"Bridging the gap". Evaluating new rapid diagnostic tests for Mycobacterium tuberculosis (MTB) disease

Preventing adverse outcomes in smear negative TB suspects in the era of collaborative TB and HIV programmes: the contribution of new TB diagnostics

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR201106000288379

Enrollment

496

Registered

2011-04-12

Start date

2011-04-07

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Tuberculosis

Interventions

second line TB testing with Genexpert test

Second line fluorescent microscopy in smear negative TB suspects

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for the trial: ¿ TB suspect with cough for 2 or more weeks; ¿ Age 16 years or above; ¿ Usual residence within catchment area for local clinic; ¿ Able and willing to participate in answering questions, and providing sputum and blood specimen for storage and HIV testing; ¿ Willing to consent to study follow-up at 3 months, with a home visit if necessary; ¿ Able and willing to provide informed written consent.

Exclusion criteria

Exclusion criteria: ¿ Age 15 years or younger ¿ Usual residence anywhere other than in catchment area of local clinic ¿ Unable to unwilling to answer questions ¿ Unable or unwilling to provide written informed consent or samples

Design outcomes

Primary

Measure	Time frame
Risk for adverse events (death, IRIS and delayed TB diagnosis)	—

Secondary

Measure	Time frame
Time to treatment initiation	—

Countries

Zimbabwe

Contacts

Public ContactLucy Mupfumi

researcher

lmupfumi@gmail.com002634735000/2

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026