Ethical considerations for involving adolescents in biomedical HIV prevention research

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Abstract

Background

Involvement of adolescent girls in biomedical HIV research is essential to better understand efficacy and safety of new prevention interventions in this key population at high risk of HIV infection. However, there are many ethical issues to consider prior to engaging them in pivotal biomedical research. In Uganda, 16–17-year-old adolescents can access sexual and reproductive health services including for HIV or other sexually transmitted infections, contraception, and antenatal care without parental consent. In contrast, participation in HIV prevention research involving investigational new drugs requires adolescents to have parental or guardian consent. Thus, privacy and confidentiality concerns may deter adolescent participation. We describe community perspectives on ethical considerations for involving adolescent girls in the MTN 034 study in Uganda.

Methods

From August 2017 to March 2018, we held five stakeholder engagement meetings in preparation for the MTN 034 study in Kampala, Uganda (NCT03593655): two with 140 community representatives, two with 125 adolescents, and one with 50 adolescents and parents. Discussions were moderated by the study team. Proceedings were documented by notetakers. Summary notes described community perspectives of adolescent participation in HIV research including convergent, divergent or minority views, challenges, and proposed solutions.

Results

Most community members perceived parental or guardian consent as a principal barrier to study participation due to concerns about adolescent disclosure of pre-marital sex, which is a cultural taboo. Of 125 adolescent participants, 119 (95%) feared inadvertent disclosure of sexual activity to their parents. Community stakeholders identified the following critical considerations for ethical involvement of adolescents in HIV biomedical research: (1) involving key stakeholders in recruitment, (2) ensuring confidentiality of sensitive information about adolescent sexual activity, (3) informing adolescents about information to be disclosed to parents or guardians, (4) offering youth friendly services by appropriately trained staff, and (5) partnering with community youth organizations to maximize recruitment and retention.

Conclusions

Stakeholder engagement with diverse community representatives prior to conducting adolescent HIV prevention research is critical to collectively shaping the research agenda, successfully recruiting and retaining adolescents in HIV clinical trials and identifying practical strategies to ensure high ethical standards during trial implementation.

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Most cited references 15

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Intimate partner violence, relationship power inequity, and incidence of HIV infection in young women in South Africa: a cohort study.

Rachel Jewkes, Kristin Dunkle, Mzikazi Nduna … (2010)

Cross-sectional studies have shown that intimate partner violence and gender inequity in relationships are associated with increased prevalence of HIV in women. Yet temporal sequence and causality have been questioned, and few HIV prevention programmes address these issues. We assessed whether intimate partner violence and relationship power inequity increase risk of incident HIV infection in South African women. We did a longitudinal analysis of data from a previously published cluster-randomised controlled trial undertaken in the Eastern Cape province of South Africa in 2002-06. 1099 women aged 15-26 years who were HIV negative at baseline and had at least one additional HIV test over 2 years of follow-up were included in the analysis. Gender power equity and intimate partner violence were measured by a sexual relationship power scale and the WHO violence against women instrument, respectively. Incidence rate ratios (IRRs) of HIV acquisition at 2 years were derived from Poisson models, adjusted for study design and herpes simplex virus type 2 infection, and used to calculate population attributable fractions. 128 women acquired HIV during 2076 person-years of follow-up (incidence 6.2 per 100 person-years). 51 of 325 women with low relationship power equity at baseline acquired HIV (8.5 per 100 person-years) compared with 73 of 704 women with medium or high relationship power equity (5.5 per 100 person-years); adjusted multivariable Poisson model IRR 1.51, 95% CI 1.05-2.17, p=0.027. 45 of 253 women who reported more than one episode of intimate partner violence at baseline acquired HIV (9.6 per 100 person-years) compared with 83 of 846 who reported one or no episodes (5.2 per 100 person-years); adjusted multivariable Poisson model IRR 1.51, 1.04-2.21, p=0.032. The population attributable fractions were 13.9% (95% CI 2.0-22.2) for relationship power equity and 11.9% (1.4-19.3) for intimate partner violence. Relationship power inequity and intimate partner violence increase risk of incident HIV infection in young South African women. Policy, interventions, and programmes for HIV prevention must address both of these risk factors and allocate appropriate resources. National Institute of Mental Health and South African Medical Research Council. Copyright 2010 Elsevier Ltd. All rights reserved.

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Creating an enabling environment for adolescent sexual and reproductive health: a framework and promising approaches.

Joar Svanemyr, Avni Amin, Omar Robles … (2015)

This article provides a conceptual framework and points out the key elements for creating enabling environments for adolescent sexual and reproductive health (ASRH). An ecological framework is applied to organize the key elements of enabling environments for ASRH. At the individual level, strategies that are being implemented and seem promising are those that empower girls, build their individual assets, and create safe spaces. At the relationship level, strategies that are being implemented and seem promising include efforts to build parental support and communication as well as peer support networks. At the community level, strategies to engage men and boys and the wider community to transform gender and other social norms are being tested and may hold promise. Finally, at the broadest societal level, efforts to promote laws and policies that protect and promote human rights and address societal awareness about ASRH issues, including through mass media approaches, need to be considered.

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Medical decision-making in children and adolescents: developmental and neuroscientific aspects

Petronella Grootens-Wiegers, Irma M Hein, Jos M. van den Broek … (2017)

Background Various international laws and guidelines stress the importance of respecting the developing autonomy of children and involving minors in decision-making regarding treatment and research participation. However, no universal agreement exists as to at what age minors should be deemed decision-making competent. Minors of the same age may show different levels of maturity. In addition, patients deemed rational conversation-partners as a child can suddenly become noncompliant as an adolescent. Age, context and development all play a role in decision-making competence. In this article we adopt a perspective on competence that specifically focuses on the impact of brain development on the child’s decision-making process. Main body We believe that the discussion on decision-making competence of minors can greatly benefit from a multidisciplinary approach. We adopted such an approach in order to contribute to the understanding on how to deal with children in decision-making situations. Evidence emerging from neuroscience research concerning the developing brain structures in minors is combined with insights from various other fields, such as psychology, decision-making science and ethics. Four capacities have been described that are required for (medical) decision-making: (1) communicating a choice; (2) understanding; (3) reasoning; and (4) appreciation. Each capacity is related to a number of specific skills and abilities that need to be sufficiently developed to support the capacity. Based on this approach it can be concluded that at the age of 12 children can have the capacity to be decision-making competent. However, this age coincides with the onset of adolescence. Early development of the brain’s reward system combined with late development of the control system diminishes decision-making competence in adolescents in specific contexts. We conclude that even adolescents possessing capacities required for decision-making, may need support of facilitating environmental factors. Conclusion This paper intends to offer insight in neuroscientific mechanisms underlying the medical decision-making capacities in minors and to stimulate practices for optimal involvement of minors. Developing minors become increasingly capable of decision-making, but the neurobiological development in adolescence affects competence in specific contexts. Adequate support should be offered in order to create a context in which minors can make competently make decisions. Electronic supplementary material The online version of this article (doi:10.1186/s12887-017-0869-x) contains supplementary material, which is available to authorized users.

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Author and article information

Contributors

Rita Nakalega: rnakalega@mujhu.org

Journal

Journal ID (nlm-ta): BMC Med Ethics

Journal ID (iso-abbrev): BMC Med Ethics

Title: BMC Medical Ethics

Publisher: BioMed Central (London )

ISSN (Electronic): 1472-6939

Publication date (Electronic): 23 September 2021

Publication date PMC-release: 23 September 2021

Publication date Collection: 2021

Volume: 22

Electronic Location Identifier: 127

Affiliations

[1 ]GRID grid.11194.3c, ISNI 0000 0004 0620 0548, Makerere University-Johns Hopkins University (MU-JHU) Research Collaboration, ; Kampala, Uganda

[2 ]GRID grid.34477.33, ISNI 0000000122986657, Department of Global Health, , University of Washington, ; Seattle, USA

[3 ]GRID grid.411943.a, ISNI 0000 0000 9146 7108, Department of Community Health, , Jomo Kenyatta University of Agriculture and Technology, ; Nairobi, Kenya

[4 ]GRID grid.11194.3c, ISNI 0000 0004 0620 0548, Infectious Diseases Institute, College of Health Sciences, , Makerere University, ; Kampala, Uganda

[5 ]GRID grid.11194.3c, ISNI 0000 0004 0620 0548, Department of Epidemiology and Biostatistics, College of Health Sciences, , Makerere University, ; Kampala, Uganda

Article

Publisher ID: 695

DOI: 10.1186/s12910-021-00695-3

PMC ID: 8461968

PubMed ID: 34556099

SO-VID: 05713d45-0d96-426a-a7a5-dd9a9a4da6b8

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 30 March 2021

Date accepted : 7 September 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100000061, Fogarty International Center;

Award ID: K43 TW010695

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ScienceOpen disciplines: Medicine

Keywords: ethics , adolescent girls , biomedical hiv prevention research , stakeholder engagement , uganda

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ScienceOpen disciplines: Medicine

Keywords: ethics , adolescent girls , biomedical hiv prevention research , stakeholder engagement , uganda

Ethical considerations for involving adolescents in biomedical HIV prevention research

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Annual Reviews HIV/AIDS: Public Health and Society

Most cited references 15

Intimate partner violence, relationship power inequity, and incidence of HIV infection in young women in South Africa: a cohort study.

Creating an enabling environment for adolescent sexual and reproductive health: a framework and promising approaches.

Medical decision-making in children and adolescents: developmental and neuroscientific aspects

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