Pathways to reduced physical intimate partner violence among women in north-western Tanzania: Evidence from two cluster randomised trials of the MAISHA intervention.

Intimate partner violence (IPV) affects over one-in-four women globally. Combined economic and social empowerment interventions are a promising IPV prevention model. However, questions remain on the mechanisms through which such interventions prevent IPV, and whether standalone social empowerment interventions can work in the absence of an economic component. This secondary analysis of MAISHA Study data (north-western Tanzania) explores pathways through which a group-based gender-training intervention, delivered to women standalone or alongside microfinance, may impact on physical IPV risk. Two cluster-randomised trials (CRT) assessed the impact of the MAISHA intervention on women's IPV risk; CRT01 among women in 66 pre-existing microfinance groups (n = 919), and CRT02 among 66 newly-formed groups not receiving microfinance (n = 1125). Women were surveyed at baseline and 29 months follow-up. Sub-group analyses explored whether intervention effects on past-year experience of physical IPV varied by participant characteristics. Mediators of intervention effect on physical IPV were explored using mixed-effects logistic regression (disaggregated by trial). In CRT01, MAISHA was associated with reduced past-year physical IPV (adjusted-OR 0.63, 95%CI 0.41-0.98), with stronger effects among those younger, more financially independent, and without prior physical IPV. CRT02 showed no impact on physical IPV, overall or among sub-groups. In CRT01, individual-level reduced acceptability of IPV and group-level confidence to intervene against IPV emerged as potential mediators of intervention effect, while relationship-level indicators of communication were not impacted. In CRT02, positive impacts on individual-level attitudes did not translate into reduced IPV risk. In CRT02, arguments with partners over perceived transgressions of gender roles increased in the intervention-arm. Neither trial resulted in increased separations. Findings illustrate the importance of addressing poverty and women's economic dependence on men, structural factors that may impede the success of socially oriented violence prevention programming. Programming with men is also crucial to ameliorate risks of backlash against attitudinal/behavioural change among women. Trial registration: ClinicalTrials.gov #NCT02592252.

Optimizing the Construction of Outcome Measures for Impact Evaluations of Intimate Partner Violence Prevention Interventions.

Most impact evaluations of intimate partner violence (IPV) prevention interventions use binary measures of "any" versus "no" physical and/or sexual IPV as their primary outcome measure, missing opportunities to capture nuance. In this study, we reanalyzed secondary data from six randomized controlled trials conducted in low- and middle-income countries-Bandebereho (Rwanda), Becoming One (Uganda), Indashyikirwa (Rwanda), MAISHA CRT01, MAISHA CRT02 (Tanzania), Stepping Stones Creating Futures (South Africa), and Unite for a Better Life (Ethiopia), to assess how different conceptualizations and coding of IPV variables can influence interpretations of the impact of an intervention. We compared the standard outcome measures to new measures that reflect the severity and intensity of violence and whether interventions prevent new cases of IPV or reduce or stop ongoing violence. Results indicate that traditional binary indicators masked some of the more subtle intervention effects, and the use of the new indicators allowed for a better understanding of the impacts of the interventions. Conclusions on whether a program is perceived "to work" are highly influenced by the IPV outcomes that the investigators choose to report, and how they are measured and coded. Lack of attention to outcome choice and measurement could lead to prematurely abandoning strategies useful for violence reduction or missing essential insights into how programs may or may not affect IPV. While these results must be interpreted cautiously, given differences in intervention types, the underlying prevalence of violence, sociodemographic factors, sample sizes, and other contextual differences across the trial sites, they can help us move toward a new approach to reporting multiple outcomes that allow us to unpack the "impact" of an intervention by assessing intervention effect by the severity of violence and type of prevention, whether primary and secondary.

Factors associated with attendance to a participatory gender training programme - A secondary analysis of data from the MAISHA study.

Participatory gender training is often included in programmes aimed at preventing intimate partner violence (IPV) in low- and middle-income countries. Higher attendance is associated with greater benefit. Using data from two trials, conducted in Tanzania from 2014 to 2019 (MAISHA study), we retrospectively examined associations between individual and group-level factors and attendance at a gender training intervention, among women in established microfinance groups (CRT01, n = 528), and in newly-formed neighbourhood groups (CRT02, n = 629). High attendance was defined as participation in 7 or more of 10 sessions. More women were high attenders in CRT02 (81.74 %) than CRT01 (66.67 %). In both trials, older age was positively associated with attendance (CRT01: adjusted odds ratio [aOR]: 2.43, 95 %CI: 1.42-4.15, p = 0.001 and CRT02: aOR: 2.00, 95 %CI: 1.10-3.61, p = 0.023). In CRT01 only, past IPV victimization was positively associated with attendance (aOR: 1.71, 95 %CI: 1.07-2.73, p = 0.024), while secondary education and larger group size were negatively associated with attendance (aOR: 0.59, 95 %CI: 0.36-0.97, p = 0.038 and aOR: 0.38, 95 %CI: 0.19-0.75, p = 0.006 respectively). There was limited evidence of associations between factors examined and attendance in CRT02. Programme implementers should consider potential barriers to women's engagement and implement strategies to support participation, particularly for younger women, given their increased risk of IPV.

Disability and intimate partner violence: A cross-sectional study from Mwanza, Tanzania.

BACKGROUND: Women with disabilities are at heightened risk of experiencing intimate partner violence [IPV], although the mechanisms through which disability acts as a risk factor for IPV are not clear. OBJECTIVE: We analyzed cross-sectional data (n = 867) from Wave 3 of the MAISHA longitudinal study, conducted in Mwanza, Tanzania, to i) describe the levels of disability and IPV amongst women, and ii) to assess the association between level and type of disability and IPV experience. METHODS: IPV was assessed using the WHO Multi-Country study instrument. Levels of disability (none, mild and severe) were categorized based on responses to the Washington Group Short Set questions. We fitted logistic regression models to determine the risk of experiencing each type of IPV according to disability level and type of disability. RESULTS: We found significant associations between mild and severe disability and different types of IPV. For example, in multivariate analyses controlling for socio-demographic variables, women reporting severe disability were significantly more likely to report physical and/or sexual IPV, sexual IPV. controlling behaviors, economic IPV, and severe IPV, whereas for mild disability compared to no disability, physical and/or sexual IPV, sexual IPV, and economic IPV were significantly more likely to be reported. Cognitive disability was a significant correlate of all forms of IPV apart from physical IPV. CONCLUSIONS: Our findings that specific types of disability and not others were associated with an elevated risk of IPV exposure indicate the need for nuanced measurement and analysis of the association between disability and IPV.

The Role of Structural Factors in Support-Seeking Among Women Experiencing Intimate Partner Violence (IPV) in Mwanza, Tanzania: Findings From a Qualitative Study.

In this qualitative study of women participating in an intimate partner violence (IPV) prevention trial, experiences of IPV and the context that shapes support-seeking were explored through in-depth interviews and focus groups discussions. Decisions to seek support were influenced by a range of factors including fear of further abuse, shame, acceptance of IPV as normal, belief that IPV is a private matter between the couple, economic dependence on male partners, and a poorly responsive legal and justice system. Gender empowerment programs need to intervene at the social, cultural, political, and economic levels that shape justification and meanings attached to IPV and women's decisions in seeking support.

Longitudinal inconsistencies in women's self-reports of lifetime experience of physical and sexual IPV: evidence from the MAISHA trial and follow-on study in North-western Tanzania.

BACKGROUND: Intimate partner violence (IPV) against women is pervasive throughout the world, with profound consequences for women's health. Research to understand the extent, causes and consequences of IPV relies on self-reported data on violence, and yet there is a paucity of research into the consistency with which women report lifetime IPV over time. METHODS: We use data from the control group of the cluster randomised trial and a follow-on longitudinal study in Tanzania to examine discrepancies in women's reported experience of lifetime physical IPV and sexual IPV over three time-points (T0, T29, T53 months). Among those reporting lifetime history of IPV at T0, we calculate the proportion who subsequently report no lifetime history at T29 and/or T53 ('discrepant' reporting). We use logistic regression to explore associations between discrepant reporting and respondent baseline characteristics, the nature of their IPV experiences at baseline, and situational factors at T53. RESULTS: Complete IPV data were available for 301 women. At T0, 154 (51%) women reported lifetime history of physical IPV, of whom 62% gave a discrepant 'never' report in a subsequent round. Among 93 (31%) with lifetime history of sexual IPV at T0, 73% provided a subsequent discrepant report. 73% of women reported lifetime physical IPV, and 55% lifetime sexual IPV in at least one survey round. For both IPV outcomes, women were less likely to provide discrepant reports if they had recent IPV at baseline, poor mental health (T53) and poor communication with partner (T53). For physical IPV only, reduced discrepant reporting was also associated with baseline household-level financial hardship and more severe or extensive experience of IPV. CONCLUSIONS: A large proportion of women provided discrepant reports over the course of the study. Prevalence estimates of lifetime IPV from one-off cross-sectional surveys are likely to be underestimates, biased towards more recent and severe cases. To improve the stability of IPV measures, researchers should explicitly clarify the meaning of reference periods such as 'ever', consider using shorter reference periods (e.g. past-year), and avoid filter questions that use positive reports of lifetime IPV as a gateway to asking about more recent experiences. TRIAL REGISTRATION: Maisha CRT01 registered at ClinicalTrials.gov #NCT02592252, registered retrospectively (13/08/2015).

A cluster randomised controlled trial to evaluate the impact of a gender transformative intervention on intimate partner violence against women in newly formed neighbourhood groups in Tanzania.

INTRODUCTION: Violence against women is a global public health concern; around a quarter of women will experience intimate partner physical or sexual violence during their lifetime. We assessed the impact of a gender transformative intervention for women designed to prevent intimate partner violence (IPV). METHODS: We conducted a cluster randomised controlled trial in Mwanza city, Tanzania, among women in newly formed neighbourhood groups to evaluate a 10-session participatory intervention that aims to empower women, prevent IPV and promote healthy relationships. Following a baseline interview, groups were randomly assigned (1:1 ratio) to the intervention or control arm. An intention-to-treat analysis was conducted to assess the impact of the intervention on the main outcomes, assessed 24 months postintervention. These included past-year physical IPV and sexual IPV (primary); past-year emotional abuse; and acceptability and tolerance of IPV. RESULTS: Between September 2015 and February 2017, 1265 women were recruited in 66 neighbourhoods and randomly allocated to intervention (n=627 women in 33 neighbourhoods) or control (n=638 women in 33 neighbourhoods). Assessment of outcomes was completed for 551 (88%) intervention and 575 (90%) control women. Among intervention women, 113 (21%) reported physical IPV compared with 117 (20%) control women (adjusted OR (aOR) 0.98, 95% CI 0.72 to 1.33, p=0.892), and 109 (20%) intervention women reported sexual IPV compared with 121 (21%) control women (aOR 0.98, 95% CI 0.72 to 1.32, p=0.881). Intervention women reported less emotional abuse (aOR 0.74, 95% CI 0.56 to 0.98, p=0.035), and were less likely to express attitudes accepting of IPV (aOR 0.49, 95% CI 0.36 to 0.66, p<0.001), and beliefs that IPV is a private matter (aOR 0.54, 95% CI 0.38 to 0.78, p=0.001), or should be tolerated (aOR 0.48, 95% CI 0.34 to 0.66, p<0.001). CONCLUSION: These results indicate that the intervention was effective in reducing emotional abuse and positively impacting attitudes and beliefs condoning IPV, but was not sufficient to reduce physical or sexual IPV. TRIAL REGISTRATION NUMBER: NCT02592252.

Exploring the feasibility and acceptability of integrating screening for gender-based violence into HIV counselling and testing for adolescent girls and young women in Tanzania and South Africa.

BACKGROUND: Gender-based violence (GBV) undermines HIV prevention and treatment cascades, particularly among women who report partner violence. Screening for violence during HIV testing, and prior to offering pre-exposure prophylaxis (PrEP) to HIV uninfected women, provides an opportunity to identify those at heightened HIV risk and greater potential for non-adherence or early discontinuation of PrEP. The paper describes our experience with offering integrated GBV screening and referral as part of HIV counselling and testing. This component was implemented within EMPOWER, a demonstration project offering combination HIV prevention, including daily oral PrEP, to young women in South Africa and Tanzania. METHODS: Between February 2017 and March 2018, a process evaluation was conducted to explore views, experiences and practices of stakeholders (study participants and study clinical staff) during implementation of the GBV screening component. This article assesses the feasibility and acceptability of the approach from multiple stakeholder perspectives, drawing on counselling session observations (n = 10), in-depth interviews with participants aged 16-24 (n = 39) and clinical staff (n = 13), and notes from debriefings with counsellors. Study process data were also collected (e.g. number of women screened and referred). Following a thematic inductive approach, qualitative data were analysed using qualitative software (NVivo 11). RESULTS: Findings show that 31% of young women screened positive for GBV and only 10% requested referrals. Overall, study participants accessing PrEP were amenable to being asked about violence during HIV risk assessment, as this offered the opportunity to find emotional relief and seek help, although a few found this traumatic. In both sites, the sensitive and empathetic approach of the staff helped mitigate distress of GBV disclosure. In general, the delivery of GBV screening in HCT proved to be feasible, provided that the basic principles of confidentiality, staff empathy, and absence of judgment were observed. However, uptake of linkage to further care remained low in both sites. CONCLUSION: Most stakeholders found GBV screening acceptable and feasible. Key principles that should be in place for young women to be asked safely about GBV during HIV counselling and testing included respect for confidentiality, a youth-friendly and non-judgmental environment, and a functioning referral network.

Disclosure of PrEP use by young women in South Africa and Tanzania: qualitative findings from a demonstration project.

Investigating how young women disclose oral pre-exposure prophylaxis (PrEP) use is important given evidence that disclosure is associated with higher adherence. We report qualitative results on PrEP disclosure among young women in South Africa and Tanzania who participated in a PrEP demonstration project (EMPOWER). In total, 81 in-depth interviews were conducted with 39 young women aged 16-24 years-25 from Johannesburg and 14 from Mwanza-at approximately 3, 6 and/or 9 months post-enrolment. Analysis of data was thematic and inductive. Most Johannesburg participants were students in the inner-city; in Mwanza, all worked in recreational venues, occasionally engaging in sexual transactions with customers. A continuum of approaches was evident. Partner disclosure was common in Johannesburg but less so in Mwanza, where many partners were feared as judgemental and potentially violent. In both sites, participants commonly disclosed to family to secure support, and to friends and work colleagues to advocate about PrEP and encourage uptake among at-risk peers. Adherence clubs appeared helpful in building participants' skills and confidence to disclose, particularly in gender-inequitable sexual relationships. PrEP counselling for young women should focus on strengthening communication skills and helping develop strategies for safe disclosure.

The transformative effects of a participatory social empowerment intervention in the MAISHA intimate partner violence trial in Tanzania.

Intimate partner violence is an important public health problem, with far-reaching consequences for women's physical and emotional health and social well-being. There is evidence that intimate partner violence is preventable. The MAISHA study, a randomised controlled trial of the impact of a gender training intervention on intimate partner violence for women in Tanzania, found that those who participated in gender training were less likely to report past-year physical violence. As part of the study, a sample of women participated in longitudinal qualitative enquiry. To better understand the processes of change associated with intimate partner violence prevention, we explored narratives from in-depth interviews and focus group discussions with women who had participated in the training. The study drew on feminist political theory on agency and change, which we sought to understand in a setting with high rates of intimate partner violence that a standalone intervention was unlikely to change. The study found that gender training, which seeks to develop political consciousness and transformation, can promote a sense of efficacy amongst participants who feel validated through the collective learning process. Important yet under examined cognitive elements of change processes deserve more attention in the design, delivery and evaluation of violence prevention gender training.

Couples data from north-western Tanzania: Insights from a survey of male partners of women enrolled in the MAISHA cluster randomized trial of an intimate partner violence prevention intervention.

INTRODUCTION: Globally, around 30% of ever-partnered women have experienced physical and/or sexual intimate partner violence (IPV) during their lifetime. To date, most research into causes and prevention of IPV involves surveys of women, with little research into risk-factors for male perpetration. This paper describes a survey of male partners of women participating in the MAISHA cluster randomised trial (CRT) of an IPV prevention intervention, in Mwanza City, Tanzania. Using linked couples' data, we explore man-, woman-, and relationship-/household-level factors associated with physical and sexual IPV. METHODS: Women were interviewed at baseline and 29-months follow-up. At follow-up, women were asked for consent to invite their partner to participate in the male survey. We describe response rates for the women's follow-up and male partners' surveys, and identify factors associated with women's consent to approach partners. Multivariate logistic regression was used to explore factors associated with women's past-year experiences of physical and sexual IPV. RESULTS: 512 (65%) partnered women consented for the partner to be approached, higher among intervention than control women. 425 (83%) male partners were interviewed. Women consenting were disproportionately likely to be in longer-term relationships. Past-year IPV was associated with lower consent among control women, but greater consent in the intervention arm. Factors associated with increased odds of physical IPV were women's childhood experiences of abuse, young age, women's lower income and women's attitudes justifying IPV. Sexual IPV was associated with women's childhood experiences of abuse, young age, educational disparity within couple, men's alcohol use and women's poor mental health. CONCLUSIONS: We successfully conducted a survey of male partners with the full consent of women trial participants. The breadth of factors associated with IPV demonstrates the need for IPV prevention interventions to work with women and men, and specifically couples. Interventions should address risk-factors for both physical and sexual IPV.

"You talk about problems until you feel free": South African adolescent girls' and young women's narratives on the value of HIV prevention peer support clubs.

BACKGROUND: Daily oral pre-exposure prophylaxis (PrEP) can reduce HIV infection in adolescent girls and young women if used consistently during periods of risk. The EMPOWER study evaluated peer-based clubs incorporating an empowerment curriculum offered to adolescent girls and young women (16-24 years) in South Africa and Tanzania for adherence support. METHODS: Using serial in-depth interviews (n = 33), we assessed the benefits and challenges of club attendance among 13 EMPOWER participants in the Johannesburg site who were randomised to clubs. We used a summary matrix of coded data to support a narrative, case-based analysis. Four case studies are presented. RESULTS: Club participants reported benefits such as increased self-esteem and self-efficacy, reduced isolation, and greater insight into gender-based violence and strategies to address it. Day-to-day PrEP adherence was not the only topic discussed in clubs; participants also appreciated the safe space for sharing problems (such as relationship conflict and PrEP stigma) and found interactive exercises helpful in improving partner communication. CONCLUSIONS: Findings support the use of peer-based clubs using a structured empowerment approach, which may offer valuable PrEP initiation support to adolescent girls and young women in settings with high HIV and gender-based violence prevalence. TRIAL REGISTRATION: Pan African Clinical Trials Registry PACTR202006754762723 , 5 April  2020, retrospectively registered.

A social empowerment intervention to prevent intimate partner violence against women in a microfinance scheme in Tanzania: findings from the MAISHA cluster randomised controlled trial.

BACKGROUND: Globally, about 30% of women have experienced physical or sexual violence, or both, from an intimate partner during their lifetime. Associations between poverty and women's increased risk of intimate partner violence have been observed. We therefore aimed to assess the effect of a violence prevention intervention delivered to women participating in a group-based microfinance scheme in Tanzania. METHODS: We did a cluster randomised controlled trial among women taking part in a microfinance loan scheme in Mwanza city, Tanzania. A microfinance loan group was only enrolled if at least 70% of members consented. We randomly assigned the microfinance groups in blocks of six to receive either the intervention (ie, the intervention arm) or be wait-listed for the intervention after the trial (ie, the control arm). Women in both arms of the trial met weekly for loan repayments. Only those in the intervention arm participated in the ten-session MAISHA intervention that aims to empower women and prevent intimate partner violence. Given the nature of the intervention, it was not possible to mask participants or the research team. The primary outcome was a composite of reported past-year physical or sexual intimate partner violence, or both. Secondary outcome measures were past-year physical, sexual, and emotional intimate partner violence; acceptability and tolerance of intimate partner violence; and attitudes and beliefs related to intimate partner violence. These outcomes were assessed 24 months after the intervention. An intention-to-treat analysis was done, adjusting for age, education, and baseline measure of the respective outcome. The study is registered with ClinicalTrials.gov, number NCT02592252. FINDINGS: Between September, 2014, and June, 2015, 66 (65%) of 101 microfinance groups approached in the study area met the trial eligibility criteria and were enrolled, of which 33 (n=544 women) were allocated to the intervention arm and 33 (n=505 women) to the control arm. Overall, 485 (89%) of 544 women in the intervention arm and 434 (86%) of 505 in the control arm completed the outcomes assessment. Among the intervention arm, 112 (23%) of 485 women reported past-year physical or sexual intimate partner violence, or both, compared with 119 (27%) of 434 in the control arm (adjusted odds ratio [aOR] 0·69, 95% CI 0·47-1·01; p=0·056). Women in the intervention arm were less likely to report physical intimate partner violence (aOR 0·64, 95% CI 0·41-0·99; p=0·043) and were less likely to express attitudes accepting of intimate partner violence (0·45, 0·34-0·61; p<0·0001) or beliefs that intimate partner violence is a private matter (0·51, 0·32-0·81; p=0·005) or should be tolerated (0·68, 0·45-1·01; p=0·055). There was no evidence of an effect on reported sexual or emotional intimate partner violence. There were no reports that participation in the trial had led to new episodes of violence or worsening of ongoing violence and abuse. INTERPRETATION: Reported physical or sexual intimate partner violence, or both, was reduced among women who participated in the intervention arm, although the effect was greater for physical intimate partner violence, suggesting that intimate partner violence is preventable in high-risk settings such as Tanzania. FUNDING: Anonymous donor and STRIVE Consortium.

Women's income and risk of intimate partner violence: secondary findings from the MAISHA cluster randomised trial in North-Western Tanzania.

BACKGROUND: Intimate partner violence (IPV) is pervasive throughout the world, with profound consequences for women's health. While women's 'economic empowerment' is touted as a potential means to reduce IPV, evidence is mixed as to the role of different economic factors in determining women's risk. This paper explores associations and potential pathways between women's income and experience of IPV, in Mwanza city, Tanzania. METHODS: We use data from married/cohabiting women (N = 740) enrolled in the MAISHA study, a cluster randomised trial of an IPV prevention intervention. Women were interviewed at baseline and 29-months later. We use logistic regression to model cross-sectional (baseline) and longitudinal associations between: a woman's monthly income (quartiles) and her past year risk of physical IPV, sexual IPV and economic abuse; and a woman's relative financial contribution to the household (same/less than partner; more than partner) and past year physical IPV and sexual IPV. RESULTS: At baseline, 96% of respondents reported earning an income and 28% contributed more financially to the household than their partner did. Higher income was associated with lower past-year physical IPV risk at baseline and longitudinally, and lower sexual IPV at baseline only. No clear associations were seen between income and economic abuse. Higher relative financial contribution was associated with increased physical IPV and sexual IPV among all women at baseline, though only among control women longitudinally. Higher income was associated with several potential pathways to reduced IPV, including reduced household hardship, fewer arguments over the partner's inability to provide for the family, improved relationship dynamics, and increased relationship dissolution. Those contributing more than their partner tended to come from more disadvantaged households, argue more over their partner's inability to provide, and have worse relationship dynamics. CONCLUSIONS: While women's income was protective against IPV, women who contributed more financially than their partners had greater IPV risk. Poverty and tensions over men's inability to provide emerge as potentially important drivers of this association. Interventions to empower women should not only broaden women's access to economic resources and opportunities, but also work with women and men to address men's livelihoods, male gender roles and masculinity norms. TRIAL REGISTRATION: ClinicalTrials.gov #NCT02592252 , registered retrospectively (13/08/2015).

Family satisfaction with critical care in the UK: a multicentre cohort study.

OBJECTIVE: To assess family satisfaction with intensive care units (ICUs) in the UK using the Family Satisfaction in the Intensive Care Unit 24-item (FS-ICU-24) questionnaire, and to investigate how characteristics of patients and their family members impact on family satisfaction. DESIGN: Prospective cohort study nested within a national clinical audit database. SETTING: Stratified, random sample of 20 adult general ICUs participating in the Intensive Care National Audit & Research Centre Case Mix Programme. PARTICIPANTS: Family members of patients staying at least 24 hours in ICU were recruited between May 2013 and June 2014. INTERVENTIONS: Consenting family members were sent a postal questionnaire 3 weeks after the patient died or was discharged from ICU. Up to four family members were recruited per patient. MAIN OUTCOME MEASURES: Family satisfaction was measured using the FS-ICU-24 questionnaire. MAIN RESULTS: A total of 12 346 family members of 6380 patients were recruited and 7173 (58%) family members of 4615 patients returned a completed questionnaire. Overall and domain-specific family satisfaction scores were high (mean overall family satisfaction 80, satisfaction with care 83, satisfaction with information 76 and satisfaction with decision-making 73 out of 100) but varied significantly across adult general ICUs studied and by whether the patient survived ICU. For family members of ICU survivors, characteristics of both the family member (age, ethnicity, relationship to patient (next-of-kin and/or lived with patient) and visit frequency) and the patient (acute severity of illness and receipt of invasive mechanical ventilation) were significant determinants of family satisfaction, whereas, for family members of ICU non-survivors, only patient characteristics (age, acute severity of illness and duration of stay) were significant. CONCLUSIONS: Overall family satisfaction in UK adult general ICUs was high but varied significantly. Adjustment for differences in family member/patient characteristics is important to avoid falsely identifying ICUs as statistical outliers. TRIAL REGISTRATION NUMBER: ISRCTN47363549.

Effect of a Nurse-Led Preventive Psychological Intervention on Symptoms of Posttraumatic Stress Disorder Among Critically Ill Patients: A Randomized Clinical Trial.

Importance: A meta-analysis of outcomes during the 6 months after intensive care unit (ICU) discharge indicate a prevalence for clinically important posttraumatic stress disorder (PTSD) symptoms of 25%. Objective: To determine whether a nurse-led preventive, complex psychological intervention, initiated in the ICU, reduces patient-reported PTSD symptom severity at 6 months. Design, Setting, and Participants: A multicenter, parallel-group, cluster-randomized clinical trial with integrated economic and process evaluations conducted in 24 ICUs in the United Kingdom. Participants were critically ill patients who regained mental capacity following receipt of level 3 (intensive) care. A total of 2961 eligible patients were identified from September 2015 to January 2017. A total of 2048 were approached for participation in the ICU, of which 1458 provided informed consent. Follow-up was completed December 2017. Interventions: Twenty four ICUs were randomized 1:1 to the intervention or control group. Intervention ICUs (n = 12; 669 participants) delivered usual care during a baseline period followed by an intervention period. The preventive, complex psychological intervention comprised promotion of a therapeutic ICU environment plus 3 stress support sessions and a relaxation and recovery program delivered by trained ICU nurses to high-risk (acutely stressed) patients. Control ICUs (n = 12; 789 participants) delivered usual care in both baseline and intervention periods. Main Outcomes and Measures: The primary clinical outcome was PTSD symptom severity among survivors at 6 months measured using the PTSD Symptom Scale-Self-Report questionnaire (score range, 0-51, with higher scores indicating greater symptom severity; the minimal clinically important difference was considered to be 4.2 points). Results: Among 1458 enrolled patients (mean [SD] age, 58 [16] years; 599 women [41%]), 1353 (93%) completed the study and were included in the final analysis. At 6 months, the mean PTSD Symptom Scale-Self-Report questionnaire score in intervention ICUs was 11.8 (baseline period) compared with 11.5 (intervention period) (difference, -0.40 [95% CI, -2.46 to 1.67]) and in control ICUs, 10.1 (baseline period) compared with 10.2 (intervention period) (difference, 0.06 [95% CI, -1.74 to 1.85]) between periods. There was no significant difference in PTSD symptom severity at 6 months (treatment effect estimate [difference in differences] of -0.03 [95% CI, -2.58 to 2.52]; P = .98). Conclusions and Relevance: Among critically ill patients in the ICU, a nurse-led preventive, complex psychological intervention did not significantly reduce patient-reported PTSD symptom severity at 6 months. These findings do not support the use of this psychological intervention. Trial Registration: ISRCTN53448131.

Providing psychological support to people in intensive care: development and feasibility study of a nurse-led intervention to prevent acute stress and long-term morbidity.

OBJECTIVES: Adverse psychological outcomes, following stressful experiences in critical care, affect up to 50% of patients. We aimed to develop and test the feasibility of a psychological intervention to reduce acute stress and prevent future morbidity. DESIGN: A mixed-methods intervention development study, using two stages of the UK Medical Research Council framework for developing and testing complex interventions. Stage one (development) involved identifying an evidence base for the intervention, developing a theoretical understanding of likely processes of change and modelling change processes and outcomes. Stage two comprised two linked feasibility studies. SETTING: Four UK general adult critical care units. PARTICIPANTS: Stage one: former and current patients, and psychology, nursing and education experts. Stage two: current patients and staff. OUTCOMES: Feasibility and acceptability to staff and patients of content and delivery of a psychological intervention, assessed using quantitative and qualitative data. Estimated recruitment and retention rates for a clinical trial. RESULTS: Building on prior work, we standardised the preventative, nurse-led Provision Of Psychological support to People in Intensive Care (POPPI) intervention. We devised courses and materials to train staff to create a therapeutic environment, to identify patients with acute stress and to deliver three stress support sessions and a relaxation and recovery programme to them. 127 awake, orientated patients took part in an intervention feasibility study in two hospitals. Patient and staff data indicated the complex intervention was feasible and acceptable. Feedback was used to refine the intervention. 86 different patients entered a separate trial procedures study in two other hospitals, of which 66 (80% of surviving patients) completed questionnaires on post-traumatic stress, depression and health 5 months after recruitment. CONCLUSION: The 'POPPI' psychological intervention to reduce acute patient stress in critical care and prevent future psychological morbidity was feasible and acceptable. It was refined for evaluation in a cluster randomised clinical trial. TRIAL REGISTRATION NUMBER: ISRCTN61088114; Results.

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. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02592252 , registered retrospectively on 13 August 2015.

Psychological Outcomes following a nurse-led Preventative Psychological Intervention for critically ill patients (POPPI): protocol for a cluster-randomised clinical trial of a complex intervention.

INTRODUCTION: Acute psychological stress, as well as unusual experiences including hallucinations and delusions, are common in critical care unit patients and have been linked to post-critical care psychological morbidity such as post-traumatic stress disorder (PTSD), depression and anxiety. Little high-quality research has been conducted to evaluate psychological interventions that could alleviate longer-term psychological morbidity in the critical care unit setting. Our research team developed and piloted a nurse-led psychological intervention, aimed at reducing patient-reported PTSD symptom severity and other adverse psychological outcomes at 6 months, for evaluation in the POPPI trial. METHODS AND ANALYSIS: This is a multicentre, parallel group, cluster-randomised clinical trial with a staggered roll-out of the intervention. The trial is being carried out at 24 (12 intervention, 12 control) NHS adult, general, critical care units in the UK and is evaluating the clinical effectiveness and cost-effectiveness of a nurse-led preventative psychological intervention in reducing patient-reported PTSD symptom severity and other psychological morbidity at 6 months. All sites deliver usual care for 5 months (baseline period). Intervention group sites are then trained to carry out the POPPI intervention, and transition to delivering the intervention for the rest of the recruitment period. Control group sites deliver usual care for the duration of the recruitment period. The trial also includes a process evaluation conducted independently of the trial team. ETHICS AND DISSEMINATION: This protocol was reviewed and approved by the National Research Ethics Service South Central - Oxford B Research Ethics Committee (reference: 15/SC/0287). The first patient was recruited in September 2015 and results will be disseminated in 2018. The results will be presented at national and international conferences and published in peer reviewed medical journals. TRIAL REGISTRATION NUMBER: ISRCTN53448131; Pre-results.

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.