research proposal first draft assignment 1

Student number :24457418
Assignment one
Quantitative Evaluation of Enhanced Tuberculosis (TB) Screening and Preventative Therapy In Primary health care clinics in the Southern District In the Western cape

Background &Rationale
Tuberculosis still continues to cause a burden in the public health system in South Africa, and specifically the most affected group are those that are living with HIV &AIDS. According to the World Health Organization (2023), which they released a report that indicated South Africa contributed an estimate of 3% to the global TB burden in 2022.TB still remains the leading cause of mortality WHO ( 2023). The South African National Government has made effects to integrate TB screening services for both TB and HIV affected individuals. TB screening has also been incorporated into every clinic visit for individuals that are vulnerable living with HIV&AIDS or attending clinics for other services. However, TB infection rates are not declining, and mortality remains largely driven by TB related causes, South African National Department of health (2022).
The South African National Department of health (2022) has issued updated national guidelines for TB screening and management. This is aimed especially at those individuals living with HIV/AIDS. The updated guidelines involve symptom-based testing. Using these four questions for the screening tool. (1) Are you coughing for two weeks or more, (2) have you experienced any unexplained weight loss, (3) Do you have drenching nights sweats, (4) Have you had fever for two weeks or more. If the individual answers yes to any of the questions, they are classified as a TB suspect. According to the national health guidelines, further tests is to be conducted on the individuals, and these include two Sputum Gene test for microscope and the other for culture, Chest Xray to be performed on site if Xray facility is available if not the individual needs to be referred for an Xray.
Another recommendation by the national government is a preventative Therapy such as Isoniazid Preventative (IPT), these are recommended to those individuals who are immunocompromised who are at risk of contracting opportunistic infections, this preventative therapy is meant to prevent the development of active TB NDOH(2022). A study conducted by, Churchyard et al,(2014) also showed evidence that IPT has reduced incidence rate among HIV positive individuals.
Despite these guidelines and recommended implementations, there is still a gap noted. According to study done by Van Ginderdeuren et al(2019) the numbers of individuals that are on IPT remains low and states the barriers of these as lack of awareness from the public and HIV individuals, logistical barriers and also individuals who experienced side effects and lastly the screening protocols are not applied consistently by healthcare professionals. Another study conducted by Nadioo et a l(2017) which examines the TB cascade in South Africa examining the estimates loss of journey of people from screening to successful TB treatment showed that 5% of the cases were lost at the stage of accessing TB test and that 13% were lost between testing receiving the diagnosis , therefore this highlights the gap of care from screening to diagnosing and treatment. These two studies highlighted shows evidence that there is a gap in the system which hinders care and integration of care(TB).
Another study conducted by Hermans et (2015), also provided evidence that there are missed screenings, even though there are guidelines issued by the national department but is not being implemented, or screenings are done but no proper documentations. Other contributions that caused these barriers of implementations of TB screening is lack of staff knowledge about updated guidelines, staff shortage and lack of training and supervision.
As much as there is evidence and clinical research done on TB, but there is still lack of evidence on the effectiveness of enhanced screenings in primary health clinics in the western cape. Most existing studies are conducted in controlled research environments or some are qualitative, this study aims to understand the effectiveness of enhanced screening and preventative therapy in primary health clinic to identify the barriers and show that if enhanced screening is done it may improve the TB detection and therapy initiation in the western cape clinics.


Research Questions and aims
Research Question
Does enhanced TB screening and structured follow-up improve TB Detection rates and Preventative therapy uptake among adults attending primary health clinics in the Western Cape Southern district

Research Aims/Hypothesis
1. To Assess the effectiveness of the enhanced TB screening in increasing TB detection rates.
2. To evaluate the uptake of TB preventative therapy among those that are eligible to enrol.
3. To identify demographic and clinical factors associated with TB screening, Diagnosis and therapy initiation in the western cape more specifically southern districts.
4. To assess healthcare workers knowledge and practice regarding Screening and preventative therapy.

Study Design
This study will use a quantitative, observational cross section study design to evaluate the TB screening and preventative therapy (IPT) outcomes in two primary health clinics in the southern district, Western cape where TB& and HIV services are provided.
Participants will be recruited over a one-year period using convenience sampling. The data will be collected through structed questionnaires paper based and tablet based (electronically), clinical records and laboratory results such as sputum test and x-rays. No randomization will occur. The study will mainly focus on measuring the outcomes such as the TB Diagnosis and IPT Treatment follow up.
This cross-sectional study ensures that data collection is collected at one specific point in time making it well suited for estimating the prevalence and exploring the potential associations. This approach enables data collections while not limiting the flow the clinic and resource availability. This study will utilize the clinic routine and already existing documentation and laboratory results.

Sample Technique
Population
• Person: Adults aged between 20 &60 attending the clinic.
• Place: The study will be conducted in two primary health clinics in the Southern District in the Western Cape.
• Time: During a one-year month period data collection period.
Inclusion Criteria
• Adults over the age of 20 attending the clinic HIV positive and close TB contact
• Able to provide informed consent either verbally or in writing
• Not currently on TB treatment
• Not relocating for one year
• Documented HIV status
• Willing to follow up during the study period
• Fluent in English, IsiXhosa
• Must reside within the Southern District in the Western Cape
• Valid South African ID or a clinic reference for record keeping
• Not currently enrolled in any other study
• Women on Contraceptives (between 20&6years)
• Chronic treatment such as diabetic and hypertension


Exclusion Criteria
• Currently Undergoing TB treatment
• Previous cancer diagnosis and current
• Newly Diagnosed HIV with viral load above 7000 copies
• Unable to provide consent to language barriers
• Known Psychiatric conditions
• Pregnant and Breastfeeding Moms
• Refusal to allow consent for medical records
• Currently enrolled in another study
• Those planning to have a baby in one year

Sampling Method.
Convenience sampling method will be used. Those eligible participants that are presenting at the clinic during the one-year study period will be enrolled in the study. This method is feasible given the clinic setting and the resources available(clinical data, laboratory, facility), although these may introduce selection bias. Participants will be approached by the trained research assistants who would do consenting once consent is obtained the participant will complete a structure questionnaire, have their records reviewed and followed up.

Sample Size
A target of 75 males and 75 females participants those that eligible and fit the criteria for enrolment of participants is proposed based on the clinic attendance rates looking at the data of the attendance in the clinic and also those exit the study before completion , and potential screen failures. This sample size will allow for meaningful comparison across the age groups.




Feasible and Limitations
This study is feasible as it is within a clinic setting using existing staff and infrastructure. The data collection will be integrated into the routine of operations of the clinic to prevent disruptions. However, some limitations may be:
• Selection bias
• Data collection during the festive season may be affected.
• Missing data such as incomplete questionaries and missing clinical records.
• Staff workload depending on the staff available the data collection may be affected.
• Ethics such as reviewing clinical results and records
• Withdrawing of participants incomplete data
• Using tablets as well as paper based to collect data, if the tablets are used and area has bad signal which could hinder data collection and storage.
• Safety concerns



















Reference list
• Churchyard, G.J., Scano, F., Grant, A.D. and Chaisson, R.E., 2014. Tuberculosis preventive therapy: An underutilized strategy to reduce individual risk of TB and population-wide TB incidence. International Journal of Tuberculosis and Lung Disease, 18(9), pp.1075–1080.

• Hermans, S.M., Kirubi, M., van den Hof, S., Lange, J.M.A. and Hoepelman, A.I.M., 2015. TB screening and prevention in South African HIV clinics: Missed opportunities and potential for improvement. BMC Infectious Diseases, 15, p.389.


• Naidoo, P., Theron, G., Rangaka, M.X., Chihota, V.N., Vaughan, L., Brey, Z., Pillay, Y. and Churchyard, G.J., 2017. The South African tuberculosis care cascade: Estimated losses and methodological challenges. Journal of Infectious Diseases, 216(Suppl 7), pp.S702–S713.

• South African National Department of Health, 2022. National Tuberculosis Management Guidelines. Pretoria: Department of Health.


• Van Ginderdeuren, E., Bassett, J., Hanrahan, C., Mutunga, L. and Van Rie, A., 2019. Health system barriers to implementation of TB preventive strategies in South African primary care facilities. PLOS ONE, 14(2), p.e0212035. doi:10.1371/journal.pone.0212035

• World Health Organization, 2023. Global tuberculosis report 2023. Geneva: WHO.