Randomized Trial of Vaccines for Zaire Ebola Virus Disease.

BACKGROUND: Questions remain concerning the rapidity of immune responses and the durability and safety of vaccines used to prevent Zaire Ebola virus disease. METHODS: We conducted two randomized, placebo-controlled trials - one involving adults and one involving children - to evaluate the safety and immune responses of three vaccine regimens against Zaire Ebola virus disease: Ad26.ZEBOV followed by MVA-BN-Filo 56 days later (the Ad26-MVA group), rVSVΔG-ZEBOV-GP followed by placebo 56 days later (the rVSV group), and rVSVΔG-ZEBOV-GP followed by rVSVΔG-ZEBOV-GP 56 days later (the rVSV-booster group). The primary end point was antibody response at 12 months, defined as having both a 12-month antibody concentration of at least 200 enzyme-linked immunosorbent assay units (EU) per milliliter and an increase from baseline in the antibody concentration by at least a factor of 4. RESULTS: A total of 1400 adults and 1401 children underwent randomization. Among both adults and children, the incidence of injection-site reactions and symptoms (e.g., feverishness and headache) was higher in the week after receipt of the primary and second or booster vaccinations than after receipt of placebo but not at later time points. These events were largely low-grade. At month 12, a total of 41% of adults (titer, 401 EU per milliliter) and 78% of children (titer, 828 EU per milliliter) had a response in the Ad26-MVA group; 76% (titer, 992 EU per milliliter) and 87% (titer, 1415 EU per milliliter), respectively, had a response in the rVSV group; 81% (titer, 1037 EU per milliliter) and 93% (titer, 1745 EU per milliliter), respectively, had a response in the rVSV-booster group; and 3% (titer, 93 EU per milliliter) and 4% (titer, 67 EU per milliliter), respectively, had a response in the placebo group (P<0.001 for all comparisons of vaccine with placebo). In both adults and children, antibody responses with vaccine differed from those with placebo beginning on day 14. CONCLUSIONS: No safety concerns were identified in this trial. With all three vaccine regimens, immune responses were seen from day 14 through month 12. (Funded by the National Institutes of Health and others; PREVAC ClinicalTrials.gov number, NCT02876328; EudraCT numbers, 2017-001798-18 and 2017-001798-18/3rd; and Pan African Clinical Trials Registry number, PACTR201712002760250.).

Contesting the crisis narrative: epidemic accounts in Sierra Leone, Tanzania, and Democratic Republic of the Congo.

Scientists and global commentators watched African countries closely in the early months of the COVID-19 pandemic, predicting an impending disaster: the virus was projected to overwhelm already weak health systems. These expectations were informed by imaginaries of Africa as an inevitable site of epidemic disaster. This paper draws on accounts from Sierra Leone, Tanzania, and Democratic Republic of the Congo to contrast global catastrophe framings with everyday imaginations and experiences of crisis and crisis management. Utilising ethnographic research, the paper initially explores how COVID-19 was understood in relation to previous epidemics, from HIV (human immunodeficiency virus) to Ebola, as well as political conflict. It then considers how global crisis narratives both inform and are in tension with everyday collective and personal experiences. The paper brings these empirical reflections into a conversation with theoretical debates on the discursive construction of crisis and its effects, and argues that these tensions matter because crisis framings have consequences.

Conducting Social Science Research During Epidemics and Pandemics: Lessons Learnt.

The COVID-19 pandemic has had a significant impact on how field-based research is being conducted globally. Given the challenges of undertaking fieldwork during epidemics and the need for mixed methods research to address the social, political, and economic issues related to epidemics, there is a small but growing body of evidence in this area. To contribute to the logistical and ethical considerations for conducting research during a pandemic, we draw on the challenges and lessons learnt from adapting methods for two research studies conducted in 2021 during the COVID-19 pandemic in low- and middle-income country (LMIC) settings: (1) in-person research in Uganda and (2) combined remote and in-person research in South and Southeast Asia. Our case studies focus on data collection and demonstrate the feasibility of conducting mixed methods research, even with many logistical and operational constraints. Social science research is often used to identify the context of specific issues, to provide a needs assessment, or inform longer-term planning; however, these case studies have shown the need to integrate social science research from the start of a health emergency and in a systematic way. Social science research during future health emergencies can also inform public health responses during the emergency. It is also crucial to collect social science data after health emergencies to inform future pandemic preparedness. Finally, researchers need to continue research on other public health issues that are ongoing even during a public health emergency.

Family Planning in the Sierra Leone Ebola Outbreak: Women's Proximal and Distal Reasoning.

Sierra Leone was highly impacted by the 2014-2016 West Africa Ebola outbreak, with 3,955 recorded deaths. Already stressed maternal health services were deeply affected by the outbreak due to fears of viral transmission, reallocation of maternity staff, and broader policies to stop transmission including travel restrictions. This research sought to explore women's perspectives on delaying pregnancy during the Ebola outbreak using family planning methods. Qualitative data collection took place in Kambia District in 2018 and included 35 women participants, with women who were either family planning users or nonusers at the time of the outbreak. Women reported a variety of reasons for choosing to take or not to take family planning during the outbreak, which we categorized as proximal (directly related to the outbreak) or distal (not directly outbreak related). Proximal reasons to take family planning included to avoid interacting with health care spaces where Ebola could be transmitted, to avoid the economic burden of additional children in a time when economic activities were curtailed and to return to school when education resumed postoutbreak. Distal reasoning included gender roles affecting women's decision making to seek family planning, concerns related to the physiological side effects of family planning, and the economic burden of paying for family planning. Women's perspectives for choosing to take or not take family planning during the Sierra Leone Ebola crisis had not been explored prior to this paper. Using the lens of family planning to consider how women choose to access health care in an outbreak gives us a unique perspective into how all health care interactions are impacted by a generalized outbreak of Ebola, and how outbreak responses struggle to ensure such services remain a priority.

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).

Women's sexual subjectivity in a Tanzania city in the era of neoliberalism and AIDS.

This paper draws on anthropological research exploring women's changing sexuality within an urban context of Tanzania. The women involved were participating in an HIV prevention trial and worked in bars, restaurants, hotels and nightclubs, or sold local beer or food in Mwanza city. In ethnographic fieldwork and interviews and group discussions with women, narratives about sexuality focused on gendered and moral discourses of sexuality, the commodification of sexuality, and emotions and intimacy in relationships. This paper discusses how women's sexual subjectivies are shaped by a city where social, structural and economic changes over an era of neoliberalism and AIDS has created both disciplinary and liberalising spaces in which gendered and moral discourses of sexuality have emerged.

Women's economic status, male authority patterns and intimate partner violence: a qualitative study in rural North West Province, South Africa.

There are conflicting views on the impact of microfinance-only interventions on women's economic empowerment and intimate partner violence in low and middle-income countries. Evidence suggests however that when microfinance is combined with complementary programmes (microfinance plus) it may be effective for empowering women and addressing intimate partner violence. We conducted in-depth interviews with adult women in rural South Africa who had received microfinance loans for more than a year and had recently completed gender training. We explored women's perceptions on income generation; the effects on their relationships, including intimate partner violence; their notions of power; and perspectives on men's reactions to their empowerment. Findings reveal that the notion of 'power within the self' is supported by women's income generation, alongside a sense of financial independence and improved social support. Women reported increased happiness and reduced financial stress, although social norms and gender expectations about women subservience and male headship remain salient, particularly among older women. Furthermore, younger women appeared to tolerate abuse due to financial and caring responsibilities. These findings underpin the importance of complementary gender training programmes and of including men as participants for enhancing the effectiveness of economic strengthening interventions.

Violence against children during the COVID-19 pandemic.

The coronavirus disease 2019 (COVID-19) pandemic has affected children's risk of violence in their homes, communities and online, and has compromised the ability of child protection systems to promptly detect and respond to cases of violence. However, the need to strengthen violence prevention and response services has received insufficient attention in national and global pandemic response and mitigation strategies. In this paper, we summarize the growing body of evidence on the links between the pandemic and violence against children. Drawing on the World Health Organization's INSPIRE framework to end violence against children, we illustrate how the pandemic is affecting prevention and response efforts. For each of the seven INSPIRE strategies we identify how responses to the pandemic have changed children's risk of violence. We offer ideas for how governments, policy-makers, and international and civil society organizations can address violence in the context of a protracted COVID-19 crisis. We conclude by highlighting how the current pandemic offers opportunities to improve existing child protection systems to address violence against children. We suggest enhanced multisectoral coordination across the health, education, law enforcement, housing, child and social protection sectors. Actions need to prioritize the primary prevention of violence and promote the central role of children and adolescents in decision-making and programme design processes. Finally, we stress the continued need for better data and evidence to inform violence prevention and response strategies that can be effective during and beyond the COVID-19 pandemic.

La pandémie de maladie à coronavirus 2019 (COVID-19) a eu un impact sur le risque de violence à l'égard des enfants à domicile, au sein de leur communauté et en ligne. Elle a également empêché les systèmes de protection de l'enfance d'identifier rapidement les situations de ce type et d'y réagir dès que possible. Pourtant, la nécessité de renforcer les services de prévention et d'action en la matière n'a pas été suffisamment prise en compte dans les stratégies nationales et internationales d'intervention et d'atténuation des effets de la pandémie. Le présent document reprend l'accumulation de preuves confirmant les liens entre pandémie et violence à l'égard des enfants. En nous inspirant du cadre INSPIRE de l'Organisation mondiale de la Santé visant à mettre fin à la violence à l'encontre des enfants, nous illustrons la façon dont la pandémie affecte les efforts de prévention et d'action. Pour chacune des sept stratégies INSPIRE, nous déterminons comment les mesures de lutte contre la pandémie ont influencé le risque de violence envers les enfants. Nous formulons des pistes pour que les gouvernements, les législateurs, les institutions internationales et les organisations de la société civile puissent remédier à cette violence dans un contexte de crise prolongée due à la COVID-19. En guise de conclusion, nous mettons en lumière les opportunités qu'offre la pandémie actuelle d'améliorer les systèmes existants de protection de l'enfance pour mieux combattre la violence envers les enfants. Nous suggérons d'accroître la collaboration entre les secteurs de la santé, de l'éducation, du maintien de l'ordre, du logement, des droits de l'enfant et de la protection sociale. Les actions entreprises doivent se focaliser sur la prévention primaire de la violence et promouvoir le rôle central des enfants et adolescents dans les processus de conception de programmes et de prise de décisions. Enfin, nous soulignons le besoin permanent de données et de preuves fiables pour orienter les stratégies de prévention et d'intervention face à la violence, afin de garantir leur efficacité pendant et après la pandémie de COVID-19.

La pandemia de la enfermedad por coronavirus (COVID-19) ha afectado al riesgo de violencia infantil que sufren los niños en sus hogares, comunidades y en línea, y ha puesto en peligro la capacidad de los sistemas de protección infantil para detectar y responder rápidamente a los casos de violencia. Sin embargo, la necesidad de reforzar los servicios de prevención y respuesta a la violencia no ha recibido suficiente atención en las estrategias nacionales y mundiales de respuesta y mitigación de la pandemia. En este documento, resumimos el creciente conjunto de pruebas sobre los vínculos entre la pandemia y la violencia infantil. Basándonos en el marco INSPIRE de la Organización Mundial de la Salud para poner fin a la violencia infantil, ilustramos cómo la pandemia está afectando a los esfuerzos de prevención y respuesta. Para cada una de las siete estrategias de INSPIRE, identificamos cómo las respuestas a la pandemia han cambiado el riesgo de violencia infantil. Ofrecemos ideas sobre cómo los gobiernos, los responsables políticos y las organizaciones internacionales y de la sociedad civil pueden abordar la violencia en el contexto de una crisis prolongada de COVID-19. Concluimos destacando cómo la pandemia actual ofrece oportunidades para mejorar los sistemas de protección infantil existentes para abordar este tipo de violencia. Sugerimos una mayor coordinación multisectorial en los sectores de la salud, la educación, la aplicación de la ley, la vivienda y la protección social infantil. Las acciones deben priorizar la prevención primaria de la violencia y promover el papel central de los niños y adolescentes en los procesos de toma de decisiones y en el diseño de programas. Por último, subrayamos la necesidad permanente de contar con mejores datos y pruebas para fundamentar las estrategias de prevención y respuesta a la violencia que puedan ser eficaces durante la pandemia de COVID-19 y seguir vigentes cuando ésta pase.

How can community engagement in health research be strengthened for infectious disease outbreaks in Sub-Saharan Africa? A scoping review of the literature.

BACKGROUND: Community engagement (CE) is a well-established practical and scholarly field, recognised as core to the science and ethics of health research, for which researchers and practitioners have increasingly asked questions about desired standards and evaluation. In infectious disease outbreak contexts, questions may be more complex. However, it is unclear what body of knowledge has been developed for CE specifically as it applies to emerging infectious diseases. This scoping review seeks to describe (1) How CE has been conceptualised and understood; and (2) What conclusions have research teams reached on the effectiveness of CE in these settings, including challenges and facilitators. METHODS: We used a scoping review framework by Arksey and O'Malley (Int J Soc Res Methodol 8:19-32, 2005) to structure our review. We conducted a brainstorming session and initial trial search to inform the protocol, search terms, and strategy. Three researchers discussed, developed and applied agreed screening tools and selection criteria to the final search results. Five researchers used the screening tools to screen abstracts and full text for inclusion by consensus. Additional publications were sought from references of retrieved publications and an expert call for literature. We analysed and reported emerging themes qualitatively. RESULTS: We included 59 papers from a total of 722 articles derived from our trial and final literature searches, as well as a process of "citation chasing" and an expert call for grey literature. The core material related exclusively to health research trials during the 2014-2016 West Africa Ebola outbreak. We synthesized reports on components of effectiveness of CE to identify and propose three themes as essential elements of effective CE. CONCLUSIONS: While there is a large volume of literature documenting CE activities in infectious disease research settings generally, there are few accounts of effectiveness dimensions of CE. Our review proposes three themes to facilitate the effectiveness of CE initiatives as essential elements of CE activities in infectious diseases studies: (1) Communication towards building collaborative relationships; (2) Producing contextual knowledge; and (3) Learning lessons over time. As there were relatively few in-depth accounts of CE from our literature review, documentation and accounts of CE used in health research should be prioritised.

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.

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.

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.

Understanding hard-to-reach communities: local perspectives and experiences of trachoma control among the pastoralist Maasai in northern Tanzania.

As progress to eliminate trachoma is made, addressing hard-to-reach communities becomes of greater significance. Areas in Tanzania, inhabited by the Maasai, remain endemic for trachoma. This study assessed the effectiveness of Mass Drug Administration (MDA) through an ethnographic study of trachoma amongst a Maasai community. The MDA experience in the context of the livelihoods of the Maasai in a changing political economy was explored using participant observation and household interviews. Factors influencing MDA effectiveness within five domains were analysed. 1) Terrain of intervention: Human movement hindered MDA, including seasonal migration, domestic chores, grazing and school. Encounters with wildlife were significant. 2) Socio-cultural factors and community agency: Norms around pregnancy led women to accept the drug but hide refusal to swallow the drug. Timing of Community Drug Distributor (CDD) visits conflicted with livestock grazing. Refusals occurred among the ilmurrani age group and older women. Mistrust significantly hindered uptake of drugs. 3) Strategies and motivation of drug distributors: Maa-speaking CDDs were critical to effective drug delivery. Maasai CDDs, whilst motivated, faced challenges of distances, encounters with wildlife and compensation. 4) Socio-materiality of technology: Decreases in side-effects over years have improved trust in the drug. Restrictions to swallowing drugs and/or water were relevant to post-partum women and the ilmurrani. 5) History and health governance: Whilst perceptions of the programme were positive, communities questioned government priorities for resources for hospitals, medicines, clean water and roads. They complained of a lack of information and involvement of community members in health care services. With elimination in sight, hard-to-reach communities are paramount as these are probably the last foci of infection. Effective delivery of MDA programmes in such communities requires a critical understanding of community experiences and responses that can inform tailored approaches to trachoma control. Application of a critical social science perspective should be embedded in planning and evaluation of all NTD programmes.

Contested legitimacy for anthropologists involved in medical humanitarian action: experiences from the 2014-2016 West Africa Ebola epidemic.

The growing involvement of anthropologists in medical humanitarian response efforts has laid bare the moral and ethical consequences that emerge from humanitarian action. Anthropologists are well placed to examine the social, political, cultural and economic dimensions that influence the spread of diseases, and the ways in which to respond to epidemics. Anthropologists are also, with care, able to turn a critical lens on medical humanitarian response. However, there remains some resistance to involving anthropologists in response activities in the field. Drawing on interviews with anthropologists and humanitarian workers involved in the 2014-2016 West African Ebola epidemic, this paper reveals the complex roles taken on by anthropologists in the field and reveals how anthropologists faced questions of legitimacy vis-à-vis communities and responders in their roles in response activities, which focused on acting as 'firefighters' and 'cultural brokers' as well as legitimacy as academic researchers. Whilst these anthropologists were able to conduct research alongside these activities, or draw on anthropological knowledge to inform response activities, questions also arose about the legitimacy of these roles for anthropological academia. We conclude that the process of gaining legitimacy from all these different constituencies is particular to anthropologists and reveals the role of 'giving voice' to communities alongside critiquing medical humanitarianism. Whilst these anthropologists have strengthened the argument for the involvement of anthropologists in epidemic response this anthropological engagement with medical humanitarianism has revealed theoretical considerations more broadly for the discipline, as highlighted through engagement in other fields, especially in human rights and global health.

Lessons learned from engaging communities for Ebola vaccine trials in Sierra Leone: reciprocity, relatability, relationships and respect (the four R's).

BACKGROUND: Building trust and engaging the community are important for biomedical trials. This was core to the set up and delivery of the EBOVAC-Salone and PREVAC Ebola vaccine trials in Sierra Leone during and following the 2014-2016 West African Ebola epidemic. Local community liaison teams (CLT) engaged with the community through public meetings, radio chat shows, and other activities, while a social science team (SST) assessed community members' and participants' perceptions and regularly updated the clinical team to adapt procedures to improve the acceptability and compliance of the trial. The objective of this study was to examine the community engagement (CE) program in these trials and to identify potential barriers and facilitators. METHODS: Fifteen CLT and SST members participated in in-depth interviews and 23 community members attended three focus groups to discuss the Ebola vaccine trials and their experiences and perspectives of the CE activities. RESULTS: A key aim of the CE program was to build trust between the community and the trial. Four main principles (the "four R's") evolved from the discussions with team members and the community that influenced this trust: reciprocity, relatability, relationships and respect. The CLT and SST ensured reciprocal communication between the trial team and the community. The CLT delivered key messages from the trial, whilst the SST completed ethnographic research in the field to uncover rumors and perceptions of the trial in the community. These ethnographic findings were shared with the CLT and addressed in targeted messaging to the community. Both the CLT and SST approached the communities in an egalitarian manner, by dressing modestly, speaking local dialects, and using relatable examples. Appreciation and understanding of the importance of interpersonal relationships and respect for the people, their customs, and traditions also played a large role in the CE program. CONCLUSION: These findings provide an in-depth understanding of how interdisciplinary community liaison and social science teams can work with a clinical team to strengthen trust. The four R's suggest the ways in which trust relations are central to CE and confidence in vaccine trials, and could offer an approach to CE in vaccine trials.

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).

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.

The impact of a human papillomavirus (HPV) vaccination campaign on routine primary health service provision and health workers in Tanzania: a controlled before and after study.

BACKGROUND: The burden of cervical cancer and shortage of screening services in Tanzania confers an urgent need for human papillomavirus (HPV) vaccination. However, the sustainability and impact of another new vaccine campaign in an under-resourced health system requires consideration. We aimed to determine the impact of the government's school-based HPV vaccine campaign in Kilimanjaro region on the provision of routine primary health services and staff workload. METHODS: Data on daily numbers of consultations were collected from health facility register books in 63 dispensaries and health centres in North-West Tanzania for 20 weeks in 2014. Changes in outpatient, antenatal care (ANC), family planning (FP) and immunisation service activity levels before, during and after the two HPV vaccination campaigns in 2014 in 30 facilities within Kilimanjaro region ('intervention facilities') were compared with changes in activity levels in 33 facilities in Arusha region ('controls'). Qualitative interviews were conducted with health workers in Kilimanjaro region who delivered HPV vaccination and those who remained at the facility during in-school HPV vaccine delivery to explore perceptions of workload and capacity. RESULTS: Health facility activity levels were low and very variable in both regions. Controlling for district, facility type, catchment population, clinical staff per 1000 catchment population and the timing of other campaigns, no evidence of a decrease in consultations at the health facility during HPV vaccination week was found across outpatient, ANC, routine immunisation and FP services. However, compared to the average week before and after the campaign, health workers reported longer working hours and patient waiting times, feeling over-stretched and performing duties outside their normal roles whilst colleagues were absent from the facility conducting the HPV vaccine campaign. CONCLUSION: Qualitative interviews with health workers revealed that staff absence from the health facility is common for a number of reasons, including vaccination campaigns. Health workers perceived that the absence of their colleagues increased the workload at the health facility. The numbers of consultations for each service on 'normal days' were low and highly variable and there was no clear detrimental effect of the HPV vaccination campaign on routine health service activity.

Local narratives of sexual and other violence against children and young people in Zanzibar.

Understandings of violence, and especially sexual violence against children, must be situated within the local context. The 2009 Violence against Children Survey in Zanzibar indicated that 6% of girls and 9% of boys reported having experienced sexual violence before the age of 18 years. This paper reports on an in-depth qualitative study conducted in Zanzibar to provide further insights to these findings by examining the circumstances for sexual and other violence against children in Zanzibar. Twenty-four in-depth interviews with young people and 18 focus-group discussions with young people and adults were conducted in rural and urban Zanzibar. A further 8 interviews were conducted with parents and key stakeholders in government and NGO offices that provide services for children. The findings revealed that religious and cultural practices, which form the foundation of Swahili culture in Zanzibar, provide a moral frame for childhood development, but structural factors make children vulnerable to sexual violence. Both boys and girls are vulnerable to sexual violence in the home, neighbourhood, at school and, in particular, at madrasa or Qur'anic schools. As religion and culture are strong influences on childhood, preventing sexual violence at madrasa schools would strengthen the positive aspects of religious teachings for ensuring a safe childhood.

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.