HIV Prevention Program for HIV Testing

(P3 Trial)

Overseen By Victoria Frye, MPH, DrPH

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: HIV-positive, Not Black, others

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

Compensation: Varies

Number of Visits: Unknown

480 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to encourage HIV testing and the use of PEP/PrEP, medications that help prevent HIV. It aims to identify the best combination of strategies to overcome barriers to testing and medication uptake. Participants will be divided into four groups to test combinations of current and new strategies, such as peer support and sexual health training, including the DIY (Do It Yourself) approach, SOC (standard of care), and TRUST program. The trial seeks Black men who have had sex with men, live in the NYC area, and are not currently on PEP or PrEP. As an unphased trial, this study offers a unique opportunity to contribute to innovative strategies that could significantly improve HIV prevention efforts.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you cannot be currently on PEP or PrEP to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both the DIY (Do It Yourself) and TRUST methods for preventing HIV are safe and easy to use.

The DIY method involves testing for HIV at home with a kit. The Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO) support this approach. Available since 2016, it has increased access to HIV testing. The FDA has approved certain self-test kits, such as the OraQuick test, to ensure safety. These tests are generally easy to use and provide results in about 20 minutes.

The TRUST method also involves self-testing for HIV. Studies indicate that self-testing reliably detects long-term infections. The WHO recommends this method as safe and effective, especially for those who might not otherwise get tested. It is designed to be simple and quick, making it a comfortable choice for many.

Overall, both the DIY and TRUST methods have the support of health organizations as safe ways to help prevent HIV. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to enhance HIV prevention and testing. The trial combines different approaches like DIY sexual health training and TRUST self-testing, offering more personalized and accessible options than traditional methods. By integrating these innovative techniques with the standard of care, the trial aims to improve engagement and effectiveness in HIV prevention, potentially making it easier for people to take control of their sexual health. This could lead to more widespread use of preventive measures like PrEP and increase regular HIV testing, ultimately reducing new infections.

What evidence suggests that this trial's treatments could be effective for HIV prevention?

This trial will evaluate different approaches to HIV prevention and testing. Participants may receive the DIY (Do It Yourself) intervention, which includes self-testing. Studies have shown that this method is generally accepted and practical, allowing people to quickly and privately determine their HIV status.

Another group will receive the TRUST intervention. Research has found that self-testing, as part of the TRUST intervention, can increase the frequency of HIV testing. A review of several studies showed that self-testing increased HIV testing by about 45% compared to standard methods. The accuracy of self-tests for detecting existing infections matches that of tests conducted by healthcare providers.

Both the DIY and TRUST interventions aim to increase testing and encourage preventive steps if needed. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for African-American/Black gay, bisexual, and same-gender loving men aged 18-65 living in the NYC area. They must be eligible for PrEP (HIV prevention medication) but not currently using it. The study excludes individuals who don't meet these criteria or can't commit to an 18-month follow-up.

Inclusion Criteria

Reside in the NYC metro area

Not HIV-positive (tested before randomization)

I was assigned male at birth.

Exclusion Criteria

Sexual identity is not an exclusion criterion

Potential participants who self-identify as Latino must also identify as Black (as per above) to be included

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a multi-component, multilevel HIV prevention intervention including TRUST, DIY, and a social/print media campaign

18 months

Regular visits as per intervention schedule

Follow-up

Participants are monitored for HIV testing and PrEP/PEP uptake and adherence

3 months

What Are the Treatments Tested in This Trial?

Interventions

• DIY (Do It Yourself)
• SOC
• TRUST

Trial Overview The study tests a new HIV prevention approach combining DIY strategies with TRUST (a program enhancing PEP/PrEP navigation) against the standard of care. Participants are randomly assigned to one of four intervention combinations and monitored over 18 months.

How Is the Trial Designed?

Group I: D. SOC, TRUST & DIY Experimental Treatment 3 Interventions

D. SOC standard of care single-session, low threshold peer/near-peer navigation to PrEP; TRUST single-session HIV self-testing training with facilitator; DIY three-session sexual health promotion/HIV prevention training with facilitator

Group II: C. SOC & DIY Experimental Treatment 2 Interventions

C. SOC standard of care single-session, low threshold peer/near-peer navigation to PrEP; DIY three-session sexual health promotion/HIV prevention training with facilitator

Group III: B. SOC & TRUST Experimental Treatment 2 Interventions

B. SOC standard of care single-session, low threshold peer/near-peer navigation to PrEP; TRUST single-session HIV self-testing training with facilitator

Group IV: A. SOC Active Control 1 Intervention

A. standard of care single-session, low threshold peer/near-peer navigation to PrEP.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

HIV self-testing can significantly improve testing coverage, but linking individuals who test positive to care remains a challenge, as highlighted by a review of 14 studies focused on various intervention strategies.

Effective strategies identified include financial incentives, technology-assisted interventions, and the involvement of community leaders, although the studies showed mixed results and lacked standardized measures for evaluating success in linking to care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of interventions to optimize linkage to HIV care and antiretroviral therapy (ART) initiation after HIV self-testing: A scoping review. Muwanguzi, PA., Otiku, PK., Gausi, B., et al.[2023]

A study involving 620 men who have sex with men (MSM) showed that providing free online HIV self-testing (HIVST) kits significantly increased the rate of HIV testing compared to traditional site-based testing methods, with a 36.7% higher testing rate at three months and 26.7% at six months.

The results indicate that online distribution of HIVST kits is an effective strategy to enhance HIV testing access for MSM who have discontinued pre-exposure prophylaxis (PrEP), suggesting its potential for broader application in public health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Online distribution of HIV self-testing kits to promote HIV testing among men who have sex with men discontinuing pre-exposure prophylaxis after demonstration project completion in China: a multicentre open-label randomized controlled trial. Zhou, H., Zhu, YY., Gao, YY., et al.[2023]

In a study of 175,683 distributed HIV self-test kits in Malawi, only 25 serious social harms were reported, indicating a low incidence of serious negative outcomes (about 1 in 10,000 kits), with marriage break-ups being the most common issue among serodiscordant couples.

Despite some reported social harms, many individuals, especially women, felt empowered by the HIV self-testing process, leading to increased trust and stronger relationships in concordant HIV-negative couples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring social harms during distribution of HIV self-testing kits using mixed-methods approaches in Malawi. Kumwenda, MK., Johnson, CC., Choko, AT., et al.[2023]

From 2016 to 2019, the purchasing population for HIV self-testing kits in China grew significantly, with rates increasing from 20.62 to 64.82 per 100,000 people, indicating a rising awareness and demand for HIV testing.

Hot spots for HIV self-testing kit purchases were primarily found in urban areas, particularly along the southeast coast, suggesting that resource allocation for HIV testing and care should focus on these high-demand regions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spatiotemporal Distribution of HIV Self-testing Kits Purchased on the Web and Implications for HIV Prevention in China: Population-Based Study. Luo, G., Su, L., Feng, A., et al.[2022]

HIV self-testing (HIVST) is a promising method that allows individuals to privately conduct and interpret their own HIV tests, which can increase access to testing and empower those who might not otherwise seek testing.

The global symposium emphasized the importance of developing evidence on the quality of HIVST and ensuring proper linkage to post-test services, while also assessing the associated risks and benefits of scaling up this testing approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Realizing the potential for HIV self-testing. Johnson, C., Baggaley, R., Forsythe, S., et al.[2022]

Offering HIV self-testing (HIVST) significantly increases HIV testing rates, as shown by numerous randomized controlled trials using free oral HIVST kits.

There is a lack of research on the effectiveness of blood-based HIVST kits and the impact of charging for these kits, indicating a need for further studies to optimize distribution methods and testing options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Evidence for HIV Self-Testing to Increase HIV Testing Rates and the Implementation Challenges that Remain. Kelvin, EA., Akasreku, B.[2022]

HIV self-testing (HIVST) is gaining traction as a strategy to improve access to HIV testing, especially for individuals who may not seek testing in traditional healthcare facilities, with evidence showing high acceptability in pilot programs in sub-Saharan Africa.

Despite the potential benefits of HIVST, challenges remain in regulatory and quality assurance policies, particularly in resource-limited settings, which could hinder its widespread implementation and effectiveness in achieving global HIV testing targets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV self-testing in resource-limited settings: regulatory and policy considerations. Wong, V., Johnson, C., Cowan, E., et al.[2014]

The FDA is considering an over-the-counter rapid HIV test for home use, which advocates believe could empower individuals and increase disease detection in hard-to-reach communities.

However, the authors caution that the test may primarily attract affluent individuals rather than those most at risk, potentially leading to increased false-positive and false-negative results, which could undermine public confidence in HIV testing and hinder efforts to identify and treat the estimated 300,000 people in the U.S. with undiagnosed HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid HIV testing at home: does it solve a problem or create one? Walensky, RP., Paltiel, AD.[2019]

HIV self-testing (HIVST) has been shown to effectively increase testing frequency among gay and bisexual men at high risk of HIV infection, as highlighted by qualitative interviews with 15 participants.

Participants emphasized that the future use of HIVST depends on the reliability of the test kits, suggesting that ensuring high accuracy is crucial for sustaining the benefits of HIVST beyond research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustaining success: a qualitative study of gay and bisexual men's experiences and perceptions of HIV self-testing in a randomized controlled trial. Zhang, Y., Guy, RJ., Smith, KS., et al.[2022]

In a study involving 16,660 residents in urban Blantyre, Malawi, community-based HIV self-testing (HIVST) achieved an impressive uptake of 83.8%, with high satisfaction rates (94.4%) and no reported incidents of partner violence or suicides related to testing.

HIVST demonstrated high accuracy, with a sensitivity of 93.6% and specificity of 99.9%, and successfully linked 56.3% of newly diagnosed HIV-positive participants to care, indicating it is a safe and effective method for early HIV diagnosis in high-prevalence areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uptake, Accuracy, Safety, and Linkage into Care over Two Years of Promoting Annual Self-Testing for HIV in Blantyre, Malawi: A Community-Based Prospective Study. Choko, AT., MacPherson, P., Webb, EL., et al.[2022]

A co-creation workshop with key stakeholders identified major barriers to HIV testing among urban men, including stigma, lack of awareness about the importance of testing, and fear of positive results.

The workshop led to the development of a tailored HIV self-testing (HIVST) delivery strategy that incorporates internal motivation and risk communication approaches to improve engagement with HIV services among urban men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-creation of HIVST delivery approaches for improving urban men's engagement with HIV services in eThekwini District, KwaZulu-Natal: nominal group technique in intervention development. Mashamba-Thompson, T., Lessells, R., Dzinamarira, T., et al.[2022]

HIV self-testing (HIVST) is a promising tool for increasing awareness of HIV status, especially in low- and middle-income countries, but the U.S. has only one approved self-test due to regulatory barriers, limiting market competition.

The COVID-19 pandemic has heightened the demand for self-testing, suggesting that HIVST programs could leverage this momentum to improve access and linkage to care for at-risk populations, ultimately aiding in the fight against the HIV epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Highlighting and addressing barriers to widespread adaptation of HIV self-testing in the United States. Ma, S., Manabe, YC.[2023]

In a pilot study involving 65 high-risk men who have sex with men (MSM), those who received HIV self-testing (HST) kits with follow-up support (eTEST) had significantly higher rates of HIV testing (100%) and repeat testing (79%) compared to a control group (72% and 41%, respectively).

The eTEST group also benefited from increased access to risk reduction counseling and prevention supplies, suggesting that combining HST with active follow-up can enhance engagement in HIV prevention services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot, Randomized Controlled Trial of HIV Self-Testing and Real-Time Post-Test Counseling/Referral on Screening and Preventative Care Among Men Who Have Sex with Men. Wray, TB., Chan, PA., Simpanen, E., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7065141/

HIV self‐testing intervention experiences and kit usability This study explored key dimensions of HIV self‐test intervention acceptability and kit usability among 37 cisgender MSM drawn from a large HIVST RCT. Self‐ ...

2. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7324a4.htm

Findings from the First Year of a Federally Funded, Direct ... This report describes a CDC-funded program that delivered approximately 440000 HIV self-tests to U.S. residents.

3. aidsmap.com aidsmap.com/about-hiv/how-accurate-self-testing-home-testing-hiv

How accurate is self-testing (home testing) for HIV? Self-tests are usually reliable for long-standing infections, but are sometimes unable to detect recent HIV infections acquired in the past few ...

4. thelancet.com thelancet.com/journals/lanhiv/article/PIIS2352-3018(24)00187-5/fulltext

Role of HIV self-testing in strengthening HIV prevention ... Both HIV self-testing-supported PrEP and self-testing-supported PEP appear to be acceptable, feasible, and potentially effective, particularly ...

5. who.int who.int/news-room/feature-stories/detail/countries-take-up-new-who-recommendations-on-self-testing-for-prep-and-pep

Countries take up new WHO recommendations on self ... “Self-testing is simple and quick, with clear instructions and results available in less than 20 minutes. This convenience ensures that tests ...

6. cdc.gov cdc.gov/stophivtogether/hiv-testing/self-testing.html

Self Testing | HIV Testing | Let's Stop HIV Together For an HIV self-test, you must swab your gums to collect an oral fluid sample and then test your sample. Your results will be ready within 20 minutes. If you ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK595333/

Rapid HIV Self-Testing - NCBI Bookshelf - NIH Self-test kits can be used in the home, alone or in the presence of another person, and they may help overcome barriers to HIV diagnosis, and ...

8. fda.gov fda.gov/vaccines-blood-biologics/approved-blood-products/information-regarding-oraquick-home-hiv-test

Information regarding the OraQuick In-Home HIV Test This approved test uses oral fluid to check for antibodies to HIV Type 1 and HIV Type 2, the viruses that cause AIDS.