Reply to Commentary: “Are HIV Infected Candidates for Participation in Risky Cure-Related Studies Otherwise Healthy.”

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"

If We Build It, Will They Come? Perceptions of HIV Cure Research by People Living with HIV in Four U.S. Cities – A Qualitative Focus Group Study

Global interest and investment in the search for an HIV cure has increased. Research has focused on what experts refer to as a sterilizing or eradicating cure, where HIV is eliminated from the body, and on what is often called a functional cure, where HIV remains, kept durably suppressed in the absence of antiretroviral treatment and therapy (ART). Many believe that a functional cure is likely to be found first.Global interest and investment in the search for an HIV cure has increased. Research has focused on what experts refer to as a sterilizing or eradicating cure, where HIV is eliminated from the body, and on what is often called a functional cure, where HIV remains, kept durably suppressed in the absence of antiretroviral treatment and therapy (ART). Many believe that a functional cure is likely to be found first. HIV cure studies will require active participation by people living with HIV (PLWHIV). Their desires and perceptions will be important to effectively recruit study participants and for the uptake of any future strategy that demonstrates safety and efficacy. The perspectives of PLWHIV are essential to advancing HIV cure research, and they should be taken into consideration as biomedical research advances. We conducted 10 focus groups in four U.S. cities, eliciting perspectives of PLWHIV on HIV cure and cure research. Most participants conceived of a cure as eradicating, and felt favorably toward it. In addition to the physical benefits of a potential cure, participants valued the possible de-stigmatization related to no longer living with HIV, liberation from concerns about transmitting HIV, and freedom from the burden of daily medication. Many participants did not regard a functional cure as an improvement over controlling HIV through ART, were distrustful about viral rebound potential, and noted concerns about medical complications and accompanying psychological distress. Some felt that the risks of HIV cure research were not worth taking. Many were skeptical about science's ability to eliminate HIV from the body

A Prospective Controlled Trial of Routine Opt-Out HIV Testing in a Men's Jail

Approximately 10 million Americans enter jails annually. The Centers for Disease Control and Prevention now recommends routine opt-out HIV testing in these settings. The logistics for performing routine opt-out HIV testing within jails, however, remain controversial. The objective of this study was to evaluate the optimal time to routinely HIV test newly incarcerated jail detainees using an opt-out strategy.This prospective, controlled trial of routine opt-out HIV testing was conducted among 298 newly incarcerated male inmates in an urban men's jail in New Haven, Connecticut. 298 sequential entrants to the men's jail over a three week period in March and April 2008 were assigned to be offered routine opt-out HIV testing at one of three points after incarceration: immediate (same day, n = 103), early (next day, n = 98), or delayed (7 days, n = 97). The primary outcome was the proportion of men in each group consenting to testing.Routine opt-out HIV testing was significantly higher for the early (53%: AOR = 2.6; 95% CI = 1.5 to 4.7) and immediate (45%: AOR = 2.3; 95% CI = 1.3 to 4.0) testing groups compared to the delayed (33%) testing group. The immediate and early testing groups, however, did not significantly differ (p = 0.67). In multivariate analyses, factors significantly associated with routine opt-out HIV testing were assignment to the 'early' testing group (p = 0.0003) and low (bond > or = $5,000, immigration or federal charges or pre-sentencing > 30 days) likelihood of early release (p = 0.04). Two subjects received preliminary positive results and one of them was subsequently confirmed HIV seropositive.In this men's jail where attrition was high, routine opt-out HIV testing was not only feasible, but resulted in the highest rates of HIV testing when performed within 24 hours of incarceration.ClinicalTrials.gov NCT00624247

Les femmes au Sénat

Si la sous-présence des femmes est un phénomène qui touche tous les domaines de la sphère politique française, c’est au Sénat qu’elle est la plus flagrante. Certes, la part des femmes élues députées est proche de celle des femmes élues sénatrices puisqu’en 1958, elles représentaient 1,6 % des élus à l’Assemblée nationale et 1,9 % au Sénat. Trente ans plus tard, 5,9 % des élus à l’Hémicycle en 1993 sont des femmes, contre 5 % aux élections sénatoriales de 1992. Pourtant, il existe une différen..

Acceptability of Cell and Gene Therapy for Curing HIV Infection among People Living with HIV in the Northwestern United States: A Qualitative Study

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

Revisiting the ‘Sterilising Cure’ Terminology: A Call for More Patient-Centered Perspectives on HIV Cure-Related Research

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

'Well, It's the Risk of the Unknown… Right?': A Qualitative Study of Perceived Risks and Benefits of HIV Cure Research in the United States.

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

Research on HIV cure: Mapping the ethics landscape.

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

Routine Opt-Out HIV Testing Strategies in a Female Jail Setting: A Prospective Controlled Trial

Background: Ten million Americans enter jails annually. The objective was to evaluate new CDC guidelines for routine optout HIV testing and examine the optimal time to implement routine opt-out HIV testing among newly incarcerated jail detainees. Methods: This prospective, controlled trial of routine opt-out HIV testing was conducted among 323 newly incarcerated female inmates in Connecticut’s only women’s jail. 323 sequential entrants to the women’s jail over a five week period in August and September 2007 were assigned to be offered routine opt-out HIV testing at one of three points after incarceration: immediate (same day, n = 108), early (next day, n = 108), or delayed (7 days, n = 107). The primary outcome was the proportion of women in each group consenting to testing. Results: Routine opt-out HIV testing was significantly highest (73%) among the early testing group compared to 55 % for immediate and 50 % for 7 days post-entry groups. Other factors significantly (p = 0.01) associated with being HIV tested were younger age and low likelihood of early release from jail based on bond value or type of charge for which women were arrested. Conclusions: In this correctional facility, routine opt-out HIV testing in a jail setting was feasible, with highest rates of testing if performed the day after incarceration. Lower testing rates were seen with immediate testing, where there is a high prevalence of inability or unwillingness to test, and with delayed testing, where attrition from jail increases with each passing day

Community HIV clinicians’ perceptions about HIV cure-related research in the Northwestern United States

Background: Research on stakeholder perspectives of HIV cure research has involved people with HIV (PWH), who generally cite the importance of HIV clinician advice in making decisions about trial participation. However, there has been little exploration of non-researcher community HIV clinician perspectives, which are clearly critical to the success of HIV cure-related research. Objective: We aimed to learn how community HIV clinicians perceive HIV cure research and identify factors that would lead them to support or discourage HIV cure trial participation by their patients. Methods: We recruited a purposive sample of 12 community HIV clinicians in metro-Seattle, WA to participate in structured interviews. We completed 11 interviews via teleconference and received one written response. We used conventional content analysis to analyze the data. Results: Overall, community HIV clinicians were supportive of patient participation in HIV cure trials. Factors affecting support included knowledge of local trials, ease of referral, patient immune function and health stability, study risks and benefits, burden of study requirements, patient characteristics, patient life stability, potential impact on engagement in care, study communication plans, and beliefs that patients should have the autonomy to decide to participate. Participants had concerns about trials requiring treatment delays or interruptions and HIV transmission risk. While their knowledge of the field was limited, they were interested in learning more about open HIV cure trials. Conclusions: It would benefit the HIV cure research community if those leading HIV cure trials make stronger efforts to engage community clinicians who care for PWH, but are not active researchers, early in the trial design process. Such engagement prior to launching HIV cure trials will improve trial designs, leading to better enrollment and retention within these important studies