Respiratory
Conditions
Interventions
Pluslife Tongue Swabs
Sponsors
Stellenbosch University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Individuals in proximity of or invited to community-based TB testing services - Age >0 years - Provision of informed consent o Written consent if age >18 years o Parental consent with minor written assent if age 15-17 years o Parental consent with minor verbal assent if age 5-14 years o Parental consent only if age 0 years - Provision of informed consent o Written consent if age >18 years o Parental consent with minor written assent if age 15-17 years o Parental consent with minor verbal assent if age 5-14 years o Parental consent only if age 0 years - Provision of informed consent o Written consent if age >18 years o Parental consent with minor written assent if age 15-17 years o Parental consent with minor verbal assent if age 5-14 years o Parental consent only if age <5 years
Exclusion criteria
Exclusion criteria: - Currently taking treatment for TB - Completed TB treatment within the past six months - Currently taking TPT - Completed TPT within the past one year - Failure to provide written informed consent/assent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This is a mixed-methods feasibility and acceptability study; no single primary outcome is specified in the traditional clinical trial sense. Instead, a set of priority outcomes has been defined a priori, under the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation). These outcomes capture the core dimensions of feasibility (e.g., proportion of valid test results, fidelity of implementation) and acceptability (e.g., willingness to participate, satisfaction, trust in results), indicators of reach, adoption, and early effectiveness. All quantitative outcomes will be measured at the point of testing or within 30 days of enrolment (for linkage-to-care outcomes). Qualitative outcomes will be assessed within two weeks of testing via in-depth interviews. The study will be considered feasible and acceptable if the data generated are sufficient to characterize implementation performance across sites and to identify barriers and enablers to scale-up. Aim 1 (Community-Based Testing): Outcomes measured at testing and 30-day follow-up. Reach/Acceptability: proportion approached who consent; demographics of those tested — at enrolment. Feasibility: swab success rate; proportion valid results; time to result delivery; retention until result — at testing. Effectiveness: diagnostic yield; cases detected; number needed to test; linkage-to-care within 15 days — at 15 and 30 days post-enrolment. Adoption: trust in results; staff satisfaction; perceived value among health authorities/community leaders — exit survey at testing; interviews within 2 weeks. Implementation: device malfunction rate; tests/battery charge; proportion of days disrupted — throughout recruitment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Aim 2 (Household Contact Investigation): Outcomes measured at time of household visit and at 30-day follow-up. • Reach/Acceptability: proportion of index patients agreeing to HCI; number and proportion of household contacts enumerated, approached, and consenting to testing — measured at time of household visit. • Feasibility: swab collection success among household contacts; proportion of valid test results; proportion of household contacts remaining for and receiving results — measured at time of testing. • Effectiveness proxies: diagnostic yield; number of TB cases detected; number needed to test to identify one case; linkage-to-care among household contacts with positive results — measured at 15 and 30 days post-enrolment. • Adoption: participant and staff satisfaction; perceived sustainability; health department willingness and readiness to incorporate HCI for community-diagnosed index cases — measured via exit survey at time of testing and key-informant interviews within two weeks. • Implementation: fidelity and quality of the diagnostic process, including timeliness of household visits, time to result delivery, and proportion of household contacts successfully provided results — measured throughout the active recruitment period. ;Aim 3 (Cost Analysis): Outcomes measured across the full recruitment period, with final cost estimates calculated at study close-out. Activity-based costs of community-based testing and HCI (start-up, recurrent, and demand-creation); personnel time per test cycle; unit costs per person screened, per TB case detected, and per TB case linked to care — stratified by country and setting. | — |
Countries
South Africa
Contacts
Public ContactRouxjeane Venter
Researcher Project Coordinator
Outcome results
None listed