"It's about time they taught us": a qualitative study evaluating the barriers to finding and screening child contacts under five at risk for TB in Gauteng Province, South Africa from the provider and caregiver perspectives.

BACKGROUND: Inadequate numbers of children under five years of age who are exposed to tuberculosis (TB) in the home (child contact) are initiated on TB preventive treatment (TPT) in South Africa. We assessed barriers of initiating isoniazid preventive therapy (IPT) in this age group. METHODS: We conducted a qualitative study at two primary health clinics in the Ekurhuleni district in Gauteng Province. Between April and July 2019, we enrolled facility managers, TB staff and parents or legal guardians of child contacts (caregivers) attending for care, at the two facilities. Semi-structured questionnaires, facility observations and in-depth interviews using a semi-structured interview guide were used to collect data. Findings from the semi-structured questionnaires with facility staff and facility observations were summarized. Thematic analysis with a deductive approach was used to analyse the data from the in-depth interviews with caregivers. RESULTS: Two facility managers took part in the study and were assisted to complete the semi-structured questionnaires by TB staff. Fifteen caregivers aged between 18 and 43 years were interviewed of which 13 (87%) were female. Facility managers and TB staff (facility staff) felt that even though caregivers knew of family members who were on TB treatment, they delayed bringing their children for TB screening and TPT. Facility staff perceived caregivers as not understanding the purpose and benefits of TB prevention strategies such as TPT. Caregivers expressed the desire for their children to be screened for TB. However, caregivers lacked knowledge on TB transmission and the value of TB prevention in children at high risk of infection. CONCLUSION: While facility staff perceived caregivers to lack responsibility, caregivers expressed limited knowledge on the value of screening their children for TB as reasons for not accessing TB preventive services. Health education on TB transmission, screening, and TB prevention strategies at a community level, clinics, creches, schools and via media are important to achieve the global end TB goal of early detection and prevention of TB.

An economic evaluation of an intervention to increase demand for medical male circumcision among men aged 25-49 years in South Africa.

BACKGROUND: Studies estimate that circumcising men between the ages of 20-30 years who have exhibited previous risky sexual behaviour could reduce overall HIV prevalence. Demand creation strategies for medical male circumcision (MMC) targeting men in this age group may significantly impact these prevalence rates. OBJECTIVES: The objective of this study is to evaluate the cost-effectiveness and cost-benefit of an implementation science, pre-post study designed to increase the uptake of male circumcision for ages 25-49 at a fixed MMC clinic located in Gauteng Province, South Africa. METHODS: A health care provider perspective was utilised to collect all costs. Costs were compared between the standard care scenario of routine outreach strategies and a full intervention strategy. Cost-effectiveness was measured as cost per mature man enrolled and cost per mature man circumcised. A cost-benefit analysis was employed by using the Bernoulli model to estimate the cases of HIV averted due to medical male circumcision (MMC), and subsequently translated to averted medical costs. RESULTS: In the 2015 intervention, the cost of the intervention was $9445 for 722 men. The total HIV treatment costs averted due to the intervention were $542,491 from a public care model and $378,073 from a private care model. The benefit-cost ratio was 57.44 for the public care model and 40.03 for the private care model. The net savings of the intervention were $533,046 or $368,628 - depending on treatment in a public or private setting. CONCLUSIONS: The intervention was cost-effective compared to similar MMC demand interventions and led to statistically significant cost savings per individual enrolled.

'They are inconveniencing us' - exploring how gaps in patient education and patient centred approaches interfere with TB treatment adherence: perspectives from patients and clinicians in the Free State Province, South Africa.

BACKGROUND: Tuberculosis (TB) treatment loss to follow up (LTFU) plays an important contributory role to the staggering TB epidemic in South Africa. Reasons for treatment interruption are poorly understood. Treatment interruption appears to be the culmination of poor health literacy of patients and inadequate health education provided by clinicians. We explored clinician and patient perspectives of the gaps in TB messaging that influence TB treatment LTFU. METHODS: We conducted semi-structured in-depth interviews between January and May 2018 with a sample of 15 clinicians managing TB and 7 patients identified as LTFU in public clinics in the Free State Province, South Africa. Thematic analysis using a mixed deductive/inductive thematic approach was used. RESULTS: Limited occupational opportunities, fear of disclosure and stigmatization all contributed to treatment LTFU. Patients felt that the TB messaging received was inadequate. Many of the clinicians interviewed felt that improving patient's TB knowledge would reinforce adherence to treatment and thus focused on sharing information on treatment completion, side effects and infection control. However, the inability of clinicians to establish rapport with patients or to identify social support challenged TB treatment adherence by patients. Clinicians perceived this as patients not following their instructions despite what they considered lengthy TB education. Having said this, clinicians concurred that their medical management of TB lacked the psycho-social dimension to treat a social disease of this magnitude. CONCLUSIONS: Limited occupational opportunities, fear of disclosure and stigmatization all contributed to treatment LTFU. Clinicians concurred that poor patient understanding of TB and that biomedical management lacking a psycho-social dimension further exacerbated the poor treatment outcome. TB remains a social disease, the successful management of which hinges on patient-centred care.

Designing an adaptive phase II/III trial to evaluate efficacy, safety and immune correlates of new TB vaccines in young adults and adolescents.

This article summarises the consensus arrived at a meeting of South African and international stakeholders on specific late phase clinical trial design issues integrating the investigation of immune correlates as an integral part of a phase III protocol for a preventative TB vaccine in an adolescent/adult population. The challenge ahead is to optimize the planning for phase 3 TB vaccine preventative trials, under resource constraints, given that there are no known correlates of protection to shorten and increase the efficiencies of efficacy trials. An adaptive, multi-arm, group sequentially designed trial protocol is proposed incorporating design features that address uncertainties arising from both advances in the field and dynamic study populations and disease states. Such a design allows modifications that protect research subjects, save time, and maximize the impact of scarce financial resources. Further, the protocol underwent joint review by regulators from several African nations at a meeting of the African Vaccine Regulatory Forum (AVAREF), a regional regulatory harmonization initiative, and recommendations are included.