1 GROUPWORK (1) Community Group: Rotational brainstorming problem analysis Consultation on ethical-legal complexities in adolescent HIV vaccine & microbicide trials: Durban, South Africa 5 September 2007

2 1. What are the key issues? Community group Defined communities we are trying to build support with CABs, Government, trial site communities, provincial, between sites Inclusion of adolescent representation on CABs –Should adolescents be included in adult CABs or should youth CABs be established? Interest in trial participation –How to build with adolescents and parents

3 1. What are the key issues? Community Communication How do site staff talk to adolescents and, potentially, to parents about adolescents, about sex, HIV/AIDS, clinical research etc.? How to get adolescents and their parents talking about sex, HIV/AIDS, clinical research etc.? –Example of youth/parent exchange How do we explain the importance of adolescent participation in clinical trials?

4 1. What are the key issues? Community Resistance from faith-based and other communities from fear that adolescent involvement in trials encourages promiscuity –E.g. resistance to the new Children’s Act Denial from adults that HIV/AIDS in adolescents is even a problem

5 1. What are the key issues? Community Communication and outreach differences in urban and rural settings Traditional beliefs vs. modern –Legal age of consent perceived to be 21 and above –Traditional age of consent perceived differently, will impact on consent Perceived gender difference in adolescents reaching maturity –“Double standard” of boys/girls and sex –Could this lead to glamorization for boys to participate in trial

6 1. What are the key issues? Community Stigma against entire communities involved in adolescent clinical trials by communities not involved or informed How to help people understand the legal/ethical rationale for running adolescent trials and how to help communities express their opinions in these areas Lack of understanding of science may cause a backlash on clinical trials and actual violence at clinic –a false positive test, outcome was rumor that sponsors are giving people HIV –means more education is needed for community

7 1. What are the key issues? Community Life skills education –Adolescents may need more assistance dealing with certain situations as a result to participating in clinical trials –false positives –side effects to medication/clinic problems –social harms –Assessing risk/benefits of participation Health care workers being perceived in the wrong light by adol, portrayed as mother figure/parent, tend to parent adolescents Parents might be friends with heath care workers But some adolescents who do not have parents, this could be a benefit

8 1. What are the key issues? Community Provision of services for those adolescents who cannot participate in trials Messaging around age inclusion criteria needs to be very clear, if there are any changes could cause a back lash by the community Increased susceptibility to positions of authority, i.e. doctors, nurses, counselors Educational levels and literacy is an issue

9 1. What are the key issues? Community Teens having increased susceptibility to social harms given “teens” –(clicks, teasing, etc.) Youth need to be empowered to be confident to stand up to peer pressure Take away social harms via community support

10 1. What are the key issues? Community In microbicide trials, how to deal with issues of adherence and possible stigma as a result of being in the trial, e.g. issue of having applicators to take home, store. All of this may be much for difficult for adolescents.

11 1. What are the key issues? Legal/ Reg group additions Generally agree with most of the previous groups comments, except where expanded and/or noted below More stigma for adolescents versus adults in general re: sexual activity Cultural Traditions: Gender-based differences in age of consent from community perspective? Is there a difference between a 16 year old boy and a 16 year old girl? Reiterating support for notions of gender-based differences within the community re: sex

12 1. What are the key issues? Legal/Regulatory group additions Importance of two-way communication regarding legal/regulatory issues (explaining to community, but also community feedback into process, affecting policy change) Age of consent, why is it? How do we get community feedback into these policies? Adolescent life skills re: assessing risks and benefits of participation –Also general level of education/literacy with regard to sex, HIV, clinical trials, etc.

13 1. What are the key issues? Legal/Regulatory group additions Resistance to authority figures versus submission to authority –Clinicians as “parental” figures versus respected (or feared) “god-like” figures –Adolescents more resistant? –Adolescents more susceptible to therapeutic misconception

14 1. What are the key issues? Legal/Regulatory group additions Contraception and family planning … acceptance of using birth control among adolescents, perception among adolescents (and parents) about impact of contraception (e.g., long-term effects on fertility) Negative social harm? Is this distinct for adolescents versus women in general (e.g., parental consent and parental refusal … “Can’t get pregnant? Can’t marry you off”

15 1. What are the key issues? Legal/Regulatory group additions Media reporting on research is different for adolescents … what is the importance for adolescent involvement in trials? Negative reporting more likely to impact adolescent involvement versus adult (recruitment and enrollment, retention) More important to do advocacy with media re: adolescents Adolescents less critical of information from media sources

16 1. What are the key issues? Legal/Regulatory group additions Policymakers and other authority figures: Is special inclusion and involvement of figures involved in overseeing adolescents needed? (e.g., educators) Policymakers resistant to community demands for providing treatment for adolescents who seroconvert

17 1. What are the key issues? Legal/Regulatory group additions Prioritization of issues: 1.Traditional conceptions about adolescence 2.Stigma and social harms 3.Education about need for adolescent involvement in trials 4.Lack of targeted services for adolescents (includes prevention packages, ancillary care, treatment for sero-converters, family planning)

18 1.What are the key issues? Ethics group additions Assumption that communities will be supportive of adolescent CABs not always true – paternalistic attitude How to ensure open communication between adolescents and parents so that when trials begin there is already this dialogue. How do you do this?

19 1. What are the key issues? Ethics group additions Faith based organizations might feel less threatened if there was already open communication about sex. Messages to adolescents in trials – we should be telling them to delay sex but need them to be sexually active so that there will be some sero-conversions to show efficacy. Some microbicide trials require certain levels of sexual activity.

20 1. What are the key issues? Ethics group additions Treatment and prevention services need to be in place in communities before trials are started with adolescents Lack of perceived vulnerability of adolescents – might impact on recruitment to trials Belief that children are not having sex – on the part of communities. Adolescents might want to be seen to be sexually active among their peers (especially men).

21 1. What are the key issues? Ethics group additions Status symbol to being involved in the trial because of requirement for certain level of sexual activity. Might be opposite for young women – attract negative comment about sexual activity Some traditional gender views that women mature faster than men.

22 1. What are the key issues? Ethics group additions Staff members recruited to trials should be adolescent friendly so that adolescents want to see them, rather than having nursing staff ‘parenting’ participants. Discussed what would happen with adolescents having to go to sites where they know the adults who are conducting the trial (in the context of trials attempting to recruit staff from local communities). Education of the staff and adolescents to know that they shouldn’t be seen by staff that they know from the community.

23 1. What are the key issues? Ethics group additions Comfort for adolescent females and males coming to the same site? Would be an issue for vaccine trials more than microbicide trials. Although sites may conduct male acceptability trials in the same place.