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

Trial Summary

What is the purpose of this trial?

The major goal of this study is to evaluate a multi-component, multilevel HIV prevention intervention that targets theoretically-informed and empirically-identified barriers to and facilitators of both HIV testing and PEP/PrEP uptake by combining existing evidence-based and novel evidence-informed components and integrating them into a community-based organization's (CBO) standard of care (SOC) PEP/PrEP navigation program. The evaluation will apply use a 2x2 factorial design to randomize and follow for 18 months 480 PrEP-eligible Black MSM (aged 18-65) living in the NYC area to one of four combinations of interventions. The impact of the social/media campaign, delivered to both geographic (print media) and Black MSM communities (social media) and launched midway through recruitment, will be assessed through assessment of timing and length of exposure as covariates in analysis.

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.

What data supports the effectiveness of the treatment DIY (Do It Yourself) for HIV prevention?

Research shows that HIV self-testing (a form of DIY testing) increases testing frequency among high-risk groups, such as gay and bisexual men, and helps connect them to prevention services. Studies found that those using self-testing kits were more likely to test regularly and receive counseling and prevention supplies compared to those who did not use self-testing. ^{1 2 3 4 5}

Is HIV self-testing generally safe for humans?

HIV self-testing is considered a safe and empowering option for individuals to test for HIV privately. However, there are concerns about potential social harms and the accuracy of results, which could lead to false positives or negatives, affecting trust in HIV testing. ^{1 6 7 8 9}

How does the HIV Prevention Program using DIY, SOC, and TRUST differ from other HIV testing treatments?

The HIV Prevention Program is unique because it includes HIV self-testing (HIVST), which allows individuals to perform and interpret their own HIV tests at home. This approach increases access to testing, especially for those who might not visit a clinic, and is part of a global effort to improve HIV testing coverage. ^{5 10 11 12 13}

Eligibility Criteria

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

I was assigned male at birth.

Not HIV-positive (tested before randomization)

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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) 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]

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]

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 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]

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]

References

1. England 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. [2022]

2. United States 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. [2019]

3. Scotland 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. [2023]

4. United States 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. [2022]

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

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring social harms during distribution of HIV self-testing kits using mixed-methods approaches in Malawi. [2023]

7. Canada 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. [2022]

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

Rapid HIV testing at home: does it solve a problem or create one? [2019]

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

Realizing the potential for HIV self-testing. [2022]

10. England 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. [2023]

11. England 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. [2022]

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

HIV self-testing in resource-limited settings: regulatory and policy considerations. [2014]

13. England pubmed.ncbi.nlm.nih.gov

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