Condition category
Infections and Infestations
Date applied
12/07/2013
Date assigned
26/07/2013
Last edited
26/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Contact tracing for tuberculosis (TB) involves visiting the home of TB patients who agree, in order to screen other household members for HIV and TB. Those found to have previously undiagnosed HIV are then referred for a CD4 count (that measures the level of a substance called CD4 in the blood) to decide whether or not they need antiretroviral therapy (drug therapy) and for access to preventive medication including isoniazid and co-trimoxazole. We want to know whether finding out the CD4 count instantly using a point-of-care machine in the household increases the chance that people newly diagnosed with HIV attend a clinic for care. We also want to know whether provision of isoniazid to the household will increase usage and completion of this important preventive therapy that reduces the risk of TB.

Who can participate?
Newly diagnosed adult TB patients in two districts of South Africa and their household members.

What does the study involve?
TB patients will be told about the study in the TB clinic and if they are eligible and consent, their household will be recruited to the study and randomly allocated to one of three groups: A, B and C. The household will then be visited and consenting household members screened for TB and HIV. All households will then be re-visited three and six months later to find out whether care was sought and if so, from where. Those diagnosed as HIV infected in households allocated to group B will also receive an immediate CD4 count. In addition, those in group C will be able to receive a course of either co-trimoxazole (if their CD4 count is <350) or isoniazid (CD4 count >350) monthly in their homes if they consent. Group A receives standard care.

What are the possible benefits and risks of participating?
All participating household members will be screened for TB and HIV, increasing their chances of receiving important care. Those diagnosed as HIV infected in households allocated to groups B or C will also receive additional treatment designed to improve their care. The main risk of participating is possible new knowledge of HIV or TB status, which may be psychologically distressing for participants.

Where is the study run from?
The Aurum Institute in Johannesburg, South Africa, in collaboration with the London School of Hygiene and Tropical Medicine, UK.

When is study starting and how long is it expected to run for?
The study has started recruiting in 2013 and will continue until early 2014. Follow-up will continue for another six months after this.

Who is funding the study?
Sanofi-Aventis, South Africa.

Who is the main contact?
Dr Liesl Page-Shipp, lpageshipp@auruminstitute.org
Dr James Lewis, james.lewis@lshtm.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Liesl Page-Shipp

ORCID ID

Contact details

The Aurum Institute
29 Queens Road
Parktown
Johannesburg
2193
South Africa

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

INHIBIT TB - AUR2-7-115

Study information

Scientific title

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

Acronym

INHIBIT TB

Study hypothesis

1. By introducing a rapid point of care (POC) CD4, the median time from enrollment to antiretroviral therapy (ART) initiation would be reudced primarily because of a reduction in the median time taken to complete CD4 staging.
2. IPT would work well in households that are TB contact traced because household contacts are likely to be healthier and thus eligible for IPT, they would also not need to visit the clinic to obtain IPT, thus limiting their exposure to infectious TB patients.

Ethics approval

University of the Witwatersrand, Human Research Ethics Commitee: Ref number: M120493

Study design

Stratified cluster randomized trial with the randomization occurring at household level

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tuberculosis (TB)

Intervention

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 be asked to provide sputum for laboratory testing. Participants with TB positive results will be contacted. Contacts less than 5 years will be referred for exclusion of active TB and management as per South African (SA) guidelines.
2. The second arm is similar to the SOC arm with the addition of a rapid point-of-care (POC) CD4 test for patients who test HIV positive.
3. The third arm which provides SOC, POC CD4 and either cotrimoxazole (CMX) for 3 months if CD4<350 or isoniazid preventative therapy (IPT) if CD4 ≥350 to participants with no TB symptoms.

Intervention type

Drug

Phase

Not Applicable

Drug names

Cotrimoxazole, Isoniazid

Primary outcome measures

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 outcome measures

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.

Overall trial start date

01/06/2012

Overall trial end date

01/07/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

11500

Participant 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

Recruitment start date

01/06/2012

Recruitment end date

01/07/2014

Locations

Countries of recruitment

South Africa

Trial participating centre

The Aurum Institute
Johannesburg
2193
South Africa

Sponsor information

Organisation

Sanofi Aventis South Africa (Pty) Ltd (South Africa)

Sponsor details

Sanofi-Aventis House
2 Bond Street Private Bag X 207
Midrand
Johannesburg
1683
South Africa

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Sanofi Aventis South Africa (Pty) Ltd, South Africa

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes