Workplace-based HIV Self-testing (HIVST) and Linkage to Care or Prevention Services Among Men in Private Security Services in Uganda: A Cluster Randomized Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Makerere University
- Enrollment
- 548
- Locations
- 2
- Primary Endpoint
- HIV self-testing
Study Overview
Brief Summary
This study seeks to determine whether workplace delivery of HIV self-testing will lead to an increase in uptake of HIV testing and subsequent linkage to care or prevention services among men in Uganda.
Detailed Description
The current coverage of HIV testing and counseling in Uganda is 60% with only 34% of these being men and only about 55% of males living with HIV know their status (MoH, 2016). The challenges with HIV testing require a new focus and new approaches to reach people with undiagnosed HIV infection.
HIV self-testing (HIVST) is one such innovative approach to making testing more accessible to several under-served populations such as men and key populations (WHO, 2013).
In this regard, this study seeks to determine whether providing HIVST in workplace settings will increase the uptake of HIV testing services among men employed in private security services in Uganda and improve linkage to treatment and prevention services.
Design: Cluster randomized trial in two Ugandan districts
Participants: Male employees of private security companies
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Eligibility Criteria:
- •18-60 years old
- •Employed >6 months in the private security company
- •Men who have not tested for HIV before
- •Men who tested HIV >one year ago
Exclusion Criteria
- Not provided
Arms & Interventions
Workplace-based HIV Self-Testing
i. Explain the procedure of conducting HIVST & interpret HIV self- test result to the user.
ii. Demonstrate how to perform the self-test and how to interpret the self-test result.
iii. Provide appointment card including information on linkage for HIV prevention services and further testing for diagnosis among those with a reactive self-test. Participants with a non-reactive self-test will be referred to HIV prevention services.
iv. Provide a toll free number for continued consultation
Intervention: Oral HIV Self-Test (OraQuick) (Device)
Workplace-based standard HIV Testing Services (HTS)
Standard of care following the HIV testing algorithm .
Outcomes
Primary Outcomes
HIV self-testing
Time Frame: Within one month of the intervention
Proportion of men who self-report testing after receiving a kit at the workplace
Secondary Outcomes
- Initiation of Antiretroviral Therapy (ART) following a confirmatory HIV test(measured at 1 and 3 months after intervention)
- Linkage into HIV care and confirmatory testing following HIV self-testing(measured at 1 and 3 months after intervention)
- Consistent condom use following HIV self-testing(measured at 1 and 3 months after intervention)
- Uptake of Voluntary Male Medical Circumcision (VMMC) following HIV self-testing(measured at 1 and 3 months after intervention)
- Uptake of PrEP by Most-At-Risk Populations (MARP) following HIV self-testing(measured at 1 and 3 months after intervention)