Celia B. Fisher Marie Ward Doty University Chair

Director Center for Ethics Education Professor Psychology Fisher@Fordham.edu

THE CENTER FOR ETHICS EDUCATION CELIA B. FISHER, PH.D., DIRECTOR

Fisher, C. B. (2010). Enhancing HIV vaccine trial consent preparedness among street drug users. Journal of Empirical Research on Human Research Ethics, 5, 65-80. Research supported by NIDA #RO1 DA015649-01A1

Why Conduct HVT with PWID? • High risk population

• Variations in course of infection via sexual transmission and injection

• Undetermined effect of extended drug use on the epidemic strains of and immunological barriers to virus

• Co-morbidities of drug abuse: poor nutritional status, local and systemic infection

Previous Research with PWIDs Meyers et al., 1994; Mills et al, 2004; Vlahov et al., 1994 • Despite childhood experiences many did not know what a

vaccine was • Confused about preventative vs. curative • HVT AIDS safe for acquisition and transmission • Mistrust Coletti et al, 2003 • Educational efforts over 18 months (22% PWID) • increased knowledge • but not already high rates of willingness to participte,

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AIMS OF STUDY • What are the HVT consent preparedness strengths and

vulnerabilities of marginalized urban street drug users?

• Can a brief lesson on the purpose and nature of HVTs increase consent preparedness and trust among members of this population?

• What are the ethically relevant misconceptions, fears, and concerns that continue to influence IDU’s attitudes toward HVT participation following exposure to the lesson?

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Recruitment • Inclusion Criteria: Illegal drug use past 30 days (other than alcohol, marijuana) Having tested negative for HIV or never tested History of IDU English proficiency

• Recruitment: shelters, harm reduction centers,

methadone mobile distribution sites

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F O R D H A M U N I V E R S I T Y Center for Ethics Education,

Director, Celia B. Fisher, Ph.D.

Demographics • 45 Male, Age 21 – 57 (M = 40.1) • 90% unemployed • 48% marginal housing

• Tested for HIV 96% • Received a vaccine 100% • Worry about getting HIV/AIDS 96% Risk Categories: 16% MSM 78% WSM 97% IDU past year 45% Shared needles past year 42% never/rarely use condoms

Participant Characteristics (N=96)

Ethnicity • 33% Black non-Hispanic • 23% Hispanic (PR) • 43% Non-Hispanic White • 1% Other Commonly used drugs • cocaine (72%) • heroin (91%) • barbituates (36%) • other opiates(25%) • crack (17%)

THE CENTER FOR ETHICS EDUCATION CELIA B. FISHER, PH.D., DIRECTOR

Procedures All participants completed demographic questions and items tapping understanding of vaccines, HIV, HVT, and research mistrust 30 participants received a brief HVT lesson These 30 were given post-lesson retest of HVT knowledge and trust items; additional questions about attitudes toward HVT and participation choices CBFisher 6-27-12

Measures HEALTH DISPARITIES (Blendon et al. 2007) “Reasons for poor quality care” • Professionals lack of training • Inability to pay • Racial/ethnic discrimination • Do not take health insurance • Services not offered • Difficulty speaking English

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OPEN-ENDED QUESTIONS What is your understanding of the term “vaccine” or “vaccination”? An HIV vaccine study is a type of research. Sometimes it is called an HIV vaccine clinical trial study. What do you think is the purpose of an HIV vaccine clinical trial research study?

VACCINE & HIV KNOWLEDGE: T-F QUESTIONS

• Vaccine knowledge: preventive versus curative nature of vaccines in general, and level of vaccine risk

• HIV knowledge: health effects of virus, needle sharing, use of condoms • HIV mistrust: HIV is man-made, a vaccine and cure exists, the health

department is working to prevent the spread • of HIV)

Adapted from Brooks et al., 2007; Coletti et al. 2003; Meyers et al., 1994.

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HVT CONSENT PREPAREDNESS: 13 True – False Questions

• Purpose of HVT (to test if vaccine works)

• Inclusion criteria (HIV negative)

• Random assignment to vaccine or placebo

• Experimental blind

• Nature of the vaccine (Does it contain the HIV virus? Can it cause transmission to others?)

• Side effects (false positives).

HIV Research Mistrust • I trust the government to make sure that vaccines they want to test are

safe before they test it on people.

• Scientists think it is more acceptable to use drug addicts as guinea pigs for HIV vaccine studies than people who are better off.

• Drug addicts can trust that researchers will be honest with them about the risks of participating in experimental vaccine studies.

• The results of experimental vaccine studies will be reported honestly if it was paid for by government.

• The results of experimental vaccine studies will be reported honestly if it was paid for by a pharmaceutical company

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Informed Choice (Marteau et al, 2001)

ATTITUDES TOWARD HVT PARTICIPATION

• good thing or bad thing, • beneficial or harmful, • important or unimportant, • Pleasant or unpleasant.

WILLINGNESS TO PARTICIPATE

1 = definitely would not participate

4 = definitely would participate

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“An informed choice is one that is based on relevant knowledge, consistent with the decision maker’s values and behaviourally implemented” O’Connor et al. 1989

Facts about HIV Vaccine Research

What is a Vaccine? • A vaccine is a drug that prevents people from

getting a disease, like hepatitis or polio.

• There is NO vaccine for HIV

HIV Vaccine Research • Researchers are testing whether new

medications can prevent HIV • These research studies are called

Experimental HIV Vaccine Studies or HIV Vaccine Clinical Trials

• For each study, researchers do not know if the vaccine works until the study is over

Researchers test whether the new vaccine works by comparing its effects to a placebo

• Half the people who agree to participate receive the experimental vaccine

• Half receive a placebo (a sugar pill or an injection that does not contain any medicine)

Randomization • Everyone who volunteers has an equal

chance of being in the experimental vaccine or placebo group.

• This is called randomization and it is like a coin toss. Neither volunteers nor researchers can choose which group people will be in.

• Neither the volunteer or the researchers know who is getting the vaccine or placebo until the study is over.

Side Effects of the Vaccine

• Side effects from the experimental vaccine are usually short-term and mild such as arm soreness, fever, headache or tiredness.

Who Can Participate?

• Because the purpose of an experimental vaccine is to prevent people from getting HIV,

• Only people who are HIV negative can participate.

• Therefore, to qualify to be in the study everyone must take an HIV test.

What Can I Expect if I Participate?

• Experimental vaccine studies usually last for 1 or 2 years and require about 6 – 20 visits.

• Most visits require participants to take a blood test and visits last anywhere from 30 minutes to 3 hours.

• Participants are paid between $50 - $150 or more a visit depending on how long the visit lasts.

How Will Researchers Know Whether the Vaccine Works?

Blood tests will tell whether people getting the vaccine build up antibodies that can fight the HIV virus

At the end of the study researchers will see whether people who received the vaccine were less likely to get HIV than those who received the placebo.

The Vaccine DOES NOT Contain the HIV Virus

• The vaccine is made from artificial material and does not contain the HIV virus. The vaccine is designed to make the body build up its own defenses against the HIV virus.

YOU CANNOT GET HIV FROM THE VACCINE

YOU CANNOT TRANSMIT HIV TO OTHERS IF YOU TAKE THE VACCINE

False Positive HIV Tests

• Since one way doctors usually diagnosis HIV is to test the body defenses to the virus, people who participate in an HIV vaccine study may test positive for HIV even though they do not have HIV

• Researchers will use special tests during the study that will provide correct test results.

Participation is Voluntary & Confidential

• Participation in these studies is always voluntary and all the facts about the study are explained to each person before they are asked if they want to participate.

• All information is given the same confidentiality protection as other medical records

Results Highlights • 50% > vaccine could help someone HIV+

• 50% > vaccine with mild side effects unsafe

• 72% accurately responded to all 4 HIV knowledge

• 50% > vaccine and a cure for HIV existed • 29% thought it was a man-made virus

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Cumulative Scores: HIV Knowledge, Vaccine Knowledge and HIV Mistrust

• No effects of gender or ethnicity (MANOVA)

• HIV mistrust & HIV knowledge (r96 = -.25, p < .05)

• HIV mistrust and health disparities (r96 = .22, p < .05).

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Pre-Post Test Knowledge Increases • Only people who do not have HIV can participate in an HIV vaccine study

40% 87% ***

• An HIV experimental vaccine will cause you to test positive for HIV even though you do not have HIV 37% 90% ***

• In an HIV vaccine clinical trial, I may be injected with the HIV virus 33% 10% *

• If I participate in an HIV vaccine trial the vaccine might make it possible for me to transmit HIV to others 43% 3% ***

• If I participate in an HIV vaccine trial I will know whether I am receiving the experimental vaccine or the placebo 63% 13% ***

• If I participate in an HIV vaccine trial the doctor will know whether I received the vaccine or the placebo 93% 27% ***

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Pre-Posttest Mistrust & Informed Choice

• No overall changes in HIV research mistrust

• Majority held positive attitudes toward participation: 81% would participate:

• Participation decision was not correlated with post-lesson HVT knowledge or trust, but

• With health disparities (r27 = .43, p < .05).

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Risks & Benefits Through Participant Lens

• Few participants endorsed items reflecting “AIDS safe” behavioral responses to HVT participation

• 83% - 90% endorsed BENEFITS (chance of protection, counseling, future knowledge)

• RISKS: 27% placebo; 10% blood tests; 63% not FDA approved

• MONETARY INCENTIVES 55% Drug users who thought the vaccine was dangerous

would not be swayed by money

77% If money was being offer drug users would not care about risks

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Implications Specific areas of consent vulnerability • recuperative value and risk of vaccines in general

• presence of the HIV virus within the vaccine

• HVT and possibility of contracting or transmitting HIV • inclusion criteria and experimental blinds

• distrust in the medical and research establishments. CBFisher 6-27-12

Implications & Future Research

• Brief lesson improves HVT knowledge….But not trust

• Non-research related health disparities research mistrust.

• High rates of participation willingness not reflected in actual enrollment

• Paradoxical nature of attitudes toward monetary incentives

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Questions/further discussion

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