Good, better or best: A study of standards of prevention and care in HIV prevention trials

Introduction This study examines the negotiation of benefits to participants in efficacy trials of biomedical HIV prevention technologies (HPT). It was conducted from 2009-2012, during which time there were positive efficacy results from six large, randomised controlled trials of HPT. Debates about obligations to trial participants are reconsidered in the light of abovementioned results. Methods Empirical • Survey of principal investigators of HPT • 14 in-depth interviews with principal investigators • Additional data from document analysis and personal communications. Normative Key normative issues examined are: • Ethical justification for antiretroviral (ARV)-based prevention • Impact of partial efficacy results on HIV prevention research • Implications of incorporating newly validated technologies into standard of prevention (SOP). Results • There is no consensus on whether or when new interventions should be added to SOP. • Access to ARV for seroconverters has become a norm. • Ancillary care provision is also a norm. • Post-trial access differs in both the duration and the timeliness of provision. Conclusion Partially effective interventions raise questions about standards in both research and implementation contexts. While ongoing research into HPT is crucial, reducing HIV incidence in trial populations remains a legitimate goal. Adding an active comparator in HIV prevention trials could balance protection of participants with research imperatives

Ethics of Ancillary Care in Clinical Trials in Low Income Countries: A Nigerian Case Study

The ethical conduct of HIV prevention researchers is subject to scrutiny. Many clinical trials take place in low and middle income countries where HIV incidence is high, but the benefits of research are often first enjoyed in high income countries. The provision of ancillary care – medical care provided to clinical trial participants during a trial, which is not related to the research question – is one way in which trial  participants can receive direct benefits from their participation in research. We argue that such care is a legitimate benefit of research participation. This care does not constitute ‘undue inducement’ if the research study itself involves minimal risk and is subject to ethical and regulatory oversight. We also  argue that research teams working with populations who have sub-optimal healthcare access have a duty to provide ancillary care within agreed limits. These limits should be negotiated to ensure that the  research remains feasible and economically viable. (Afr J Reprod Health 2014; 18[3]: 135-142)Keywords: Ancillary care; ethics, HIV prevention, undue inducementLa conduite éthique des chercheurs dans le domaine de la prévention du VIH est soumise au contrôle. De nombreux essais cliniques ont lieu dans les pays à faible et moyen revenu où l'incidence du VIH est élevée, mais les avantages de la recherche sont souvent d'abord appréciés dans les pays à revenu élevé. La prestation de soins auxiliaires – les soins médicaux fournis aux participants des essais cliniques au cours d'un procès, qui n'est pas liée à la question de la recherche - est une façon pour les participants à l'essai de recevoir des prestations directes pour leur participation à la recherche. Nous soutenons que ces soins constituent un bénéfice légitime de participation à la recherche. Ce soin ne constitue pas «une incitation indue» si l'étude elle-même implique un risque minimal et elle est soumise à la surveillance éthique et réglementaire. Nous soutenons également qu’il incombe aux équipes de recherche qui  travaillent avec les populations qui ont accès à des soins de santé sous-optimal de leur fournir des soins auxiliaires dans les limites convenues. Ces limites doivent être négociées pour s'assurer que la recherche demeure réalisable et économiquement viable. (Afr J Reprod Health 2014; 18[3]: 135-142)Mots-clés: Soins auxiliaires, éthique, prévention du VIH, incitations indue

Research priorities during infectious disease emergencies in West Africa.

OBJECTIVES: This paper presents the results of the consultations conducted with various stakeholders in Africa and other experts to document community perspectives on the types of research to be prioritised in outbreak conditions. The Delphi method was used to distill consensus. RESULTS: Our consultations highlighted as key, the notion that in an infectious disease outbreak situation, the need to establish an evidence base on how to reduce morbidity and mortality in real time takes precedence over the production of generalizable knowledge. Research studies that foster understanding of how disease transmission could be prevented in the future remain important, implementation research that explores how to mitigate the impact of outbreaks in the present should be prioritized. Clinical trials aiming to establish the safety profile of therapeutic interventions should be limited during the acute phase of an epidemic with high fatality-and should preferably use adaptive designs. We concluded that community members have valuable perspectives to share about research priorities during infectious disease emergencies. Well designed consultative processes could help identify these opinions

Reciprocity, Fairness and the Financial Burden of Undertaking COVID-19 Hotel Quarantine in Australia

In late March 2020 in response to the COVID-19 pandemic, Australia introduced mandatory 14-day supervised quarantine at hotels and other designated facilities for all international arrivals. From July 2020, most states and territories introduced a fixed charge for quarantine of up to $3220 per adult. The introduction of the fee was rationalised on the basis that Australians had been allowed sufficient time to return and there was a need to recover some of the cost associated with administering the program. Drawing on an empirical study of 58 returned Australian citizens and residents quarantined between March 2020 and January 2021, this paper aims to explore how people experienced paying for hotel quarantine, particularly with respect to fairness and relatedly, the principle of reciprocity. Reciprocity requires that the state has an obligation to assist individuals in discharging their duty to comply with public health measures and avoid disproportionate burdens accruing to populations or individuals. Though participants had varying opinions on whether they thought it fair to be charged for their quarantine, for many, the fee constituted a significant burden and source of stress. Given the undertaking of quarantine is primarily for the benefit of the public good, we argue the financial cost imposed on individuals does not meet the demands of reciprocity. It is imperative that future quarantine and isolation arrangements consider seriously the need to minimise burdens of individuals subject to such measures, and that fees do not become a new norm in public health and infectious disease control

Considerations for community engagement when conducting clinical trials during infectious disease emergencies in West Africa.

Community engagement in research, including public health related research, is acknowledged as an ethical imperative. While medical care and public health action take priority over research during infectious disease outbreaks, research is still required in order to learn from epidemic responses. The World Health Organisation developed a guide for community engagement during infectious disease epidemics called the Good Participatory Practice for Trials of Emerging (and Re-emerging) Pathogens that are Likely to Cause Severe Outbreaks in the Near Future and for which Few or No Medical Counter-Measures Exist (GPP-EP). This paper identified priorities for community engagement for research conducted during infectious disease outbreaks drawing on discussions held with a purposive sample of bioethicists, social scientists, researchers, policy makers and laypersons who work with ethics committees in West Africa. These perspectives were considered in the light of the GPP-EP, which adds further depth and dimension to discussions on community engagement frameworks. It concludes that there is no presumptive justification for the exclusion of communities in the design, implementation and monitoring of clinical trials conducted during an infectious disease outbreak. Engagement that facilitates collaboration rather than partnership between researchers and the community during epidemics is acceptable

Factors Associated with Transgender and Gender Diverse People's Experience of Sexual Coercion, and Help-Seeking and Wellbeing Among Victims/Survivors: Results of the First Australian Trans and Gender Diverse Sexual Health Survey

Purpose: Our study examined factors associated with transgender and gender diverse (“trans”) people's experience of sexual coercion, as well as the factors associated with help-seeking and wellbeing among victims/survivors. Methods: We analyzed cross-sectional data from the first Australian Trans and Gender Diverse Sexual Health Survey, conducted in 2018. Logistic regressions were undertaken to identify factors associated with sexual coercion, help-seeking, and wellbeing. Results: Of the sample of 1448 participants, 53.4% had been sexually coerced, which was associated with older age, Aboriginal or Torres Strait Islander descent, nonbinary gender, being presumed female gender at birth, currently living publicly some or all the time as their affirmed gender, having regular sex, and use of drugs to enhance or alter sexual experiences. Protective factors included having a higher income and access to gender affirming care. Help-seeking was reported among 49.5% of victims/survivors and was associated with having more trans friends. Wellbeing among victims/survivors was associated with being older, residing in regional/remote areas, having higher levels of education and annual income, being presumed female gender at birth, having stronger satisfaction with one's sex life, and good health care access. Wellbeing was not associated with help-seeking. Conclusion: Sexual coercion was prevalent among participants, but help-seeking behavior was low. Protective factors identified underscore the importance of socioeconomic supports, access to health and gender affirming care, and peers. Accessible peer-led and culturally safe preventive and trauma-focused supports should also be considered for trans people who experience sexual coercion

The impact of blood donation deferral strategies on the eligibility of men who have sex with men and other sexual risk behavior in Australia

Background In Australia, a man cannot donate blood if he has had sex with another man within the past 3 months. However, this policy has been criticized as being discriminatory as it does not consider lower risk subgroups, and led to calls for modifications to the policy that more accurately distinguish risk among gay, bisexual, and other men who have sex with men (GBM). Study Design and Methods We used data from a nationally representative survey to estimate the proportion of GBM aged 18–74 years old who would be eligible to donate under current criteria and other scenarios. Results Among the 5178 survey participants, 155 (3.0%) were classified as GBM based on survey responses, Among the GBM, 40.2% (95% CI 28.0%–53.7%) were eligible to donate based on current criteria, and 21.0% (95% CI 14.5%–29.5%) were ineligible due to the 3 months deferral alone. Eligibility among GBM, all men, and the population increased as criteria were removed. Under the new Australian plasma donation criteria, 73.6% (95% CI 64.4%–81.1%) of GBM, 68.4% (95% CI 65.5%–71.2%) of all men, and 60.8% (95% CI 58.8%–62.8%) of the full population were estimated to be eligible. Only 16.1% (95% CI 8.6%–28.1%) of GBM knew that the male-to-male sex deferral period is 3 months. Discussion Changing the deferral criteria and sexual risk evaluation would lead to a higher proportion of GBM being eligible to donate blood. Knowledge of the current GBM deferral period is very low. Improved education about the current criteria and any future changes are required to improve blood donation rates

Unwanted sex due to intoxication among Australians aged 16–69 years

Intoxication can be a factor in unwanted sex, but research on the extent of the issue in both women and men is limited. We assessed the prevalence, correlates, and 10-year time-trends of unwanted sex due to intoxication among a representative sample of 4,279 women and 3,875 men aged 16–69 years in Australia and considered how these vary by gender. In 2012–13, 16% of women and 10% of men reported ever having had a sexual experience when they “did not want to because they were too drunk or high at the time.” For both women and men, this was associated with younger age, bisexual activity, and reports of lifetime injection drug use, sexually transmitted infections, and forced sex. Among women only, it was associated with drinking above guideline levels and ever having terminated a pregnancy. Among men only, it was associated with current tobacco smoking, elevated psychosocial distress, and poor general health. Compared with 2001–02 data, fewer men reported unwanted intoxicated sex, while there were no changes for women as a whole. Interpreting these findings through an intersectional assemblage framework supports stronger understanding of the multiple factors influencing sexuality and substance use with implications for promoting equity, safety, and sexual health