Home-based Plus Self-testing to Improve HIV Testing Coverage in Rural Lesotho - a Cluster Randomized Controlled Trial in Rural Lesotho.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 10,000
- Locations
- 2
- Primary Endpoint
- HIV testing coverage
Study Overview
Brief Summary
This cluster-randomized trial aims to evaluate the efficacy of the use of oral HIV self-testing (HIVST) among individuals who are absent or who decline HIV testing during home-based HIV testing
Detailed Description
By launching the 90-90-90 strategy UNAIDS has shown a way forward in controlling and finally eradicating the deadly AIDS epidemic. Recent global data shows that progress towards the first UNAIDS target, i.e. to ensure that 90% of HIV-positive individuals are aware of their status, is lower than progress in other areas of the HIV care cascade. It is estimated that still approximately 2.7 million HIV-positive people do not know their HIV status.
Home- or community-based HIV testing has been proven to be very effective in resource-limited settings and therefore is a key strategy endorsed by WHO. Although acceptance of testing during such campaigns is usually very high, coverage remains low due to absent household members. And usually these absent people are men and young adults - both of which have a disproportionately high risk of HIV acquisition and poorer clinical outcomes once infected.
Oral HIV self-testing (HIVST) has shown to be an accurate diagnostic tool with a high acceptance and feasibility in sub-Saharan Africa. Experiences from the sub-Saharan region suggest that when HIV self-testing is provided as part of a home-based HIV testing campaigns, it can increase uptake of testing and facilitate linkage to care, especially among individuals who are at high risk of HIV infection.
The HOSENG study is linked to a follow-up trial, the VIBRA study. Together they are called the GET ON ("GETing tOwards Ninety") research project. The HOSENG study with its home-based HIV testing campaign provides the platform for the VIBRA study.
The HOSENG study is a cluster randomized, parallel-group (1:1:1:1 allocation), open-label, superiority, prospective clinical trial. Clusters are stratified by district, size of village, and village access to the nearest health facility.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
HIV testing coverage
Time Frame: within 120 days after enrolment (i.e. HTS campaign)
HIV testing coverage among individuals aged 12 years or older in the surveyed area within 120 days after the HIV testing and service (HTS) campaign, defined as the proportion of all individuals 12 years or older living in a household of the surveyed area with a confirmed HIV test result
Secondary Outcomes
- HIV testing coverage among adolescents and young adults (ADORE nested study outcome)(within 120 days after enrolment (i.e. HTS campaign))
- Blood-based HIV testing uptake(at enrolment (i.e. HTS campaign))
- Overall HIV testing coverage(within 120 days after enrolment (i.e. HTS campaign))
- Oral HIVST uptake using OraQuick(at enrolment (i.e. HTS campaign) and within 120 days after enrolment (i.e. HTS campaign))
Investigators
Tracy Glass
Head of Statistics, Principal Investigator
Swiss Tropical & Public Health Institute