Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
- Conditions
- Tuberculosis
- Interventions
- Other: Active TB case finding
- Registration Number
- NCT02808507
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4852
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Facility-based screening Active TB case finding This strategy will be implemented at all clinics (n=28) within this arm for 18 months. Study staff will encourage providers at each of the clinics to screen all consenting patients attending the clinic, regardless of the original reason for clinic presentation. Upon presenting for care (e.g., while waiting for their healthcare provider), patients will be informed about the study and screened for cough of any duration, fever, weight loss, or night sweats. Participants who are symptomatic and provide a sputum specimen (according to the clinic standard of care) will be given a study flyer informing them that they may be contacted by study staff, and a brief summary of the study. Per standard of care, all sputum samples will be sent to the local National Health Laboratory Service laboratory for Xpert testing. Contact screening Active TB case finding This arm is comprised of two sub-arms: In the household contact screening sub-arm, a mobile field team visits the household of each consenting newly diagnosed pulmonary TB index case. Each visit consists of a household census, consent of all eligible household members for TB screening, administration of a brief questionnaire, sputum collection for testing with Xpert Mycobacterium tuberculosis (MTB)/rifampin (RIF) and the offer of HIV testing. In the incentive-based contact screening sub-arm, all consenting newly diagnosed active TB cases are provided with 10 coupons for free TB screening to give to close contacts. When a contact presents at clinic with a coupon, they and the index case each receive a small amount of money. If the contact is diagnosed with active TB and starts treatment, the index case receives an additional larger amount of money. Each contact receives a brief questionnaire, TB symptom screen, optional HIV testing, and sputum sample collection for Xpert MTB/RIF.
- Primary Outcome Measures
Name Time Method Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms 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.
Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics 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.
- Secondary Outcome Measures
Name Time Method Comparative Number of Secondary TB Cases Identified in Incentive-based Versus Household-based Contact Tracing 36 months The pre-specified secondary study outcome was the number of Xpert-based TB diagnoses made among enrolled contacts ("secondary cases") by arm.
Total Cost of Household Contact Investigation Strategies 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.
Estimated Costs Per Contact Person Screened in the Household-based and Incentive-based Contact Investigation Arms 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.
Cost Per Secondary Case of TB Identified Among Contacts, Per Arm 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.
Incremental Cost-effectiveness Ratio 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)
Trial Locations
- Locations (2)
Waterberg health subdistrict
🇿🇦Mokopane, Limpopo, South Africa
Vhembe health subdistrict
🇿🇦Louis Trichardt, Limpopo, South Africa