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
| ISRCTN | ISRCTN88864357 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88864357 |
| Secondary identifying numbers | INHIBIT TB - AUR2-7-115 |
- Submission date
- 12/07/2013
- Registration date
- 26/07/2013
- Last edited
- 24/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
The Aurum Institute
29 Queens Road
Parktown
Johannesburg
2193
South Africa
Study information
| Study design | Stratified cluster randomized trial with the randomization occurring at household level |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | INHIBIT TB |
| Study objectives | 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(s) | University of the Witwatersrand, Human Research Ethics Commitee: Ref number: M120493 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cotrimoxazole, Isoniazid |
| Primary outcome measure | 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 study start date | 01/06/2012 |
| Completion date | 01/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 11500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 01/07/2014 |
Locations
Countries of recruitment
- South Africa
Study participating centre
2193
South Africa
Sponsor information
Industry
Sanofi-Aventis House
2 Bond Street Private Bag X 207
Midrand
Johannesburg
1683
South Africa
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 02/03/2018 | 24/01/2019 | Yes | No |
Editorial Notes
24/01/2019: Publication reference added
