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 Number of TB cases in SA,

No country with a severe HIV epidemic is controlling TB

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 Control IEC Condoms Multisectoral STIs Community contribution Medical approaches Hospital Clinic Community Decentralisation

Methods – Study Setting ZAMSTAR

Methods – Study Setting Zambia Sites: TB /100,000/year HIV 15-30% Cape Town Sites: TB /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 – Intervention ECF 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 – Intervention Household 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

Zamstar South 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

Consent Forms

Preparation of syringes

BCG

Inject

Fear

???

No Assent

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 consent forms handed out Mantouxs injected 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 = HIV oral test samples in Zambia To negotiate oral HIV testing in SA

Case study 1 IC 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

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

Methodology Broad 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