Intensified HIV/TB prevention linking home-based HIV testing, including the option of self-testing, with HIV care

Plain English summary of protocol

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.

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

What does the study involve?
28 neighbourhoods of about 1,200 adult residents are randomly allocated to one of two groups: one group of 14 neighbourhoods receiving the self-testing intervention; one group of 14 neighbourhoods receive standard care. Each neighbourhood is 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 investigates the amount of undiagnosed HIV left after the study. Adults from the intervention neighbourhoods are offered local HIV test services from the house of one of their neighbours who is trained as a resident community counsellor. Residents are able to bring their partners so that they can test together. Each resident is 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 is carried out with HIV counselling before the test. After the test, community counsellors provide information that can be given without knowing the result. All participants are 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 are provided with information and a ‘self-referral’ slip to encourage them to access local HIV care services. Antiretroviral treatment is provided through national HIV care services. HIV-positive adults for the intervention neighbourhoods are 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 are used to identify whether or not they live in a study cluster. Four volunteers are recruited from each of the study neighbourhoods to meet regularly with study staff. Volunteers report any deaths occurring in their neighbourhood. Households are 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?
March 2012 to September 2015

Who is funding the study?
The Wellcome Trust (UK)

Who is the main contact?
Dr Liz Corbett
liz.corbett@lshtm.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Malawi
• United Kingdom

Study participating centre

Sponsor information

London School of Hygiene and Tropical Medicine (UK)
University/education

Keppel Street
London
WC1E 7HT
England
United Kingdom

Phone	+44 (0)20 7927 2626
Email	patricia.henley@lshtm.ac.uk
Website	http://www.lshtm.ac.uk/
"ROR"	https://ror.org/00a0jsq62

Funders

Funder type

Charity

Results and Publications

Study outputs

Editorial Notes

17/07/2020: Publication reference added.
15/11/2017: Publication reference added.
16/06/2017: Publication reference added.
23/03/2017: Publication references added.