The purpose of INROADS is to promote innovation to improve patient outcomes in support of the South African National Strategic Plan on HIV, STIs, and TB 2012-2016 (NSP). The framework for INROADS is based on NSP Strategic Objective 3, which aims to reduce deaths and disability from HIV and TB through universal access to diagnosis, care, and treatment. By using the NSP as a guide for identifying priority activities, this framework ensures that program results will be relevant and useful to the South African Government (SAG), as well as to PEPFAR and other stakeholders. The INROADS framework identifies five technical focus areas for data analysis, program evaluation, cost-effectiveness analysis, policy recommendations, and capacity strengthening:

Focus Area 1: HIV care and treatment: linkages, retention, and outcomesdata analysis to assess existing HIV programs for children, adolescents, pregnant women, and other adults and identify opportunities for improvement through innovation. Focus Area 2: TB/HIV: case-finding, diagnosis, and treatmentcost-effectiveness analysis of innovative case finding and treatment delivery models and decentralized MDR-TB treatment. Focus Area 3: Service delivery models and treatment guidelinesevaluation of task shifting, integrated service delivery and other proposed guideline changes and innovative models for delivering high quality, cost-effective care and treatment to children and adults. Focus Area 4: Cost and budget modeling and technical assistancemodeling of national costs and budgetary needs for HIV and TB care and treatment and technical assistance to the NDOH. Focus Area 5: Cervical cancer: screening and treatmentcost-effectiveness analysis of innovative strategies and models for expanding access to cervical cancer services.

1.1 Cost effectiveness analysis of TB/HIV active case finding

TB contact tracing and case finding are high priority interventions but have not been implemented successfully at scale. Innovative, cost-effective strategies are required.

Analyze cost-effectiveness of Massive Case Finding project implemented in Matlosana District, NW.

Analyze cost and effectiveness data

Analyze cost-effectiveness of Xpert vs liquid culture for case finding among asymptomatic TB contacts.

1.2 Operations research on MDR-TB treatment and evaluation of new MDR-TB guidelines

Decentralized treatment of MDR-TB is being introduced, but little evidence about its effectiveness and costs is available.

Observational cohort analysis of drug-resistant patients treated at Helen Joseph TB focal point.

Observational cohort analysis of linkages to care for all persons diagnosed with drug-resistant TB at the NHLS laboratory based at Helen Joseph hospital.

Match the NHLS data warehouse to the EDR.net to parameterize model for MDR-TB diagnosis and treatment.

1.3 National TB Cost Modeling for the roll-out of Xpert

Initial models developed in 2011 will need to be adapted to incorporate Xpert for the diagnosis of EPTB.

Match the NHLS data warehouse to the ETR.net at a facility level to identify Xpert positive cases.

Draft protocol and submit for ethics approval for the matching of patient-level data of ETR.net and NHLS laboratory specimens.

Draft protocol to estimate the cost of the use of FNA and Xpert for the detection of EPTB, operational research being completed in 2013 by Annelies van Rie.

1.4 Costs of drug sensitive TB treatment in South Africa

One analysis of the costs of TB treatment has been conducted for South Africa, and although it pre-dates the roll-out of ART and the rapid increase in TB incidence and mortality, is widely used for modeling and budgeting because it is the only source.

Analyze cost of hospitalized TB treatment at Klerksdorp.

1.5 Cost and burden of integrated TB/HIV care at Primary Health Care facilities

HIV/TB care is being moved from dedicated Comprehensive Care, Management and Treatment (CCMT) sites to Primary Health Care facilities and is being integrated into their package of services. This potentially increases access by having more facilities in locations that are easy to access for patients. It does place an added burden on the already struggling primary healthcare infrastructure. There has been no work to identify the additional relative burden that this model places on the primary health care facility in terms of absolute patient numbers but also costs and resources. This evaluation aims to determine the relative cost and burden of integrated HIV/TB treatment at the primary health care level.

Expand existing work, which examines the costs of HIV/TB treatment at the primary health care level to include all other services offered at the facility. The aim is to identify the relative burden and cost of HIV/TB on the facility compared to other conditions traditionally treatment at the primary health care facility.

Develop a protocol, submit to ethics and government, get approval

Estimate the overall cost of running the primary health care facility (top down) including all services

Determine the service utilization at the clinic by primary reason for visit, including time in motion component (Finish in 2014)

1.1 Data analysis and evaluations to improve treatment outcomes and retention for adolescent patients

As HIV infected children transition into adolescence, the issues they face will likely result in a need for targeted strategies to effectively manage and support this vulnerable population. As the number of adolescents on treatment at any one clinic is small, large databases which pool patients across multiple clinics are needed to identify best practices for providing care to this population.

Using the existing Right to Care (RTC) Adolescent Cohort, develop an analytic plan for a baseline study to identify the extent of and reasons for poor outcomes and loss to care among adolescent ART patients.

Generate data analysis tables describing treatment outcomes for adolescents compared to adults

Write and submit an abstract to a national and international conference

Write up results for presentation to key stakeholders and for publication

1.2 Faster initiation of appropriate antiretroviral treatment (ART) regimens among antenatal patients newly diagnosed with HIV

Evaluate the impact of a pilot program to support faster initiation of appropriate ART regimens and improved adherence to ANC visit schedules after the first ANC visit for the mothers own health and to prevent mother-to-child transmission of HIV (PMTCT).

Complete enrolment of baseline patients

Start and complete enrolment of intervention arm

Finalize database

Start analysis

1.2 Data analysis and research to strengthen PMTCT and ART access for pregnant women

Changes to treatment guidelines calling for earlier treatment of HIV-positive pregnant women could dramatically increase the number of pregnant women on ART but could also lead to increased attrition after delivery. Utilizing large existing databases allows for monitoring policy implementation and identification of strategies that will improve care.

Develop an analytic plan for a baseline analysis to identify the extent of and reasons for loss of pregnant women from HIV care after delivery

Generate data analysis tables describing loss over time and in relation to pregnancy as well as predictors of loss

Write and submit an abstract to a national and international conference

1.1 Development of large patient databases to assess clinical outcomes under different models of care:

The databases will be used to answer the primary questions for focus area one and will provide data to answer the objectives of other focus areas as well. Attention will be paid to ensure data quality. These databases include the Right to Care patient database (>75,000 patients treated in the public sector) and the Right to Care Health Services database (25,000 patients treated in the private sector).

Conduct data audits on each database and treatments site to determine data quality

Generate data cleaning reports on priority variables that will be used for many analyses including drug regimens, baseline lab values, follow up CD4 and viral load, etc.

Use the database to begin to evaluate risk factors and clinical outcomes for all pre-ART and ART patients under South Africas new treatment guidelines, extending analysis to 10+ years on treatment.

1.2 Analysis of need and potential for third-line ARV regimens:

As the treatment program matures and patients are on ART longer, an increasing number of patients will fail second-line therapy. Large databases are needed to quantify the likelihood of this event, assess ways to prevent it, and evaluate the effectiveness of third line regimens.

Using the datasets described above, develop an analytic plan for an analysis of the need for third-line therapy in South Africas public sector

Conduct an analysis describing the rate of second-line failure and current practice for patients failing second line ART

Conduct an analysis of treatment outcomes on second-line therapy and model the expected costs and cost-effectiveness of a third-line regimen

1.3 Cost effectiveness analysis of task shifting from doctors to nurses

If the provision of HIV care and treatment is to continue to expand, shifting of effort from expensive and scarce labor cadres (doctors, public health nurses) to less expensive and more easily trained cadres (lay personnel, junior nurses) is essential. This has already been done from doctors to nurses for the initiation and maintenance of HIV positive patients onto antiretrovirals. While already being rolled out the true cost and effectiveness needs to be estimated to understand the impact this will have on the national ART program.

Ongoing study. Using a matched cohort design, evaluate the cost effectiveness of NIMART at PHCs over the first 24 months of treatment, relative to doctor-managed care at CCMT sites.

Develop database

Collect data patient and cost

Generate preliminary results

1.1 Data analysis and evaluations to improve treatment outcomes and retention for adolescent patients

As HIV infected children transition into adolescence, the issues they face will likely result in a need for targeted strategies to effectively manage and support this vulnerable population. As the number of adolescents on treatment at any one clinic is small, large databases which pool patients across multiple clinics are needed to identify best practices for providing care to this population.

Using the existing Right to Care (RTC) Adolescent Cohort, develop an analytic plan for a baseline study to identify the extent of and reasons for poor outcomes and loss to care among adolescent ART patients.

Generate data analysis tables describing treatment outcomes for adolescents compared to adults

Write and submit an abstract to a national and international conference

Write up results for presentation to key stakeholders and for publication