The HI V O pen Call on I nformed C onsent and E thics in Research (VOICE) for Adolescents and Young Adults: A Digital Crowdsourcing Open Call in Low- and Middle-Income Countries.

BACKGROUND: Many adolescents and young adults (AYAs; 10-24 years old) are excluded from HIV research because of social, ethical, and legal challenges with informed consent, resulting in limited AYA-focused data. We use a participatory approach to identify strategies for improving AYA consent processes in HIV research in low- and middle-income countries (LMICs). METHODS: We conducted a digital crowdsourcing open call for ideas to improve AYA consent to HIV research in LMICs. Crowdsourcing involves engaging a group of people in problem-solving, then sharing emergent solutions. Submissions were evaluated by 3 independent judges using predefined criteria, with exceptional strategies receiving prizes. Demographic data were collected, and textual data were qualitatively analyzed for emergent themes in barriers and facilitators for improving AYA consent in HIV research, guided by a socioecological model. RESULTS: We received 110 strategies total; 65 were eligible for evaluation, 25 of which were identified as finalists. Fifty-eight participants from 10 LMICs submitted the 65 eligible submissions, of which 30 (52%) were 18 to 24 years old. Thematic analysis identified 10 barriers to AYA consent, including HIV stigma, limited education, and legal/regulatory barriers. Strategies for improving AYA consent processes revealed 7 potential facilitators: enhancing AYA engagement in research, involving parents/guardians, improving education/awareness, improving institutional practices/policy, making research participation more AYA-friendly, enhancing engagement of other key communities of interest, and empowering AYA. CONCLUSIONS: Diverse communities of interest in LMICs developed compelling strategies to enhance informed consent that may improve AYA inclusion in HIV research. These data will be used to develop practical guidance on improving AYA consent processes.

Reporting Individual-Level Research Results from Neurocognitive and Psychological Research in People Living with HIV: Lessons from Dementia Research.

PURPOSE OF REVIEW: There are growing expectations for the return of individual-level research results (RoR), which promotes autonomy and potential clinical and personal benefits. There are ethical and practical challenges, however, that may be exacerbated in research that assesses neurocognitive and psychological outcomes, including HIV-associated neurocognitive disorder (HAND). This paper reviews central concepts for RoR and recent empirical and conceptual articles from Alzheimer's disorder (AD) as a model for HIV. RECENT FINDINGS: Data from AD studies indicate high participant interest and low risk of harm from RoR, though additional research is needed. Investigators report a range of benefits, potential risks, and feasibility concerns. Standardized, evidence-based approaches are needed for RoR. For HIV research, we recommend a default position of offering RoR for cognitive and psychological outcomes. Investigators should justify decisions not to return results after assessing the potential value and feasibility of RoR. Longitudinal research is needed for feasible and evidence-based best practices.

Key ethical issues encountered during COVID-19 research: a thematic analysis of perspectives from South African research ethics committees.

BACKGROUND: The COVID-19 pandemic presents significant challenges to research ethics committees (RECs) in balancing urgency of review of COVID-19 research with careful consideration of risks and benefits. In the African context, RECs are further challenged by historical mistrust of research and potential impacts on COVID-19 related research participation, as well as the need to facilitate equitable access to effective treatments or vaccines for COVID-19. In South Africa, an absent National Health Research Ethics Council (NHREC) also left RECs without national guidance for a significant duration of the COVID-19 pandemic. We conducted a qualitative descriptive study that explored the perspectives and experiences of RECs regarding the ethical challenges of COVID-19 research in South Africa. METHODS: We conducted in-depth interviews with 21 REC chairpersons or members from seven RECs at large academic health institutions across South Africa that were actively involved in the review of COVID-19 related research from January to April 2021. In-depth interviews were conducted remotely via Zoom. Interviews (60-125 min) were conducted in English using an in-depth interview guide, until data saturation was achieved. Audio-recordings were transcribed verbatim and field notes were converted into data documents. Line-by-line coding of transcripts was performed, and data were organised into themes and sub-themes. An inductive approach to thematic analysis was used to analyse data. RESULTS: Five main themes were identified, namely: rapidly evolving research ethics landscape, extreme vulnerability of research participants, unique challenges to informed consent, challenges to community engagement during COVID-19, and overlapping research ethics and public health equity issues. Sub-themes were identified for each main theme. CONCLUSIONS: Numerous, significant ethical complexities and challenges were identified by South African REC members in the review of COVID-19 related research. While RECs are resilient and adaptable, reviewer and REC member fatigue were major concerns. The numerous ethical issues identified also highlight the need for research ethics teaching and training, especially in informed consent, as well as the urgent requirement for the development of national guidelines for research ethics during public health emergencies. Further, comparative analysis between different countries is needed to develop the discourse around African RECs and COVID-19 research ethics issues.

Stakeholder views on informed consent models for future use of biological samples in Malawi and South Africa.

BACKGROUND: Current advances in biomedical research have introduced new ethical challenges in obtaining informed consent in low and middle-income settings. For example, there are controversies about the use of broad consent in the collection of biological samples for use in future biomedical research. However, few studies have explored preferred informed consent models for future use of biological samples in Malawi and South Africa. Therefore, we conducted an empirical study to understand preferred consent models among key stakeholders in biomedical studies that involve collection of biological samples in Malawi and South Africa. The main objective of the study was to explore views of key stakeholders on current policies on informed consent in Malawi and South Africa. METHODS: This was a qualitative study involving in-depth interviews and focus group discussions. Thirty-four in-depth interviews and 6 focus group discussions were conducted with REC members, Funders, Policymakers, CAB members and Research Participants in Malawi and South Africa to gather their views on models of informed consent. The study was conducted in Cape Town, South Africa, and Blantyre and Lilongwe in Malawi. RESULTS: Most key stakeholders preferred broad consent and tiered consent to specific consent. Some participants expressed a strong preference for specific consent to other models of informed consent in biomedical research. Few participants did not have any preference for a consent model, opting for any consent model which provides adequate information about the proposed research and what their national consent regulations require. Finally, very few participants preferred blanket consent to other informed consent models. CONCLUSIONS: This study aimed to help fill the gap in the scientific literature on key stakeholder views on consent models for future use of biological samples in Malawi and South Africa. The findings of the study have provided some evidence that may support policies on permissible consent models for future use of biological samples in sub-Saharan Africa considering the differences in informed consent regulations and guidelines. Finally, the findings can inform ongoing discussions on permissible consent models to be used for future use of biological samples.

Attitudes About Analytic Treatment Interruption (ATI) in HIV Remission Trials with Different Antiretroviral Therapy (ART) Resumption Criteria.

HIV remission trials often require temporary stopping of antiretroviral therapy (ART)-an approach called analytic treatment interruption (ATI). Trial designs resulting in viremia raise risks for participants and sexual partners. We conducted a survey on attitudes about remission trials, comparing ART resumption criteria (lower-risk "time to rebound" and higher-risk "sustained viremia") among participants from an acute HIV cohort in Thailand. Analyses included Wilcoxon-Ranks and multivariate logistic analysis. Most of 408 respondents supported ATI trials, with slightly higher approval of, and willingness to participate in, trials using time to rebound versus sustained viremia criteria. Less than half of respondents anticipated disclosing trial participation to partners and over half indicated uncertainty or unwillingness about whether partners would be willing to use PrEP. Willingness to participate was higher among those who rated higher trial approval, lower anticipated burden, and those expecting to make the decision independently. Our findings support acceptability of ATI trials among most respondents. Participant attitudes and anticipated behaviors, especially related to transmission risk, have implications for future trial design and informed consent.

Improving the Continuity of Care for People Living with HIV Experiencing Incarceration in North Carolina Jails: Stakeholder Perspectives.

BACKGROUND Jail detention can disrupt the continuity of care for people living with HIV/AIDS (PLWH). Using a state's "Data to Care" (D2C) program might help overcome this barrier, but raises important questions of data security, personal privacy, resource allocation, and logistics.METHODS As part of a study involving in-depth expert stakeholder interviews, a 1-day workshop was convened to identify and discuss potential ethical challenges in extending North Carolina's D2C program to jail settings. Workshop participants included public health officials, community advocates, HIV clinicians, jail administrators, privacy experts, criminal justice researchers, and a formerly incarcerated PLWH. Workshop participants discussed the results of earlier stakeholder interviews with the goal of identifying the most important points to consider in assessing the merits of extending D2C surveillance to jail settings.RESULTS Although the workshop participants expressed support for improving the continuity of HIV care for jail detainees, they had mixed perspectives on whether a jail-based D2C program should include in-jail or post-release follow-up interventions. Their positions were influenced by their views on 4 sets of implementation issues: privacy/data-sharing; government assistance/overreach; HIV criminalization/exceptionalism; and community engagement.LIMITATIONS The limitations of this stakeholder engagement exercise include its purposive recruitment, relatively small number of participants, and limited duration.CONCLUSIONS Improving the continuity of HIV care in particular jail settings will depend on a number of local considerations. In deciding between models featuring in-jail and post-release follow-up care, the most important of these considerations will be the possibility of establishing good partnerships between the jail, the health department, and the community. Additional research on the dynamics and impact of different models is needed.

Pathways to Depression and Poor Quality of Life Among Adolescents in Western Kenya: Role of Anticipated HIV Stigma, HIV Risk Perception, and Sexual Behaviors.

Depression is a major cause of disease burden and is linked to poor quality of life (QOL) among adolescents. We examined the roles of sexual behaviors, HIV risk perception, and anticipated HIV stigma on depressive symptomatology and QOL among 4096 adolescents in a rural region of western Kenya with a high burden of HIV. Participants were aged 15-19 years, had not been tested for HIV in the previous 6 months, and had never been diagnosed with HIV. Anticipated stigma and risk perception were directly associated with depressive symptomatology and QOL. There was evidence of small indirect effects-through stigma-of risk perception on depressive symptomatology and QOL. Gender moderated relationships between sexual behavior and risk perception, depressive symptomatology, and QOL. Results suggest that developing effective gender-based interventions to address stigma, sexual behavior, and risk perception may be important for improving adolescent well-being in high HIV prevalence contexts.

RESUMEN: La depresión es una de las principales causas de carga de morbilidad y se asocia con una pobre calidad de vida (CdV) de los adolescentes. Nosotros estudiamos el papel de los comportamientos sexuales, la percepción de riesgo del VIH, y el estigma anticipado del VIH en relación con la sintomatología depresiva y la CdV de 4 096 adolescentes provenientes de una región rural del oeste de Kenia con alta carga de VIH. Los participantes, adolescentes de entre 15 y 19 años, no se habían hecho la prueba de detección del VIH en los últimos 6 meses y, además, nunca habían sido diagnosticados con VIH. El estigma anticipado y la percepción de riesgo estaban asociados directamente con la sintomatología depresiva y la CdV. Hubo evidencia de pocos efectos indirectos de percepción de riesgo­generados por el estigma­en la sintomatología depresiva y la CdV. El género moderó las relaciones entre el comportamiento sexual y la percepción de riesgo, la sintomatología depresiva y la CdV. Los resultados sugieren que desarrollar intervenciones con enfoque de género para abordar el tema del estigma, los comportamientos sexuales y la percepción de riesgo, puede ser importante para mejorar el bienestar de los adolescentes que viven en un contexto con alta prevalencia de VIH.

Ethical considerations for HIV remission clinical research involving participants diagnosed during acute HIV infection.

HIV remission clinical researchers are increasingly seeking study participants who are diagnosed and treated during acute HIV infection-the brief period between infection and the point when the body creates detectable HIV antibodies. This earliest stage of infection is often marked by flu-like illness and may be an especially tumultuous period of confusion, guilt, anger, and uncertainty. Such experiences may present added ethical challenges for HIV research recruitment, participation, and retention. The purpose of this paper is to identify potential ethical challenges associated with involving acutely diagnosed people living with HIV in remission research and considerations for how to mitigate them. We identify three domains of potential ethical concern for clinicians, researchers, and ethics committee members to consider: 1) Recruitment and informed consent; (2) Transmission risks and partner protection; and (3) Ancillary and continuing care. We discuss each of these domains with the aim of inspiring further work to advance the ethical conduct of HIV remission research. For example, experiences of confusion and uncertainty regarding illness and diagnosis during acute HIV infection may complicate informed consent procedures in studies that seek to recruit directly after diagnosis. To address this, it may be appropriate to use staged re-consent procedures or comprehension assessment. Responsible conduct of research requires a broad understanding of acute HIV infection that encompasses its biomedical, psychological, social, and behavioral dimensions. We argue that the lived experience of acute HIV infection may introduce ethical concerns that researchers and reviewers should address during study design and ethical approval.

HIV prevention research and COVID-19: putting ethics guidance to the test.

BACKGROUND: Critical public health measures implemented to mitigate the spread of the novel coronavirus disease (COVID-19) pandemic have disrupted health research worldwide, including HIV prevention research. While general guidance has been issued for the responsible conduct of research in these challenging circumstances, the contours of the dueling COVID-19 and HIV/AIDS pandemics raise some critical ethical issues for HIV prevention research. In this paper, we use the recently updated HIV Prevention Trials Network (HPTN) Ethics Guidance Document (EGD) to situate and analyze key ethical challenges related to the conduct of HIV prevention research during the COVID-19 pandemic as well as identify potential areas for refinement of the guidance document based on this unprecedented state of affairs. MAIN BODY: Necessary actions taken for HIV prevention research studies due to the COVID-19 pandemic involve an array of ethical issues including those related to: (1) risk mitigation; (2) behavior change; (3) compounding vulnerability; (4) community engagement; (5) trial reopening; and 6) shifting research priorities. CONCLUSIONS: In the context of the dueling HIV and COVID-19 global pandemics, research teams and sponsors must be nimble in responding to the rapidly changing environment by being sensitive to the associated ethical issues. The HTPN EGD provides a rich set of tools to help identify, analyze and address many of these issues. At the same time, future refinements of the HPTN EGD and other research ethics guidance could be strengthened by providing explicit advice regarding the ethical issues associated with disrupted research and the reopening of studies. In addition, additional consideration should be given to appropriately balancing domains of risk (e.g., physical versus social), addressing the vulnerability of research staff and community partners, and responding to un-anticipatable ancillary care needs of participants and communities. Appropriately addressing these issues will necessitate conceptual work, which would benefit from the careful documentation of the actual ethical issues encountered in research, the strategies implemented to overcome them, and their success in doing so. Throughout all of these efforts, it is critical to remember that the HIV pandemic not be forgotten in the rush to deal with the COVID-19 pandemic.

Moral practices shaping HIV disclosure among young gay and bisexual men living with HIV in the context of biomedical advance.

Biomedical advances in diagnostics, treatment and prevention increase the means available to reduce HIV transmission risk. Subsequent shifts in HIV status disclosure obligation and ethics may impact how those living with HIV view, enact and experience disclosure. We analysed focus group and interview data to explore how these changes are reflected in disclosure decision-making to sexual partners among young gay and bisexual men living with HIV in the USA. Three interrelated themes were identified: engaging with partners' varying HIV knowledge; attribution of blame; and negotiating disclosure-related harms. Participants experienced blame from partners that questioned the timing of HIV testing, status disclosure and sex events without regards for viral suppression or use of pre-exposure prophylaxis. Substantial HIV stigma was described in response to disclosure, mitigated in some cases by partners' higher HIV knowledge. Overall, an uneven diffusion of HIV treatment and prevention knowledge and continuing HIV stigma seemed to limit the translation of biomedical advances into improved disclosure experiences. Our findings suggest that young gay and bisexual men living with HIV may continue to perform much of the moral labour involved in disclosure by managing others' reactions, correcting inaccurate sexual health information, and negotiating the risks of disclosure-related harm.

Allocation of scarce resources in Africa during COVID-19: Utility and justice for the bottom of the pyramid?

The COVID-19 pandemic has raised important universal public health challenges. Conceiving ethical responses to these challenges is a public health imperative but must take context into account. This is particularly important in sub-Saharan Africa (SSA). In this paper, we examine how some of the ethical recommendations offered so far in high-income countries might appear from a SSA perspective. We also reflect on some of the key ethical challenges raised by the COVID-19 pandemic in low-income countries suffering from chronic shortages in health care resources, and chronic high morbidity and mortality from non-COVID-19 causes. A parallel is drawn between the distribution of severity of COVID-19 disease and the classic "Fortune at the bottom of the pyramid" model that is relevant in SSA. Focusing allocation of resources during COVID-19 on the 'thick' part of the pyramid in Low-to-Middle Income Countries (LMICs) could be ethically justified on utilitarian and social justice grounds, since it prioritizes a large number of persons who have been economically and socially marginalized. During the pandemic, importing allocation frameworks focused on the apex of the pyramid from the global north may therefore not always be appropriate. In a post-COVID-19 world, we need to think strategically about how health care systems can be financed and structured to ensure broad access to adequate health care for all who need it. The root problems underlying health inequity, exposed by COVID-19, must be addressed, not just to prepare for the next pandemic, but to care for people in resource poor settings in non-pandemic times.

Addressing Ethical Challenges in US-Based HIV Phylogenetic Research.

In recent years, phylogenetic analysis of HIV sequence data has been used in research studies to investigate transmission patterns between individuals and groups, including analysis of data from HIV prevention clinical trials, in molecular epidemiology, and in public health surveillance programs. Phylogenetic analysis can provide valuable information to inform HIV prevention efforts, but it also has risks, including stigma and marginalization of groups, or potential identification of HIV transmission between individuals. In response to these concerns, an interdisciplinary working group was assembled to address ethical challenges in US-based HIV phylogenetic research. The working group developed recommendations regarding (1) study design; (2) data security, access, and sharing; (3) legal issues; (4) community engagement; and (5) communication and dissemination. The working group also identified areas for future research and scholarship to promote ethical conduct of HIV phylogenetic research.

Expert stakeholders' perspectives on a Data-to-Care strategy for improving care among HIV-positive individuals incarcerated in jails.

Data-to-Care (D2C) uses surveillance data (e.g., laboratory, Medicaid billing) to identify out-of-care HIV-positive persons to re-link them to care. Most US states are implementing D2C, yet few studies have explored stakeholders' perspectives on D2C, and none have addressed these perspectives in the context of D2C in jail. This article reports findings from qualitative, semi-structured interviews conducted with expert stakeholders regarding their perspectives on the ethical challenges of utilizing D2C to understand and improve continuity of care among individuals incarcerated in jails. Participants included 47 professionals with expertise in ethics and privacy, public health and HIV care, the criminal justice system, and community advocacy. While participants expressed a great deal of support for extending D2C to jails, they also identified many possible risks. Stakeholders discussed many issues specific to D2C in jails, such as heightened stigma in the jail setting, the need for training of jail staff and additional non-medical community-based resources, and the high priority of this vulnerable population. Many experts suggested that the actual likelihood of benefits and harms would depend on contextual details. Implementation of D2C in jails may require novel strategies to minimize risk of disclosing out-of-care patients' HIV status.

Broadening community engagement in clinical research: Designing and assessing a pilot crowdsourcing project to obtain community feedback on an HIV clinical trial.

BACKGROUND/AIMS: Community engagement is widely acknowledged as an important step in clinical trials. One underexplored method for engagement in clinical trials is crowdsourcing. Crowdsourcing involves having community members attempt to solve a problem and then publicly sharing innovative solutions. We designed and conducted a pilot using a crowdsourcing approach to obtain community feedback on an HIV clinical trial, called the Acceptability of Combined Community Engagement Strategies Study. In this work, we describe and assess the Acceptability of Combined Community Engagement Strategies Study's crowdsourcing activities in order to examine the opportunities of crowdsourcing as a clinical trial community engagement strategy. METHODS: The crowdsourcing engagement activities involved in the Acceptability of Combined Community Engagement Strategies Study were conducted in the context of a phase 1 HIV antibody trial (ClinicalTrials.gov identifier: NCT03803605). We designed a series of crowdsourcing activities to collect feedback on three aspects of this clinical trial: the informed consent process, the experience of participating in the trial, and fairness/reciprocity in HIV clinical trials. All crowdsourcing activities were open to members of the general public 18 years of age or older, and participation was solicited from the local community. A group discussion was held with representatives of the clinical trial team to obtain feedback on the utility of crowdsourcing as a community engagement strategy for informing future clinical trials. RESULTS: Crowdsourcing activities made use of innovative tools and a combination of in-person and online participation opportunities to engage community members in the clinical trial feedback process. Community feedback on informed consent was collected by transforming the clinical trial's informed consent form into a series of interactive video modules, which were screened at an open public discussion. Feedback on the experience of trial participation involved designing three fictional vignettes which were then transformed into animated videos and screened at an open public discussion. Finally, feedback on fairness/reciprocity in HIV clinical trials was collected using a crowdsourcing idea contest with online and in-person submission opportunities. Our public discussion events were attended by 38 participants in total; our idea contest received 43 submissions (27 in-person, 16 online). Facebook and Twitter metrics demonstrated substantial engagement in the project. The clinical team found crowdsourcing primarily useful for enhancing informed consent and trial recruitment. CONCLUSION: There is sufficient lay community interest in open calls for feedback on the design and conduct of clinical trials, making crowdsourcing both a novel and feasible engagement strategy. Clinical trial researchers are encouraged to consider the opportunities of implementing crowdsourcing to inform trial processes from a community perspective.

Ethics of pursuing targets in public health: the case of voluntary medical male circumcision for HIV-prevention programs in Kenya.

The use of targets to direct public health programmes, particularly in global initiatives, has become widely accepted and commonplace. This paper is an ethical analysis of the utilisation of targets in global public health using our fieldwork on and experiences with voluntary medical male circumcision (VMMC) initiatives in Kenya. Among the many countries involved in VMMC for HIV prevention, Kenya is considered a success story, its programmes having medically circumcised nearly 2 million men since 2007. We describe ethically problematic practices in Kenyan VMMC programmes revealed by our fieldwork, how the problems are related to the pursuit of targets and discuss possible approaches to their management. Although the establishment and pursuit of targets in public health can have many benefits, assessments of target-driven programmes tend to focus on quantifiable outcomes rather than the processes by which the outcomes are obtained. However, in order to speak more robustly about programmatic 'success', and to maintain community trust, it is vital to ethically evaluate how a public health initiative is actually implemented in the pursuit of its targets.

"Meet people where they are": a qualitative study of community barriers and facilitators to HIV testing and HIV self-testing among African Americans in urban and rural areas in North Carolina.

BACKGROUND: HIV testing programs in the United States aim to reach ethnic minority populations who experience high incidence of HIV, yet 40% of African Americans have never been tested for HIV. The objective of this study is to identify community-based strategies to increase testing among African Americans in both urban and rural areas. METHODS: This study conducted focus group discussions (FGDs) informed by community-based participatory research principles to examine African American's concerns and ideas around HIV testing and HIV self-testing. Participants included highly affected (i.e., PLWH, MSM, PWID, low-income, teens and young adults) populations from African American communities in North Carolina, aged 15 years and older. We digitally transcribed and analyzed qualitative data using MAXQDA and axial coding to identify emergent themes. RESULTS: Fifty-two men and women between 15 to 60 years old living in urban (n=41) and rural (n=11) areas of North Carolina participated in focus group discussions. HIV testing barriers differed by HIV testing setting: facility-based, community-based, and HIV self-testing. In community-based settings, barriers included confidentiality concerns. In facility-based settings (e.g., clinics), barriers included negative treatment by healthcare workers. With HIV self-testing, barriers included improper use of self-testing kits and lack of post-test support. HIV testing facilitators included partnering with community leaders, decentralizing testing beyond facility-based sites, and protecting confidentiality. CONCLUSIONS: Findings suggest that HIV testing concerns among African Americans vary by HIV testing setting. African Americans may be willing to test for HIV at community events in public locations if client confidentiality is preserved and use HIV self-testing kits in private if post-test social support and services are provided. These community-identified facilitators may improve African American testing rates and uptake of HIV self-testing kits.

How Biomedical HIV Prevention Trials Incorporate Behavioral and Social Sciences Research: A Typology of Approaches.

In the field of biomedical HIV prevention, researchers have meaningfully incorporated behavioral and social sciences research (BSSR) into numerous clinical trials, though the timing and degree of integration have been highly variable. The literature offers few frameworks that systematically characterize these collaborations. To fill this gap, we developed a typology of BSSR approaches within biomedical HIV prevention research. Focusing on trials that had safety and/or efficacy endpoints, we identified five approaches for combining BSSR and clinical research: formative, embedded, parallel, explanatory, and implications. We describe each approach and provide illustrative examples. By offering a shared vocabulary for distinguishing the timing and design of collaborative BSSR and clinical research, this typology can facilitate greater transparency in collaborators' expectations and responsibilities, and help collaborators address challenges likely to be associated with such interdisciplinary research.

Consent Challenges and Psychosocial Distress in the Scale-up of Voluntary Medical Male Circumcision Among Adolescents in Western Kenya.

In priority sub-Saharan African countries, on the ground observations suggest that the success of voluntary medical male circumcision (VMMC) programs should not be based solely on numbers of males circumcised. We identify gaps in the consent process and poor psychosocial outcomes among a key target group: male adolescents. We assessed compliance with consent and assent requirements for VMMC in western Kenya among males aged 15-19 (N = 1939). We also examined differences in quality of life, depression, and anticipated HIV stigma between uncircumcised and circumcised adolescents. A substantial proportion reported receiving VMMC services as minors without parent/guardian consent. In addition, uncircumcised males were significantly more likely than their circumcised peers to have poor quality of life and symptoms of depression. Careful monitoring of male adolescents' well-being is needed in large-scale VMMC programs. There is also urgent need for research to identify effective strategies to address gaps in the delivery of VMMC services.

Penile transplantation as an appropriate response to botched traditional circumcisions in South Africa: an argument against.

Traditional male circumcision is a deeply entrenched cultural practice in South Africa. In recent times, there have been increasing numbers of botched circumcisions by untrained and unscrupulous practitioners, leading to genital mutilation and often, the need for penile amputation. Hailed as a world's first, a team of surgeons conducted the first successful penile transplant in Cape Town, South Africa in 2015. Despite the euphoria of this surgical victory, concerns about the use of this costly intervention in a context of severe resource constraints have been raised. In this paper, we explore some of the ethical implications of penile transplants as a clinical and public health response to the adverse consequences of traditional male circumcision. Given the current fiscal deficits in healthcare and public health sectors, how can one justify costly, high-technology interventions for conditions affecting a small section of the population? Since botched traditional male circumcisions are preventable, is a focus on penile transplantation as a form of treatment reasonable? Finally, do such interventions create undue expectations and false hope among a highly vulnerable and stigmatised group of young men? In this paper, we argue that given limited healthcare resources in South Africa and competing healthcare needs, prevention is a more appropriate response to botched traditional circumcisions than penile transplants.