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Analytic treatment interruptions (ATIs) are currently the standard for assessing the impact of experimental interventions aimed at inducing sustained antiretroviral therapy (ART)-free remission in trials related to HIV cure. ATIs are associated with substantial risk to both study participants and their sexual partner(s). Two documented HIV transmissions occurring in the context of ATIs have been recently reported, but recommendations for mitigating the risk of such events during ATIs are limited. We outline a practical approach to risk mitigation during ATI studies and describe strategies we are utilising in an upcoming clinical trial that may be applicable to other centres.

Purpose of review Partnerships between academia and the community led to historic advances in HIV and paved the way for ongoing community engagement in research. Three decades later, we review the state of community engagement in HIV research, discuss best practices as supported by literature, explore innovations, and identify ongoing gaps in knowledge. Recent findings The community of people living with and at risk for HIV remains actively involved in the performance of HIV research. However, the extent of participation is highly variable despite long standing and established principles and guidelines of good participatory practices (GPP) and community-based participatory research (CBPR). Current literature reveals that known barriers to successful community engagement continue to exist such as power differences, and poor scientific or cultural competency literacy. Several high-quality studies share their experiences overcoming these barriers and demonstrate the potential of CBPR through reporting of qualitative and quantitative outcomes. Summary Greater time and attention should be placed on the development of community engagement in HIV research. A large body of literature, including innovative cross-cutting approaches, exists to guide and inform best practices and mitigate common barriers. However, we recognize that true growth and expansion of CBPR within HIV and in other fields will require a greater breadth of research reporting qualitative and quantitative outcomes.

Introduction Little is known about the effects of HIV reservoir research at the end of life on staff members involved. Staff members’ perceptions and experiences were assessed related to their involvement in the Last Gift, a rapid autopsy study at the University of California San Diego enrolling people living with HIV who are terminally ill and have a desire to contribute to HIV cure-related research. Methods Two focus group discussions consisting of clinical (n = 7) and rapid research autopsy (n = 8) staff members were conducted to understand the perspectives of staff members and the impact the Last Gift rapid autopsy study had on them. The total sample consisted of 66.7% females and 33.3% males and was ethnically diverse (66.7% Caucasian, 6.7% African American, 20.0% Asian descent, 6.7% Hispanic descent and American Indian) with a range of experience in the HIV field from 1 year to 30 years. Results Qualitative focus group data revealed five major themes underlying study staff members’ multilayered mental and practical involvement: 1) positive perceptions of the Last Gift study, with sub-themes including Last Gift study participants’ altruism, fulfillment, and control at the end of life, 2) perceptions of staff members’ close involvement in the Last Gift study, with sub-themes related to staff members’ cognitive processing, self-actualization and fulfillment, stress management and resilience, coping mechanisms, and gratitude toward Last Gift participants and toward the study itself, 3) considerations for successful and sustainable study implementation, such as ethical awareness and sustained community and patient engagement, 4) collaborative learning and organizational processes and the value of interdependence between staff members, and 5) considerations for potential study scale-up at other clinical research sites. Discussion Understanding staff members’ nuanced emotional and procedural experiences is crucial to the Last Gift study’s sustainability and will inform similar cure research studies conducted with people living with HIV at the end of life. The study’s potential reproducibility depends on a robust research infrastructure with established, interdependent clinical and rapid autopsy teams, continuous community engagement, and an ethical and well-informed engagement process with people living with HIV.

Background The U.S. National Institute of Allergies and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH) have a new research priority: inclusion of terminally ill persons living with HIV (PLWHIV) in HIV cure-related research. For example, the Last Gift is a clinical research study at the University of California San Diego (UCSD) for PLWHIV who have a terminal illness, with a prognosis of less than 6 months. Discussion As end-of-life (EOL) HIV cure research is relatively new, the scientific community has a timely opportunity to examine the related ethical challenges. Following an extensive review of the EOL and HIV cure research ethics literature, combined with deliberation from various stakeholders (biomedical researchers, PLWHIV, bioethicists, and socio-behavioral scientists) and our experience with the Last Gift study to date, we outline considerations to ensure that such research with terminally ill PLWHIV remains ethical, focusing on five topics: 1) protecting autonomy through informed consent, 2) avoiding exploitation and fostering altruism, 3) maintaining a favorable benefits/risks balance, 4) safeguarding against vulnerability through patient-participant centeredness, and 5) ensuring the acceptance of next-of-kin/loved ones and community stakeholders. Conclusion EOL HIV cure-related research can be performed ethically and effectively by anticipating key issues that may arise. While not unique to the fields of EOL or HIV cure-related research, the considerations highlighted can help us support a new research approach. We must honor the lives of PLWHIV whose involvement in research can provide the knowledge needed to achieve the dream of making HIV infection curable.

Author(s): Perry, K; Taylor, J; Concha-Garcia, S; Javadi, S; Patel, H; Kaytes, A; Little, S; Smith, D; Gianella, S; Dube, K

Providing incentives is an accepted and common practice in human subjects research, including clinical HIV research. While we know that financial incentives among similar studies can greatly vary, surprisingly little research exists on how to determine when such incentives are excessive or constitute an "undue inducement." Multiple factors, such as risks and benefits, study procedures, study budget, historical precedent, recommendations from institutional review boards, advice from other investigators, and local regulations may influence decisions about appropriate incentives, but little empirical data exist about what incentives are offered to potential research participants. Rules for acceptable gifts, services, and compensation should consider study location and population, but without a clearer understanding of currently offered incentives and how these practices match up to ethical beliefs of appropriateness, we continue to follow perceived trends without critical assessment. Here, we present one potential approach to explore the impact of financial incentives on biomedical HIV research and to further clarify undue inducement: the development of a framework to support ethical decision-making about payment to participate. This framework is based on input from people living with HIV, biomedical HIV researchers, ethicists, former study participants, and IRB members and includes a database that allows for tracking payment practices.

Strategies to control HIV in the absence of antiretroviral therapy are needed to cure HIV. However, such strategies will require analytical treatment interruptions (ATIs) to determine their efficacy. We investigated how U.S. stakeholders involved in HIV cure research perceive ATIs. We conducted 36 in-depth interviews with three groups of stakeholders: 12 people living with HIV, 11 clinician-researchers, and 13 policy-makers/bioethicists. Qualitative data revealed several themes. First, there was little consensus on when ATIs would be ethically warranted. Second, the most frequent perceived hypothetical motivators for participating in research on ATIs were advancing science and contributing to society. Third, risks related to viral rebound were the most prevalent concerns related to ATIs. Stakeholders suggested ways to minimize the risks of ATIs in HIV cure research. Increased cooperation between scientists and local communities may be useful for minimizing risk. Further ethics research is necessary.

Introduction The search for an HIV cure involves important behavioural and social processes that complement the domains of biomedicine. However, the field has yet to tap into the full potential of behavioural and social sciences research (BSSR). In this article, we apply Gaist and Stirratt’s BSSR Functional Framework to the field of HIV cure research. Discussion The BSSR Functional Framework describes four key research domains: (1) basic BSSR (understanding basic behavioural and social factors), (2) elemental BSSR (advancing behavioural and social interventions), (3) supportive BSSR (strengthening biomedically focused clinical trials), and (4) integrative BSSR (building multi‐disciplinary combination approaches for real‐world implementation). In revisiting and applying the BSSR Functional Framework, we clarify the importance of BSSR in HIV cure research by drawing attention to such things as: how language and communication affect the meaning of “cure” to people living with HIV (PLHIV) and broader communities; how cure affects the identity and social position of PLHIV; counselling and support interventions to address the psychosocial needs and concerns of study participants related to analytical treatment interruptions (ATIs); risk reduction in the course of ATI study participation; motivation, acceptability, and decision‐making processes of potential study participants related to different cure strategies; HIV care providers’ perceptions and attitudes about their patients’ participation in cure research; potential social harms or adverse social events associated with cure research participation; and the scalability of a proven cure strategy in the context of further advances in HIV prevention and treatment. We also discuss the BSSR Functional Framework in the context of ATIs, which involve processes at the confluence of the BSSR domains. Conclusions To move HIV cure regimens through the translational research pathway, attention will need to be paid to both biomedical and socio‐behavioural elements. BSSR can contribute an improved understanding of the human and social dimensions related to HIV cure research and the eventual application of HIV cure regimens. The BSSR Functional Framework provides a way to identify advances, gaps and opportunities to craft an integrated, multi‐disciplinary approach at all stages of cure research to ensure the real‐world applicability of any strategy that shows promise.

Multiple strategies to cure HIV infection are under investigation, including cell and gene therapy (C&GT) approaches. Research, and ultimately treatment, with these novel strategies will require patients' willingness to participate. To elicit the perspectives of people living with HIV specific to these novel approaches, we conducted 4 focus group discussions with a diverse group of 19 English-speaking men and women living with HIV in care at a large academic HIV clinic in the northwestern United States. Thematic analysis indicated participants expressed initial fear about C&GT research. They articulated specific concerns about risks, including analytical treatment interruptions, and thought only a person in desperate straits would participate. They voiced significant mistrust of research in general and believed there was already a cure from HIV that was being withheld from the poor. Overall, they were satisfied with their health and quality of life on antiretroviral therapy. These findings suggest the importance of community engagement and educational efforts about C&GT for HIV cure to ensure optimal collaborative partnerships.

The literature on HIV therapeutics research is rife with terminology associating ���sterilisation��� with HIV cure. We find connotations of the word ���sterilising��� problematic for the HIV cure research field. In this viewpoint, we review associations of sterilising with concepts of disinfection or cleansing, as well as coerced sterilisation. We discuss emerging findings from socio-behavioural research that show aversion from people living with HIV towards the ���sterilising cure��� nomenclature. We call for more collaborations with people with HIV as partners to help define what would be a more acceptable terminology for describing an HIV cure.

Summary Analytical antiretroviral treatment interruption (ATI) is an important feature of HIV research, seeking to achieve sustained viral suppression in the absence of antiretroviral therapy (ART) when the goal is to measure effects of novel therapeutic interventions on time to viral load rebound or altered viral setpoint. Trials with ATIs also intend to determine host, virological, and immunological markers that are predictive of sustained viral control off ART. Although ATI is increasingly incorporated into proof-of-concept trials, no consensus has been reached on strategies to maximise its utility and minimise its risks. In addition, differences in ATI trial designs hinder the ability to compare efficacy and safety of interventions across trials. Therefore, we held a meeting of stakeholders from many interest groups, including scientists, clinicians, ethicists, social scientists, regulators, people living with HIV, and advocacy groups, to discuss the main challenges concerning ATI studies and to formulate recommendations with an emphasis on strategies for risk mitigation and monitoring, ART resumption criteria, and ethical considerations. In this Review, we present the major points of discussion and consensus views achieved with the goal of informing the conduct of ATIs to maximise the knowledge gained and minimise the risk to participants in clinical HIV research.

Curing HIV infection moved from the aspirational to the theoretically plausible with the apparent elimination of latent HIV from Timothy Ray Brown, also known as the Berlin Patient, after receipt of a stem cell transplant from a donor homozygous for the CCR5-��32 gene deletion. As HIV cure-related research has expanded, much of the science has centred on biomedical outcomes, and less on the people for whom a cure is being sought. Specifically, there has been limited inquiry directed towards understanding the motivations, perceptions, desires, needs, and experiences of people living with HIV who are asked to participate in cure-related research. This relative lack of attention is troubling when considering trade-offs, risks, demands, and burdens accompanying many of these investigations, such as intensively monitored antiretroviral pauses in effective HIV therapy, large volume blood draws and leucaphereses, and dosing with experimental immunotherapies.

To the Editor���We are writing to express concerns regarding facts reported in 2 recent Journal of Infectious Diseases articles pertaining to the ANRSLIGHT study, conducted in 18 clinical sites in France between September 2013 and May 2015. Initially, we were delighted to see the authors implemented several inclusion criteria that we believe were likely to ensure safety of participants during the analytical treatment interruption (ATI) that occurred during the trial, for example a nadir of CD4+ T-cell count of ���300 cells/mm3 and an initial CD4+ T-cell count of ���600/mm3. However, other aspects are dismaying, including the detailed identifying information about the index participant and partner. We fear it is possible to identify both persons from the elaborate medical and nonmedical history provided. After contacting the study Principal Investigator, Dr Leli��vre, through a European colleague, it appears there were no consents to disclose this information. Thus, we feel strongly that it was inappropriate to include such comprehensive, potentially identifying details.

Along with a dearth of regulatory guidance, little empirical research has examined factors related to participant payment in research. We conducted a cross-sectional study of 100 institutional review board (IRB)–approved sociobehavioral human subjects research protocols at a large research university in Southern California. The proportion of studies that paid participants differed significantly by type of research ( p < .001) and study population ( p = .009). The average payment amount also differed significantly by study population ( p < .001) and type of participation (in-person vs. remote; p < .001). In addition, studies that required more visits ( p < .001) and more time ( p = .011) paid significantly more than studies with fewer and shorter visits, respectively. These findings provide data to help inform future ethical payment practices.

We respond to Eyal et al.’s commentary focusing on how people living with HIV participating in HIV cure-related studies are defined. We argue that the types of participants enrolled in research cannot be dissociated from the study interventions, the types of anticipated risks, and the background standard of care. As the field of HIV cure research advances, more nuance and granularity will be needed to define research criteria and acceptable risk/benefit ratios for cure study participants, as well as specific tiered protocol designs that serve to protect various participant populations from untoward risks, especially in very early phase research with interventions known to have potentially serious toxicities. We highlight key lessons from the ACTIVATE study involving a latency-reversing agent, Panobinostat, for HIV cure study design involving “otherwise healthy volunteers”.

Over the past several years there has been intense activity directed at the possibility of achieving remission or eradication of HIV infection. Current assays for the measurement of latent HIV are insufficient to demonstrate complete clearance of replication-competent HIV. Therefore, the ultimate test for assessing whether investigational interventions have resulted in HIV remission or eradication is to interrupt standard antiretroviral therapy (ART) in a carefully controlled clinical trial setting. These procedures, known as analytic treatment interruptions (ATIs), raise important scientific and ethical questions. The lack of definitive assays for measuring viral reservoirs not only makes research on HIV remission or cure challenging, it also affects the ability to assess risks from ATIs themselves. In spite of these challenges, basic ethical criteria can be met with careful study design and close monitoring. In this brief report we outline ethical standards for HIV cure research involving ATIs. These criteria should be revisited as the science evolves.

Author(s): Dube, Karine; Perry, Kelly E; Mathur, Kushagra; Lo, Megan; Javadi, Sogol S; Patel, Hursch; Concha-Garcia, Susanna; Taylor, Jeff; Kaytes, Andy; Dee, Lynda; Campbell, Danielle; Kanazawa, John; Smith, David; Gianella, Sara; Auerbach, Judith D; Saberi, Parya; Sauceda, John A | Abstract: IntroductionThe question of what motivates people to participate in research is particularly salient in the HIV field. While participation in HIV research was driven by survival in the 1980's and early 1990's, access to novel therapies became the primary motivator with the advent of combination antiretroviral therapy (cART) in the late 1990s. In the HIV cure-related research context, the concept of altruism has remained insufficiently studied.MethodsWe conducted a scoping review to better contextualize and understand how altruism is or could be operationalized in HIV cure-related research. We drew from the fields of altruism in general, clinical research, cancer, and HIV clinical research-including the HIV prevention, treatment, and cure-related research fields.DiscussionAltruism as a key motivating factor for participation in clinical research has often been intertwined with the desire for personal benefit. The cancer field informs us that reasons for participation usually are multi-faceted and complex. The HIV prevention field offers ways to organize altruism-either by the types of benefits achieved (e.g., societal versus personal), or the origin of the values that motivate research participation. The HIV treatment literature reveals the critical role of clinical interactions in fostering altruism. There remains a dearth of in-depth knowledge regarding reasons surrounding research participation and the types of altruism displayed in HIV cure-related clinical research.ConclusionLessons learned from various research fields can guide questions which will inform the assessment of altruism in future HIV cure-related research.

On May 30, 2018, the Right-To-Try bill, allowing the use of experimental, non-Food and Drug Administration (FDA)–approved drugs as a last resort for those unable to participate in clinical testing who have also exhausted all other treatment options, was signed into law ([1][1]). At the time this

In an essay, Karine Dubé and coauthors discuss the ethics of preclinical and clinical studies relevant to achieving an HIV cure.

Objective To identify the main types of HIV cure-related strategies and examine possible risks (and benefits) associated with participating in HIV cure-related research studies. Methods We undertook a scoping review to first map out the landscape of HIV cure-related research and then examined the risks and potential benefits associated with participating in HIV cure research. Given the early stage of many HIV cure-related studies, we used proxy literatures from non-cure HIV research and cancer research in order to anticipate possible motivators and deterrents of participation in HIV cure-related studies. Results We discussed four main categories of HIV cure-related research: (1) early antiretroviral treatment (ART); (2) latency-reversing agents (LRAs); (3) therapeutic vaccinations and immune-based therapies (IBT); and (4) stem-cell transplantation and gene therapy. At this juncture, these categories of HIV cure-related research have substantial individual risks and negligible individual and clinical benefits. Non-cure HIV research (including HIV prevention and treatment) and cancer research have empirical similarities (and differences) to HIV cure research and may provide an opportunity to anticipate ethical and logistical challenges associated with HIV cure-related research participation and decision-making. Learning from the cancer field, a strong foundation of patient-participant and clinician-researcher trust will need to be established to facilitate recruitment of participants into HIV cure-related studies. Conclusion Further empirical social science and ethics research will be necessary to inform clinical HIV cure-related research. The study of participation in HIV cure-related research can gain insights from proxy fields by incorporating study elements to clearly explain motivators and deterrents to participation and to inform the implementation of HIV cure-related studies. Study-specific contexts from the reviewed literature further demonstrate the importance of various types of research to assess factors affecting participation in HIV cure-related research, including adequate formative and ethics research.

Introduction Biomedical research towards an HIV cure is advancing in the United States and elsewhere, yet little is known about perceptions of risks and benefits among potential study participants and other stakeholders. We conducted a qualitative study to explore perceived risks and benefits of investigational HIV cure research among people living with HIV (PLWHIV), biomedical HIV cure researchers, policy-makers and bioethicists. Methods We conducted a qualitative research study using in-depth interviews with a purposive sample of PLWHIV, biomedical HIV cure researchers, policy-makers and bioethicists in 2015–2016. We analysed interview transcripts using thematic analysis anchored in grounded theory. Results We conducted and analyzed 36 key informant interviews. Qualitative analysis revealed four main findings. 1) Potential HIV cure study volunteers noted needing more information and education about the potential risks of HIV cure research. 2) Biomedical HIV cure researchers, policy-makers and bioethicists showed less awareness of social and financial risks of HIV cure research than PLWHIV. 3) Most respondents across the different categories of informants identified some risks that were too great to be acceptable in HIV cure research, although a subset of PLWHIV did not place an upper limit on acceptable risk. 4) PLWHIV showed a better awareness of potential psychological benefits of participating in HIV cure research than other groups of stakeholders. Conclusion Our research suggests that PLWHIV have a variable understanding of the individual risks, sometimes substantial, associated with participating in biomedical HIV cure research studies. Community engagement and increased research literacy may help improve community understanding. Intensive informed consent procedures will be necessary for ethical study implementation. The current state of HIV cure research offers greater potential benefits to society than to participants. There is likely to be disagreement among regulators, researchers, clinicians, and potential participants about what constitutes acceptable risk for HIV cure studies.

Early-phase HIV cure research is conducted against a background of highly effective antiretroviral therapy, and involves risky interventions in individuals who enjoy an almost normal life expectancy. To explore perceptions of three ethical topics in the context of HIV cure research—(a) equipoise, (b) risk–benefit ratios, and (c) “otherwise healthy volunteers”—we conducted 36 in-depth interviews (IDIs) with three groups of purposively selected key informants: clinician-researchers ( n = 11), policy-makers and bioethicists ( n = 13), and people living with HIV (PLWHIV; n = 12). Our analysis revealed variability in perceptions of equipoise. Second, most key informants believed there was no clear measure of risk–benefit ratios in HIV cure research, due in part to the complexity of weighing (sometimes unknown) risks to participants and (sometimes speculative) benefits to science and society. Third, most clinician-researchers and policy-makers/bioethicists viewed potential HIV cure study participants as “otherwise healthy volunteers,” but this perception was not shared among PLWHIV in our study.

In this issue of The Lancet HIV, Katherine Kranzer and colleagues report that economic incentives for caregivers in Zimbabwe increased uptake of HIV testing and counselling by children aged 8���17 years compared with caregivers with no financial incentive. HIV testing of groups that are hard to reach is a formidable challenge worldwide, and innovative strategies to reach adolescents in particular are crucial to reaching UNAIDS��� 90-90-90 goals

Among 149 men who survived Ebola virus disease (EVD) and donated semen 260–1016 days after EVD onset, Ebola virus (EBOV) ribonucleic acid (RNA) was detected in 13 (9%). Of 137 men who donated semen 2 years after EVD onset, 11 (8%) had an EBOV RNA-positive specimen. The mechanism underlying the persistence of EBOV RNA in semen is unclear, and it is unclear whether the detection of viral RNA represents the presence of infectious virus.

OBJECTIVE:: To estimate whether continuous combined oral contraceptive pill (OCP) use leads to higher continuation and lower pregnancy rates over 12 months than cyclic use in a developing country setting. METHODS:: We enrolled healthy women aged 18 to 30 years in Santo Domingo Dominican Republic. We randomly assigned women to cyclic or continuous use of OCPs. Participants made quarterly clinic visits for 12 months. During follow-up we reviewed OCP adherence and continuation side effects and bleeding and we tested for pregnancy. RESULTS:: We enrolled 358 women (mean age 22.7 years) and 335 (93.6%) completed the study. In intent-to-treat analyses 77.6% of the continuous use group and 71.7% of the cyclic group continued OCPs at 12 months (P=.21). The main reason for OCP discontinuation in both groups was running out of OCPs or forgetting. Across all visits 26.1% of women in the continuous use group and 22.3% of women in the cyclic group ever reported missing three or more OCPs in the past month (P=.43). In multivariable analyses regimen was not associated with discontinuation but both previous birth and perceived ease of use of OCPs decreased risk of discontinuation whereas desire for reduced menstruation increased risk of discontinuation. Although more women reported amenorrhea or infrequent bleeding in the continuous use group more women in the cyclic group found their bleeding patterns acceptable. Bleeding was not associated with discontinuation in multivariable analyses. Pregnancy rates at 12 months were similar (16.2% continuous and 17.4% cyclic). CONCLUSIONS:: Continuous and cyclic OCP regimens were associated with similar 12-month continuation and pregnancy rates. Few factors predicted OCP discontinuation or pregnancy. CLINICAL TRIAL REGISTRATION:: ClinicalTrials.gov www.clinicaltrials.gov NCT00570440. LEVEL OF EVIDENCE:: I.

Objective: To evaluate the effect of nevirapine-containing antiretroviral therapy (ART) on combined oral contraceptive (COC) effectiveness. Design: Nonrandomized prospective clinical trial. Methods: We enrolled HIV-infected women aged 18–35 years in South Africa and Uganda who had regular menses were sexually active and had no medical contraindications to COC use. We enrolled 196 women taking nevirapine-containing ART and 206 women not yet eligible for ART as a control group. We treated all participants with low-dose COCs. Our main outcomes were ovulation and pregnancy rates. We estimated ovulation in the first two cycles using weekly serum progesterone and tested for pregnancy monthly for 24 weeks. Results: The median age of participants was 29 and their median CD4þ cell count was 486. In the ART group 43 of 168 (26%) ovulated in cycle 1 30 of 163 (18%) in cycle 2 and 18 of 163 (11%) in both cycles. In the non-ART group 26 of 168 (16%) ovulated in cycle 1 31 of 165 (19%) in cycle 2 and 20 of 165 (12%) in both cycles. We found no significant difference in ovulation rates between groups: unadjusted odds ratio 1.36 (95% confidence interval 0.85–2.18). Pregnancy rates also did not differ: 10.0 per 100- women-years in the ART group and 10.1 per 100-women-years in the non-ART group. Self-reported COC adherence condom use vaginal bleeding and adverse events were similar. Five serious adverse events were reported all in the non-ART group. Conclusion: ART use did not affect risk of ovulation or pregnancy in women taking COCs suggesting that nevirapine-containing ART does not interfere with COC contraceptive effectiveness.

Cette recherche qualitative à portée exploratoire porte sur les représentations sociales, les attitudes et les impacts associés au phénomène des cyanobactéries et s’inscrit dans une perspective constructiviste liée à l’écologie politique. Les cyanobactéries sont des microorganismes présents de façon naturelle dans la plupart des plans d’eau, et certaines espèces peuvent libérer des toxines susceptibles de causer des problèmes de santé chez les êtres humains, surtout si elles se trouvent en forte concentration. Au Québec, lorsque les risques sont jugés élevés, les autorités de santé publique émettent des mises en garde concernant la pratique d’activités nautiques et la consommation d’eau potable, mais la population ne s’y conforme pas toujours. Dans le but de mieux comprendre les attitudes des citoyens à l’égard des cyanobactéries et des mesures de santé publique, nous avons réalisé une enquête visant à identifier les significations attribuées à ce phénomène – en accordant une attention particulière aux représentations sociales du risque – ainsi que les autres facteurs qui influencent les attitudes et plus spécifiquement l’observance des mesures prescrites par les autorités. Des groupes de discussion et des entrevues individuelles semi-dirigées ont été réalisés en 2009 et 2010 au lac William, à la baie Missisquoi et au lac Roxton, auprès de différents groupes d’acteurs sociaux et illustrent que différentes représentations sociales du phénomène coexistent, et modulent le processus de gestion du risque. Cette étude montre l’intérêt d’aborder des phénomènes naturels tels que la prolifération des cyanobactéries en tant que construits socioculturels, car cette approche permet d’envisager les impacts liés à de tels phénomènes sous un angle différent et d’améliorer ainsi les interventions des gestionnaires afin de limiter ces impacts., Using a constructivist political ecology perspective, this exploratory qualitative research examines the social representations, attitudes and impacts that exist in relation to the phenomenon of cyanobacteria. Cyanobacteria are naturally occurring microorganisms found in most bodies of water ; certain species, especially when they are highly concentrated, release toxins that can pose a threat to population health. In Quebec, when the level of risk is considered serious, public health officials issue warnings concerning water-related activities and water consumption, but people do not always act in accordance with them. A qualitative study was undertaken with the aim of gaining a better understanding of the attitudes of citizens towards cyanobacteria and public health measures. It enabled us to identify both the meanings attached to this phenomenon – by drawing attention mainly on social representations of risk – and the other driving forces behind the attitudes and, in particular, towards compliance with measures prescribed by the authorities. Focus groups and semi-directed individual interviews involving several groups of social actors were conducted in 2009 and 2010 on Lake William, in the Missisquoi Bay and on Lake Roxton. Results illustrate coexistence of different social representations of the same phenomenon, which could modulate risk management process. This study points to the importance of considering natural phenomena such as the proliferation of cyanobacteria as socio-cultural constructs, because this approach can be applied to address the impacts of such phenomena from a different perspective and therefore improve management practices to reduce these impacts.

The quest for a cure for HIV remains a timely and key challenge for the HIV research community. Despite significant scientific advances, current HIV therapy regimens do not completely eliminate the negative impact of HIV on the immune system; and the economic impact of treating all people infected with HIV globally, for the duration of their lifetimes, presents significant challenges. This article discusses, from a multi-disciplinary approach, critical social, behavioral, ethical, and economic issues permeating the HIV cure research agenda. As part of a search for an HIV cure, both the perspective of patients/participants and clinical researchers should be taken into account. In addition, continued efforts should be made to involve and educate the broader community.

In preparation for trials of new HIV prevention methods, willingness to participate (WTP) was assessed in Beira, Mozambique. A totla of 1 019 women participating in an HIV incidence study, and 97 men participating in a separate WTP survey, were interviewed. When comparing the answers to questions that were identical in the two studies, WTP was higher among women than men for all prevention methods. Among women, WTP was highest for trials evaluating daily oral pre-exposure prophylaxis (PrEP; 84.4% reporting very likely to participate), followed by vaccination (77.8%), daily vaginal gel use (67.7%), coital vaginal gel use (67.1%) and monthly vaginal ring use (47.7%). Among men, WTP was highest for trials evaluating vaccination (57.6%), followed by daily vaginal gel use for female sexual partners (52.5%), daily oral PrEP (49.5%), coital vaginal gel use for female sexual partners (46.4%) and monthly vaginal ring use for female sexual partners (39.4%). Among men, the most important motivators for trial participation were social benefits, whereas personal risks (most notably receiving injections and/or blood draws) were deterrents; this was not assessed in women. Other important lessons learnt are that male circumcision and antiretroviral drugs were not generally recognised as ways to prevent HIV, that having to use hormonal contraception during trial participation will likely reduce WTP, and that evening clinics are not likely to be popular. The barriers reported in this and other studies may be challenging but are not impossible to overcome.Keywords: HIV prevention, Mozambique, pre-exposure prophylaxis, vaccine, vaginal microbicide, willingness to participate

Using a political ecology perspective, this research examines the social issues of cyanobacteria. In Québec (Canada), public health officials issue warnings concerning water-related activities and water consumption. An ethnographic study was undertaken with the aim of gaining a better understanding of the attitudes of citizens toward cyanobacteria and public health measures. It enabled us to identify both the meanings attached to this phenomenon and the other driving forces behind the attitudes and, in particular, toward compliance with measures prescribed by the authorities. Focus groups and semidirected individual interviews involving several groups of social actors were conducted in 2009 and 2010 on three communities. This study points to the importance of considering natural phenomena such as the proliferation of cyanobacteria as sociocultural constructs, because this approach can be applied to address the impacts of such phenomena from a different perspective and therefore improve management practices to reduce these impacts.

Language used to describe clinical research represents a powerful opportunity to educate volunteers. In the case of HIV cure research there is an emerging need to manage expectations by using the term ‘experiment’. Cure experiments are proof-of-concept studies designed to evaluate novel paradigms to reduce persistent HIV-1 reservoirs, without any expectation of medical benefit.

Objectives To estimate the prevalence, incidence and determinants of herpes simplex type 2 (HSV-2) infection, and associations between HSV-2 and incident HIV infection, among women at higher risk for HIV infection in Beira, Mozambique. Methods Between 2009 and 2012, 411 women aged 18���35 years at higher risk of HIV acquisition (defined as having had two or more sexual partners in the month prior to study enrollment) were enrolled and followed monthly for one year. At each study visit, they were counseled, interviewed, and tested for HSV-2 and HIV antibodies. Results The HSV-2 prevalence at baseline was 60.6% (95% CI: 55.7% ���65.4%). Increasing age (aOR���=���2.94, 95% CI: 1.74���4.97, P

Background: Ebola virus (EBOV) RNA persistence in semen, reported sexual transmission, and sporadic clusters at the end of the 2013-2016 epidemic have prompted recommendations that male survivors refrain from unprotected sex unless their semen is confirmed to be EBOV free. However, there is no fully validated assay for EBOV detection in fluids other than blood. Methods: The Cepheid Xpert Ebola assay for EBOV RNA detection was validated for whole semen and blood using samples obtained from uninfected donors and spiked with inactivated EBOV. The validation procedure incorporated standards from Clinical and Laboratory Standards Institute and Good Clinical Laboratory Practices guidelines for evaluating molecular devices for use in infectious disease testing. Results: The assay produced limits of detection of 1000 copies/mL in semen and 275 copies/mL in blood. Limits of detection for both semen and blood increased with longer intervals between collection and testing, with acceptable results obtained up to 72 hours after specimen collection. Conclusions: The Cepheid Xpert Ebola assay is accurate and precise for detecting EBOV in whole semen. A validated assay for EBOV RNA detection in semen informs the care of male survivors of Ebola, as well as recommendations for public health.

Background The prevalence and determinants of HIV and late diagnosis of HIV in young women in Beira, Mozambique, were estimated in preparation for HIV prevention trials. Methods An HIV prevalence survey was conducted between December 2009 and October 2012 among 1,018 women aged 18���35 with two or more sexual partners in the last month. Participants were recruited in places thought by recruitment officers to be frequented by women at higher-risk, such as kiosks, markets, night schools, and bars. Women attended the research center and underwent a face-to-face interview, HIV counseling and testing, pregnancy testing, and blood sample collection. Results HIV prevalence was 32.6% (95% confidence interval (CI) 29.7%���35.5%). Factors associated with being HIV infected in the multivariable analysis were older age (p

Background: HIV is prevalent in Sofala Province, Mozambique. To inform future prevention research, we undertook a study in the provincial capital (Beira) to measure HIV incidence in women at higher risk of HIV and assess the feasibility of recruiting and retaining them as research participants.Methods: Women age 18-35 were recruited from schools and places where women typically meet potential sexual partners. Eligibility criteria included HIV-seronegative status and self-report of at least 2 sexual partners in the last month. History of injection drug use was an exclusion criterion, but pregnancy was not. Participants were scheduled for monthly follow-up for 12 months, when they underwent face-to-face interviews, HIV counseling and testing, and pregnancy testing.Results: 387 women were eligible and contributed follow-up data. Most were from 18-24 years old (median 21). Around one-third of participants (33.8%) reported at least one new sexual partner in the last month. Most women (65.5%) reported not using a modern method of contraception at baseline. Twenty-two women seroconverted for a prospective HIV incidence of 6.5 per 100 woman-years (WY; 95% confidence interval (CI): 4.1-9.9). Factors associated with HIV seroconversion in the multivariable analysis were: number of vaginal sex acts without using condoms with partners besides primary partner in the last 7 days (hazard ratio (HR) 1.7; 95% CI: 1.2-2.5) and using a form of contraception at baseline other than hormonal or condoms (vs. no method; HR 25.3; 95% CI: 2.5-253.5). The overall retention rate was 80.0% for the entire follow-up period.Conclusions: We found a high HIV incidence in a cohort of young women reporting risky sexual behavior in Beira, Mozambique. HIV prevention programs should be strengthened. Regular HIV testing and condom use should be encouraged, particularly among younger women with multiple sexual partners.