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

Background• 2004:

HIV= 7.5% (6 out of 80)Syphilis = 6.3% (5 out of 80)

2004

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

What was going on in other communities?

2006

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

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

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

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

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

Ethics in the field

2006-2007

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

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

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

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

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?

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…

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

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

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

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

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

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

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

Thank you

2004