Beyond translations, perspectives for researchers to consider to enhance comprehension during consent processes for health research in sub-saharan Africa: a scoping review.

BACKGROUND: Literature on issues relating to comprehension during the process of obtaining informed consent (IC) has largely focused on the challenges potential participants can face in understanding the IC documents, and the strategies used to enhance comprehension of those documents. In this review, we set out to describe the factors that have an impact on comprehension and the strategies used to enhance the IC process in sub-Saharan African countries. METHODS: From November 2021 to January 2022, we conducted a literature search using a PRISMA tool. We searched electronic databases (PubMed, EMBASE, EBSCOHOST) to identify relevant peer reviewed studies. We then reviewed the references of these articles to find additional literature that might have been missed through the initial search. We were particularly interested in full text articles in English that focused on the IC process in SSA published between 2006 and 2020. We included systematic reviews, and studies from Western and Asian countries that included data about SSA. We excluded articles that focused on medical interventions and studies that did not require IC. RESULTS: Out of the 50 studies included most were multi-country (n = 13) followed by single country studies in South Africa (n = 12); Kenya, Tanzania, Uganda (n = 5) each; Gambia, Ghana and Nigeria (n = 2)each ; and one each for Botswana, Malawi, Mali, Mozambique. We identified three areas of focus: (1) socio-cultural factors affecting IC; (2) gaps in the ethical and legal frameworks guiding the IC process; and (3) strategies used to improve participants' understanding of IC. CONCLUSION: Our review showed wide recognition that the process of achieving IC in SSA is inherently challenging, and there are limitations in the strategies aimed at improving comprehension in IC. We suggest that there is a need for greater flexibility and negotiation with communities to ensure that the approach to IC is suited to the diverse socio-cultural contexts. We propose moving beyond the literal translations and technical language to understanding IC comprehension from the participants' perspectives and the researchers' views, while examining contextual factors that impact the IC process.

Ethically acceptable consent approaches to adolescent research in South Africa.

Background: Adolescents are a unique population with significant unmet health needs. They are often excluded from research that may benefit them as they are perceived as vulnerable and needing protection from research participation. For Research Ethics Committees, conflicting positions in statutes, regulations and ethical guidelines about who provides informed consent for adolescent involvement in health research can be a significant barrier to approving adolescent research. For researchers, the requirement for parental/guardian proxy consent or prolonged approval processes may potentially result in the exclusion of those adolescents most vulnerable and at risk, particularly if issues such as gender-based violence, gender identity, sexuality and sexual practices are in question. Objectives: To describe the challenges to adolescent research and suggest strategies to address these. Method: We consider the legal and ethical framework in South Africa regarding the consenting age for adolescents in research, outline the challenges and, using examples of best practices, suggest strategies to address the current conundrum. Results: We suggest three principles to guide Research Ethics Committees on their approach to reviewing health research involving adolescents. Strategies to develop ethically acceptable approaches to adolescent research and consent processes are described, which include community involvement. We elaborate on examples of nuanced approaches to adolescent research. Conclusion: The inclusion of adolescents in research is critical in informing appropriate and effective health services for this vulnerable population, whilst providing an opportunity to link them into care and services where relevant.

Parental waivers to enable adolescent participation in certain forms of health research: lessons from a South African case study.

BACKGROUND: The South African legal framework requires mandatory parental/legal guardian consent for all research with children. Ethics guidelines provide some reprieve by allowing RECs to grant waivers of parental or guardianship consent in certain defined circumstances. In the first instance, consent may be provided by a proxy when parents or guardians are unavailable, for example with orphaned children. In the second instance, guidelines permit adolescent self-consent when the nature of the study justifies this approach, for example, research on sensitive issues like sexual behaviour or substance use. DISCUSSION: South African guidelines set several conditions that must be met for waivers to be granted. These norms overlap with those in international guidelines. However, the ethical norms, especially related to self-consent are sometimes vague. This article critically evaluates the consent norms in the national ethics guidelines and makes recommendations for reform to ethics guidelines in a way that recognises the value of child participation in research, their evolving decision-making capacity and their best interests. CONCLUSION: Recommendations are made to harmonise ethics guidelines and law in a way that promotes child participation in research, to ensure additional protections for adolescents when self-consent is allowed, and to withdraw procedural requirements for the community endorsement of self-consent strategies.

The ethical-legal requirements for adolescent self-consent to research in sub-Saharan Africa: A scoping review.

Support for the enrolment of adolescents in research has been constrained by uncertainties in parental involvement, and the lack of clarity in the ethical and legal frameworks. We conducted a scoping review to examine articles that explored the opinion of scholars on the question of adolescent consent and conditions for parental waivers in research in sub-Saharan Africa (SSA). Guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) tool, we searched electronic databases (PubMed, EMBASSE, EBSCOHOST) and also reviewed the references of articles identified for additional relevant literature. We included full text English articles focusing on adolescent consent and parental waivers in SSA that were published between 2004 and 2020. We excluded studies focusing on healthcare, theses, and reviews. We reviewed a total of 21 publications from South Africa (n = 12), Kenya (n = 4) and Botswana, Malawi, Nigeria, Uganda and Zimbabwe (n = 1 each). We identified four broad thematic issues: the current position regarding parental waivers and self-consent; parental involvement in the consent process; the role of community approval or consent when adolescent self-consent approaches were used; and complexities and ambiguities in legal requirements and ethical guidelines on adolescent consent. Our findings show inconsistencies and ambiguities in the existing legal and ethical frameworks within and across different countries, and underscore the need for consistent and clearer guidance on parental waivers and adolescent self-consent. Harmonization of the legal and ethical frameworks taking into account varying contexts is critically important to ensure research on adolescents in SSA meets adolescents' specific unmet needs.

Adolescent participation in HIV research: consortium experience in low and middle-income countries and scoping review.

Adolescents in low and middle-income countries (LMICs) have a high prevalence of HIV, therefore, it is important that they are included in HIV research. However, ethical challenges regarding consent can hinder adolescent research participation. We examined examples from the Prevention and Treatment Through a Comprehensive Care Continuum for HIV-affected Adolescents in Resource Constrained Settings (PATC3H) research consortium, which investigates adolescent HIV prevention and treatment in seven LMICs: Brazil, Kenya, Mozambique, Nigeria, South Africa, Uganda, and Zambia. PATC3H researchers were asked to identify ethical and practical challenges of adolescent consent to research participation in these countries. We also did a scoping review of strategies that could improve adolescent participation in LMIC HIV studies. Examples from PATC3H research highlighted many ethical challenges that affect adolescent participation, including inconsistent or absent consent guidance, guidelines that fail to account for the full array of adolescents' lives, and variation in how ethical review committees assess adolescent studies. Our scoping review identified three consent-related strategies to expand adolescent inclusion: waiving parental consent requirements, allowing adolescents to independently consent, and implementing surrogate decision making. Our analyses suggest that these strategies should be further explored and incorporated into ethical and legal research guidance to increase adolescent inclusion in LMIC HIV research.

Be legally wise: When is parental consent required for adolescents' access to pre-exposure prophylaxis (PrEP)?

BACKGROUND: South African adolescents (12-17 years) need an array of prevention tools to address their risk of acquiring the life-long, stigmatized condition that is HIV. Prevention tools include pre-exposure prophylaxis (PrEP). However, service providers may not be clear on the instances where self-consent is permissible or when parental consent should be secured. AIM: To consider the legal norms for minor consent to PrEP using the rules of statutory interpretation. SETTING: Legal and policy framework. RESULTS: We find that PrEP should be interpreted as a form of 'medical treatment'; understood broadly so that it falls within the ambit of one of consent norms in the Children's Act. When PrEP is interpreted as 'medical treatment', then self-consent to PrEP is permissible for persons over 12 years, if they have the mental capacity and maturity to understand the benefits, risks, social and other implications of the proposed treatment. Currently, PrEP is only licensed for persons over 35 kg. Reaching the age of 12 years is a necessary but not sufficient criteria for self-consent and service-providers must ensure capacity requirements are met before implementing a self-consent approach. Decisional support and adherence support are critical. CONCLUSIONS: We recommend that service-providers should take steps to ensure that those persons who meet an age requirement for self-consent, also meet the capacity requirement, and that best practices in this regard be shared. We also recommend that policy makers should ensure that PrEP guidelines are updated to reflect the adolescent consent approach articulated above. It is envisaged that these efforts will enable at-risk adolescents to access much needed interventions to reduce their HIV risk.

Acceptability, safety, and patterns of use of oral tenofovir disoproxil fumarate and emtricitabine for HIV pre-exposure prophylaxis in South African adolescents: an open-label single-arm phase 2 trial.

BACKGROUND: HIV incidence among adolescents in southern Africa remains unacceptably high. Pre-exposure prophylaxis (PrEP) is an effective HIV prevention intervention but there are few data on its implementation among adolescents. We aimed to investigate the safety, feasibility, and acceptability of PrEP with oral tenofovir disoproxil fumarate and emtricitabine as part of a comprehensive HIV prevention package in an adolescent population in South Africa. METHODS: This open-label single-arm phase 2 study (PlusPills) was done in two research clinics in Cape Town and Johannesburg, South Africa. Adolescents aged 15-19 years were recruited into the study through recruitment events and outreach in the community. Potential participants were eligible for enrolment if they reported being sexually active. Exclusion criteria were a positive test for HIV or pregnancy at enrolment, breastfeeding, or any relevant co-morbidities. Participants were given oral tenofovir disoproxil fumarate and emtricitabine for PrEP to take daily for the first 12 weeks and were then given the choice to opt in or out of PrEP use at three monthly intervals during scheduled clinic visits. Participants were invited to monthly visits for adherence counselling and HIV testing during the study period. The primary outcomes were acceptability, use, and safety of PrEP. Acceptability was measured by the proportion of participants who reported willingness to take up PrEP and remain on PrEP at each study timepoint. Use was defined as the number of participants who continued to use PrEP after the initial 12-week period until the end of the study (week 48). Safety was measured by grade 2, 3, and 4 laboratory and clinical adverse events using the Division of AIDS table for grading the severity of adult and paediatric adverse events, version 1.0. Dried blood spot samples were collected at each study time-point to measure tenofovir diphosphate concentrations. This trial is registered with ClinicalTrials.gov, NCT02213328. FINDINGS: Between April 28, 2015, and Nov 11, 2016, 244 participants were screened, and 148 participants were enrolled (median age was 18 years; 99 participants [67%] were female) and initiated PrEP. PrEP was stopped by 26 of the 148 (18%) participants at 12 weeks. Cumulative PrEP opt-out, from the total cohort, was 41% (60 of 148 participants) at week 24 and 43% (63 of 148 participants) at week 36. PrEP was well tolerated with only minor adverse events (grade 2) thought to be related to study drug, which included headache (n=4, 3%), gastrointestinal upset (n=8, 5%), and skin rash (n=2, 1%). Two participants (1%) experienced grade 3 weight loss, which was deemed related to the study drug and resolved fully when PrEP was discontinued. Tenofovir diphosphate concentrations were detectable (>16 fmol/punch) in dried blood spot samples in 108 (92%) of 118 participants who reported PrEP use at week 12, in 74 (74%) of 100 participants at week 24, and in 22 (59%) of 37 participants by the study end at week 48. INTERPRETATION: In this cohort of self-selected South African adolescents at risk of HIV acquisition, PrEP appears safe and tolerable in those who continued use. PrEP use decreased throughout the course of the study as the number of planned study visits declined. Adolescents in southern Africa needs access to PrEP with tailored adherence support and possibly the option for more frequent and flexible visit schedules. FUNDING: National Institute of Allergy and Infectious Diseases of the US National Institutes of Health.

An open-label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose).

INTRODUCTION: Young women in Southern Africa have extremely high HIV incidence rates necessitating the availability of female-controlled prevention methods. Understanding adolescent preference for seeking contraception would improve our understanding of acceptability, feasibility and adherence to similar modes of delivery for HIV prevention. METHODS: UChoose was an open-label randomized crossover study over 32 weeks which aimed to evaluate the acceptability and preference for contraceptive options in healthy, HIV-uninfected, female adolescents aged 15 to 19 years, as a proxy for similar HIV prevention methods. Participants were assigned to a contraceptive method for a period of 16 weeks in the form of a bi-monthly injectable contraceptive, monthly vaginal Nuvaring® or daily combined oral contraceptive (COC) and then asked to state their preference. At 16 weeks, participants crossed over to another contraceptive method, to ensure that all participants tried the Nuvaring® (least familiar modality) and additionally, either the injection or COC. Primary outcomes were contraceptive acceptability and preference. At the end of the 32 weeks they were also asked to imagine their preference for an HIV prevention modality. Secondary endpoints included changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods. RESULTS: Of the 180 participants screened, 130 were enrolled and randomized to the Nuvaring® (n = 45), injection (n = 45) or COC (n = 40). Significantly more Nuvaring® users (24/116; 20.7%) requested to change to another contraceptive option compared to injection (1/73; 1.4% p = 0.0002) and COC users (4/49; 8% p = 0.074). Of those that remained on the Nuvaring® , adherence was significantly higher than to COC (p < 0.0001). Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring® (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034). Overall, the preferred contraceptive choice was injection, followed by the ring and lastly the pill. CONCLUSIONS: Adherence to daily COC was difficult for adolescents in this cohort and the least favoured potential HIV prevention option. While some preferred vaginal ring use, these data suggest that long-acting injectables would be the preferred prevention method for adolescent girls and young women. This study highlights the need for additional options for HIV prevention in youth.

Reflecting on adolescents' evolving sexual and reproductive health rights: canvassing the opinion of social workers in KwaZulu-Natal, South Africa.

In South Africa children under the age of 18 are legal minors and considered not fully capable of acting independently. However, in certain defined circumstances the law has granted minors the capacity to act independently, including regarding their sexual and reproductive health (SRH). This study explored the perspectives and practices of 17 social workers from KwaZulu-Natal on legislation relevant to adolescents' evolving sexual and reproductive health and rights and the decriminalisation of consensual underage sex. A key finding was that many social workers have conservative views about adolescent access to SRH advice and services and many were critical of the recent decriminalisation of underage consensual sex. In the main, social workers were concerned that adolescents lack the capacity to make SRH care decisions and that liberal laws promote underage sex rather than protect adolescents. Despite antagonistic views of SRH laws related to adolescents, many social workers felt that they are able to uphold their professional rather than personal views in their work. These findings are important given that a key barrier to adolescent access and uptake of SRH advice and services relates to concerns that they will be judged. Therefore service providers need to be regularly updated on adolescent SRH issues (including rights, laws, and policies) and be engaged in critical thinking about conflicting cultural, moral and personal judgements around adolescent sexuality. Such training should include counselling and communication skills that address issues on confidentiality, adolescents' dignity, privacy and best interests.

HIV testing of children is not simple for health providers and researchers: Legal and policy frameworks guidance in South Africa.

Antiretroviral treatment coverage for children and adolescents is significantly lower than that for adults. A first step in improving this situation is ensuring increased access to HIV counselling and testing services. Current legal and policy frameworks outline four norms that should inform HIV testing of children in South Africa: limiting HIV testing to defined circumstances, and ensuring that consent is obtained, counselling is provided and confidentiality is maintained. Implementing these norms is not simple. We discuss the challenges and opportunities these norms present for children, their families, health providers and researchers working in this area. Better alignment between evolving public health approaches and the HIV counselling and testing legal/policy frameworks (and the internal coherence of domestic frameworks) would better serve children, their parents and those who work with them.

Falling through the gaps: how should HIV programmes respond to families that persistently deny treatment to children?

INTRODUCTION: Children living with HIV rely on adult caregivers for access to HIV testing and care, including clinical monitoring and adherence to treatment. Yet, many caregivers confront barriers to ensuring children's care, including fear of disclosure of the child's or the parents' HIV status, competing family demands, fluctuating care arrangements and broader structural factors such as entrenched poverty or alternative beliefs about HIV's aetiology and treatment. Thus, many children are "falling through the gaps" because their access to testing and care is mediated by guardians who appear unable or unwilling to facilitate it. These children are likely to suffer treatment failure or death due to their caregivers' recalcitrance. DISCUSSION: This Commentary presents three cases from paediatric HIV services in Zimbabwe that highlight the complexities facing health care providers in providing HIV testing and care to children, and discusses the implications as a child's rights issue requiring both legal and programmatic responses. The cases provide examples of how disagreements between family members about appropriate care, conflicts between a child and caregiver and religious objections to medical treatment interrupt children's engagement with HIV services. In all three cases, no social or legal mechanisms were in place for health staff to intervene and prevent "loss to follow up." CONCLUSIONS: We suggest that conceptualizing this as a child's rights issue may be a useful way to raise the debate and move towards improved treatment access. Our cases reflect policy failure to facilitate access to children's HIV testing and treatment, and are likely to be similar across international settings. We propose sharing experiences and encouraging dialogue between health practitioners and global advocates for children's right to health to raise awareness that children are the bearers of rights even if they lack legal capacity, and that the failure of either the state or their caregiver to facilitate access to care is in fact a rights violation.

Amendments to the Sexual Offences Act dealing with consensual underage sex: Implications for doctors and researchers.

In terms of the Sexual Offences and Related Matters Amendment Act, consensual sex or sexual activity with children aged 12 - 15 was a crime, and as such had to be reported to the police. This was challenged in court in the Teddy Bear case, which held that it was unconstitutional and caused more harm than good. In June 2015, the Amendment Act was accepted by both the National Assembly and the National Council of Provinces, and came into operation on the 3 July 2015. This article looks at the amendments to sections 15 and 16 of the Act and what the reporting obligations for medical professionals and researchers are in light of the amendments, as well as the duty to provide medical services and advice to adolescents.

Child research in South Africa: How do the new regulations help?

Child research is governed by legal norms in the National Health Act (2003) and the Regulations. There is increasing harmony between the two on many issues, including the conditions under which children should be enrolled in research. The most striking disjuncture in the ethical-legal framework remains the allowable consent strategy for child research, where the law requires mandatory parental or legal guardian consent for all child research, while ethical guidelines afford research stakeholders the discretion to implement exceptions to this approach in specific justifiable circumstances.

New law on HIV testing in Botswana: The implications for healthcare professionals.

BACKGROUND: Botswana is one of the countries with the highest HIV prevalence rates in the world. Innovative HIV testing strategies are required to ensure that those infected or at risk of infection become aware of their HIV status and are able to access treatment, care and support. Despite this public health imperative, HIV testing strategies in Botswana will in future be based around the principles in the new Public Health Act (2013). The present article describes the HIV testing norms in the Act, and sets out the strengths and weaknesses of this approach and its implications for healthcare professionals in Botswana. OBJECTIVES: To compare international norms on HIV testing with the provisions governing such testing in the new Botswana Public Health Act and to assess the extent to which the new Act meets international human rights norms on HIV testing. METHOD: A 'desktop' review of international human rights norms and those in the Botswana Public Health Act. CONCLUSION: HIV testing norms in the new Public Health Act in Botswana violate individual rights and will place healthcare workers in a position where they will have to elect between acting lawfully or ethically. Law reform is required in order to ensure that HIV testing achieves the joint goals of public health and human rights.

Boni Mores and Consent for Child Research in South Africa

Consent is required for almost all health research. In order for consent to be valid a number of requirements must be met including that the consent cannot be contra bonos mores or contrary to public policy. This principle has its roots in the common law and it is used to ensure that the consent to harm; or the risk of harm; is permitted or ought to be permitted by the legal order. Recently; it has also become a statutory requirement embedded in the consent obligations relating to non-therapeutic health research with minors. Section 71 of the National Health Act provides that the Minister of Health (or potentially his or her delegated authority) must provide consent to non-therapeutic research with minors. However; such consent may not be granted if 'the reasons for the consent to the research or experimentation are contrary to public policy'. Limited work has been done on how to determine when consent to health research with children would be contrary to public policy. This article attempts to begin the debate by describing the boni mores principle; setting out some of the general factors that could be used to assess whether consent is consistent with it and suggesting how they could be applied to health research.The article concludes by stating that simply requiring proxy consent for non-therapeutic health research with children is insufficient as it cannot always be assumed that proxy consenters will act in the best interests of the child. Thus the boni mores principle acts as a limit on autonomy in order to protect the child participant. It is further submitted that establishing when consent to health research is consistent with public policy requires an assessment of whether the research is consistent with constitutional values; prevailing legal norms regarding children; and an assessment of the legal convictions of the community

New Law on HIV Testing in Botswana: The Implications for Healthcare Professionals

Background: Botswana is one of the countries with the highest HIV prevalence rates in the world. Innovative HIV testing strategies are required to ensure that those infected or at risk of infection become aware of their HIV status and are able to access treatment; care and support. Despite this public health imperative; HIV testing strategies in Botswana will in future be based around the principles in the new Public Health Act (2013). The present article describes the HIV testing norms in the Act; and sets out the strengths and weaknesses of this approach and its implications for healthcare professionals in Botswana.Objectives: To compare international norms on HIV testing with the provisions governing such testing in the new Botswana Public Health Act and to assess the extent to which the new Act meets international human rights norms on HIV testing.Method: A 'desktop' review of international human rights norms and those in the Botswana Public Health Act.Conclusion: HIV testing norms in the new Public Health Act in Botswana violate individual rights and will place healthcare workers in a position where they will have to elect between acting lawfully or ethically. Law reform is required in order to ensure that HIV testing achieves the joint goals of public health and human rights

"She made up a choice for me": 22 HIV-positive women's experiences of involuntary sterilization in two South African provinces.

Since 1998 South African law has provided that adults should have access to sterilization but only with their informed consent. However, the right to sterilization and other sexual and reproductive rights have not been fully realized as women struggle to access limited services, and there are allegations of discrimination and sterilization abuses. This qualitative study explores the experiences of 22 HIV-positive women in two provinces who reported being sterilized between 1996 and 2010 without their informed consent (n=18) or without their knowledge (n=4). Key issues reported by participants included failure to respect their autonomy, lack of information given about what sterilization entailed, and subtle or overt pressure to sign the consent form. Although the legal framework was intended to ensure informed decision-making regarding sterilization, these protections appear to have failed the HIV-positive women in this study. The findings suggest that some health professionals may consider a signature on a consent form as sufficient regardless of how it was obtained. Furthermore the women's perceptions that they were singled out as needing to be sterilized simply because they were HIV-positive warrants further investigation. More research is required on the nature of the problem and on other stakeholders' perceptions.

Disability rights in the context of HIV and AIDS: a critical review of nineteen Eastern and Southern Africa (ESA) countries.

PURPOSE: Many Eastern and Southern African (ESA) states are obliged to review and amend their legal frameworks with regards to disability since signing and ratifying the UN Convention on the Rights of Persons with Disabilities (CRPD). The HIV epidemic is one of the main health concerns in the region and is becoming increasingly associated with causing disabilities. In addition, people with disabilities are particularly at risk of exposure to HIV. Despite this, HIV programming has not yet included the interrelationship of disability and HIV. The principles within the CRPD may create much-needed international pressure and so provide a platform for the integration and inclusion of disability into HIV policies and programs. METHOD: This paper is based on a review of the legal framework in relation to HIV and disability in 19 ESA countries. It identifies 12 key articles of the Convention, which are particularly relevant to the interrelationship of HIV and disability. The paper assesses how these are integrated in the region's disability or HIV legal frameworks and identifies the main gaps within these legal systems. RESULTS: While many country's constitutions, disability and HIV laws protect certain key rights, such as the rights to equality and nondiscrimination, employment and health, there are clear gaps in the legal responses to disability and HIV. In particular, legal frameworks fail to provide adequately for accessibility, mobility and access to justice and protection from violence for people with disabilities. This results in limited protection for people with disabilities from HIV exposure and access to services to address HIV-related health and welfare needs. CONCLUSIONS: The paper identifies the gaps and makes recommendations for implementing steps toward the integration of disability into HIV-related laws, policies and programs.