HIV InfectionsNCT04164433
Workplace-based HIV Self-testing Among Men in Uganda (WISe-Men)
A study testing Oral HIV Self-Test (OraQuick) in people with HIV Infections, run by Makerere University at 2 sites in Uganda.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Oral HIV Self-Test (OraQuick)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 548 participants
- Where
- 2 sitesUganda
- Study dates
- 1 Feb 2020to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
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
Trial locations and contacts
2 sites in 1 country.
Uganda2 sites, 2 recruiting
- Recruiting
Security companies
Hoima
Racheal Nabunya, BSN
Patience A. Muwanguzi, PhD
- Recruiting
Security companies
Kampala
Racheal Nabunya, BSN
Patience Muwanguzi, PhD
About this study
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
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.
Read the 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
- Conditions
- HIV Infections
- Being tested
- Oral HIV Self-Test (OraQuick)
- Keywords
- HIV self-testing, Men, Workplace, Security Services, Linkage
- Medical subject headings
- HIV Infections, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Oral HIV Self-Test (OraQuick) |
| Workplace-based standard HIV Testing Services (HTS) | No intervention | Standard of care following the HIV testing algorithm . |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV self-testing
Proportion of men who self-report testing after receiving a kit at the workplace
Measured: Within one month of the intervention
Secondary outcomes (5)
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: 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: 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: 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: 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: measured at 1 and 3 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start1 Feb 2020
- Primary completion5 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 548 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patience A. Muwanguzi, Principal investigator, Makerere UniversityNelson K. Sewankambo, Study director, Makerere UniversityNoah Kiwanuka, Study director, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164433
- Sponsor's protocol ID
- SHSREC 2018-054
- Other IDs
- HS 2672
- Status last verified
- Sep 2020
- First submitted
- 9 Nov 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34723826Muwanguzi 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.
PubMed 33883157
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04164433
- Acronym / sponsor ID
- SHSREC 2018-054
- Conditions
- HIV Infections
- Keywords
- HIV self-testing, Men, Workplace, Security Services, Linkage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 548 participants (estimated)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 5 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Workplace-based HIV Self-Testing | Experimental | Device: Oral HIV Self-Test (OraQuick)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 |
| Workplace-based standard HIV Testing Services (HTS) | No intervention | –Standard of care following the HIV testing algorithm . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Workplace-based HIV Self-Testing |
Primary outcome
HIV self-testing
Time frame: Within one month of the intervention
Proportion of men who self-report testing after receiving a kit at the workplace
5 secondary outcomes
Linkage into HIV care and confirmatory testing following HIV self-testing
Time frame: measured at 1 and 3 months after intervention
Consistent condom use following HIV self-testing
Time frame: measured at 1 and 3 months after intervention
Initiation of Antiretroviral Therapy (ART) following a confirmatory HIV test
Time frame: measured at 1 and 3 months after intervention
Uptake of Voluntary Male Medical Circumcision (VMMC) following HIV self-testing
Time frame: measured at 1 and 3 months after intervention
Uptake of PrEP by Most-At-Risk Populations (MARP) following HIV self-testing
Time frame: measured at 1 and 3 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 34723826Muwanguzi 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.
- Derived from this study: PubMed 33883157Muwanguzi 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.
- The Uganda HIV and AIDS country progress report July 2015-June 2016Link provided by the sponsor.
- 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-upLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patience A. Muwanguzi principal investigator
Makerere University
Nelson K. Sewankambo study director
Makerere University
Noah Kiwanuka study director
Makerere University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral HIV Self-Test (OraQuick) in people with HIV Infections, run by Makerere University at 2 sites in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patience Muwanguzi, PhD (+256777036811, pamuwanguzi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV self-testing (time frame: Within one month of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04164433, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.