Ethical considerations in handling HIV prevention research protocols - - PowerPoint PPT Presentation
Ethical considerations in handling HIV prevention research protocols Brandon Brown Director of GHREAT UC Irvine Program in Public Health Irvine, CA USA 1 Discussion Points Issues in engaging participants in HIV 1. prevention research
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Director of GHREAT UC Irvine Program in Public Health Irvine, CA USA
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All heard-Historic events
Nazi experiments-no consent
Trovan Trial-no consent
Tuskegee study-withholding information
(www.hopkinsmedicine.org)
Previous HIV vaccine studies did not work
‘you are just testing on me’
Experience-researchers taking advantage
Collect data and take away
Question of sustainability and impact
Tested here, but not available here
10-20 years for item to reach LMIC after approval
PrEP (iPrEx) tested in Peru, not there HPV vaccine
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Council for International Organizations of. Medical
“Payment in money or in kind to research subjects
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Growing sample size of HIV prevention
efficacious treatments and prevention activities
HIV testing, microbicides, PrEP, PEP, prevention with
Limits on what can be used as a control
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Gold standard for comparison
Intervention arm at one site is standard of care in
Gold standard not available
Research protocol including PrEP uptake in USA
PrEP is approved and provided for the site in USA Not available in Nigeria or part of guidelines Demonstration project here may be necessary
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What happens when you don’t meet your
Intervention deemed ineffective
Conflicts of interest
Multiple players with multiple conflicts
study team, IRBs
Site may need study to keep afloat In debt to sponsor
How are you going to pay participants
Different amounts in different places?
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Incentives often necessary to obtain study
may jeopardize voluntary participation Economic pressure Non-monetary goods/services otherwise
Medical care
Little work on incentives
No parameters/rules/guidelines exist
When, how much, what kind to give?
Dickert and Grady 1999 ‘Price of a research subject’
Ethical issues on payment remain unresolved
Dickert et al.2002 ‘Paying research subjects’
20% of groups knew what % of their studies paid
Grady et al. 2005 ‘Analysis of US Practices’
467 clinical studies with range of payment $5-$2000
Where are they?
Very difficult to collect incentive info from intl. sites
Most don’t appear on www.clinicaltrials.gov
Little work done around the world and in
No international classifications of incentives Is some consistency needed on payment in
South Africa unofficial guidelines on payment per visit 150 Rand per trial visit=15 US Dollars
COUNTRY INTERVENTION INCENTIVE(S) Tanzania TESTING HIV blood test & counseling USA EDUCATION $20 for the first interview and HIV test & for the follow-up interview Kenya & Uganda PRE-EXPOSURE DRUG(S) 500-1000 (Kenyan) or 15,000-30,000 (Ugandan) shillings per visit & tea/soda/snacks* Chili EDUCATION 2,000 Chilean peseos ($5 US) each questionnaire for travel & refreshments Liberia EDUCATION $2 US per survey, $8 US total Uganda CIRCUMCISION/TESTING HIV testing* USA EDUCATION $50 Gift card for first session & $25 cash for the follow-up survey Uganda VOCATIONAL TRAINING Vocational training with local artisans in hairdressing, catering, tailoring etc.* USA COUPLE-BASED EDUCATION Monetary compensation for baseline & each follow-up assessment. Malawi WEANING 600 MK ($4 US) for transport & 1 kilogram fortified corn-soya Tajikistan EDUCATION A total of $20 for all three surveys. Japan EDUCATION Individual counseling sessions. USA EDUCATION After completion of each session, $25 was given for any expenses incurred. Bahamas PARENTAL EDUCATION No incentives were given for participation in the intervention.* USA PRE-EXPOSURE DRUG(S) Study medication, HIV test, counseling, condoms, & management of infections. USA PEER EDUCATION Index received $10 for each RNM who enrolled & $30 for baseline visit. India TESTING/EDUCATION Refreshments. South Africa MICROBICIDE None listed. USA & Puerto Rico PARENT EDUCATION Sites were compensated $5,000 & could determine what incentives to offer. Kazakhstan COUPLE-BASED EDUCATION Goods equal to US$1, US$5, & US$7 for screening, assessment, & intervention. Armenia EDUCATION $5 for each recruit, $20 for participation, & physician/attorney services. USA FEMALE CONDOM $5 for screening, $30 for baseline, & $15 for each follow-up assessment. USA EDUCATION $20 for the baseline, $25 for the 3-month, & $30 for the 6-month follow-up. Zimbabwe PAYMENT Food, school fees & supplies, uniforms & helpers received $15 US/term. Trinidad & Tobago EDUCATION TT $500/US$83 for intervention families & controls received TT $200/US$35 Bahamas CONDOM USE Monetary compensation for answering questionnaires.* USA CONDOM PROMOTION $10 GC/baseline, $5 GC/1-month, $5 bonus, $10 GC/follow-up & $5 bonus
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Range $0 to $83 per visit
HIV study incentives usually include more
Gifts, services, food, transportation, medicine Attention for basic medical needs addressed in
Undue inducement may play a bigger role
Lack of resources Incentives may overshadow perceptions of risk
Study 1 Study 2 Study 3 Type of clinical trial Vaccine Vaccine treatment Incentives
makeup, purse, wallet
genital wart removal, condoms and lubricants, HIV testing
perfume, makeup, purse, wallet, hair dryer, lunches
removal, condoms and lubricants, STD treatment for participant and partner, free medical attention for participants, children, and partners, Pap smear, HIV testing
removal, HIV testing, anal Pap smear, syndromic treatment
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Incentives Money Gifts Health services Other Features of Index Protocol Condition under study Study population Risks Prospect of direct benefit Recruitment strategies Features of Research Setting Locale Daily Income Major Causes of disease Availability of health services
Brown 2013, IRB