GCM CONSULT CONSULTATION ON ETHICAL -LEGAL CONCERNS IN HIV VACCINE AND MICROBICIDE TRIALS UMHLANGA POTEA HOTEL, SOU

1. GCM CONSULT CONSULTATION ON ETHICAL -LEGAL CONCERNS IN HIV VACCINE AND MICROBICIDE TRIALS UMHLANGA POTEA HOTEL, SOUTH AFRICA 5/6 SEPT. 2007 ADOLESCENTS IN TRIALS: AN ADVOCACY PERSPECTIVE KOLAWOLE OYEDEJI PhD NIGERIA HIV VACCINE AND MICROBICIDE ADVOCACY GROUP(NHVMAG) SARETI FELLOW 5TH SEPT. 2007.

2. What is advocacy? • Advocacy can be defined as a systematic and collective effort to influence the political environment, policy and program/research decisions, legislations, public perceptions of social norms, funding decisions and community support for and involvement in a particular issue , through a set of planned actions that are undertaking by a group of committed individuals or collaborating organizations1 1.UNFPA. Advocacy policy guidelines Draft, 2 July 2002

3. Attributes of advocacy • Advocacy recognizes that one cannot simply impose views and standards on a national government or community without respect to their culture, religious values and traditions • Advocates helps to shape or influence the ideas and decisions that influence policy and individual/group practices • Advocacy creates the political will and momentum necessary to move the process of vaccine and microbicide development and trial forward

4. Attributes • Advocacy sustains the needed pressure on the government to ensure that structures are put in place that would facilitate the prompt and wide access of people to the developed and successful microbicide and vaccine candidate. • Advocacy ensures accountability on the part of the science process to ensure that the public interest and that of the trial participants are protected • Advocacy help to build capacity at grassroots and within the wider NGO community so that we all understand the science, ethics and issues of microbicide and vaccine development and trial.

5. Functions of advocacy • Promote or reinforces changes in social norms, policies and program and legal frameworks • Advocacy removes environmental constraints and create a supportive politico-administrative, organizational and socio cultural environment for effective research study and program1 • Advocacy helps to address ethical-legal, religious and socio cultural barriers for research through dialogue, debate, and networking among the concerned groups • Advocacy as a “watch-dog”-facilitates research literacy within the community as well as researcher –community interaction.

6. Types of advocacy • Faith based advocacy- involving religious leaders and groups • Community based advocacy-parents and other various gatekeepers such as the media • Peer education advocacy-organizing workshops where peers will be speaking and there will be room to ask questions • Policy makers advocacy- for legislative support and conducive politico-administrative environment

7. Why adolescents? in HIV vaccine trial. Who is an adolescent? • Loveland Prescott ;“Adolescent is not just an age , it is a mindset" It is a hard to define time or period somewhere between being a child and an adult. It is the stage of physical, mental and social transition when people shape themselves and are shaped by the world around them. • Therefore agreed age for adolescent has a lot of disparity ranging from 12-15or16(US FDA)2,12-16or18(ICH, 2000)3,others 12-18yrs . 2.http://www.fda.gov. 3.http://www.emea.eu.int/pdfs

8. Reasons • Just a small number of adolescents can identify at least two ways to avoid getting HIV infection or other STI infections • Adolescents are poorly informed about sexuality, prevention of STI and the consequences of unprotected sex or drug use and abuse. • The perceptions and opinions of many policy makers, public opinion leaders and gatekeepers are sometime not supportive to sexual issues among adolescents-they think adolescent will be more promiscuous if they learn about sexuality and prevention of HIV/AIDS4 • Open discussions about adolescent is either non existent, limited or conservative. 4.http://www.unaids.org

9. Reasons • Adolescents are severely affected by the HIV epidemic-Globally, 50%of new HIV infections are in the 15-24 age group(UNAIDS,2006)4 • Consideration must be given to fair subject selection • Vaccine responses may differ in different age groups • Adolescence is the right time for vaccination against sexually transmitted infections (STI). • Advocacy on sponsor’s commitment- treatment for the participants that may become infected with HIV during the vaccine trial.

10. 4-operational strategies of advocacy • Public communication and enlightenment: -Through workshops and seminars, communication (press articles, TV/radio appearances, publications etc), advocacy visits, meetings, exhibitions, public speaking engagements -Emphasis on the target groups-direct campaigns towards parent, peer educators ,civic leaders etc, -faith based advocacy, community based advocacy , media campaigns –through open dialogue with media and religious leaders -Encourage the mass media to promote positive messages http://www.nhvmag.org

11. Inform the issue, debate and share accurate information; -Publicize the magnitude of adolescent HIV epidemic -Raise awareness of the need for adolescent HIV vaccine trial among parents, religious leaders, media representatives, policy makers and other community members -Explain the unknown risks that may result from the vaccine product itself -The potential for testing false positive using standard HIV test -Stress from repeated HIV testing, potentials for stigma or discrimination should participation be disclosed and how to overcome this -Anxiety and discomfort from blood draws and intrusive questions relating to risk behavior.

12. 4-operational strategies: • Policy advocacy: -involvement of key government functionaries and legal luminaries in the debate -policy formulations and clarifications of certain areas of the constitution through consultative meetings -Harmonizing key ethical guidelines on standards for adolescents participation in research • Capacity building and empowerment : -community research literacy efforts -Researchers compliance with GCP through effective monitoring -building consensus amongst key gate keepers such as RECs on the kinds of protocols that could be considered ethically and legally sound with adolescent participants5 • National and international networking: -Engage in networking activities-between policymakers, media professionals, counselors, peer educators, parents , religious leaders -Gain support from politicians policy makers, sometimes careful use of a public opinion poll may be useful. -Ensuring protection of the national interest in attracting trials or support from the international bodies. 5.Strode et.al.,(2005) SAJS 101: 224-228

13. Challenges • Vaccine and microbicide trials involve the recruitment of healthy volunteers who may become infected in the course of the trial. This require a great advocacy to convince the community of the relevance of the trial. • Difficulty in adolescent enrollment-age limit for informed consent e.g. adolescents who may be reluctant to involve their parents or guardians in trials that monitor sexual behavior5 • Great opposition from various gatekeepers such as parents, religious leaders, media, and other stakeholders-Advocacy plan in advance and prepare proactively to manage oppositions. • Level of sponsor’s commitments-provision of post trial care and for how long?

14. Lessons from NHVMAG • The composition of NHVMAG enabled confidence building between scientists, advocates and regulators to achieve effective partnership. • This facilitated the maintenance of a delicate balance between activism, consultation and capacity building. • NHVMAG composition: A coalition of partners: • Advocates, NGOs • Media professionals • Scientists/researchers • People living with HIV • Sexual diversity groups (MSM etc) • Government partners • A rainbow of expertise: • Advocates, journalists, PLWH • Scientists, researchers • Lawyers, ethicists • Policy makers

15. Our objectives • Promote public understanding and support for the participation of Nigeria in international HIV vaccine and microbicide development efforts • Promote early involvement of Nigeria in microbicide and vaccine R & D efforts relevant to her HIV/AIDS control plans • Mobilize active participation of Nigeria and her nationals in vaccine and microbicide research and development activities • Ensure access by Nigerians to a safe, effective and affordable HIV vaccine and microbicide when developed • Collaborate with other institutions and organizations locally and internationally for the rapid development of a safe and effective HIV vaccine and microbicide for all humanity THROUGH EFFECTIVE PARTNERSHIP http://www.nhvmag.org

16. NHVMAG MISSION To halt the spread of HIV and AIDS in Nigeria by ensuring the availability of safe, effective, acceptable and affordable HIV vaccine and microbicide products for all Nigerians as soon as they are developed

17. LANDMARKS • In 2002-2004, NHVMAG collaborated with the Nigerian government in development of the National HIV Vaccine Plan. NHVMAG designated as advocacy/public communication partners for the Plan • In 2004, NHVMAG invited by Nigeria’s health minister to facilitate development of a national microbicide development plan for Nigeria • NHVMAG, in collaboration with stakeholders and the adhoc National Ethics Board, developed “Guidelines for Standard of Care for New HIV Prevention Technologies in Nigeria” (January 2006). • NHVMAG successfully set up a monitoring team for community monitoring of NPT studies in Nigeria (2006) • Publications: • “Situation analysis of New Prevention Technologies in Nigeria” (2004) • “Frequently asked questions on vaccines and microbicide” (2004) • Guidelines for standard of care for NPT research in Nigeria (2006) • Fact sheets on vaccines and microbicide • Training manuals and self training CDs on community mobilization for NPT and the ethics of NPT research and development http://www.nhvmag.org

18. Thank you for listening