of taking photographs in the community before being asked to spend one week photographing everyday lives in their community with a focus on healthy relationships. The participants are then interviewed and asked to provide oral narratives of the photographs they have taken. Participatory observations are being conducted at selected microfinance loan group meetings and at the MAISHA curriculum sessions, ensuring that each session is observed at least once. Social scientists conduct informal  conversations with study participants to assess their impressions of the curriculum sessions and its immediate impact. Questionnaire data collected from study participants at baseline and at 29 months post-randomization are recorded directly onto a tablet computer. The questionnaire forms have in-built checks to minimize the level of missing data and to minimize entry of erroneous data. The data recorded on the tablet computer are uploaded to the study database daily and checked for missing and/or erroneous data. Any data queries are sent to the team leader to be resolved with the research assistants conducting the interviews. Attendance at the MAISHA curriculum sessions and reasons for non-attendance are recorded on paper and entered into the study database following double-entry data procedures. Data are checked for missing and/or erroneous data. Any data queries are sent to the team leader to be resolved with the MAISHA curriculum facilitators. All IDIs and FGDs are recorded with the participants’ consent. Hand written notes are taken during the participatory observations of the MAISHA curriculum sessions and microfinance loan group meetings. Audio recordings and hand written notes are transcribed and translated from Swahili (the national language) into English. A sample of the transcripts are checked for quality of transcription and translation. Transcripts are imported to the qualitative analysis package NVIVO (QSR International Pty Ltd, Doncaster, Australia). All visual material, including photographs from the photo voices activities, are imported into the same package. All study data are stored in secure databases with restricted access. Each participant is allocated a unique study identifier. Names and other identifiers are not recorded in the study database. Paper records – e.g. consent forms, tracking forms with names and contact details – are stored securely in locked filing cabinets in secure offices within the study coordinating center at MITU, which has 24-h security and restricted access. A detailed statistical analysis plan will be prepared prior to follow-up interviews. Data from the baseline interviews will be used to verify the sample size calculations and to identify differences between clusters. The coefficient of variation across clusters will be calculated based on the reported prevalence of IPV. Data from the baseline quantitative interviews will also be used to identify important predictors for IPV and important health-related outcomes, such as poor mental health. The primary study analysis will adopt an intention to treat approach, assessing the impact of the intervention on women in the intervention arm at 29 months post-randomization (24 months post-intervention), irrespective of whether or not they received the full “dose” (i.e. 10 sessions) of the MAISHA curriculum. Secondary analyses will be conducted to investigate differences in impact according to the dose of the intervention received. The primary outcome variable (reported experience of a composite of physical and/or sexual IPV during the past 12 months) will be analyzed in a random intercepts logistic regression model to account for the clustered study design, and adjusted for differences in baseline characteristics where relevant. The analysis will be repeated to examine the secondary outcome variables – reported experience of physical IPV, sexual IPV and emotional/psychological abuse during the past 12 months, attitudes towards the acceptability of IPV and, disclosure of violence to others among women who report having experienced physical and/or sexual IPV during the past 12 months. Multiple imputation will be used to simulate missing outcome data. The imputation model will be informed by empirical patterns in the IPV data at baseline and at follow-up. A sensitivity analysis will be conducted, excluding women who participated in the qualitative sub-study (including IDIs, FGDs and photo voices) on the basis that the additional contact of this sub-sample with the study team, as part of these activities, may impact on the effect of the intervention. The analysis will assess if there is any change in the magnitude of the effect. Steps have been taken to minimize contamination of the control arm, which includes recording women’s attendance at the MAISHA curriculum sessions. The potential for direct and indirect contamination of control arm women will be investigated by asking women during follow-up if they attended any of the MAISHA curriculum sessions or if they have discussed any of the sessions with other women participating in the MAISHA study. Given that no outcome data (i.e. experiences of IPV) are collected during the five-month intervention period or during the period up to 24 months post-intervention, a data monitoring committee has not been established as no interim analyses are planned. The study is being conducted following the WHO’s guidelines on researching violence against women [15]. Female interviewers for the quantitative baseline and follow-up interviews and for the qualitative IDIs have received training in interviewing techniques, gender issues, violence and ethical issues related to research on IPV. It is anticipated that any harm to women as a result of taking part in the study will be minimal. All participants are provided with information about organizations offering support to women (and their children, if appropriate) experiencing violence and other forms of abuse. Participants who report violence and other forms of abuse are offered counseling by a trained member of the study team and referral to an appropriate organization for ongoing support. Regular audits of the conduct of the study are carried out by members of the study team. These include checks that participant informed consent procedures have been followed correctly, observation and assessments of facilitation of the MAISHA curriculum sessions, and monitoring of participant attendance at MAISHA curriculum sessions and follow-up of non-attenders. Once a microfinance loan group is identified as meeting eligibility, the study team attends the weekly meetings to present information about the study and provides a copy of the participant information sheet (see: Additional file 1) to each of the microfinance loan group members. Each microfinance loan group member meets with a member of the study team to go through the participant information sheet in detail and to allow the microfinance loan group member to ask questions about the study. If the woman agrees to participate and has demonstrated that she understands the study procedures, she is invited to sign the consent form (see: Additional file 1). Participants and key informants who are invited to take part in IDIs are given a participant information sheet providing information about the IDI (see: Additional file 2). A member of the study team meets with the participant/key informant to go through the participant information sheet in detail and to allow the participant to ask any questions. If the participant/key informant agrees to participate in the IDI she/he is invited to sign a consent form (see: Additional file 2). Participants who are invited to take part in an FGD are given an information sheet about the FGD (see: Additional file 3) following the same procedures described above for obtaining informed consent. Participants’ names and any information that could identify them is kept confidential. Women are allocated a unique study identifier. The questionnaires for the quantitative baseline and follow-up interviews are anonymous and responses to questions are entered directly onto a tablet computer. On the same day as the interview, data are uploaded to the secure study database and removed from the tablet computer before the next interview is conducted. Qualitative IDIs are audio recorded with the participants’ consent. The recordings are labelled with the study identifier only and are destroyed once the recording has been transcribed and translated to English. All personal identifiers will be destroyed at the end of the study. During the 24-month follow-up period following delivery of the intervention, the study team maintains regular contact with participants in order to minimize losses to follow-up. Women who report violence and other forms of abuse during this time are offered support and referred to appropriate organizations for ongoing support post-study. Since the start of recruitment, there has been one amendment to the protocol approved by the ethics committees. The follow-up period has been extended from 12 months post-intervention to 24 months post-intervention following confirmation of the additional funding required. The study investigators felt that this would be a more appropriate time point at which to assess the effectiveness of the MAISHA curriculum in reducing women’s experience of IPV, and to ensure greater comparability with the IMAGE study. In addition, the secondary outcomes were reviewed and amended to ensure that they were clearly defined, specific and measurable. The study findings will be widely disseminated through both formal and informal mechanisms. Meetings will be held with participants to inform them of the results of the study. For women in the control arm, information will be provided as to how the MAISHA curriculum will be expanded into their communities, if it is shown to impact on levels of IPV. The study findings will be presented to key stakeholders at local, regional and national level in Tanzania and at relevant regional, national and international conferences and meetings. Reports of the study will be prepared by the study team for submission to peer-review scientific journals. Other strategies to facilitate dissemination of the results of the study will be developed through collaboration with organisations, consortia and forums such as the STRIVE Research Programme Consortium (Tackling the structural drivers of HIV) and the Sexual Violence Research Initiative (SVRI).