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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

548 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-01-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Oral HIV Self-Test (OraQuick)

Intervention Type DEVICE

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.

Workplace-based standard HIV Testing Services (HTS)

Standard of care following the HIV testing algorithm .

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Oral HIV Self-Test (OraQuick)

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes