1. Ethical considerations on HIV and Syphilis research in indigenous communities in Peru Instituto Nacional de Salud Ministerio de Salud PERÚ Centro Nacional de Salud Intercultural

2. Background 2004: HIV= 7.5% (6 out of 80) Syphilis = 6.3% (5 out of 80) 2004

3. Background At the time, the MoH had no antiretroviral treatment in the region Treatment for syphilis was provided to positive cases Preventive measures and diagnosis interventions were prioritized in the area 2005

4. What was going on in other communities? 2006

5. Study Description: A quantitative component was designed: –To learn the prevalence of HIV and Syphilis in other indigenous communities within the same ethnic group –We calculate a sample of 856 >14 years old, both males and females, from 20 communities –HIV rapid test and Syphilis RPR were performed in the field and then confirmed by WB and TTPA 2006

6. Study Description A qualitative component regarding knowledge, attitudes, and practices about HIV/AIDS and STDs In-depth interviews with key informants and group interviews with randomly selected community members 2006

7. Protocol was submitted to an IRB The IRB made some recommendations: –The protocol and informed consent must be reviewed by a sociologist and a physician, both experts in indigenous issues –The experts recommended using two informed consents, one for the community leader called “Apu” and one for the head of the household (father) 2006

8. Results Quantitative Qualitative HIV: 3/733; (0.4%, 95% CI: 0.1-1.2%) Syphilis: 13/733 (1.8%, 95% CI: 1.0- 3.0%) The information collected suggests a lack of information regarding HIV/AIDS and STDs among this population, participants expressed fears about using condoms, traditional healers were knowledgeable about sexual health and STDs. 2007

9. Ethics in the field –In every community the project was explained in Spanish and in the indigenous language –Community delegates assembly was consulted about doing the intervention or not –The consent form was presented and explained by the investigators and by trained translators 2006-2007

10. Ethics in the field 2006-2007

11. Ethics in the field A consent form was presented to the Apu for his permission by signing the format A family consent was presented to every father to ask about his family participation The family consent included an item about future sample use for other STDs tests 2006-2007

12. Ethics on the field Results: –Pre and post counseling was provided –Rapid Test results were delivered in the field to each participant, verbally and printed (coded) results were used. –Positive cases were confirmed and notified through the Ministry of Health staff individually (also verbally and printed) –We reported a summary of the findings to the local and national indigenous organizations –We reported a summary of the findings to the local and national health authorities 2006-2007

13. Ethics in the field Treatment –Syphilis: The study provided treatment for every positive case according to the MoH protocol –HIV: Confirmed cases were reported to the local MoH for follow up The MoH has been offered HAART to these persons but they found some troubles to get a good compliance 2006-2007

14. What we didn’t know is what allowed us to learn

15. Discussion 1.¿Why they refused to participate? 2.¿ What is the best way to publish the results? 3.¿The informed consent is a format or is a process?

16. Refused to participate From the more distant community only one family accepted to participate from about 50 families They argued : –“Taking my blood is taking my spirit” We did not know: –Anything about the meaning of body fluids to the community before going into the field…

17. Refused to participate When the father was absent the mother was not in a position to talk with foreign people We did not know –The possibility of disturbing a family if we agreed to include some females without their husbands’ approval

18. Publication The 2004 intervention is published The article mentioned the name of the ethnic group and its location 2007 Zavaleta C et al. Am J Trop Med Hyg 2007;76(4):703-5

19. Publication There were two responses: Immediate actions from the MoH to know the AIDS situation among this and other ethnic groups in Perú Press reports mentioning that this ethnic group had high HIV rates and MSM behavior None of the authors or reviewers called the attention to any potential harm to the ethnic group 2007

20. Publication For future studies: –Group identity is as important as individual identity at the moment of publishing results –We should discuss the best way to publish the results with the community assembly –IRB could review a version of the article before publishing 2008

21. Future use of samples We obtained consent for future use of samples, specifically for other STD’s –Assess the risk-benefit ratio of additional testing in terms of finding other highly prevalent diseases that need control measures but could be stigmatizing 2008

22. Consent Form…as a process –Were the participants fully aware of the study when they signed the informed consent? –There is still work to do 2008

23. Consent Form…as a process –When planning research involving indigenous people, it is convenient to explore the consent as a process –Before, we can involving a group of them (female and male) and discussing every phase of the research to identify the positive and the negative effects for the participants 2008

24. Thank you 2004