TITLE: Scale up of TB/HIV activities in 15 districts and support 42 districts

NEED and COMPARATIVE ADVANTAGE: Scale-up of TB/HIV activity will contribute to the PEPFAR and

national targets of providing care and treatment services to PLHA. By the end of 2008, with support from

Global Fund to Fight AIDS, TB and Malaria (GFATM), Program for Appropriate Technology in Health

(PATH) and Clinton HIV/AIDS Initiative (CHAI). TB/HIV services will be provided in about 100 districts in the

country; 57 districts will be supported by PEPFAR (42 existing and 15 new districts). Expansion in 15

districts will result in 6000 TB patients receiving diagnostic counseling and testing (DCT) and 1500 (40%)

receiving Anti-Retroviral drugs (ARV). By the end of 2009 it is expected that the services will be scaled up to

226 service outlets resulting to 24011 (80%) TB patients receiving DCT and 6002 (40%) on ARV. Scale-up

of TB/HIV services will be challenged with increased workload and quality of the results. These challenges

call for task shifting, human capacity building, strengthening system quality and increasing capacity for acid-

fast bacilli (AFB) microscopy, which should be supported by higher volume equipment, Mycobacterium

Growth Indicator Tubes (MGIT) and quality assurance. In order to improve quality of TB/HIV monitoring

data and increase efficiency in report generation, the Electronic TB Register (ETR) needs to be expanded

and decentralized at the district level.

ACCOMPLISHMENTS: A total of 381 health care workers (HCW) trained on TB/HIV activities. Protocol for

Extensively Resistant TB (XDR) and Multi-Drug Resistant TB (MDR) resistance surveillance finalized.

From July 2005 and March 2007, a total of 6,387 (75%) TB patients were tested and received their HIV

results, 733 on ARV and 1,474 cotrimoxazole prevention therapy (CPT) (from CDC supported sites).

Currently, TB/HIV services are implemented in 61 service outlets in 14 districts. TB/HIV policy was

developed and is now in the process of final review. Modified TB data collection tools including forms and

registers which are currently in use. Developed TB screening tool for PLHA. Supportive supervision

conducted in 61 outlets and sensitization conducted to 237 health management team members.

ACTIVITIES: 1) Establish TB/HIV services within 15 new districts to increase access to services; 1a)

Conduct needs assessment in 15 new districts; 1b) Hiring 15 supervisor staff at district level and 30

clinicians to support provision of ART in TB clinic; 1c) Procure and maintain 15 motorcycles to enhance

mobility of supervisors staff; 1d) Facilitate planning for TB/HIV activities to ensure TB/HIV activities are

incorporated into Comprehensive Council Health Plans (CCHP).

2) Strengthen capacity for the districts, managers and health workers in both the public and private sector to

provide quality TB/HIV services; 2a) Train 350 HCW and supervisors on TB/HIV activities. 2b) Conduct

supervision to ensure quality services.

3) Strengthen mechanism for collaboration and improve linkage and referral system to ensure patients'

follow up, effective coordination and harmonization of services; 3a) Facilitate monthly facility technical

meetings to strengthen referrals and linkages between TB and HIV sites; 3b) Facilitate quarterly

coordinating and information exchange meetings at regional and districts levels; 3c) Document and share

best practices and disseminate information twice per year.

4) Enhance community participation in TB/HIV through awareness activities to create demand and

utilization of services; 4a) Sensitize 309 Health Management Teams; (HMTs) 4b) Print and distribute IEC

materials, broadcasting, and social marketing; 4c) Conduct advocacy meeting to districts leaders and

influential community leaders on TB/HIV interventions and use of IEC; 4d) Community sensitization to

educate public on TB/HIV services.

5) Support the implementation of services in 42 existing districts to ensure continuation and sustainability of

established TB/HIV services; 5a) Pay salary to 50 staff at the national and district levels; 5b) Provide

administrative cost at the district, regional and national levels; 5c) conduct quarterly coordinating meetings

at all levels; 5d) Conduct supervision at all levels including M&E, TB/HIV information, and the use of the

Electronic TB Register (ETR.Net); 5e) Disseminate TB/HIV information at the national and international

levels; 5f) Document and share best practices twice per year; 5h) Facilitate district planning; 5g) Conduct

Advocacy Communication and Social Mobilization 5h) Conduct refresher training to 250 HCW on TB/HIV

services.

6) Strengthen laboratory TB/HIV activities; 6a) Train 140 laboratory staff on TB, AFB Microscopy,

Mycobacterium culture and first line drug susceptibility testing; 6b) Strengthen national QA network for AFB

microscopy; 6c) Procure one MGIT machine through RPSO to improve diagnosis of TB to HIV patients and

strengthen surveillance of MDR; 6d) Procure 57 Light Emitted Diod (LED) microscopy (one per district) 6e)

Liaise with TB/HIV Regional laboratory training center to be established in Southern African regions for

training and certifying personnel in standardized techniques and promoting external quality assessment

(EQA) activities.

7) Coordinate and collaborate with Columbia University in providing Technical Assistance in the

implementation of TB Infection control in care and treatment clinics.

8) Strengthen M&E systems to improve data management. This will allow districts, regions and central

levels to generate TB/HIV reports and facilitate monitoring of patients. 8a) Orient all HCW in TB clinic on the

use of modified TB forms and registers in 14 districts; 8b) update and maintain the ETR.Net software to

generate TB/HIV standardized reports; 8c) train 38 TB/HIV assistants, District TB and Leprosy Coordinators

(DTLC) and 17 administrators on the use of ETR.net; 8d) procure 33 computers and accessories for 29

districts and for M&E at central a level unit; 8e) update print and distribute

TB/HIV data collection tools; 8f) conduct mid term evaluation to determine whether TB surveillance system

is being used.

LINKAGES: NTLP works in collaboration with NACP and other development partners such as WHO, KNCV,

and GLRA who provide technical/financial support to help the program to meet its goals. It also works with

other implementing partners: PATH, CHAI, Harvard university, Columbia university, EGPAF, FHI, FBOs and

private care sectors to ensure coordination and harmonization of services. TB/HIV activities are conducted

within the framework of the health system.

Activity Narrative: CHECK BOXES: The areas of emphasis are chosen because NTLP will focus on in-services training of

providers in TB clinics and HIV sites to ensure quality of services. Building regional capacity to roll out

TB/HIV training and ensure sustainability. Renovation of infrastructure in TB clinics for provision of ARVs

services. These activities will ensure patients to access both TB and care and treatment services under one

roof, accelerate the number of TB/HIV co infected patients enrolled for ART and reduce transmission of TB

to immuno-compromised patients attending CTC.

M&E: 5% of the total budget is allocated for M&E. NTLP has developed standardize data tools that are

used in the country. At facility and district levels paper-based tools are used as a source for an electronic

database at the national level. Installation of ETR.Net will capture data electronically from the district to the

national level. On quarterly basis, data is collected, compiled and analyzed at all levels. Feedback of the

analyzed data from the national level is sent back to the respective regions. NTLP conduct regional,

quarterly, and bi-annual national coordinators' meetings to monitor program progress. Technical assistance

for both paper-based and electronic tools is provided through supervisions. The NTLP through NACP will

establish strong linkages with ART treatment partners to ensure M&E capacity building. This will include

tracking cross referrals, data quality decentralization of ETR, and data use for patient management at

facility level and program improvement.

SUSTAINAIBLITY: To ensure sustainability TB/HIV activities will be incorporated into comprehensive

council health management plans. So that in future, these activities will be directly funded by the counsels

and the government. The recruited staff in this project will be gradually absorbed into the government

establishment and paid by the government. Training of trainers will be done to ensure that local capacity is

build at the district levels. TB/HIV services are integrated into the existing health care system to avoid

formation of parallel program activities.

Title of Study: Cost and cost-effectiveness of TB-HIV/AIDS collaboration in Tanzania

Expected Timeframe of Study

Twelve months

Investigators:

Principal Investigator: Dr.Eliud Wandwalo (MD, MPhil, PhD), TB/HIV coordinator, National TB and Leprosy

Programme (NTLP), Ministry of Health and Social welfare (MOHSW), Dar es Salaam-Tanzania

Co-Investigators: Dr.Saidi Egwaga (MD, MMED), Program Manager, NTLP-MOHSW, Dar es Salaam-

Tanzania; National AIDS Control Programme (Name to be decided)

International co-investigator: Filip Meheus MSc-Royal Tropical Institute, The Netherlands

Study advisors: Centre for Disease Control (CDC) (Name to be decided), World Health Organization (WHO)

(Name to be decided).

Collaborating Institutions:

The Ministry of Health and Social Welfare (MoHSW) through the National TB/Leprosy Programme (NTLP)

and the National AIDS Control Programme (NACP), Royal Tropical Institute, the Netherlands (KIT), Centre

For Disease Control (CDC), World Health Organization (WHO). We also plan collaboration with a public

health evaluation in Tanzania examining the cost and cost-effectiveness of HIV treatment.

Project Description:

Tanzania started scaling-up of collaborative TB/HIV activities in 2006. This study builds on work from a multi

-country study (Tanzania and Ethiopia, with World Health Organisation (WHO) and the Royal Tropical

Institute of the Netherlands (KIT)) measuring unit cost of implementing TB/HIV collaborative activities (see

below). This new project aims to assess the population impact and cost-effectiveness of combined TB/HIV

interventions, compared with other modes of service delivery for identifying and treating co-infected

patients. This information is important for decision making about best models of service delivery for co-

infected patients.

Evaluation Question:

Is the current model of collaborative TB/HIV intervention cost-effective with a better population impact

compared to a model of separate TB and HIV/AIDS services?

Methods:

The collaborative TB/HIV activities were first piloted in three districts in Tanzania before being scaled-up to

involve more districts. These activities include TB Clinic based HIV testing and counselling, cotrimoxazole

administration where appropriate, and onward referral to Care and Treatment Centres (CTCs).

The MoHSW/WHO/KIT multi-country study is being conducted by the same researchers using three initial

TB/HIV collaborative pilot districts (3 hospitals and 6 health centres). The study included both provider and

patient costs. This ongoing study has measured the unit cost of implementing TB/HIV collaborative activities

in addition to cost of treatment for the TB aspect of HIV/TB co-infection. The study is expected to end in

December, 2007.

Evaluation of Costs, Cost-Effectiveness and Population Impact

The new study will estimate not only the total costs but also the cost effectiveness and the population

impact of different modes of delivery. This might inform a strategic choice about mode of service delivery,

as well as helping with estimation of resource requirements.

The study will estimate costs of identifying and managing co-infected patients in separate HIV and TB

programmes replicating methods used in the MoHSW/WHO/KIT multi-country study for later comparisons.

The evaluation of HIV treatment costs will be in collaboration with another multi-country study investigating

the cost and cost-effectiveness of HIV treatment. If possible, the costs of providing ARV treatment in TB

clinics will also be measured (if this initiative is piloted in a timely fashion). Patient costs will be included.

Total, average and average incremental costs of each intervention will be measured. Economic and

financial costs will be measured separately. Economic costs will include a valuation of a considerable

amount of volunteer time and other donated inputs. The capital costs of all interventions will be measured

and from this an estimation of the infrastructure costs will be made. Specific attention will be given to the

human resource (HR) costs required for the scaling-up of the TB and HIV/AIDS and TB/HIV combined

programmes. In addition, the study will measure the health systems costs of activities not included in the

direct delivery of services, but required to support them such as: health sector planning, management and

supervision, management systems and the recurrent training costs of key staff.

The investigators are still exploring different approaches to measuring population impact in this study. This

is a complex intervention to assess as it involves testing and treatment. TB patients may receive some, all

or none of the steps in the intervention and this alters the cost effectiveness and the population impact. It

will therefore be important to know the probability of a co-infected TB patient getting tested and then getting

onto HIV treatment in the different models of care. This should feed into cost effectiveness analysis to give

an accurate cost per life year based on mean costs and benefits in the TB clinic population, in integrated

and separate service delivery models:

Cost-Effectiveness=mean cost of HIV testing and treatment / mean life years saved from HIV treatment

This measure alone will not capture the benefit of one model of service delivery achieving a higher rate of

introduction to treatment for the part of the population requiring treatment. The "population" are patients

attending TB clinics. There may be a trade-off between cost effectiveness and population impact. So it will

be important to define the population impact of combined HIV/TB services compared with separate HIV and

TB services:

Population-Impact=population starting HIV treatment / population requiring HIV treatment

Activity Narrative: A strategic choice about integrating HIV testing and treatment services with TB services might be informed

by comparing the cost effectiveness of identifying patients in this way compared to others. The choice

might also benefit from a consideration of the epidemiological impact of identifying patients requiring

treatment whilst they have TB, as opposed to at various other opportunities, including after treatment for

TB? How much does an integrated TB/HIV service increase the identification of HIV patients amongst the

whole HIV positive population in the medium term?

Reference will be made to existing surveys and, where possible, effectiveness and impact data will be

drawn from these. The different models of care will be evaluated to help quantify the probability of co-

infected TB patients being identified and receiving treatment for their HIV and, in addition, the predicted

population impact of these services. The methodologies will be developed with WHO/KIT/CDC technical

assistance. Qualitative and quantitative assessment of current progress (and success/failure) in TB/HIV

integration will mainly comprise case-studies of TB/HIV interventions at pilot sites and some comparison

sites with non integrated services.

Population of Interest: The study will be conducted in four districts in all four zones of the country to ensure

representativeness. Data will be collected from both health facilities and patients. The MoHSW/WHO/KIT

study was conducted in three districts in Eastern, Southern and Northern parts of the country. This study

will expand to include the Western zone. Districts will represent urban, semi-urban and rural settings. In

each district, health facilities will be chosen to represent all levels of health care delivery. The study will

purposively select the facilities piloting the TB/HIV integrated approach (in some cases including ARVs at

TB clinic) in addition to comparison facilities using traditional approaches.

Ethical clearance for the study will be sought from National Institute for Medical Research and the Ministry

of Health.

Information Dissemination Plan: Dissemination of the study findings will be carried-out at all levels. As part

of dissemination plan a workshop will be conducted to orient key stakeholders about the study including

important cost effective analysis concepts. After the analysis of the findings dissemination of results will be

conducted at district, regional and national levels. Results will also be disseminated at local and

International conferences. The study results will be made available to the ministry for decision making.

Reports will be written for local and international publication including peer reviewed papers.

Budget (US$): salary/fringe benefits: 84,200

a. PI and Local co-Investigators: 36000

b. Research assistants and site supervisors: 19200

c. Statistician and data clerk: 6000

d. KIT consultant: 23,000:

Supplies: 10,000

Supervision and travel: 21,400

Others

a. Workshops and training: 20,000

b. Study running costs: 14,400

Total: 150,000

Salary/Fringe benefits: This will be required for principal investigator, co-investigators and research

assistants according to their level of involvement to the study. It is envisaged that PI will spent up to 40

percent of his time in the study and co-investigators 25 percent. The consultant from KIT will be paid fees

for his involvement in the study. KIT and WHO will be requested to supplement the fees of engaging a

consultant to this project. In each site three research assistants will be engaged. Statistician and data clerk

will be required for data entry and to advice during data analysis

Supplies: Will be required for stationeries, printing and other materials

Supervision and travel: This will involve supervision of sites by investigators and research assistants

Others: Study running costs including communications, workshop for key stakeholders as part of

dissemination plan, data analysis and training of research assistants.