# Presentation: 233020

## Ethical dimensions in HIV testing for surveillance

- Theresa Diaz
- Surveillance Team
- Surveillance and Infrastructure Development Branch
- Global AIDS Program

**Improving Laboratory Support for HIV Surveillance, October 19-21, 2004**

## Presentation

- Review HIV surveillance systems that require laboratory support
- General ethical issues related to these surveillance systems
- Ethical issues unique to laboratory component of these surveillance systems

## HIV/AIDS Surveillance requiring laboratory support

- Sentinel HIV surveillance in ANC clinics
- Left-over blood taken for routine health care
- Unlinked anonymous testing
- No test results returned, women unaware of testing
- Sentinel HIV surveillance in high risk groups
- Persons consented for HIV testing
- Sometimes those tests not returned
- Referral for free VCT when test results not returned
- Population-based HIV surveys
- Household surveys
- Persons consented for HIV testing
- Usually those tests not returned
- Usually referral for free VCT

## HIV/AIDS Surveillance requiring laboratory support

- ARV drug resistance surveillance
- Propose to use specimens already collected for surveillance
- Persons unaware of testing or findings
- HIV surveillance for recent infections
- Propose to use specimens already collected for surveillance
- Persons unaware of testing or findings

## Strengths of UAT

- Minimizes self-selection bias for HIV testing – increases data validity
- Can be carried out where counseling and care/treatment services are not (easily) available
- UAT does not preclude testing by informed consent – e.g. ante-natal clinics offering PMTCT and function as surveillance sites

## General ethical issues: HIV sentinel surveillance in ANC clinics

- Women are not consented for testing
- Women are not provided HIV test results
- 1994 AZT found effective in preventing transmission of HIV from mother to infant; missed opportunity to prevent HIV transmission

## History of UAT HIV surveys in the United States 

- CDC family of surveys – (1987 – 1999)
- UAT HIV testing in STI patients, drug treatment centers, prisoners, military, job corps, hospitals, university students, child-bearing women
- Above surveys, except for child-bearing women survey, ended for reasons concerning scientific value
- National survey of child-bearing women
- Newborns were tested for HIV (heel prick) – used anonymous approach, women were not informed of HIV test result
- 1994 AZT found to prevent transmission
- In the face of inquiries by members of Congress and the media the survey was stopped

## Background ethical issues UAT for HIV

- In 1998 an ethical consultation on UAT for HIV surveillance was held at CDC
- Recommendation that HIV test result did not have to be provided to participants if:
- No extra blood drawn for HIV test
- Community was aware of survey
- True anonymity – identifiers irreversibly stripped
- Local access to counseling and testing should be available
- Data used to benefit community
- UAT testing HIV surveillance is endorsed in resource constrained countries:
- WHO/AFRO Technical network emphasizes that questions related to ethics of UAT are misdirected, as the major ethical problem is lack of services.

## General ethical issues: Population based surveys, high risk group HIV surveillance

- Although persons are aware they will be HIV tested those test results not often returned
- Returning test results
- Can confidentiality be maintained?
- Potential harm – violence against partner
- Potential benefit – knowledge of HIV status
- Provision of referral for free VCT
- Is it accessible?
- Will persons go get tested?

## General ethical issues: ARV drug resistance surveillance, recent infections

- Added on to existing surveillance systems so persons unaware of results
- ARV drug resistance
- Is there benefit to individual patient if physician aware of findings?
- Is community awareness sufficient?
- Recent infections
- What benefit, if any, of individual knowledge of result?
- Scientifically individual results may not be valid (meant for population interpretation)

## Ethical issues related to laboratory component of HIV surveillance: Potential problems

- Poor quality HIV testing
- Inaccurately recording results
- Mislabeling specimens
- Not following de-linking procedures for anonymous testing
- Not maintaining confidentiality for linked testing

## Ethical issues related to laboratory component of HIV surveillance: Potential consequences

- Over or underestimation of magnitude
- Public health actions that would have otherwise not been taken
- Notifying persons of wrong test results
- Releasing the identity of HIV infected persons (resulting in stigma etc)

## Summary

- Often HIV surveillance systems do not return test results, thus encouraging persons to get HIV tested is important
- Anonymity or confidentiality must be maintained by laboratory personnel
- Poor quality HIV testing for surveillance poises multiple ethical issues

## Steps forward

- Make sure laboratory personnel are aware of general ethical issues related to surveillance systems
- Provide adequate training for HIV testing including recording results, labeling specimens, de-linking, and maintaining confidentiality
- Provide ongoing quality assurance
- Community-based consent