Informed Consent in a Community Based Tuberculosis Prevention Study in the Western Cape, South...

Informed Consent in a Informed Consent in a Community Based Community Based

Tuberculosis Prevention Tuberculosis Prevention Study in the Western Cape, Study in the Western Cape,

South AfricaSouth Africa

Prof Keymanthri Moodley , Prof Nulda Beyers,, Dr Sharon Kling, Ms Kathy Lawrence, Prof Landon Myer

BIOETHICS UNIT –TYGERBERG DIVISION & DESMOND TUTU TB CENTREFACULTY OF HEALTH SCIENCESUNIVERSITY OF STELLENBOSCHCopyright 2008 All rights reserved on this presentation

Zamstar TB Prevention Study

Prevalence, Prevalence, Incidence Incidence

Community Community randomisatiorandomisation for n for intervention intervention trialstrials

Khayelitsha-Cape Town, Khayelitsha-Cape Town, South AfricaSouth Africa

Fieldworkers – Fieldworkers – communities – IC – communities – IC – verbal & written, verbal & written, sputum collections sputum collections

Population of Khayelitsha – 1million

Site B 255 000

Study pop 25 000

ObjectivesObjectives

1.1. To develop an appropriate tool to measure To develop an appropriate tool to measure understanding of consent material.understanding of consent material.

2.2. To evaluate the IC process in the Zamstar To evaluate the IC process in the Zamstar TB prevalence study.TB prevalence study.

3.3. To make changes ( if necessary) to improve To make changes ( if necessary) to improve understanding of consent information.understanding of consent information.

4.4. To develop capacity of the research team in To develop capacity of the research team in obtaining IC for the continued phases of obtaining IC for the continued phases of the study.the study.

MethodologyMethodology IC document & process of TB IC document & process of TB

prevalence study discussed prevalence study discussed with Zamstar teamwith Zamstar team

Test of understanding: Quality Test of understanding: Quality of IC (QuIC) questionnaire of IC (QuIC) questionnaire based on Common Rule based on Common Rule

TB prevalence IC doc TB prevalence IC doc compared with Common Rule compared with Common Rule req for ICreq for IC

Elements of IC – Common Elements of IC – Common RuleRule

1.1. Explanation of research and its purposeExplanation of research and its purpose

2.2. RisksRisks

3.3. BenefitsBenefits

4.4. Alternative treatmentsAlternative treatments

5.5. ConfidentialityConfidentiality

6.6. Injury due to participationInjury due to participation

7.7. Contact personnelContact personnel

8.8. VoluntarinessVoluntariness

MethodologyMethodology

Semi-structured questionnaire Semi-structured questionnaire developed to test developed to test understandingunderstanding

15 field workers trained15 field workers trained Written ICWritten IC XhosaXhosa Khayelitsha – home basedKhayelitsha – home based

Results – Results – Informed Informed

Consent StudyConsent Study

445/515 responses = 86%445/515 responses = 86%

Gender: Female = 69%Gender: Female = 69% Mean age 36 years (Range 14-Mean age 36 years (Range 14-81)81) 98.8% Xhosa speakers – all 98.8% Xhosa speakers – all could read the newspaper in could read the newspaper in Xhosa &/or EnglishXhosa &/or English

ResultsResults Original IC form - TB Original IC form - TB Prevalence Study: Flesch Prevalence Study: Flesch Reading Level = grade 9.Reading Level = grade 9.

< Grade 9 : 180/445 (40%) < Grade 9 : 180/445 (40%)

16/445 (3.6%) – no schooling16/445 (3.6%) – no schooling



Trial Specific Questions:Trial Specific Questions:

RESEARCH?RESEARCH?

391/445 (87,9%) understood 391/445 (87,9%) understood the reason for the studythe reason for the study



CHOICE/VOLUNTARINESSCHOICE/VOLUNTARINESS

435/445 (97,8 %) - Yes435/445 (97,8 %) - Yes 9/445 (2,0%) - No9/445 (2,0%) - No 1/445 (0,2%) - Unsure1/445 (0,2%) - Unsure



IC PROCESSIC PROCESS

Verbal explanation – 95,5% Verbal explanation – 95,5%

Clarity of explanation – 94%Clarity of explanation – 94%



IC FORMIC FORM

95,7% received a form95,7% received a form



IC FORMIC FORM

Understandable ? :Understandable ? :

Yes 71,5%Yes 71,5%

No 19,3%No 19,3%

Missing data 9,2%Missing data 9,2%



IC FORM – NOT UNDERSTANDABLE - IC FORM – NOT UNDERSTANDABLE - 19,3%19,3%

Printing too smallPrinting too small Difficult WordsDifficult Words Sentences too longSentences too long Form too longForm too long Too much informationToo much information

Other – did not read formOther – did not read form



BENEFITS BENEFITS 2/3 yes2/3 yes Did not have to go to clinicDid not have to go to clinic Gained Gained knowledge/informationknowledge/information Are sure they don’t have TBAre sure they don’t have TB Family benefitFamily benefit



BENEFITS BENEFITS

1/3 NO 1/3 NO

““because they did not bring because they did not bring my results back”my results back”



RISKS RISKS

YES – 19/445 (4,3%)YES – 19/445 (4,3%)

1.1. Trust & suspicionTrust & suspicion

2.2. StigmaStigma

3.3. Contamination of sputaContamination of sputa



CONFIDENTIALITY CONFIDENTIALITY

Most people (65,1%) Most people (65,1%) had a median of 2 had a median of 2 other family members other family members present when present when fieldworkers visited.fieldworkers visited.



CONFIDENTIALITY CONFIDENTIALITY

Most (73,3%) did not Most (73,3%) did not mind having others mind having others around during visits & around during visits & proceduresprocedures

Discussion – IC Discussion – IC StudyStudy

Understanding of TB Understanding of TB Prevalence study – goodPrevalence study – good

Form –difficulties – 20%Form –difficulties – 20% Major problem – lack of Major problem – lack of

return of results to return of results to participants – 1/3participants – 1/3

Confidentiality ?????Confidentiality ?????

RecommendationsRecommendations

IC forms – grade 6 level + styleIC forms – grade 6 level + style Return of results + or – or clarify Return of results + or – or clarify

in IC processin IC process Feedback data to field workers in Feedback data to field workers in

all communities – SA & Zambia – all communities – SA & Zambia – for future trainingfor future training

ConclusionConclusion

Study objectives achievedStudy objectives achieved

IC process in TB prevalence study IC process in TB prevalence study ethically acceptableethically acceptable

Communities benefit from home Communities benefit from home based researchbased research

Return of results importantReturn of results important

Informed Consent in a Community Based Tuberculosis Prevention Study in the Western Cape, South...

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