Adolescents In HIV Vaccine Trials Research Articles

Feasibility and acceptability of conducting HIV vaccine trials in adolescents in South Africa: Going beyond willingness to participate towards implementation.

HIV/AIDS remains a leading cause of death in adolescents (aged 15 - 25 years), and in sub-Saharan Africa HIV-related deaths continue to rise in this age group despite a decline in both adult and paediatric populations. This is attributable in part to high adolescent infection rates and supports the urgent need for more efficacious prevention strategies. In particular, an even partially effective HIV vaccine, given prior to sexual debut, is predicted to significantly curb adolescent infection rates. While adolescents have indicated willingness to participate in HIV vaccine trials, there are concerns around safety, uptake, adherence, and ethical and logistic issues. To initiate a national, multisite project with the aim of identifying obstacles to conducting adolescent HIV vaccine trials in South Africa (SA). A simulated HIV vaccine trial was conducted in adolescents aged 12 - 17 years across five SA research sites, using the already licensed Merck human papillomavirus vaccine Gardasil as a proxy for an HIV vaccine. Adolescents were recruited at community venues and, following a vaccine discussion group, invited to participate in the trial. Consent for trial enrolment was obtained from a parent or legal guardian, and participants aged 16 - 17 years were eligible only if sexually active. Typical vaccine trial procedures were applied during the five study visits, including the administration of vaccination injections at study visits 2, 3 and 4. The median age of participants was 14 years (interquartile range 13 - 15), with 81% between the ages of 12 and 15 years at enrolment. Overall, 98% of screened participants opted to receive the vaccine, 588 participants enrolled, and 524 (89%) attended the final visit. This trial showed that adolescents can be recruited, enrolled and retained in clinical prevention trials with parental support. While promising, these results were tempered by the coupling of sexual-risk eligibility criteria and the requirement for parental/guardian consent, which was probably a barrier to the enrolment of high-risk older adolescents. Further debate around appropriate consent approaches for such adolescents in HIV prevention studies is required.

Feasibility and acceptability of conducting HIV vaccine trials in adolescents in South Africa: Going beyond willingness to participate towards implementation

Background. HIV/AIDS remains a leading cause of death in adolescents (aged 15 - 25 years), and in sub-Saharan Africa HIV-related deaths continue to rise in this age group despite a decline in both adult and paediatric populations. This is attributable in part to high adolescent infection rates and supports the urgent need for more efficacious prevention strategies. In particular, an even partially effective HIV vaccine, given prior to sexual debut, is predicted to significantly curb adolescent infection rates. While adolescents have indicated willingness to participate in HIV vaccine trials, there are concerns around safety, uptake, adherence, and ethical and logistic issues. Objectives. To initiate a national, multisite project with the aim of identifying obstacles to conducting adolescent HIV vaccine trials in South Africa (SA). Method. A simulated HIV vaccine trial was conducted in adolescents aged 12 - 17 years across five SA research sites, using the already licensed Merck human papillomavirus vaccine Gardasil as a proxy for an HIV vaccine. Adolescents were recruited at community venues and, following a vaccine discussion group, invited to participate in the trial. Consent for trial enrolment was obtained from a parent or legal guardian, and participants aged 16 - 17 years were eligible only if sexually active. Typical vaccine trial procedures were applied during the five study visits, including the administration of vaccination injections at study visits 2, 3 and 4. Results. The median age of participants was 14 years (interquartile range 13 - 15), with 81% between the ages of 12 and 15 years at enrolment. Overall, 98% of screened participants opted to receive the vaccine, 588 participants enrolled, and 524 (89%) attended the final visit. Conclusions. This trial showed that adolescents can be recruited, enrolled and retained in clinical prevention trials with parental support. While promising, these results were tempered by the coupling of sexual-risk eligibility criteria and the requirement for parental/guardian consent, which was probably a barrier to the enrolment of high-risk older adolescents. Further debate around appropriate consent approaches for such adolescents in HIV prevention studies is required.

Adolescent decision making about participation in a hypothetical HIV vaccine trial

PurposeThe purpose of this study was to examine the process of adolescent decision-making about participation in an HIV vaccine clinical trial, comparing it to adult models of informed consent with attention to developmental differences. MethodsAs part of a larger study of preventive misconception in adolescent HIV vaccine trials, we interviewed 33 male and female 16–19-year-olds who have sex with men. Participants underwent a simulated HIV vaccine trial consent process, and then completed a semistructured interview about their decision making process when deciding whether or not to enroll in and HIV vaccine trial. An ethnographic content analysis approach was utilized. ResultsTwelve concepts related to adolescents’ decision-making about participation in an HIV vaccine trial were identified and mapped onto Appelbaum and Grisso's four components of decision making capacity including understanding of vaccines and how they work, the purpose of the study, trial procedures, and perceived trial risks and benefits, an appreciation of their own situation, the discussion and weighing of risks and benefits, discussing the need to consult with others about participation, motivations for participation, and their choice to participate. ConclusionThe results of this study suggest that most adolescents at high risk for HIV demonstrate the key abilities needed to make meaningful decisions about HIV vaccine clinical trial participation.

Preventive misconception and adolescents’ knowledge about HIV vaccine trials

ObjectiveAdolescents have had very limited access to research on biomedical prevention interventions despite high rates of HIV acquisition. One concern is that adolescents are a vulnerable population, and trials carry...

Inclusion of South African adolescents in HIV vaccine trials.

South Africa has more people living with HIV than any other nation. The HIV epidemic in South Africa is being driven by new infections among adolescents. Inclusion of adolescents in HIV vaccine trials is essential for successful vaccine development, however, recruitment and retention of at-risk South African adolescents into these trials poses a number of legal, ethical and operational challenges. This article discusses the South African ethico-legal context in which future adolescent HIV vaccine trials would be conducted followed by a review of available data regarding strategies for recruitment into these trials and retention of trial participants.

P2-S1.06 Adolescents' willingness to participate in HIV vaccine clinical trial preparedness in Nigeria

BackgroundRoutine vaccination of recommended vaccines in adolescents/children from 1999 would prevent >14 million disease cases and 33 000 deaths over the lifetime of each birth cohort. Data from National sero-prevalence...

Reopening Old Divisions

Reopening Old Divisions

Why We Don't Need a Relative Risk Standard for Adolescent HIV Vaccine Trials in South Africa

Click to increase image sizeClick to decrease image size Acknowledgments HAVEG's adolescent work has been funded by the South African AIDS Vaccine Initiative (SAAVI) and the European and Developing Countries Clinical Trials Partnership (EDCTP). The views represented here are not necessarily the views of SAAVI or EDCTP, nor the National Health Research Ethics Council (NHREC) of which the author is a member.

A qualitative assessment of perspectives on the inclusion of adolescents in HIV vaccine trials in South Africa

Adolescents are at high risk for HIV acquisition, and thus need to be included in HIV vaccine trials. In preparation for inclusion of adolescents in HIV vaccine trials in an urban community in Cape Town with a high antenatal HIV prevalence, the study assessed the attitudes towards the inclusion of adolescents in HIV vaccine trials. A total of 18 focus group discussions were conducted using a semistructured interview guide. The participants (n = 200) were adolescents, young adults, parents and other key informants. Participants from all groups welcomed the inclusion of adolescents in HIV vaccine trials due to their high-risk status. There were, however, concerns about sexual disinhibition, fear of side-effects, fear of HIV testing and disclosure of HIV status, mistrust of nurses and clinics. The study highlighted a number of ethical and social issues that need to be addressed before the trials.

Community perspectives on the ethical issues surrounding adolescent HIV vaccine trials in South Africa

Adolescents globally are at high risk for HIV acquisition and are the targets of HIV prevention interventions such as HIV vaccines. In order to understand stakeholders’ attitudes towards the ethical issues of adolescent involvement in HIV vaccine trials, we conducted focus group discussions with key members of a semi-urban, informal Cape Town community with high HIV prevalence in which HIV vaccine trials are taking place. Themes were identified from focus group transcripts by four researchers, and included necessity of guardian consent, age of independent consent, and confidentiality of in-trial medical results. In general, ethical adolescent HIV vaccine trials will be feasible in this community.

Knowledge and attitudes towards HIV vaccines among Soweto adolescents

BackgroundTo explore adolescent HIV risk perception, HIV vaccine knowledge, willingness to participate in future HIV vaccine clinical trials, and the factors that influence willingness to participate among high school students in Soweto, South Africa, we recruited school-going youth through randomly selected local high schools. All pupils within the selected schools from whom parental consent and child assent could be obtained were eligible for participation. A self-administered, facilitated questionnaire was completed by all participants.FindingsPerception of adolescent HIV risk was high. Some misconceptions regarding vaccine research were common, particularly regarding placebo and potential eligibility criteria for prophylactic vaccine trials. Of 240 responses to the willingness item, 84 (35%) indicated they were "probably willing" and 126 (52.5%) that they were "definitely willing to participate". There were no significant differences in willingness by gender, age, school grade, or institution. Factors that were rated as "very important" in determining willingness included receiving current information about HIV research [n = 201 (88.9%)], doing something to honour people who have HIV or have died of AIDS [n = 168 (70.9%)], getting free counselling and testing [n = 167 (70.5)], that participants may receive some protection against HIV infection from the vaccine [n = 160 (70.2%)], and improving motivation to avoid risky behaviour [n = 134 (59%)].ConclusionSoweto school-going youth report high degrees of willingness to participate in HIV vaccine trials. This may be related to the high levels of adolescent HIV risk perception. Whether hypothetical willingness translates to participation will await data from adolescent HIV vaccine trials.

Executive summary and recommendations from WHO/UNAIDS and AAVP consultation on: ‘The inclusion of adolescents in HIV vaccine trials’, 16–18 March 2006 in Gaborone, Botswana

This report summarizes the discussions and recommendations from a consultation held in Gaborone, Botswana (16-19 March 2006), organized by the joint World Health Organization (WHO)/United Nations Programme on HIV/AIDS (UNAIDS) HIV Vaccine Initiative (HVI) and the African AIDS Vaccine Programme (AAVP). The consultation considered key challenges and strategies in enrolling adolescents into HIV vaccine clinical trials, relevant to developing countries, in particular in eastern and southern Africa. Approaches were identified that might address and resolve country-specific challenges related to scientific, legal, ethical, regulatory and community aspects of the involvement of adolescents in HIV vaccine trials. This executive summary is formulated for a broader dissemination of the outcomes of the meeting to the general clinical, scientific and regulatory community involved in the review, approval and monitoring of clinical trials and potential licensing of HIV vaccine candidates. Four major topics were discussed and recommendations developed with regard to: (i) criteria for products selection and clinical trial design; (ii) ethical and legal issues; (iii) community acceptance and participation; and (iv) regulatory considerations. The recommendations of this meeting were further discussed and endorsed by the WHO/UNAIDS HIV Vaccine Advisory Committee.

Enrolling adolescents in HIV vaccine trials: reflections on legal complexities from South Africa

BackgroundSouth Africa is likely to be the first country in the world to host an adolescent HIV vaccine trial. Adolescents may be enrolled in late 2007. In the development and review of adolescent HIV vaccine trial protocols there are many complexities to consider, and much work to be done if these important trials are to become a reality.DiscussionThis article sets out essential requirements for the lawful conduct of adolescent research in South Africa including compliance with consent requirements, child protection laws, and processes for the ethical and regulatory approval of research.SummaryThis article outlines likely complexities for researchers and research ethics committees, including determining that trial interventions meet current risk standards for child research. Explicit recommendations are made for role-players in other jurisdictions who may also be planning such trials. This article concludes with concrete steps for implementing these important trials in South Africa and other jurisdictions, including planning for consent processes; delineating privacy rights; compiling information necessary for ethics committees to assess risks to child participants; training trial site staff to recognize when disclosures trig mandatory reporting response; networking among relevant ethics commitees; and lobbying the National Regulatory Authority for guidance.

Adolescents and HIV Vaccine Trials

Adolescents worldwide are at high risk for HIV, which makes them essential candidates for HIV vaccine trials. However, enrollment of adolescents into such trials has implications for trial sites. Adolescents are considered vulnerable subjects and require proxy consent in addition to their assent, which brings issues of confidentiality and access into play. HIV vaccine trial sites often do not have experience recruiting and retaining adolescents, and creating youth-friendly environments that are comfortable for guardians. This includes development of education materials that target both youth and their parents. Because these trials are of minimal individual benefit, sites will likely need to provide service in the form of health care and supportive structures to adolescents. Finally, a number of trial design options exist, and researchers will need to balance the risks and benefits of each, as for all issues surrounding the involvement of adolescents in HIV vaccine trials.

Can we involve adolescents in HIV vaccine trials - can we afford not to?

No abstract available.

Need for more women, adolescents in HIV vaccine trials

Need for more women, adolescents in HIV vaccine trials