Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN02004005
Enrollment
13500
Registered
2012-02-29
Start date
2012-03-01
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV)/Tuberculosis (TB) Infections and Infestations Human immunodeficiency virus (HIV) disease/Tuberculosis

Interventions

Intervention versus Standard of Care (SOC) Intervention: 1. Provision of access to home-based HIV testing and counselling and tuberculosis (TB) symptom screening, incl

Sponsors

London School of Hygiene and Tropical Medicine (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The case-notification rate of bacteriologically-confirmed TB in adult (16 yrs or older) cluster residents, in months 7 to 31 of intervention

Secondary

MeasureTime frame
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)

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026