Human Immunodeficiency VirusNCT04431154
Incentives to Promote Sustained Linkage to HIV Care
A study testing Provision of HIV self-screen kit with incentives and linkage promotion in people with Human Immunodeficiency Virus and HIV/AIDS, run by University of Pennsylvania at 1 site in South Africa.
Trial summary
This study aims to test if small incentives promote linkage to care and 6-month viral suppression among individuals recently tested for HIV at selected sites within Johannesburg, South Africa. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, HIV/AIDS
- What is being tested?
- Provision of HIV self-screen kit with incentives and linkage promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSouth Africa
- Study dates
- 20 Jul 2020to 30 Jul 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Reported HIV positive
- Have a personal and/or valid phone number, that will remain active for 6 months
- Have a phone with WhatsApp, or text message feature
- Understand the Informed Consent form
Who cannot join
- Unwilling to provide informed consent
- Any condition which would make the participant unsuitable or unsafe for enrollment, i.e. being unable to see or read by forgetting to bring reading glasses, being intoxicated or acute sickness
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Ezintsha Clinical Research Center
Johannesburg, Gauteng, 2193
About this study
Official title: Financial Incentives to Promote Linkage to Care and Viral Suppression Following HIV Testing: a Randomized Controlled Trial
This study aims to test if small incentives promote linkage to care and 6-month viral suppression among individuals recently tested for HIV at selected sites within Johannesburg, South Africa. Individuals who obtain a reactive HIV test result will be randomized to receive either the standard of care (SOC) for linkage to care or to receive financial incentives for confirmatory testing, linkage to care and viral suppression.
Read the detailed description
This study is in collaboration with Ezintsha, a sub-division of Wits Reproductive Health and HIV Institute (WRHI) in South Africa. This study will leverage on the existing research infrastructure of Ezintsha, including, HIVSS testing through the STAR initiative (Self-Test Africa), as well as HIV positive persons identified through other Ezintsha research studies and at Eztinsha affiliated health clinics.
This study will use a randomized trial design to test the effectiveness of incentives to increase confirmatory testing, linkage to care and viral suppression. The aim of this study is to determine whether HIV-infected men and women are more likely to achieve or maintain HIV virologic suppression if offered financial incentives vs. no incentives (standard of care).
Individuals who report receiving a reactive HIVSS test result on the STAR programme, or a HIV reactive test in another research study or at a affiliated clinic, will be randomized into one of two groups: a) a control group that receives the standard of care (SOC) for linkage to care; and b) an intervention group that receives financial incentives for confirmatory testing, linkage to care, and viral suppression.
- Conditions
- Human Immunodeficiency Virus, HIV/AIDS
- Being tested
- Provision of HIV self-screen kit with incentives and linkage promotion
- Keywords
- HIV self-testing, Behavioral sciences, Financial incentives, Viral suppression
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of HIV self-screen kit with incentives and linkage promotionBehavioural
This arm will receive a HIV self-screen kit and additional incentives to promote adherence and linkage to care
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Usual care | No intervention | Participants randomized to this arm will receive the standard of care (SOC) following the STAR program protocol in various sites in Johannesburg. This will include provision of an HIV self-screening test kit, the standard linkage officer follow-up call following report of a positive HIVSS test and an invitation to i) participate in study visit 1 to have their positive HIVSS result confirmed and complete blood collection for viral load PCR testing and to ii) participate in study visit 2 at 6 months for Viral Load PCR. Individuals with a positive HIV test result from another Ezintsha study or an affiliated clinic will also be invited to participate in study visit 1 for baseline viral load PCR testing. |
| Experimental: Incentives and linkage promotion | Experimental | Participants randomized to this arm will receive the same standard HIV self-screen test kit and linkage officer follow-up call including the invitation to i) participate in study visit 1 and ii) study visit 2. In addition, they will receive a financial incentive if they complete a confirmatory HIV test at visit 1 and if they demonstrate viral suppression at study visit 2, approximately 6 months after positive HIVSS result. They will also receive monthly reminders and incentives to pick up HIV medication. Individuals with a positive HIV test result from another Ezintsha study or an affiliated clinic will also be invited to participate in study visit 1 for baseline viral load PCR testing. Receives: Behavioral: Provision of HIV self-screen kit with incentives and linkage promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral suppression at 6 months
Viral suppression (plasma HIV RNA <400 copies/mL) at approximately 6 months after a positive HIV result
Measured: approximately 6 months
Secondary outcomes (2)
Confirmatory testing
Laboratory HIV confirmatory testing within approximately 4 weeks for participants with a positive HIV self-screening result.
Measured: approximately 4 weeks
ART initiation
ART initiation within approximately 4 weeks after for those newly diagnosed with HIV
Measured: approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start20 Jul 2020
- Primary completion17 Dec 2020
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals who report results of a positive HIV test will be randomized 1:1 to the intervention (incentives) or control (no incentives) arm.
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Wits Reproductive Health and HIV Institute, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Harsha Thirumurthy, PhD, Principal investigator, University of PennsylvaniaMohammed Majam, MBA, Principal investigator, Ezintsha, sub-division of Wits Reproductive Health and HIV Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431154
- Sponsor's protocol ID
- HSTAR013
- Status last verified
- Jul 2022
- First submitted
- 10 Jun 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives to Promote Linkage to Care and Viral Suppression Following HIV Testing: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04431154
- Acronym / sponsor ID
- HSTAR013
- Conditions
- Human Immunodeficiency Virus, HIV/AIDS
- Keywords
- HIV self-testing, Behavioral sciences, Financial incentives, Viral suppression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Wits Reproductive Health and HIV Institute, Bill and Melinda Gates Foundation
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 17 Dec 2020 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 16 Jun 2020 (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 aims to test if small incentives promote linkage to care and 6-month viral suppression among individuals recently tested for HIV at selected sites within Johannesburg, South Africa. Individuals who obtain a reactive HIV test result will be randomized to receive either the standard of care (SOC) for linkage to care or to receive financial incentives for confirmatory testing, linkage to care and viral suppression.
Detailed description
This study is in collaboration with Ezintsha, a sub-division of Wits Reproductive Health and HIV Institute (WRHI) in South Africa. This study will leverage on the existing research infrastructure of Ezintsha, including, HIVSS testing through the STAR initiative (Self-Test Africa), as well as HIV positive persons identified through other Ezintsha research studies and at Eztinsha affiliated health clinics.
This study will use a randomized trial design to test the effectiveness of incentives to increase confirmatory testing, linkage to care and viral suppression. The aim of this study is to determine whether HIV-infected men and women are more likely to achieve or maintain HIV virologic suppression if offered financial incentives vs. no incentives (standard of care).
Individuals who report receiving a reactive HIVSS test result on the STAR programme, or a HIV reactive test in another research study or at a affiliated clinic, will be randomized into one of two groups: a) a control group that receives the standard of care (SOC) for linkage to care; and b) an intervention group that receives financial incentives for confirmatory testing, linkage to care, and viral suppression.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individuals who report results of a positive HIV test will be randomized 1:1 to the intervention (incentives) or control (no incentives) arm.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Usual care | No intervention | –Participants randomized to this arm will receive the standard of care (SOC) following the STAR program protocol in various sites in Johannesburg. This will include provision of an HIV self-screening test kit, the standard linkage officer follow-up call following report of a positive HIVSS test and an invitation to i) participate in study visit 1 to have their positive HIVSS result confirmed and complete blood collection for viral load PCR testing and to ii) participate in study visit 2 at 6 months for Viral Load PCR. Individuals with a positive HIV test result from another Ezintsha study or an affiliated clinic will also be invited to participate in study visit 1 for baseline viral load PCR testing. |
| Experimental: Incentives and linkage promotion | Experimental | Behavioral: Provision of HIV self-screen kit with incentives and linkage promotionParticipants randomized to this arm will receive the same standard HIV self-screen test kit and linkage officer follow-up call including the invitation to i) participate in study visit 1 and ii) study visit 2. In addition, they will receive a financial incentive if they complete a confirmatory HIV test at visit 1 and if they demonstrate viral suppression at study visit 2, approximately 6 months after positive HIVSS result. They will also receive monthly reminders and incentives to pick up HIV medication. Individuals with a positive HIV test result from another Ezintsha study or an affiliated clinic will also be invited to participate in study visit 1 for baseline viral load PCR testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Reported HIV positive
- Have a personal and/or valid phone number, that will remain active for 6 months
- Have a phone with WhatsApp, or text message feature
- Understand the Informed Consent form
Key exclusion criteria (2 listed)
- Unwilling to provide informed consent
- Any condition which would make the participant unsuitable or unsafe for enrollment, i.e. being unable to see or read by forgetting to bring reading glasses, being intoxicated or acute sickness
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 |
|---|---|---|
| Provision of HIV self-screen kit with incentives and linkage promotionThis arm will receive a HIV self-screen kit and additional incentives to promote adherence and linkage to care | Behavioural | Experimental: Incentives and linkage promotion |
Primary outcome
Viral suppression at 6 months
Time frame: approximately 6 months
Viral suppression (plasma HIV RNA <400 copies/mL) at approximately 6 months after a positive HIV result
2 secondary outcomes
Confirmatory testing
Time frame: approximately 4 weeks
ART initiation
Time frame: approximately 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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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.
Harsha Thirumurthy, PhD principal investigator
University of Pennsylvania
Mohammed Majam, MBA principal investigator
Ezintsha, sub-division of Wits Reproductive Health and HIV Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provision of HIV self-screen kit with incentives and linkage promotion in people with Human Immunodeficiency Virus and HIV/AIDS, run by University of Pennsylvania at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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: finished, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral suppression at 6 months (time frame: approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2022.