Tuberculosis Clinical Trial
— IPTOfficial title:
Feasibility and Effectiveness of Community Based Isoniazid Preventive Therapy in Kenya
Verified date | May 2013 |
Source | KNCV Tuberculosis Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | Kenya: Kenya Medical Research Institute |
Study type | Interventional |
Isoniazid preventive therapy (IPT) is a well studied clinical intervention for primary and
secondary prevention of active tuberculosis (TB) after infection with Mycobacterium
tuberculosis. It is widely used in industrialized countries in TB outbreak management,
focusing on high risk groups such as close contacts in the family, in congregate settings,
and in the workplace amongst others. Individuals infected with Human Immunodeficiency Virus
(HIV) have a markedly higher risk of acquiring a TB-infection and developing consequently
active TB, making HIV-infected individuals a target population for IPT. Studies of IPT in
HIV infected persons in the nineties demonstrated the efficacy of IPT in the prevention of
active TB in Sub -Saharan Africa and more recent studies suggest that the protective effect
remains present in individuals on antiretroviral therapy.
Despite the proven efficacy of IPT this intervention has not been taken up by most HIV and
TB control programmes in Africa where the burden of TB/HIV is highest. The reasons for the
low uptake of IPT are many and varied but include fears of expansion of isoniazid resistance
and subsequently the development of multi -drug resistant TB with widespread use of IPT.
Additionally screening protocols for excluding active TB and selecting persons for IPT have
not been uniformly agreed upon. There have also been concerns that programmes designed to
provide IPT may shift TB control programmes from their primary responsibility of finding and
treating active TB. Finally it has been unclear as to which programme, between the HIV and
the TB control programme, has the primary responsibility of managing the provision of the
IPT intervention.
The World Health Organization and other technical agencies engaged in global TB control have
recently re-emphasized the need to scale up IPT. In this proposal we outline an operational
research study to evaluate the introduction of IPT at community level and to measure its
effectiveness at preventing TB. The study is based on the context of expansion of
Community-Based Direct Observed Therapy Short Course (CB-DOTS), home-based care and the
concept of HIV prevention with positives (PwPs), where there is a real opportunity to focus
on the household as a source of HIV-associated tuberculosis.
The study is designed as a cluster randomized trial. It compares the incidence of TB in
household contacts including children under 5 of identified TB/HIV co-infected patients, who
received IPT through proactive community intervention and those in a control group where the
community was handled in the "usual way". In the intervention group household contacts of
index cases of HIV positive, smear positive PTB will be visited at home and consenting
contacts will be screened for active TB using a simple questionnaire. Those found to be fit
will receive isoniazid 300mg (5 mg per Kg for children) once daily for 6 months, regardless
of the HIV-status. Those found not to be fit will be referred for further evaluation at the
nearest TB diagnostic centre. In the control group, routine care following national
guidelines will be offered. This consists of contact invitation and assessment of
eligibility for IPT, especially, in children less than 5 years. Both groups will be followed
up monthly through household visits. Follow up will be for a total of 24 months including
the six months when IPT is provided.
A confidential HIV screening test will be provided to all consenting contacts in both
intervention and control group after appropriate counseling.
The primary outcome is the incidence of TB in the intervention and control household
contacts. The difference in incidence between the two groups is a measure of efficacy of the
intervention. In addition the efficacy of the intervention will be estimated stratified by
HIV status of household contacts if data allows. Secondary outcomes are the incidence of
adverse events, the incidence of TB-related symptoms, measures on the uptake of IPT
(proportion of contacts starting and discontinuing IPT, treatment adherence) and
programmatic indicators, i.e. percentage of persons eligible for IPT and resources needed.
Status | Completed |
Enrollment | 1259 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 15 Years and older |
Eligibility |
Index cases - New sputum smear positive pulmonary tuberculosis (PTB) patients initiating treatment for TB - HIV infected - Resident in the catchment area of the TB diagnostic facility - Written informed consent - Age equal or greater than 15 years. Contacts - Household contacts of a HIV infected smear positive PTB - No plans to relocate to another area for at least the next two years - Asymptomatic (Fit) with no cough in last 2 weeks, fever, weight loss (or failure to gain weight in children), haemoptysis or chronic diarrhea at least for the last one month. - Written informed consent |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Kenya | KAPSABET District Hospital | Kapsabet-Nandi | North Rift |
Kenya | NYALENDA | Kisumu district | Nyanza North |
Kenya | Makuyu H/C | Makuyu-Muranga | Central |
Kenya | Kadem leprosy, Migori | Migori District | Nyanza South |
Kenya | Muhuru Health centre, Migori | Migori District | Nyanza South |
Kenya | Blue House, Mathare | Nairobi | Nairobi South |
Kenya | Huruma Lions -Central district | Nairobi | Nairobi North |
Kenya | Jericho HC | Nairobi | Nairobi South |
Kenya | Kangemi HC | Nairobi | Nairobi North |
Kenya | Kibera AMREF | Nairobi | Nairobi South |
Kenya | MMM, Mukuru, Embakasi | Nairobi | Nairobi South |
Kenya | Pumwani Majengo H/C | Nairobi | Nairobi South |
Kenya | Remand H/C | Nairobi | Nairobi South |
Kenya | Soweto Kayole, Embakasi | Nairobi | Nairobi South |
Kenya | Lanet | Nakuru | RVS |
Kenya | Nakuru West | Nakuru | RVS |
Kenya | Narok District Hosp | Narok | RVS |
Kenya | Awendo SDH | Rongo district | Nyanza South |
Lead Sponsor | Collaborator |
---|---|
KNCV Tuberculosis Foundation | Centres for Disease Control and Prevention, Kenya., Division of Leprosy Tuberculosis and Lung Disease, MOPHS, Kenya, Kenya Medical Research Institute, Kenya National AIDS & STI Control Programme, Ministry of Public Health and Sanitation, Kenya, Stichting Mondiale Tuberculose (SMT) |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence of TB in household contacts | 12, 18, 24 months | No | |
Secondary | incidence of adverse events in household contacts | 12, 18, 24 months | Yes | |
Secondary | incidence of TB-related symptoms in household contacts | 12, 18, 24 months | No | |
Secondary | proportion of household contacts starting IPT | 12, 18, 24 months | No | |
Secondary | proportion of household contacts discontinuing IPT | 12, 18, 24 months | No | |
Secondary | proportion of household contacts adhering to IPT treatment | 12, 18, 24 months | No |
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