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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04164433
• Other study ID #: SHSREC 2018-054
• Secondary ID: HS 2672
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: September 2020
• Source: Makerere University
• Contact: Patience Muwanguzi, PhD
• Phone: +256777036811
• Email: pamuwanguzi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 548
• Est. completion date: January 31, 2021
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Uganda	Security companies	Hoima
Uganda	Security companies	Kampala

Sponsors (1)

Lead Sponsor	Collaborator
Makerere University

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV self-testing	Proportion of men who self-report testing after receiving a kit at the workplace	Within one month of the intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Report on the first international symposium on self-testing for HIV: The legal, ethical, gender, human rights and public health implications of self-testing scale-up
•   The Uganda HIV and AIDS country progress report July 2015-June 2016