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Intensified HIV / TB prevention linking home-based HIV testing, including the option of self-testing, with HIV care
ISRCTN ISRCTN02004005
DOI 10.1186/ISRCTN02004005
ClinicalTrials.gov identifier
EudraCT number
Public title Intensified HIV / TB prevention linking home-based HIV testing, including the option of self-testing, with HIV care
Scientific title Intensified HIV / TB prevention linking home-based HIV testing, including the option of self-testing, with HIV care: a cluster-randomised trial in Blantyre, Malawi
Acronym N/A
Serial number at source 1.1
Study hypothesis A package of care including:
1. Convenient local access to home-based human immunodeficiency virus (HIV) self-testing, provided with generic (not results based) counselling and
2. Facilitated access to HIV care including isoniazid preventive therapy and routine antiretroviral therapy (ART), will have sufficient impact on the uptake and timeliness of HIV diagnosis and care to result in population-level reduction in TB incidence and untreated HIV infections.
Lay summary Background and study aims
All countries in Southern Africa, including Malawi, have been affected by greatly increasing rates of tuberculosis (TB) because of the Human immunodeficiency virus (HIV) epidemic. People with HIV infection have a high risk of getting sick with TB if they become infected. In countries where both TB and HIV infection are common, such as Malawi, about one third of adults have TB infection in the body (latent TB infection) and most TB patients are HIV positive. People with HIV can be protected from TB using drugs to treat their HIV (antiretroviral treatment), or drugs to treat latent TB infection. However, uptake and frequency of HIV testing through routine services remains too low to identify HIV before the onset of TB in many patients, and when HIV is diagnosed many patients delay seeking care for many months or even years.
The aim of this study is to investigate whether or not local HIV testing and counselling services will increase knowledge of HIV status and encourage early entry into HIV care leading to fewer new episodes of TB among the entire community. HIV testing will include the option of self-testing for HIV at home and in private. HIV care will be provided through the routine public health services, but with the addition of a drug (isoniazid) provided by the study team to prevent TB.
28 neighbourhoods of about 1,200 adult residents will be randomly allocated to one of two groups: one group of 14 neighbourhoods will receiving the self-testing intervention; one group of 14 neighbourhoods will receive standard care. Each neighbourhood will be followed up for two and half years, with recording of all TB cases and adult deaths. A survey at the end of two and half years will investigate the amount of undiagnosed HIV left after the study.

Who can participate
All adults living in the 14 neighbourhoods that receive the self-testing intervention.

What does the study involve?
Adults from the intervention neighbourhoods will be offered local HIV test services from the house of one of their neighbours who will be trained as a resident community counsellor. Residents will be able to bring their partners so that they can test together. Each resident will be able to receive two HIV tests in the first year of study, and can choose to self-test in private without having to disclose their results. TB symptom screening will be carried out with HIV counselling before the test. After the test, community counsellors will provide information that can be given without knowing the result. All participants will be advised to go to their local primary care clinic for confirmatory testing for HIV and HIV care if their self-test was positive. All participants will be provided with information and a ‘self-referral’ slip to encourage them to access local HIV care services. Antiretroviral treatment will be provided through national HIV care services. HIV positive adults for the intervention neighbourhoods will be offered isoniazid preventive therapy (which is national policy, but not yet implemented in Malawi) as part of their routine HIV care.
Addresses from TB patients registering for treatment with the routine health services will be used to identify whether or not they live in a study cluster. 4 volunteers will be recruited from each of the study neighbourhoods to meet regularly with study staff. Volunteers will report any deaths occurring in their neighbourhood. Households will be visited when a death occurs in order to interview the main carer about the circumstances leading up to the person’s death.

What are the possible benefits and risks for participating?
Having an HIV test is stressful, and some people find it difficult to cope after a positive result. Some studies have shown that relationships can suffer, including a risk of violence, if one partner is found to be HIV-positive. There is very little known about self-testing for HIV, but there may be an increased risk of not coping when people decide to self-test and then find themselves to be HIV positive without a counsellor there to help them. People who are HIV infected are less likely to die or suffer serious illnesses if they find out and start taking treatment before their HIV infection is very advanced. Isoniazid preventive therapy is international standard of care for people living with HIV, and reduces the risk of getting sick with TB. There is a small risk of side effects, including inflammation of the liver.

Where is the study run from
The study neighbourhoods are all in poor suburbs in the City of Blantyre, Malawi. The study is run from the Malawi-Liverpool-Wellcome Trust Clinical Research Programme and the College of Medicine, both of which are in Blantyre, Malawi, and is supported from the London School of Hygiene and Tropical Medicine and Liverpool School of Tropical Medicine, in the UK.

When is the study starting and how long is it expected to run for?
The study will start on the March 1, 2012. It will run until Sept 30, 2015.

Who is funding the study?
The Wellcome Trust, London, UK

Who is the main contact?
Dr Liz Corbett
liz.corbett@lshtm.ac.uk
Ethics approval 1. College of Medicine Research Ethics (COMREC), 1st April 2011, ref: P02/11/1037
2. London School of Hygiene and Tropical Medicine (LSHTM), 6th Sept 2011, ref: 6021
Study design Cluster randomised trial
Countries of recruitment Malawi
Disease/condition/study domain Human immunodeficiency virus (HIV) / Tuberculosis (TB)
Participants - inclusion criteria Home-based HIV testing and counselling:
1. Age 16 years or above
2. Usual residence within a study cluster
3. Able and willing to provide written or witnessed informed consent to HTC, either as standard counsellor-provided or as supervised self-testing

Supervised self-testing only:
1. Attends in person to collect kit
2. Passes a test of understanding
3. Agrees to return test kit packaging and the used kit in a sealed envelope
4. Agrees to receive post-test health information
Participants - exclusion criteria 1. Age 15 years or below
2. Usual residence outside of the intervention cluster
3. Has tested previously on 2 occasions under the community counsellor system
Anticipated start date 01/03/2012
Anticipated end date 30/09/2015
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants The aim is to achieve uptake of HIV testing by 80% of intervention arm cluster residents (~13,500) and linkage into HIV care (IPT with or without ART) for 80% of HIV-positive adult cluster residents
Interventions Intervention versus Standard of Care (SOC)

Intervention:
1. Provision of access to home-based HIV testing and counselling and tuberculosis (TB) symptom screening, including the option of self-testing (without need to disclose results), through resident community counsellors
2. Faciliated access into routine facility-based HIV and TB care services through use of a "self-referral" card and post-test information provided at the time of community-based HIV testing and counselling
3. Delivery of isoniazid preventive therapy (300mg once daily for 6 months) and pyridoxine (25mg once daily while taking IPT) through the existing facility-based routine HIV care services for all intervention-arm adult cluster residents accessing local HIV care services.

SOC: Routine facility-based access to HIV testing and care services

All clusters - adult residents will be followed for TB over 2.5 years, ending with an HIV/TB survey in month 31.
Primary outcome measure(s) Comparison between randomisation arms of the case-notification rate of bacteriologically-confirmed TB in adult (16 yrs or older) cluster residents, in months 7 to 31 of intervention
Secondary outcome measure(s) Comparison between randomisation arms of: -
1. The case-notification rate of bacteriologically-confirmed TB in HIV-positive adult residents in months 7 to 31 of intervention. This analysis will use cluster-specific HIV prevalence estimate from a post-intervention HIV/TB prevalence survey as the denominator
2. The prevalence of HIV infection that, by self-report, is either undiagnosed (no previous positive HIV test) or not being treated [neither antiretroviral therapy (ART), nor cotrimoxazole nor isoniazid preventive therapy (IPT)] at the time of the post-intervention prevalence survey (month 31 after the start of intervention)
Sources of funding Wellcome Trust (UK) - Senior Fellowship Renewal (GR014469)
Trial website
Publications
Contact name Dr  Elizabeth  Corbett
  Address Clinical Research Department
London School of Hygiene and Tropical Medicine
Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Email Liz.corbett@lshtm.ac.uk
Sponsor London School of Hygiene and Tropical Medicine (UK)
  Address Keppel Street
  City/town London
  Zip/Postcode WC1E 7HT
  Country United Kingdom
  Tel +44 (0)20 7927 2626
  Fax +44 (0)20 7580 5636
  Email patricia.henley@lshtm.ac.uk
  Sponsor website: http://www.lshtm.ac.uk/
Date applied 26/02/2012
Last edited 22/05/2012
Date ISRCTN assigned 29/02/2012
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