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

NCT04164433 | Unknown

• 2 other identifiers: SHSREC 2018-054HS 2672
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 2

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.

Conditions

HIV Infections

Keywords

HIV self-testing; Men; Workplace; Security Services; Linkage

Outcome Measures

Primary Outcomes (1)

• HIV self-testing

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

  Within one month of the intervention

Secondary Outcomes (5)

• Linkage into HIV care and confirmatory testing following HIV self-testing

  measured at 1 and 3 months after intervention

• Consistent condom use following HIV self-testing

  measured at 1 and 3 months after intervention

• Initiation of Antiretroviral Therapy (ART) following a confirmatory HIV test

  measured at 1 and 3 months after intervention

• Uptake of Voluntary Male Medical Circumcision (VMMC) following HIV self-testing

  measured at 1 and 3 months after intervention

• Uptake of PrEP by Most-At-Risk Populations (MARP) following HIV self-testing

  measured at 1 and 3 months after intervention

Study Arms (2)

Workplace-based HIV Self-Testing

EXPERIMENTAL

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)

Workplace-based standard HIV Testing Services (HTS)

NO INTERVENTION

Standard of care following the HIV testing algorithm .

Interventions

Oral HIV Self-Test (OraQuick) 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 HIV Self-Testing

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Makerere University: lead

Study Sites (2)

Security companies

Hoima, Uganda

RECRUITING

Security companies

Kampala, Uganda

RECRUITING

Related Publications (2)

• 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.

  PMID: 34723826 DERIVED

• 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.

  PMID: 33883157 DERIVED

Related 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

MeSH Terms

Conditions

HIV Infections; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Patience A. Muwanguzi

  Makerere University

  PRINCIPAL INVESTIGATOR

• Nelson K. Sewankambo

  Makerere University

  STUDY DIRECTOR

• Noah Kiwanuka

  Makerere University

  STUDY DIRECTOR

Central Study Contacts

Patience Muwanguzi, PhD

CONTACT

+256777036811; pamuwanguzi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2019
• First Posted: November 15, 2019
• Study Start: February 1, 2020
• Primary Completion: December 5, 2020
• Study Completion: January 31, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

UG (2)