INHIBIT TB - Assessment of household isoniazid preventive therapy (IPT) and point-of-care CD4 testing in a tuberculosis household contact tracing program within South Africa

Assessment of household IPT and point-of-care CD4 testing in a tuberculosis household contact tracing program within South Africa: a cluster randomized trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN88864357

Enrollment

11500

Registered

2013-07-26

Start date

2012-06-01

Completion date

Unknown

Last updated

2019-02-11

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

Conditions

Tuberculosis (TB) Infections and Infestations Tuberculosis

Interventions

We will be evaluating three arms of care. 1. A standard of care (SOC) arm where a TB symptom screening is administered to consenting participants. Participants with any TB symptom will

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Index patient Inclusion Criteria: 1. Age over18 years 2. Sputum smear-positive, culture positive or Xpert MTB/RIF positive 3. Started on TB treatment within the past 3 months 4. Index patient Exclusion Criteria: 4.1. Live alone Household contact inclusion criteria: 1. Any individuals who have been in contact with the index patient and generally sleep and eat in the same household

Exclusion criteria

Exclusion criteria: Household contact exclusion criteria 1. Children under 5 years will not be part of the randomization into the intervention but will be offered standard of care; consent will be asked for record review and follow up 2. Declines to participate and/or refusal to sign informed consent 3. Not available for interview after 3 visits to the household

Design outcomes

Primary

Measure	Time frame
Primary objectives: To compare primary outcomes by arm 1. To determine the effect of point of care CD4 on entry into HIV care for those who are diagnosed HIV positive in the household intervention, as measured by self-report at the three month visit. 2. To determine the effect of providing household IPT on uptake and completion of IPT, as measured at nine months by clinic records for Arm B and by our study pharmacy records for Arm C.	—

Measure

Time frame

Primary objectives: To compare primary outcomes by arm 1. To determine the effect of point of care CD4 on entry into HIV care for those who are diagnosed HIV positive in the household intervention, as measured by self-report at the three month visit. 2. To determine the effect of providing household IPT on uptake and completion of IPT, as measured at nine months by clinic records for Arm B and by our study pharmacy records for Arm C.

—

Secondary

Measure	Time frame
Secondary objectives: 1. To determine effect of point of care CD4 on uptake of HIV testing, as measured by uptake of HIV testing at the baseline visit. 2. To determine the effect of providing cotrimoxazole in households on entry into care, as measured by self-report at the three month visit. 3. To assess TB incidence 6 months after initial home visit, as measured by self-report at the six month visit.	—

Measure

Time frame

Secondary objectives: 1. To determine effect of point of care CD4 on uptake of HIV testing, as measured by uptake of HIV testing at the baseline visit. 2. To determine the effect of providing cotrimoxazole in households on entry into care, as measured by self-report at the three month visit. 3. To assess TB incidence 6 months after initial home visit, as measured by self-report at the six month visit.

—

Countries

South Africa

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026