Ethical considerations for involving adolescents in biomedical HIV prevention research

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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From (Un)Willingness to InvolveMENt: Development of a Successful Study Brand for Recruitment of Diverse MSM to a Longitudinal HIV Research

International Journal of Population Research ◽

10.1155/2013/624245 ◽

2013 ◽

Vol 2013 ◽

pp. 1-9 ◽

Cited By ~ 4

Author(s):

Paula M. Frew ◽

Victoria A. Williams ◽

Eve T. Shapiro ◽

Travis Sanchez ◽

Eli S. Rosenberg ◽

...

Keyword(s):

Hiv Prevention ◽

Brand Strategy ◽

Black Msm ◽

Prevention Research ◽

Chi Square ◽

Active Involvement ◽

Brand Development ◽

Prevention Studies ◽

Hiv Research ◽

Behavioral Communication

Background. HIV continues to be a major concern among MSM, yet Black MSM have not been enrolled in HIV research studies in proportionate numbers to White MSM. We developed an HIV prevention research brand strategy for MSM. Methods. Questionnaires and focus groups were conducted with 54 participants. Descriptive statistics and chi-square analyses were performed and qualitative data were transcribed and content analyzed to identify common themes. Results. Formative research results indicated that younger Black MSM (18–29 years) were less likely to think about joining prevention studies compared to older (≥30 years) Black MSM (x2=5.92, P=0.015). Qualitative and quantitative results indicate four prominent themes related to brand development: (1) communication sources (message deliverer), (2) message (impact of public health messaging on perceptions of HIV research), (3) intended audience (underlying issues that influence personal relevance of HIV research), and (4) communication channels (reaching intended audiences). Conclusion. The findings highlight the importance of behavioral communication translational research to effectively engage hard-to-reach populations. Despite reservations, MSM in our formative study expressed a need for active involvement and greater education to facilitate their engagement in HIV prevention research. Thus, the brand concept of “InvolveMENt” emerged.

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Child privacy rights: A ‘Cinderella’ issue in HIV-prevention research

Southern African Journal of HIV Medicine ◽

10.4102/sajhivmed.v14i3.62 ◽

2013 ◽

Vol 14 (3) ◽

pp. 108-110 ◽

Cited By ~ 1

Author(s):

Ann Elaine Strode ◽

Catherine Slack

Keyword(s):

Hiv Prevention ◽

South African ◽

Research Participation ◽

Children's Rights ◽

Mandatory Reporting ◽

Children’S Rights ◽

Best Interests ◽

Prevention Research ◽

Privacy Rights ◽

Hiv Research

Legal debates regarding child participation in HIV research have tended to focus on issues of informed consent. However, much less attention has been given to privacy; accordingly, we classify this as a ‘Cinderella issue’ that has been excluded from ‘the ball’ (academic debate). Here we argue that privacy issues are as important as consent issues in HIV-prevention research. We describe a child’s right to privacy regarding certain health interventions in South African law, and identify four key norms that flow from the law and that could be applied to HIV-prevention research: (i) children cannot have an expectation of privacy regarding research participation if they have not given independent consent to the study; (ii) children may have an expectation of privacy regarding certain components of the study, such as HIV testing, if they consent independently to such services; (iii) children’s rights to privacy in health research are limited by mandatory reporting obligations; (iv) children’s rights to privacy in HIV-prevention research may be justifiably limited by the concept of the best interests of the child. We conclude with guidelines for researchers on how to implement these principles in HIV-related research studies.

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Depression and Sexual Trauma Among Adolescent Girls and Young Women in HIV-Prevention Research in Tanzania

Maternal and Child Health Journal ◽

10.1007/s10995-020-02888-5 ◽

2020 ◽

Vol 24 (5) ◽

pp. 620-629

Author(s):

Emily M. Cherenack ◽

Elizabeth E. Tolley ◽

Sylvia Kaaya ◽

Jennifer Headley ◽

Joy Noel Baumgartner

Keyword(s):

Hiv Prevention ◽

Adolescent Girls ◽

Young Women ◽

Sexual Trauma ◽

Prevention Research

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Inclusion of adolescent girls in HIV prevention research - an imperative for an AIDS-free generation

Journal of the International AIDS Society ◽

10.7448/ias.17.1.19075 ◽

2014 ◽

Vol 17 (1) ◽

pp. 19075 ◽

Cited By ~ 9

Author(s):

Quarraisha Abdool Karim ◽

Rachael Dellar

Keyword(s):

Hiv Prevention ◽

Adolescent Girls ◽

Prevention Research ◽

Free Generation

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Sexuality, HIV risk and potential acceptability of involving adolescent girls in microbicide research in Kisumu, Kenya

Sexual Health ◽

10.1071/sh08011 ◽

2008 ◽

Vol 5 (4) ◽

pp. 339 ◽

Cited By ~ 4

Author(s):

Michele Montandon ◽

Nuriye Nalan Sahin-Hodoglugil ◽

Elizabeth Bukusi ◽

Kawango Agot ◽

Brigid Boland ◽

...

Keyword(s):

Hiv Prevention ◽

Sexual Activity ◽

Adolescent Girls ◽

High Risk Group ◽

Sub Saharan Africa ◽

Adolescent Sexuality ◽

Future Research ◽

The Individual ◽

Prevention Methods ◽

Adolescent Sexual Activity

Background: Current microbicide clinical trials primarily enroll adult participants; however, females under the age of 18, because of their high rates of HIV acquisition, represent an important population for future microbicide clinical research. We sought to understand the individual, family and community-level factors that may influence the acceptability of microbicide use and research involving adolescent girls. Methods: We conducted 30 interviews with adolescent girls aged 14–17 and nine focus group discussions with adolescent girls, parents and community leaders in Kisumu, Kenya. Participants discussed adolescent sexuality, HIV prevention methods, perceptions about microbicide use and views about microbicide research involving adolescent girls. Results: Adolescent sexual activity is stigmatised yet acknowledged to be a natural part of the ‘adolescent stage.’ Desperation to stop the spread of HIV among youth and support for female-initiated HIV prevention methods led to enthusiasm about microbicides and future microbicide research. Yet concerns about microbicides were numerous and included: difficulty using it in a timely manner due to the rushed, unplanned nature of adolescent sex; a fear of trying experimental products; concerns about microbicide efficacy; and parental worry that supporting microbicide use in youth would defy societal pressures that denounce adolescent sexual activity. Conclusions: Microbicide acceptability for youth in sub-Saharan Africa may be bolstered by desperation for new methods to stop the spread of HIV, yet hindered by misgivings about experimental HIV prevention methods for youth. Understanding and addressing the microbicide’s perceived benefits and shortcomings, as well as the broader context of adolescent sexuality and HIV prevention, may facilitate future research and promotion of microbicides in this high-risk group.

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