Clinical trial NCT02808507: Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
Official title: Comparative Effectiveness/Implementation of TB Case Finding in Rural South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tuberculosis
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Perinatal HIV Research Unit of the University of the Witswatersrand
First posted: 2016-06-21
Enrollment: 4852
Sex: ALL
Minimum age (years): 0
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Treatment Initiation Ratio in Facility Versus Contact Investigation Clinics
timeFrame: 18 months
measure: Comparative Treatment Initiation Ratio in the Incentive-based Versus Household-based Contact Investigation Arms
timeFrame: 36 months
Secondary outcomes:
measure: Comparative Number of Secondary TB Cases Identified in Incentive-based Versus Household-based Contact Tracing
timeFrame: 36 months
measure: Total Cost of Household Contact Investigation Strategies
timeFrame: 36 months
measure: Estimated Costs Per Contact Person Screened in the Household-based and Incentive-based Contact Investigation Arms
timeFrame: 36 months
measure: Cost Per Secondary Case of TB Identified Among Contacts, Per Arm
timeFrame: 36 months
measure: Incremental Cost-effectiveness Ratio
timeFrame: 36 months
Other outcomes:
Locations:
city: Louis Trichardt
country: South Africa
facility: Vhembe health subdistrict
state: Limpopo
city: Mokopane
country: South Africa
facility: Waterberg health subdistrict
state: Limpopo
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: David Dowdy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baik Y, Hanrahan CF, Mmolawa L, Nonyane BAS, Albaugh NW, Lebina L, Siwelana T, Martinson N, Dowdy DW. Conditional Cash Transfers to Incentivize Tuberculosis Screening: Description of a Novel Strategy for Contact Investigation in Rural South Africa. Clin Infect Dis. 2022 Mar 23;74(6):957-964. doi: 10.1093/cid/ciab601.
citation: Hanrahan CF, Nonyane BAS, Mmolawa L, West NS, Siwelana T, Lebina L, Martinson N, Dowdy DW. Contact tracing versus facility-based screening for active TB case finding in rural South Africa: A pragmatic cluster-randomized trial (Kharitode TB). PLoS Med. 2019 Apr 30;16(4):e1002796. doi: 10.1371/journal.pmed.1002796. eCollection 2019 Apr.
citation: Kerrigan D, West N, Tudor C, Hanrahan CF, Lebina L, Msandiwa R, Mmolawa L, Martinson N, Dowdy D. Improving active case finding for tuberculosis in South Africa: informing innovative implementation approaches in the context of the Kharitode trial through formative research. Health Res Policy Syst. 2017 May 30;15(1):42. doi: 10.1186/s12961-017-0206-8.