zamstar - the zambian south african tb and aids reduction trial zambart, unza desmond tutu tb...
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ZAMSTAR - the Zambian South African TB and AIDS
Reduction trial
ZAMBART, UNZA
Desmond Tutu TB Centre, Univ Stellenbosch
CBOH, Zambia
LDHMT, Zambia
Prov TB Programme, Western Cape
City of Cape Town, SA
LSHTM, UK
Objective
• To evaluate novel public health strategies to reduce the prevalence of tuberculosis in communities where the existing international tuberculosis control strategy is insufficient due to the interaction between the tuberculosis and HIV epidemics.
2002
0
50000
100000
150000
200000
250000
1996 1997 1998 1999 2000 2001 2002
All TB cases Pulmonary TB (PTB) New smear positive cases
Number of TB cases in SA, 1996-2002
No country with a severe HIV epidemic is controlling TB
R2 = 0.7547
0
100
200
300
400
500
600
0 10 20 30
Adult HIV seroprevalence (%) UNAIDS estimates
TB
in
cid
en
ce
(/1
00
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0/y
r) G
TB
es
tim
ate
s
HIV-TB
• Urbanisation of TB
• Health system burden – supply and demand
• Stigma
Other relevant background studies
• Obstacles to diagnosis include– cost (Needham et al. Lancet 1996, IJTLD 1997)
– perception of services (PGF et al. IJTLD 2002)
– community beliefs (Beyers et al. SAMJ 1997)
• High levels of ongoing transmission – within households (Beyers et al. Thorax 1999)
– and within the community (Beyers et al. Lancet 2000, IJTLD 2003)
Improving case detection
Enhanced Case-Finding– Strengthen laboratories– Improve access to laboratories– Engage communities– Empower communities
Active Case-Finding– Screen communities
TB and HIV - converging philosophies
TB Control
DOTS
Need for care
HIV ControlIECCondomsMultisectoral
STIs
Communitycontribution
Medical approaches
Hospital Clinic Community
Decentralisation
Methods – Study SettingZAMSTAR
Methods – Study SettingZambia Sites:
TB 300-1500/100,000/year
HIV 15-30%
Cape Town Sites:
TB 1000-1100/100,000/year
HIV 12-25%
Methods – Study Design
4-arm Community Randomised Trial (Factorial design)
• Clinic TB and HIV activities
• Enhanced Tuberculosis Case Finding (ECF)
• Household intervention (HH)
• Enhanced case finding + Household intervention (ECF+HH)
Methods – Study Design
• All communities will have clinic TB and HIV activities– DOTS strengthening– TB/HIV Combined Activities – Reporting to Provincial and National TB Control
• All communities will have enhanced M&E using standard indicators and targets for TB and HIV.
Methods – InterventionECF
Educational theatreSchool Intervention Fast track sputum point
1. Develop IEC
2. Establish ECF register
3. QA
1. Develop school TB/HIV curriculum
2. Three times per year intervention in all schools in intervention area
3. Establish ECF register
4. Sputum collection
1. Develop IEC/Outreach activities
2. Weekly Outreach activities
3. Establish ECF register
4. Sputum collection
Methods – InterventionHousehold HIV/TB Intervention
1. All TB patients recruited
2. Asked for consent and to ask household for consent
1. Household members documented and consent
2. TB and HIV group education and counselling
3. All HH members screened for TB
4. HIV+ and children<5 given IPT
5. Adherence support using family network
Visits month 0,1,2,6/8
Monitoring (All):
TB outcome
Additional cases of TB
Uptake and adherence IPT
Methods - Endpoints
• Primary endpoints– 5000 adults per community used to determine the
prevalence of culture +ve TB after 3 years of the intervention
– Sputum will be taken from every adult – Sputa will be transported to TB labs for culture
Methods - Endpoints• Secondary endpoints
– TST prevalence• TST prevalence measured again and compared to
baseline– HIV Incidence in households
• Blood collected at baseline, year 2 and year 3• HIV measured by ELISA
– TB, HIV TC & IPT uptake and outcomes• Standardised, adapted registers used in all sites to
compare uptake, adherence and TB outcomes
Ethical Issues
• Consent and ethical procedures– Ethical approval from University of Zambia,
Stellenbosch University and LSHTM.– Individual written consent for household studies,
prevalence study and TST surveys• Community involvement and support
– Community advisory boards consisting of local leaders and representatives established in all communities.
Methods – Logistics
• Year 1– recruited and trained teams: epidemiology and social
science– Established CABs in all sites– Mapped all study areas geographically and socially– Identified primary schools in evaluation area– TST survey on 6-7 year olds– Prevalence surveys in 2 neighboring areas– Collated all data from TB and HIV programmes from study
areas
ZamstarSouth Africa study sites
Tuberculin Skin Test (TST) Surveys
Methods • Training
• Standardisation
SA and Zam
Methods • Sampling
– All grade 1 and 2 children (sometimes grade 3)
– Schools closest to TB Treatment Centre
• Preparation of Schools
Challenges • Fears, Satanism
• Absenteeism
• Line-up
Line-up
Line-up
ConsentForms
Preparation of syringes
BCG
Inject
Fear
???
NoAssent
Methods
• Data collection– Name– Address (challenge)– BCG– Mantoux size
Methods
– Letter home with children– Negative Mantoux – no action– Positive Mantoux – refer to clinic– Challenge – keep track of children to
measure incidence of infection for secondary outcome
Results to date
• Consent rate low to medium
• All sites completed
• 26 508 consent forms handed out
• 17 907 Mantouxs injected
• 16 487 Mantouxs read
Results - distribution
Results to date
• Mantoux 15 mm and bigger:– Variation 8-20%
• Issues– Rabies– Negative/positive– Abscess– Strategies to follow up children
Benefits
• Relationship with clinics• Relationship with schools• Childhood TB Cases diagnosed • Social mobilisation
Challenges
Lessons Learnt• About 6-9 meetings are needed in a
community before the TST survey can start in the schools – very time consuming
• Parent meetings often at night. • Distribution curves indicate small effect of
BCG and NTM
Prevalence surveys
Methods 1• Sampling
– Enumeration areas mapped and random order for sampling generated
• Recruitment– All households in EA visited and all consenting
adults recruited
• Data collection– Questionnaire– Sputum sample (1)– Oral fluid for HIV (Z only)
Methods 2
• Positive samples– All positive samples are traced to the individual– The individual is revisited and asked to produce 2
further sputum samples (spot and morning)– CXR is taken on all individuals
• Care is given according to a standard algorithm
Samples to date
• Consent rate ~90%
• 3 sites completed, I site ongoing
• Total sputum samples = 14 194
• HIV oral test samples in Zambia
• To negotiate oral HIV testing in SA
Case study 1IC Linda
82M living with 17 year old grandson KK.Coughing >3 weeks, went to clinic but was not requested to
give a sputum sample.MGIT +ve for both IC and KK
IC believes he contracted TB after eating in a house in the village where a woman had aborted
KK smear negative- currently on run from police- location unknown!
Case study 2
BM & CC
Young married couple, unemployed, baby died last year.
Both positive MGITs, BM smear +, CC smear –.
Both tested for HIV and were positive
Commencing ARVs
Additional Benefit
• VCT centres augmented• Full time counsellors
employed• Increased uptake in sites
noted• ARV access improved 0
50
100
150
200
250
300
Q1 Q2 Q3
counselled tested positive
Challenges
Challenges
Lessons Learnt
• 98% of adults are able to produce some respiratory sample that can be cultured
• The study is very “popular” with participants- teams get “mobbed” by individuals who want to join in
• Follow up of the positive samples is extremely time and resource consuming
Aims:– To provide synthesised, shallow and wide data on the 24
communities
– To understand the range and variability of social systems (differences & similarities across sites)
– To assess patterns of TB knowledge, diagnosis, treatment and care
Social Science
MethodologyBroad Brush Survey (BBS)
– all sites• NHC/CAB meeting• Transect walks• Observations & Time Charts
– Transport depot– Hair salon + women’s space– Video club / Juke Box/Bar
+ men’s space– Health centre
Outcome –wide profile of each community
Intensive Fieldwork (5 sites Zambia / 2 sites SA)• Focus Group Discussions
– School children – Traditional Healers – Community based carers
• 8 – 10 TB Patient/household Interviews (Case Studies)
Outcome - in-depth qualitative data
Early Findings: Highlights
• Association between TB & HIV
• Blaming Others
• Significant Treatment Options
• TB Hot Spots
Treatment Options - Zambia
Treatment Options - SA
TB “Hot Spots”
• In both countries: bars/taverns/shebeens; health facilities; churches; hair salons; overcrowded houses & compounds & residential areas
• In Zambia also: open markets; schools; video clubs; public transport; funeral homes; police cells; mines; prisons; brothels
• In South Africa also: supermarkets; braai areas; juke boxes; hostels; construction sites; container businesses (e.g. cell phone shop); community hall (Delft); asbestos houses, library
Housing - Zambia
Housing - SA
Video Clubs (Zam) & Games Shops (SA)
Bars / Taverns - Zambia
Shebeens - SA
Hair Salon
SA – Poor Sanitation