Hegemonic masculinity: combining theory and practice in gender interventions.

The concept of hegemonic masculinity has been used in gender studies since the early-1980s to explain men's power over women. Stressing the legitimating power of consent (rather than crude physical or political power to ensure submission), it has been used to explain men's health behaviours and the use of violence. Gender activists and others seeking to change men's relations with women have mobilised the concept of hegemonic masculinity in interventions, but the links between gender theory and activism have often not been explored. The translation of 'hegemonic masculinity' into interventions is little examined. We show how, in South Africa and Sweden, the concept has been used to inform theoretically-based gender interventions and to ensure that men are brought into broader social efforts to build gender equity. We discuss the practical translational challenges of using gender theory broadly, and hegemonic masculinity in particular, in a Swedish case study, of the intervention Machofabriken [The Macho Factory], and illustrate how the concept is brought to life in this activist work with men. The concept has considerable practical application in developing a sustainable praxis of theoretically grounded interventions that are more likely to have enduring effect, but evaluating broader societal change in hegemonic masculinity remains an enduring challenge.

Stakeholder views of ethical guidance regarding prevention and care in HIV vaccine trials.

BACKGROUND: South Africa is a major hub of HIV prevention trials, with plans for a licensure trial to start in 2015. The appropriate standards of care and of prevention in HIV vaccine trials are complex and debated issues and ethical guidelines offer some direction. However, there has been limited empirical exploration of South African stakeholders' perspectives on ethical guidance related to prevention and care in HIV vaccine trials. METHODS: Site staff, Community Advisory Board members and Research Ethics Committee members involved with current HIV vaccine trials in South Africa were invited to participate in an exploration of their views. A questionnaire listed 10 care and 10 prevention recommendations drawn from two widely available sets of ethical guidelines for biomedical HIV prevention trials. Respondents (n = 98) rated each recommendation on five dimensions: "Familiarity with", "Ease of Understanding", "Ease of Implementing", "Perceived Protection", and "Agreement with" each ethical recommendation. The ratings were used to describe stakeholder perspectives on dimensions for each recommendation. Dimension ratings were averaged across the five dimensions and used as an indication of overall merit for each recommendation. Differences were explored across dimensions, between care-oriented and prevention-oriented recommendations, and between stakeholder groups. RESULTS: Both care and prevention recommendations were rated highly overall, with median ratings well above the scale midpoint. In general, informed consent recommendations were most positively rated. Care-related recommendations were rated significantly more positively than prevention-related recommendations, with the five lowest-rated recommendations being prevention-related. The most problematic dimension across all recommendations was "Ease of Implementing," and the least problematic was "Agreement with," suggesting the most pressing stakeholder concerns are practical rather than theoretical; that is, respondents agree with but see barriers to the attainment of these recommendations. CONCLUSIONS: We propose that prevention recommendations be prioritized for refinement, especially those assigned bottom-ranking scores for "Ease of Implementing", and/ or "Ease of Understanding" in order to assist vaccine stakeholders to better comprehend and implement these recommendations. Further qualitative research could also assist to better understand nuances in stakeholder reservations about implementing such recommendations.

The subjective experience of using Ignatian meditation by male and female South African university students: an exploratory study.

This study is set out to examine the subjective experience of using the Ignatian method of meditation to reflect on and pray through Ruth 2. A group of male and female Theology students from the University of KwaZulu-Natal were invited to reflect upon/pray through Ruth 2 using Ignatian meditation. Following this exercise, participants were invited to participate in a focus group in which they shared their experience of this exercise, focusing particularly on some of the gendered aspects of the experience. The transcribed focus group material was subjected to a critical thematic analysis, in order to identify which core aspects of the experience of using this method of meditation and reflection were responsible for the reported subjective experiences. The analysis also included a comparison of the experience for men and women participating in this exercise, and the differential effect of various aspects of the exercise on men and women.

'It looks like you just want them when things get rough': civil society perspectives on negative trial results and stakeholder engagement in HIV prevention trials.

Civil society organizations (CSOs) have significantly impacted on the politics of health research and the field of bioethics. In the global HIV epidemic, CSOs have served a pivotal stakeholder role. The dire need for development of new prevention technologies has raised critical challenges for the ethical engagement of community stakeholders in HIV research. This study explored the perspectives of CSO representatives involved in HIV prevention trials (HPTs) on the impact of premature trial closures on stakeholder engagement. Fourteen respondents from South African and international CSOs representing activist and advocacy groups, community mobilisation initiatives, and human and legal rights groups were purposively sampled based on involvement in HPTs. Interviews were conducted from February-May 2010. Descriptive analysis was undertaken across interviews and key themes were developed inductively. CSO representatives largely described positive outcomes of recent microbicide and HIV vaccine trial terminations, particularly in South Africa, which they attributed to improvements in stakeholder engagement. Ongoing challenges to community engagement included the need for principled justifications for selective stakeholder engagement at strategic time-points, as well as the need for legitimate alternatives to CABs as mechanisms for engagement. Key issues for CSOs in relation to research were also raised.

Civil society perspectives on negative biomedical HIV prevention trial results and implications for future trials.

Community engagement is crucial to ongoing development and testing of sorely needed new biomedical HIV prevention technologies. Yet, negative trial results raise significant challenges for community engagement in HIV prevention trials, including the early termination of the Cellulose Sulfate microbicide trial and two Phase IIb HIV vaccine trials (STEP and Phambili). The present study aimed to explore the perspectives and experiences of civil society organization (CSO) representatives regarding negative HIV prevention trial results and perceived implications for future trials. We conducted in-depth interviews with 14 respondents from a broad range of South African and international CSOs, and analyzed data using thematic analysis. CSO representatives reported disappointment in response to negative trial results, but acknowledged such outcomes as inherent to clinical research. Respondents indicated that in theory negative trial results seem likely to impact on willingness to participate in future trials, but that in practice people in South Africa have continued to volunteer. Negative trial results were described as having contributed to improving ethical standards, and to a re-evaluation of the scientific agenda. Such negative results were identified as potentially impacting on funding for trials and engagement activities. Our findings indicate that trial closures may be used constructively to support opportunities for reflection and renewed vigilance in strategies for stakeholder engagement, communicating trial outcomes, and building research literacy among communities; however, these strategies require sustained resources for community engagement and capacity-building.

Advice-giving difficulties in voluntary counselling and testing: a distinctly moral activity.

Advice-giving in voluntary counselling and testing (VCT) is demanding as it involves the discussion of difficult topics such as the morality of sexual risk and behaviour. We conducted a detailed exploration of how the giving and receiving of advice is managed in VCT, and how this is achieved against the backdrop of the competing public health and counselling imperatives that shape VCT practice. Informed by social constructionism and adopting a discursive approach, a sample of 27 videotaped simulated VCT sessions in South Africa were analysed. Two prominent advice strategies were identified. The combined effect of the discursive techniques used in the "making appeals strategy" (using a question which morally obligated the client to respond, drawing on the clients' views about condom use in framing the advice and finally evoking the client's responsibilities to protect others) eventually resulted in the uptake of the counsellor's advice. In the "prescribing rules for living" strategy, little attempt was made to include the client's concerns and views in the advice formulation instead the counsellor relied more on her authoritative, persuasive and professional position to enforce behaviour change - this led to client resistance of the advice. In both strategies, when confronted with certain contextual triggers counsellors invariably up-graded their advice in moral terms. In the first strategy, the moral upgrade had a positive effect on the outcome, in the second, it did not. VCT involves talk about HIV sexual risk behaviour. As such, a moral context is likely to be evoked in these conversations. The challenge is to assist counsellors to address the moral questions surrounding HIV risk in a way that places responsibility not blame onto clients.

Stakeholder perspectives on ethical challenges in HIV vaccine trials in South Africa.

There is little published literature on the ethical concerns of stakeholders in HIV vaccine trials. This study explored the ethical challenges identified by various stakeholders, through an open-ended, in-depth approach. While the few previous studies have been largely quantitative, respondents in this study had the opportunity to spontaneously identify the issues that they perceived to be of priority concern in the South African context. Stakeholders spontaneously identified the following as ethical priorities: informed consent, social harms, collaborative relationships between research stakeholders, the participation of children and adolescents, access to treatment for participants who become infected with HIV, physical harms, fair participant and community selection, confidentiality, benefits, and payment. While there is some speculation that research in developing countries poses special ethical challenges, overall no issues were identified that have not been anticipated in international guidance, literature and popular frameworks. However, the South African context affords a distinctive gloss to these expected issues; for example, respondents were concerned that the predominant selection of black participants may perpetuate racist practices of apartheid. Stakeholders should be aware of contextual factors impacting on the implementation of ethical principles. We make a series of recommendations for South African trials, including amendments to the ethical-legal framework and research policies, and, for further research.

Commentary on "A Framework for Community and Stakeholder Engagement: Experiences From a Multicenter Study in Southern Africa".

Community and stakeholder engagement (CSE) is increasingly acknowledged as foundational to global health research. This commentary builds on the multisite framework for CSE described in an eco-health study conducted in Southern Africa. We acknowledge the context-specific nature of some of the challenges for CSE and draw attention to significant issues and concerns that arose from our studies of CSE in the context of multisite HIV prevention trials in South Africa, India, and Canada: (a) Pretrial-historically based mistrust, identification of appropriate gatekeepers, and considering the breadth of community; (b) Trial implementation-impact of early trial cessations, appropriate community roles and responsibilities, and multifaceted stigma; and (c) Posttrial-supporting and sustaining CSE mechanisms independent of particular trials. Many of these challenges are exacerbated by widespread disparities in wealth and power between trial sponsors and participating communities, further supporting the central importance of sound CSE practices and infrastructures to advance ethical biomedical and public health research.

"Why Don't You Go Into Suburbs? Why Are You Targeting Us?": Trust and Mistrust in HIV Vaccine Trials in South Africa.

Trust is a key element of high-quality stakeholder relations, which are themselves essential for the success of HIV vaccine trials. Where trust is absent, community stakeholders might not volunteer to become involved in key trial activities, and potential participants might not volunteer for enrollment. We explored site staff and Community Advisory Board (CAB) members' experiences of trust/mistrust among community members and potential participants. We analyzed 10 focus group discussions with site staff and CAB members at two active South African HIV vaccine trial sites. We report on key characteristics perceived to contribute to the trustworthiness of communicators, as well as factors associated with mistrust. Attributes associated with trustworthy communicators included shared racial identity, competence, and independence (not being "captured"). Key foci for mistrust included explanations about site selection, stored samples, vaccination, and Vaccine Induced Sero-Positivity (VISP). Our findings suggest that community members' trust is not necessarily global, in which trials are trusted or not; rather, it appears fairly nuanced and is impacted by various perceived attributes of communicators and the information they provide. We make recommendations for clinical trial site stakeholders invested in building trust and for future research into trust at these sites.

Local knowledge and experiences of vaccination: implications for HIV-preventive vaccine trials in South Africa.

This study forms part of the preparation of communities for HIV-preventive vaccine trials in South Africa. On the basis of the assumption that attitudes to any HIV vaccine or vaccine trials will partly be influenced by experiences of vaccination in general, this study aimed to investigate knowledge of, attitudes to, and experiences of vaccination in a small semirural community in KwaZulu-Natal, South Africa. The study also sought to investigate the effect of traditional, cultural, and religious beliefs on attitudes to vaccination, as well as to get some indication of willingness to participate in potential HIV vaccine trials. Overall, the findings reveal a good knowledge of, and positive attitudes to, vaccination, with little negative effect of traditional, cultural, and religious beliefs. The findings also reveal a generally positive attitude to HIV vaccines and vaccine trials. Barriers identified, such as anxiety about safety, were not surprising.

Training South African mental health care providers to talk about sex in the era of AIDS.

OBJECTIVE: Mental health care providers in South Africa often lack the skills to conduct effective prevention activities in psychiatric settings. This article describes the development and evaluation of an HIV education program for mental health care providers at three psychiatric institutions in South Africa. METHODS: The research team worked with a core group of 16 mental health care providers to assess HIV training needs and to develop a training intervention focused on identified issues. The training intervention was administered to three groups (42 total) during three 1.5-day workshops. Providers completed pre- and post-intervention assessments that measured knowledge and attitudes about HIV and AIDS. RESULTS: Data analysis revealed a significant increase in reported levels of comfort with HIV care (d=.54), perceived knowledge of HIV (d=1.17), and factual knowledge (d=.74). CONCLUSIONS: This contextually relevant HIV education curriculum changed providers' attitudes and knowledge, demonstrated the feasibility of administering the training program, and provided a foundation for further prevention activities.

". . . I've Gone Through This My Own Self, So I Practice What I Preach . . . ".

There has not been enough study of the processes by which site staff help participating community members and potential participants to understand complicated concepts for HIV vaccine trials. This article describes strategies reported in six focus group discussions with Community Advisory Board members, educators, and consent counselors at an active HIV vaccine trial site in South Africa. Thematic analysis identified a considerable range of strategies, and findings suggest that such staff do not only try to promote understanding of critical information but also try to build trust in communicated information, to respect cultural differences, and to promote voluntariness. Findings also suggest occasional tensions between these implicit goals. Actual engagement and consent encounters at HIV vaccine trial sites should be observed, recorded, and analyzed; and the relationship between practices and valued outcomes should be assessed. These efforts may help to make consent-related encounters as "potent" as possible given finite resources.

Social and behavioral aspects of child and adolescent participation in HIV vaccine trials.

Recent data indicate that the worldwide rate of HIV infection in adolescents is steadily increasing. Internationally, more than 7000 youths between 15 and 24 years of age are infected with HIV daily, resulting in more than 2.5 million new infections annually. Almost two thirds (1.7 million) of these new infections occur in Africa. Estimates in 2000 showed that the number of South Africans between 15 and 49 years of age infected with HIV was 4.7 million. This number equates to a prevalence rate of 15.4% in those younger than 20 years. Adolescents form an important target group not only for preventative efforts but also for HIV vaccine trials. This article focuses on the social and psychological factors that affect adolescent decision making by considering adolescent risk-taking behaviors, problems associated with predicting adolescent behavior, peer relationships and decision making, sexual disinhibition, and the role of family relationships in adolescent decision making.

I'm positive, but i'm negative: Competing Voices in Informed Consent and Implications for HIV vaccine trials.

HIV vaccine trials (HVTs) are ethically complex, and sound informed consent processes should facilitate optimal decision-making for participants. This study aimed to explore representations of critical HVT-related concepts to enhance the consent process. Four focus group discussions were conducted with participants from key constituencies at a South African HVT site. Thematic analysis was employed to identify representations of key HVT-related concepts. The findings suggest that (potential) participants may negotiate multiple, competing versions of HVT-related concepts in a somewhat unrecognized process, which may have significant implications for the consent process. Stakeholders involved in consent and engagement activities at sites should be assisted to elicit, engage, and resolve competing representations of HVT-related concepts. More empirical research is needed to explore how such stakeholders address competing representations in their interactions with potential participants.

Towards a Science of Community Stakeholder Engagement in Biomedical HIV Prevention Trials: An Embedded Four-Country Case Study.

OBJECTIVES: Broad international guidelines and studies in the context of individual clinical trials highlight the centrality of community stakeholder engagement in conducting ethically rigorous HIV prevention trials. We explored and identified challenges and facilitators for community stakeholder engagement in biomedical HIV prevention trials in diverse global settings. Our aim was to assess and deepen the empirical foundation for priorities included in the GPP guidelines and to highlight challenges in implementation that may merit further attention in subsequent GPP iterations. METHODS: From 2008-2012 we conducted an embedded, multiple case study centered in Thailand, India, South Africa and Canada. We conducted in-depth interviews and focus groups with respondents from different trial-related subsystems: civil society organization representatives, community advocates, service providers, clinical trialists/researchers, former trial participants, and key HIV risk populations. Interviews/focus groups were recorded, and coded using thematic content analysis. After intra-case analyses, we conducted cross-case analysis to contrast and synthesize themes and sub-themes across cases. Lastly, we applied the case study findings to explore and assess UNAIDS/AVAC GPP guidelines and the GPP Blueprint for Stakeholder Engagement. RESULTS: Across settings, we identified three cross-cutting themes as essential to community stakeholder engagement: trial literacy, including lexicon challenges and misconceptions that imperil sound communication; mistrust due to historical exploitation; and participatory processes: engaging early; considering the breadth of "community"; and, developing appropriate stakeholder roles. Site-specific challenges arose in resource-limited settings and settings where trials were halted. CONCLUSIONS: This multiple case study revealed common themes underlying community stakeholder engagement across four country settings that largely mirror GPP goals and the GPP Blueprint, as well as highlighting challenges in the implementation of important guidelines. GPP guidance documents could be strengthened through greater focus on: identifying and addressing the community-specific roots of mistrust and its impact on trial literacy activities; achieving and evaluating representativeness in community stakeholder groups; and addressing the impact of power and funding streams on meaningful engagement and independent decision-making.

Informed consent in an antiretroviral trial in Nigeria.

We examined the process of informed consent in an antiretroviral trial in Nigeria. A semi-structured questionnaire was administered to 88 out of 180 people enrolled in the trial. This covered all aspects of the information disclosed in the leaflet of the antiretroviral trial. We found that 75 (85 per cent) of the respondents knew that the purpose of the research was to test a new drug and 13 (14 per cent) believed that they were receiving free treatment for HIV. Participants understood certain aspects of the research, especially the benefits and duration. Their understanding of the trial's risks and their right to refuse to participate and to withdraw was low. Their level of understanding was significantly related to age but not to gender, marriage, education, religion, employment and occupation. Signed informed consent is not a guarantee that participants have understood the information given to them and therefore made a voluntary decision to participate. Researchers should make sure that the process of obtaining informed consent achieves the desired outcome. This is especially important in the developing world where access to health care is limited, potential participants are poor and literacy levels are low.

Beyond the checklist: assessing understanding for HIV vaccine trial participation in South Africa.

OBJECTIVES: Informed consent and understanding are essential ethical requirements for clinical trial participation. Traditional binary measures of understanding may be limited and not be the best measures of level of understanding. This study designed and compared 4 measures of understanding for potential participants being prepared for enrollment in South African HIV vaccine trials, using detailed operational scoring criteria. METHODS: Assessment of understanding of 7 key trial components was compared via self-report, checklist, vignettes, and narrative measures. Fifty-nine participants, including members of vaccine preparedness groups and 1 HIV vaccine trial, took part. RESULTS: There were significant differences across the measures for understanding of 5 components and for overall understanding. Highest scores were obtained on self-report and checklist measures, and lowest scores were obtained for vignettes and narrative descriptions. CONCLUSIONS: The findings suggest that levels of measured understanding are dependent on the tools used. Forced-choice measures like checklists tend to yield higher scores than open-ended measures like narratives or vignettes. Consideration should be given to complementing checklists and self-reports with open-ended measures, particularly for critical trial concepts, where the consequences of misunderstanding are potentially severe.

Socio-behaviour challenges to phase III HIV vaccine trials in Sub-Saharan Africa.

BACKGROUND: A number of countries in sub-Saharan Africa are preparing for HIV vaccine efficacy trials. Social and behavioural factors related to HIV transmission require examination in each setting where these trials are considered. As part of this, several countries have also recently begun preparatory research investigating relevant social and behavioural issues. There is a need for a review of the literature to help focus such research efforts in Sub-Saharan Africa. OBJECTIVES: To examine key social and behavioural issues that may impact on the conduct of HIV vaccine efficacy trials in sub-Saharan Africa. DESIGN: Literature review METHODS: Major databases (PubMed, PsychInfo, EBSCOhost, and AIDSline) were searched for literature that discussed social and behavioural issues related to HIV vaccine trials. Three areas are highlighted as being particularly significant for HIV vaccine research: (1) willingness to participate in future HIV vaccine efficacy trials, (2) retention of participants in studies, and (3) sexual risk reporting during trials. For each of these topics, major findings from both developed and developing countries are described and avenues for further research are discussed. RESULTS: There are few data from Sub-Saharan Africa regarding willingness to participate in HIV vaccine trials. Data on participant retention rates varies widely, and maintaining large cohorts of individuals within Phase III trials presents an important challenge. In addition, the possible impact of trial participation on sexual disinhibition, and response bias on sexual risk-reporting remain as issues for HIV vaccine trials in African contexts. CONCLUSION: Social and behavioural research forms an important part of preparations for HIV vaccine efficacy trials, and there is a clear need for more research of this type in Sub-Saharan Africa. Innovative approaches are required to address issues such as willingness to participate in vaccine research, participant retention during efficacy trials, and the accurate reporting by participants of sexual risk behaviours.