Clinical trial NCT04164433: 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
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Keywords: HIV self-testing
Men
Workplace
Security Services
Linkage
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 548
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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

Primary outcomes:
measure: HIV self-testing
timeFrame: Within one month of the intervention
Secondary outcomes:
measure: Linkage into HIV care and confirmatory testing following HIV self-testing
timeFrame: measured at 1 and 3 months after intervention
measure: Consistent condom use following HIV self-testing
timeFrame: measured at 1 and 3 months after intervention
measure: Initiation of Antiretroviral Therapy (ART) following a confirmatory HIV test
timeFrame: measured at 1 and 3 months after intervention
measure: Uptake of Voluntary Male Medical Circumcision (VMMC) following HIV self-testing
timeFrame: measured at 1 and 3 months after intervention
measure: Uptake of PrEP by Most-At-Risk Populations (MARP) following HIV self-testing
timeFrame: measured at 1 and 3 months after intervention
Other outcomes:
Locations:
city: Hoima
country: Uganda
facility: Security companies
city: Kampala
country: Uganda
facility: Security companies
Study officials:
affiliation: Makerere University
name: Patience A. Muwanguzi
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Nelson K. Sewankambo
role: STUDY_DIRECTOR
affiliation: Makerere University
name: Noah Kiwanuka
role: STUDY_DIRECTOR
References:
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.
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.