HIV Self-Test for HIV

Recruiting in Fort Lauderdale (>99 mi)

Overseen By Stella Chan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: bioLytical Laboratories

Must not be taking: PrEP, Anti-Retrovirals

Disqualifiers: HIV+, Bleeding disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

1700 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using Anti-Retroviral medication or are on a PrEP regimen.

What data supports the effectiveness of the treatment INSTI HIV Self-Test for HIV?

Research shows that the INSTI HIV Self-Test is effective in increasing access to HIV testing, especially in underserved populations, and can provide results in about one minute, which is faster than standard tests. ^{1 2 3 4 5}

Is the INSTI HIV Self-Test safe for humans?

The INSTI HIV Self-Test, which involves integrase strand transfer inhibitors (INSTIs), is generally considered safe and well-tolerated in humans. However, there have been some reports of potential side effects, such as neural tube defects during pregnancy and possible cardiovascular issues, so it's important to discuss any concerns with a healthcare provider. ^{6 7 8 9 10}

How is the INSTI HIV Self-Test different from other HIV treatments?

The INSTI HIV Self-Test is unique because it allows individuals to test themselves for HIV at home using a simple blood test, providing results in just 60 seconds. This rapid self-testing approach increases accessibility and frequency of testing, especially for those who may not have easy access to traditional healthcare settings. ^{1 3 11 12 13}

What is the purpose of this trial?

The objective of this study is to evaluate the performance, usability, and result interpretation of the INSTI® HIV Self-Test (referred to INSTI® HIV ST) in the intended use population across the United States (US). The INSTI® HIV Self-Test is a single use in vitro test that is used as a self-test for the detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood. This study is designed to evaluate INSTI® HIV ST performance in the hands of non-professionals and untrained lay users who are inexperienced in HIV blood-based self-testing. The study aims to: To evaluate the clinical performance (i.e., diagnostic sensitivity and specificity) of the INSTI® HIV Self-Test in a lay user population. To assess the user's comprehension of the INSTI® HIV ST results (e.g., interpreting positive, negative, and invalid results). To evaluate the usability of the INSTI® HIV ST and understand users' experience in performing the test.

Research Team

Steven Geller, MD

Principal Investigator

Centennial Medical Group

Anthony LaMarca

Principal Investigator

Therafirst Medical Centers Inc.

Eligibility Criteria

This trial is for individuals in the US, aged 18 or older, who can read/write English or Spanish and are willing to participate in HIV counseling. They must be able to provide a fingerstick blood sample, have an unknown HIV status, and agree to standard care testing results.

Inclusion Criteria

The study team has filled out my enrollment questionnaire.

I have signed the Informed Consent Form.

I can attend all required test days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Performance Evaluation

Participants perform the INSTI® HIV Self-Test without intervention, followed by a comparator test for result comparison

12 months

Multiple visits (in-person)

Mock Results Interpretation and Usability Evaluation

A subset of participants interpret mock test results and complete a usability questionnaire

12 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the main study activities

4 weeks

Treatment Details

Interventions

• INSTI® HIV Self-Test

Trial Overview The INSTI® HIV Self-Test is being evaluated for its performance by non-professionals. It's a single-use test for detecting antibodies to HIV-1 and HIV-2 using fingerstick blood. The study assesses accuracy, ease of use, and result interpretation by lay users.

Participant Groups

Group I: Performance Experimental Treatment 1 Intervention

INSTI® HIV ST devices are provided to the enrolled participants to conduct the self test using the provided instruction for use while being observed by an operator. The operator records the INSTI® HIV ST results interpreted by the subjects. The operator then performs the comparator test to compare the results with the INSTI® HIV ST.

Group II: Mock results interpretation study and Usability evaluation Active Control 1 Intervention

A subset of the enrolled subjects (500 subjects) will participate in the mock results interpretation study and usability evaluation. For the mock study, the subjects will be presented with 5 mock INSTI® HIV ST devices with different results, and the subject's interpretation of each device will be recorded. The percentage of subjects who interpreted the mock results correctly for each result type will be calculated. For the INSTI® HIV ST usability evaluation, the subjects will be presented with a questionnaire. The overall results of the questionnaire will be used to determine the percentage of subjects who found the INSTI® HIV ST easy to use.

INSTI® HIV Self-Test is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as INSTI HIV Self Test for:

• Detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood

Approved in United States as INSTI HIV Self Test for:

• Detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood

Approved in European Union as INSTI HIV Self Test for:

• Detection of antibodies to HIV-1 and HIV-2 in human fingerstick blood

Who Is Running the Clinical Trial?

bioLytical Laboratories

Lead Sponsor

Trials

9

Recruited

10,700+

Findings from Research

The INSTI HIV self-test demonstrated high accuracy, with a 100% positive agreement and 99.5% negative agreement compared to laboratory testing, based on a study of 678 completed tests.

Participants found the self-test easy to use, with a 92.4% success rate in critical steps and 95% expressing willingness to use the test again, indicating it could effectively increase HIV testing rates in Canada.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada. Galli, RA., Lo Hog Tian, JM., Sumner-Williams, M., et al.[2021]

Only about 24.5% of South African women of reproductive age are aware of HIV self-testing (HIVST), highlighting a significant gap in knowledge that needs to be addressed.

Women with higher education levels and those living in urban areas are more likely to know about HIVST, indicating that educational campaigns should target socio-economically disadvantaged groups to improve awareness and access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between socio-economic factors and HIV self-testing knowledge amongst South African women. Ekholuenetale, M., Nzoputam, CI., Okonji, OC.[2022]

In a study of 40 patients with acute HIV infection (AHI), 57.5% tested positive using the STAT-VIEW rapid self-test, indicating that while these tests can detect HIV, their sensitivity is limited during the early stages of infection.

The study found that the probability of detecting HIV with rapid tests significantly increases over time, reaching 75.5% at 5 weeks post-exposure, suggesting that individuals should not rely on negative results within this timeframe to rule out HIV infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensitivity of the STAT-VIEW rapid self-test and implications for use during acute HIV infection. Boukli, N., Boyd, A., Wendremaire, N., et al.[2019]

HIV self-testing (HIV-ST) is generally accepted and considered appropriate in low- and middle-income countries (LMIC), with 75% of studies focusing on its implementation in Africa, highlighting its convenience and confidentiality compared to standard testing.

Despite high diagnostic accuracy, challenges such as user errors and higher program costs could hinder successful implementation, indicating a need for future research to address these issues and improve sustainability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation outcomes of HIV self-testing in low- and middle- income countries: A scoping review. Rivera, AS., Hernandez, R., Mag-Usara, R., et al.[2023]

The use of the INSTI point-of-care HIV test significantly increased the number of clients tested for HIV in a mobile testing program, with the intervention team testing 7,403 clients compared to 2,426 by the standard care team, demonstrating its effectiveness in reaching more individuals.

The faster testing method also led to a higher number of identified HIV-positive clients (142 vs. 88), although the proportion of positive cases was lower due to the increased testing volume, highlighting the potential of rapid tests to enhance outreach and early detection in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Findings from a novel and scalable community-based HIV testing approach to reduce the time required to complete point-of-care HIV testing in South Africa. Mabuto, T., Setswe, G., Mshweshwe-Pakela, N., et al.[2023]

Integrase strand transfer inhibitors (INSTIs) are the preferred antiretroviral treatment for HIV-1 due to their strong safety and efficacy profile, with low rates of discontinuation from adverse events.

However, specific INSTIs like dolutegravir have been linked to potential adverse effects, including neuropsychiatric disorders and weight gain, highlighting the need for physicians to monitor patients for these issues while continuing to recommend INSTIs as a primary treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nothing is perfect: the safety issues of integrase inhibitor regimens. Scévola, S., Tiraboschi, JM., Podzamczer, D.[2022]

In a nationwide analysis of pregnancy outcomes, exposure to integrase strand transfer inhibitors (InSTIs) like dolutegravir, raltegravir, and elvitegravir during the first trimester showed a very low rate of major birth defects, with no cases of neural tube defects reported.

The study included a limited number of pregnancies (49 for dolutegravir, 240 for raltegravir, and 70 for elvitegravir), indicating that while the initial findings are reassuring, further research is needed to confirm the safety of these medications in pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is There a Safety Signal for Dolutegravir and Integrase Inhibitors During Pregnancy? Chouchana, L., Beeker, N., Treluyer, JM.[2021]

In a study of 29,340 adults living with HIV, exposure to integrase strand-transfer inhibitors (INSTIs) was associated with an increased risk of cardiovascular disease in the first 24 months, with a significant incidence rate of 8.46 events per 1000 person-years for those exposed for 0 to 6 months.

After 24 months of INSTI exposure, the risk of cardiovascular disease decreased to levels similar to those with no exposure, suggesting that while there is an initial risk, longer-term use may not carry the same cardiovascular risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations between integrase strand-transfer inhibitors and cardiovascular disease in people living with HIV: a multicentre prospective study from the RESPOND cohort consortium. Neesgaard, B., Greenberg, L., Miró, JM., et al.[2023]

In a study of 1419 drug-naive HIV patients, high baseline viral load (≥100,000 copies/mL) and having an AIDS-defining event were significant risk factors for treatment failure with integrase strand transfer inhibitors (InSTIs).

Patients with higher CD4 counts (above 200 cells/µL) had a lower risk of treatment failure, and those on dolutegravir-based therapy experienced a shorter time to viral suppression, indicating its efficacy in managing HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Virological Failure and Time to Viral Suppression of First-Line Integrase Inhibitor-Based Antiretroviral Treatment. Pyngottu, A., Scherrer, AU., Kouyos, R., et al.[2021]

Integrase strand transfer inhibitors (INSTIs) like raltegravir, elvitegravir, and dolutegravir are generally well tolerated in both HIV-infected and uninfected patients, with mild side effects such as headaches and gastrointestinal issues being the most common.

While INSTIs show favorable effects on lipid metabolism compared to older treatments, they can cause mild-to-moderate kidney function changes, and rare severe reactions like hypersensitivity and rhabdomyolysis have been reported, highlighting the need for ongoing safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tolerability of HIV integrase inhibitors. Lee, FJ., Carr, A.[2021]

The INSTI HIV-1/HIV-2 Rapid Antibody test demonstrated high sensitivity (99.84% for HIV-1 and 100% for HIV-2) and specificity (99.80%) when tested with plasma specimens, making it a reliable option for detecting HIV antibodies.

INSTI was able to detect HIV infections significantly earlier than other FDA-approved rapid tests, identifying reactivity 9 days before a positive Western blot result, which is crucial for timely diagnosis and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance evaluation of the point-of-care INSTI™ HIV-1/2 antibody test in early and established HIV infections. Adams, S., Luo, W., Wesolowski, L., et al.[2019]

The INSTI™ HIV-1/HIV-2 antibody test is a rapid point-of-care test that provides results in under 5 minutes and is easy to use, making it a valuable tool for HIV prevention and control programs globally.

While the INSTI™ test shows comparable performance to other rapid tests, it detects HIV seroconversion later than standard laboratory assays, indicating it may not be the first choice for early detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The INSTI HIV-1/HIV-2 antibody test: a review. Singh, AE., Lee, B., Fenton, J., et al.[2013]

The INSTI HIV-1/-2 antibody test demonstrated 100% sensitivity and specificity when evaluated against existing rapid tests in a study of 386 pregnant women in South Africa, indicating it is highly accurate for detecting HIV.

Pooled nucleic acid amplification testing (NAAT) confirmed that all participants with negative rapid test results were indeed HIV-negative, supporting the reliability of the INSTI test for use in antenatal clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Field performance of the INSTI HIV-1/-2 antibody test in two South African antenatal clinics. Mayaphi, SH., Martin, DJ., Quinn, TC., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

An observed, prospective field study to evaluate the performance and acceptance of a blood-based HIV self-test in Canada. [2021]

2. South Africa pubmed.ncbi.nlm.nih.gov

Association between socio-economic factors and HIV self-testing knowledge amongst South African women. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Sensitivity of the STAT-VIEW rapid self-test and implications for use during acute HIV infection. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Implementation outcomes of HIV self-testing in low- and middle- income countries: A scoping review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Findings from a novel and scalable community-based HIV testing approach to reduce the time required to complete point-of-care HIV testing in South Africa. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Nothing is perfect: the safety issues of integrase inhibitor regimens. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Is There a Safety Signal for Dolutegravir and Integrase Inhibitors During Pregnancy? [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Associations between integrase strand-transfer inhibitors and cardiovascular disease in people living with HIV: a multicentre prospective study from the RESPOND cohort consortium. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Predictors of Virological Failure and Time to Viral Suppression of First-Line Integrase Inhibitor-Based Antiretroviral Treatment. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Tolerability of HIV integrase inhibitors. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Performance evaluation of the point-of-care INSTI™ HIV-1/2 antibody test in early and established HIV infections. [2019]

12. England pubmed.ncbi.nlm.nih.gov

The INSTI HIV-1/HIV-2 antibody test: a review. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Field performance of the INSTI HIV-1/-2 antibody test in two South African antenatal clinics. [2023]