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

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(/1

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TB

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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