Adolescent-focused research and development: an imperative on all fronts

unati dikani
SHARE staff

The number of youth in Africa is growing rapidly: by 2030, it will have doubled since the start of the HIV epidemic. And although new HIV infections are decreasing, AIDS is still a leading cause of mortality among young people in the region. Despite this, and the fact that people under the age of 18 make up about 25% of the global population, research among adolescents has been a neglected area. We know that it is important to conduct research among pediatric and adolescent populations, but to date the focus has remained on adults. 

The advent of the 2nd International Workshop on HIV Adolescence: Challenges and Solutions is a sign that this is starting to change. The workshop has brought together a diverse group of people from various countries, representing different experiences – but all passionate about ensuring that adolescents have access to the knowledge and services they need to thrive and live their best lives.

On day one of the workshop, Monday 10 October, just how significant the risks are of not including adolescents in clinical trials emerged as a key theme, and with it the logistical, ethical, legal, justice, and human rights considerations that need to be taken into account when designing and implementing research involving adolescents.

trials justificationProfessor Linda-Gail Bekker, the workshop chair, noted that there has been an “explosion” of new products developed to prevent and treat HIV, from microbicide rings to new drug regimens, including pre-exposure prophylaxis (PrEP). Importantly, adolescents are one of the primary user groups of many of these products, and consequently must be included in their clinical trials. An important advance is the new regulatory requirement to include pediatric development plans in the product licensing approval process.

Speakers acknowledged that research involving adolescents can be challenging, with unique considerations that need to be addressed at various levels, from individual, family, and community, to societal and structural factors. Sinead Delaney, from the Wits Reproductive Health and HIV Institute (Wits RHI), emphasized that clinical trials with adolescents are feasible and acceptable, highlighting lessons learned by Wits RHI on human papillomavirus (HPV) vaccination and PrEP. These included a better understanding of the multiple levels of decision-making and consent on adolescent issues, and the critical role of collaborative partnerships with youth and youth community advisory boards (YCABs), parents, and communities.

Lee Fairlie, also from Wits RHI, added lessons learned on adolescent recruitment, such as engaging participants at HIV testing events held during soccer games, movie nights, or other social gatherings. She recommended integrating clinical trial visits into a “one-stop shop” providing comprehensive services, such as mental health/psychosocial support, sexually transmitted infection (STI) screening, and support groups, to increase the value exchange for youth and make it as easy and appealing as possible for them to participate.

Unati Dikani
             Unati Dikani

Youth voices featured among the speakers, providing pointed and relevant direction and fresh ideas. The Youth Trials Board, for example, is piloting the development of a model of youth participation in pediatric HIV clinical trials in four sites: the UK, South Africa, Uganda, and Zimbabwe. Unati Dikani, representing YCABS in South Africa, asked probing questions about how adolescents are being involved in clinical trials, such as at what stage they are engaged and why they are engaged. She stated that youth are sometimes only involved to help problem-solve mid-way through the clinical trial, or in order to check a box on youth engagement. She encouraged participants to “stop writing a lot of things on paper. Let’s do things that will make them sing and dance – something they love.”

Afternoon breakout sessions allowed participants to engage in discussion on what the dream clinical trial would look like for adolescents. The overwhelming consensus was that clinical trials must closely and carefully assess the specific context and population of adolescents to be engaged and inform every aspect of that engagement. Adolescents are in a unique developmental stage where identity is being shaped and risky behavior is natural. Those engaging them should work within this context, helping adolescents to learn and grow.

In addition, participants agreed that how youth are engaged is critical, including the use of popular and accessible digital platforms and appropriate language. Engagement strategies and messaging should feature youth, be contextually and culturally relevant, and be visually appealing.

Participants were reminded that adolescents – and their needs – change over time, so plans should be adaptable and flexible. Youth participants were encouraged to embrace the science and challenge themselves to learn the sometimes complex language and concepts of clinical studies.

Tags:
microbicide rings, pre-exposure prophylaxis (PrEP), clinical trials, research ethics committees, ethics guidelines, legal and policy frameworks, adolescents, trial regulations, adolescent health, adolescent HIV, adolescent treatment services, 2nd International Workshop on HIV Adolescence