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

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

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.

Study Overview

• Status: Unknown
• Conditions: HIV Infections
• Intervention / Treatment: Device: Oral HIV Self-Test (OraQuick)

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 Type: Interventional
• Enrollment (Anticipated): 548
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Hoima, Uganda
    • Recruiting
    • Security companies
    • Contact: Racheal Nabunya, BSN
    • Principal Investigator: Patience A. Muwanguzi, PhD
  • Kampala, Uganda
    • Recruiting
    • Security companies
    • Contact: Racheal Nabunya, BSN
    • Principal Investigator: Patience Muwanguzi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
No Intervention: Workplace-based standard HIV Testing Services (HTS); 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

Collaborators and Investigators

• Sponsor: Makerere University
• Investigators: Principal Investigator: Patience A. Muwanguzi, Makerere University; Study Director: Nelson K. Sewankambo, Makerere University; Study Director: Noah Kiwanuka, Makerere University

Publications and helpful links

General Publications

• Muwanguzi PA, Ngabirano TD, Kiwanuka N, Nelson LE, Nasuuna EM, Osingada CP, Nabunya R, Nakanjako D, Sewankambo NK. The Effects of Workplace-Based HIV Self-testing on Uptake of Testing and Linkage to HIV Care or Prevention by Men in Uganda (WISe-Men): Protocol for a Cluster Randomized Trial. JMIR Res Protoc. 2021 Nov 1;10(11):e25099. doi: 10.2196/25099.
• Muwanguzi PA, Kutyabami P, Osingada CP, Nasuuna EM, Kitutu FE, Ngabirano TD, Nankumbi J, Muhindo R, Kabiri L, Namutebi M, Nabunya R, Kiwanuka N, Sewankambo N. Conducting an ongoing HIV clinical trial during the COVID-19 pandemic in Uganda: a qualitative study of research team and participants' experiences and lessons learnt. BMJ Open. 2021 Apr 21;11(4):e048825. doi: 10.1136/bmjopen-2021-048825.

Helpful Links

• The Uganda HIV and AIDS country progress report July 2015-June 2016
• 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

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Anticipated): December 5, 2020
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: November 9, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Workplace; HIV self-testing; Men; Linkage; Security Services
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: SHSREC 2018-054; HS 2672 (Other Identifier: Uganda National Council of Science and Technology)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No