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Completed

NCT Number: NCT02808507

Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa

The purpose of this study is to compare three strategies for finding TB cases in a rural Sub-Saharan African setting: 1) Screening all attendees of primary care clinics for TB; 2) Conducting household contact investigations of newly diagnosed TB cases; 3) Providing incentives to newly diagnosed TB cases and their contacts to promote contact screening for TB. For each intervention, investigators will measure comparative effectiveness in terms of cases identified as well as the cost-effectiveness and feasibility of implementation.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections

Age range

0 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vhembe health subdistrict, Louis Trichardt, Limpopo, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Facility-based screening arm

  • Age 0-99 years
  • Informed consent provided (or assent plus parent/guardian consent)
  • Attending any of the study 28 study clinics in the facility-based screening arm

Contact tracing arm- Index Case

  • Age 0-99 years
  • Informed consent provided (or assent plus parent/guardian consent)
  • Newly diagnosed (last 2 months) with TB at any of the 28 study clinics in the contact tracing arm

Contact tracing arm- Household Contact

  • Age 0-99 years
  • Informed consent provided (or assent plus parent/guardian consent)
  • Living in the same household as an enrolled Index case (see above)

Contact tracing arm- Non-household Close Contact

  • Age 0-99 years
  • Informed consent provided (or assent plus parent/guardian consent)
  • Referred to the study as a close contact of an enrolled Index case (see above)

Exclusion criteria

(all arms):

  • Unable to provide informed consent.

Treatment and study plan

Active TB case finding

Other

Active TB case finding (ACF) refers to any number of strategies used to identify individuals with active TB disease, outside of passive case finding. In passive case finding, individuals with symptoms present at health centers for diagnosis. In active case finding, the health system makes an effort to identify TB cases before they present passively.

Primary outcomes

  1. Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics

    Time frame: 18 months

    The primary analysis was based on the facility- level rate ratio, and we first calculated an unadjusted ratio of the treatment initiation rates between the two arms and the corresponding 95% confidence interval (CI). We then adjusted for any residual confounding by district stratification and the historical annual number of people started on TB following a two-stage approach. The first step of this approach fits a Poisson regression to the facility-level counts and the district and historical volume covariates irrespective of study arm. The residuals ratios, calculated as the ratio of the observed over the expected counts, are then used in the second stage to estimate the between-arm rate ratio and the corresponding 95% CI.

  2. Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms

    Time frame: 36 months

    The primary outcome of the study was the comparative number of people with incident TB diagnosed and started on treatment at study clinics in the two contact tracing arms, excluding the six-month washout period.

Secondary outcomes

  1. Comparative Number of Secondary TB Cases Identified in Incentive-based Versus Household-based Contact Tracing

    Time frame: 36 months

    The pre-specified secondary study outcome was the number of Xpert-based TB diagnoses made among enrolled contacts ("secondary cases") by arm.

  2. Total Cost of Household Contact Investigation Strategies

    Time frame: 36 months

    This measure is the total cost of household contact investigation in both the household-based and incentive-based arms in 2018 United States dollar (USD) collected from the societal perspective (including both health systems and patient-level costs). As these are actual measured (not estimated) costs, no 95% confidence interval is reported.

  3. Estimated Costs Per Contact Person Screened in the Household-based and Incentive-based Contact Investigation Arms

    Time frame: 36 months

    These are estimated costs in 2018 USD for the cost per contact person screened in each arm, collected from the societal perspective including health system and patient-level costs.

  4. Cost Per Secondary Case of TB Identified Among Contacts, Per Arm

    Time frame: 36 months

    Cost were measured in 2018 US dollars from the societal perspective, including both health systems and patient level costs. Total costs per arm were divided by the number of secondary TB cases identified among contacts in that arm.

  5. Incremental Cost-effectiveness Ratio

    Time frame: 36 months

    (Total costs of incentive-based contact investigation-total costs of household-based contact investigation)/(effectiveness of incentive-based contact investigation-effectiveness of household-based contact investigation)

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Perinatal HIV Research Unit of the University of the Witswatersrand

Registry information

Acronym: Kharitode TB

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jun 21, 2016
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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