Workplace-based HIV Self-testing Among Men in Uganda (WISe-Men)

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

Official Title
-----------------
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

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Device: Oral HIV Self-Test (OraQuick)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Workplace-based HIV Self-Testing<br>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 | Device: Oral HIV Self-Test (OraQuick)<br>* The oral HIV self-test is a device for taking a test which is painless. The user gently swipes the test swab along the upper gums once and the lower gums once. The swab is then inserted inside the test tube provided and results are ready in 20 minutes.<br>|
| No Intervention: Workplace-based standard HIV Testing Services (HTS)<br>Standard of care following the HIV testing algorithm . | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV self-testing | Proportion of men who self-report testing after receiving a kit at the workplace | Within one month of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Linkage into HIV care and confirmatory testing following HIV self-testing | Proportion of participants who self report confirmatory testing from a health facility for all participants with a reactive-self test | measured at 1 and 3 months after intervention | 
| Consistent condom use following HIV self-testing | Proportion of participants who use a condom for each sexual encounter in a month. | measured at 1 and 3 months after intervention | 
| Initiation of Antiretroviral Therapy (ART) following a confirmatory HIV test | Proportion of participants who self report ART initiation following a positive result from a confirmatory HIV test result or evidence of an ART card. Data will be collected using a questionnaire. | measured at 1 and 3 months after intervention | 
| Uptake of Voluntary Male Medical Circumcision (VMMC) following HIV self-testing | Proportion of previously uncircumcised participants who self report Voluntary Male Medical Circumcision (VMMC). | measured at 1 and 3 months after intervention | 
| Uptake of PrEP by Most-At-Risk Populations (MARP) following HIV self-testing | Proportion of participants considered as Most-At-Risk Populations (MARP) who initiate Pre-exposure prophylaxis (PrEP) | measured at 1 and 3 months after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV self-testing, Men, Workplace, Security Services, Linkage