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

Primary Purpose

HIV Infections

Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Oral HIV Self-Test (OraQuick)
Sponsored by
Makerere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HIV Infections focused on measuring HIV self-testing, Men, Workplace, Security Services, Linkage

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Security companiesRecruiting
  • Security companiesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Workplace-based HIV Self-Testing

Workplace-based standard HIV Testing Services (HTS)

Arm Description

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

Standard of care following the HIV testing algorithm .

Outcomes

Primary Outcome Measures

HIV self-testing
Proportion of men who self-report testing after receiving a kit at the workplace

Secondary Outcome Measures

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
Consistent condom use following HIV self-testing
Proportion of participants who use a condom for each sexual encounter in a month.
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.
Uptake of Voluntary Male Medical Circumcision (VMMC) following HIV self-testing
Proportion of previously uncircumcised participants who self report Voluntary Male Medical Circumcision (VMMC).
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)

Full Information

First Posted
November 9, 2019
Last Updated
September 14, 2020
Sponsor
Makerere University
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1. Study Identification

Unique Protocol Identification Number
NCT04164433
Brief Title
Workplace-based HIV Self-testing Among Men in Uganda (WISe-Men)
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
December 5, 2020 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Makerere University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV self-testing, Men, Workplace, Security Services, Linkage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
548 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Workplace-based HIV Self-Testing
Arm Type
Experimental
Arm Description
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
Arm Title
Workplace-based standard HIV Testing Services (HTS)
Arm Type
No Intervention
Arm Description
Standard of care following the HIV testing algorithm .
Intervention Type
Device
Intervention Name(s)
Oral HIV Self-Test (OraQuick)
Intervention Description
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.
Primary Outcome Measure Information:
Title
HIV self-testing
Description
Proportion of men who self-report testing after receiving a kit at the workplace
Time Frame
Within one month of the intervention
Secondary Outcome Measure Information:
Title
Linkage into HIV care and confirmatory testing following HIV self-testing
Description
Proportion of participants who self report confirmatory testing from a health facility for all participants with a reactive-self test
Time Frame
measured at 1 and 3 months after intervention
Title
Consistent condom use following HIV self-testing
Description
Proportion of participants who use a condom for each sexual encounter in a month.
Time Frame
measured at 1 and 3 months after intervention
Title
Initiation of Antiretroviral Therapy (ART) following a confirmatory HIV test
Description
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.
Time Frame
measured at 1 and 3 months after intervention
Title
Uptake of Voluntary Male Medical Circumcision (VMMC) following HIV self-testing
Description
Proportion of previously uncircumcised participants who self report Voluntary Male Medical Circumcision (VMMC).
Time Frame
measured at 1 and 3 months after intervention
Title
Uptake of PrEP by Most-At-Risk Populations (MARP) following HIV self-testing
Description
Proportion of participants considered as Most-At-Risk Populations (MARP) who initiate Pre-exposure prophylaxis (PrEP)
Time Frame
measured at 1 and 3 months after intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patience Muwanguzi, PhD
Phone
+256777036811
Email
pamuwanguzi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patience A. Muwanguzi
Organizational Affiliation
Makerere University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nelson K. Sewankambo
Organizational Affiliation
Makerere University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Noah Kiwanuka
Organizational Affiliation
Makerere University
Official's Role
Study Director
Facility Information:
Facility Name
Security companies
City
Hoima
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Racheal Nabunya, BSN
First Name & Middle Initial & Last Name & Degree
Patience A. Muwanguzi, PhD
Facility Name
Security companies
City
Kampala
Country
Uganda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Racheal Nabunya, BSN
First Name & Middle Initial & Last Name & Degree
Patience Muwanguzi, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34723826
Citation
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.
Results Reference
derived
PubMed Identifier
33883157
Citation
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.
Results Reference
derived
Links:
URL
http://www.unaids.org/sites/default/files/country/documents/UGA_2017_countryreport.pdf
Description
The Uganda HIV and AIDS country progress report July 2015-June 2016
URL
http://apps.who.int/iris/bitstream/handle/10665/85267/9789241505628_eng.pdf;jsessionid=22DEE411C5D604E96F5601F74A42BA89?sequence=1
Description
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

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

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