Digital Intervention for HIV/STI Testing in Black Women

No longer recruiting at 4 trial locations

Overseen By Liesl A Nydegger, PhD

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Non-black, Non-cisgender, Rural, others

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based program called "Empowered to Test Yourself," designed to encourage more Black women at risk for HIV and other sexually transmitted infections (STIs) to use home testing kits. Participants will engage in five online sessions over four weeks, learning about home testing and connecting to care and prevention services like PrEP (a medication to prevent HIV). The trial will compare this program to a standard educational approach to determine which is more effective. Women who have not tested for HIV/STIs in the past year, live in certain Texas cities, and have recently had condom-less sex may be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative approaches in health education and prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this digital intervention is safe for increasing HIV/STI testing in Black women?

Research has shown that digital tools for HIV self-testing are safe and easy to use. These tools provide more accurate results and are popular with users. Online programs enhance the appeal of self-testing and encourage more individuals to undergo HIV testing. Studies confirm that self-testing effectively reaches more people who need testing. No major safety issues have been reported, making digital tools a promising method to increase HIV testing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the digital intervention "Empowered to Test Yourself" because it offers a unique approach to HIV/STI testing for Black women. Unlike traditional testing methods, this program delivers five tailored web-based sessions over four weeks, giving individuals the tools and knowledge to test themselves in the comfort of their own homes. This personalized and convenient approach aims to increase testing rates and early detection, potentially improving health outcomes by making testing more accessible and less intimidating.

What evidence suggests that this digital intervention is effective for increasing HIV/STI testing in Black women?

This trial will compare the effectiveness of a digital intervention called "Empowered to Test Yourself" with an educational control. Studies have shown that digital tools can effectively encourage more people to test themselves for HIV. Research indicates that online resources make testing for HIV and other sexually transmitted infections (STIs) easier and more appealing, especially for higher-risk groups like Black women. These tools increase the number of people getting tested and connect them to necessary care, such as starting pre-exposure prophylaxis (PrEP) to prevent HIV. Digital supports also ensure accurate test results and are often preferred by users. Overall, these digital methods have successfully promoted testing and connected people to care, making them a promising way to improve health engagement and outcomes. ^{2 4 6 7 8}

Who Is on the Research Team?

Liesl A Nydegger, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

This trial is for Black women aged 15-59 living in Travis County who haven't tested for HIV/STIs in the past year, had unprotected sex during that time, and can use a smartphone with internet. It's not open to those outside this age range or location, who've been recently tested, always used protection, or lack English fluency.

Inclusion Criteria

I am between 15 and 59 years old.

Identify as Black/African-American (Black/African American mixed race/ethnicity is included)

Read/speak/type in English

Exclusion Criteria

Live in rural areas of Texas or urban/suburban areas other than Austin, Dallas, Houston, or San Antonio, Texas

Use condoms 100% of the time during vaginal/anal sex in the past 6 months

I am either over 59 years old or younger than 15.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Conduct formative research to develop the intervention with focus groups

Not specified

Field Testing

Test the preliminary feasibility and acceptability of the intervention with 6 participants

Not specified

Feasibility Pilot

Conduct a feasibility pilot of the intervention among 60 Black women

4 weeks

5 web-based sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Web-based assessments at 2, 4, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Empowered to Test Yourself

Trial Overview The study tests a web-based intervention aimed at increasing home testing for HIV among Black women at risk. The program encourages self-testing and connects participants to healthcare services and PrEP evaluation to prevent HIV infection.

How Is the Trial Designed?

Group I: Empowered to Test Yourself Experimental Treatment 1 Intervention

There will be 5 tailored web based sessions of the intervention over 4 weeks, all of which will follow the same format.

Group II: Educational Control Active Control 2 Interventions

Participants will receive a generic standard of care via a combination of videos, audio, and text/graphics across 5 sessions during 4 weeks.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A telehealth intervention for STI testing among partnered gay, bisexual, and other men who have sex with men (GBMSM) was highly accepted, with 92% rating the quality of telehealth calls as very good and 96% returning specimens for testing.

The intervention identified a 9% positivity rate for chlamydia or gonorrhea among participants, all of whom were successfully linked to care, suggesting that telehealth can effectively address barriers to STI testing in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Feasibility of a Telehealth Intervention for STI Testing Among Male Couples. Sullivan, SP., Sullivan, PS., Stephenson, R.[2021]

A study involving 41 transgender women across six US cities highlighted the potential benefits of using innovative technologies like HIV self-testing (HIVST) and mobile apps for engaging participants in HIV research, promoting increased engagement and a sense of agency.

However, participants raised concerns about barriers such as housing instability, inconsistent access to technology, and confidentiality, indicating that researchers must address these issues to ensure equitable access and minimize health disparities in HIV research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived acceptability and feasibility of HIV self-testing and app-based data collection for HIV prevention research with transgender women in the United States. Akinola, M., Wirtz, AL., Chaudhry, A., et al.[2021]

HIV self-testing (HIVST) has been widely adopted globally, with almost 100 countries incorporating it into their national testing strategies, significantly increasing access to testing for key populations.

Digital interventions have been developed to enhance the HIVST experience by addressing challenges like pre-and post-test counseling and linking users to care, but more large-scale studies are needed to demonstrate their effectiveness and standardize data collection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolution of HIV self-testing and the introduction of digital interventions to improve HIV self-testing. Fischer, AE., Abrahams, M., Shankland, L., et al.[2023]

The development of HealthMpowerment.org, an online HIV/STI prevention intervention for young Black men who have sex with men (BMSM), involved extensive input from the target audience through focus groups and interviews, ensuring the intervention is tailored to their needs.

Preliminary results indicate high satisfaction and usability of the website, suggesting that the Internet is an effective platform for delivering risk reduction messages to this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HealthMpowerment.org: development of a theory-based HIV/STI website for young black MSM. Hightow-Weidman, LB., Fowler, B., Kibe, J., et al.[2022]

Patients diagnosed with bacterial STIs expressed strong support for including HIV self-testing (HIVST) kits with patient-delivered partner therapy (PDPT), highlighting motivations such as early HIV detection and convenience.

Concerns about the quality of HIVST kits and potential negative reactions from partners indicate a need for more information and skills training to ensure safe and effective use of HIVST in conjunction with PDPT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Addressing missed opportunities for HIV testing by including rapid-HIV self-testing kits with patient-delivered partner therapy. John, SA.[2020]

A significant majority (86%) of participants in New Orleans expressed willingness to use a free home-based HIV test if it were mailed to them, indicating a strong interest in self-testing for HIV.

Almost all respondents (99%) stated they would seek treatment if they received a positive result, highlighting the potential for home-based testing to facilitate early intervention and support the National HIV/AIDS Strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences for Home-Based HIV Testing Among Heterosexuals at Increased Risk for HIV/AIDS: New Orleans, Louisiana, 2013. Robinson, WT., Zarwell, M., Gruber, D.[2020]

In Miami-Dade County, African Americans represent only 17% of the population but account for 59% of HIV-related deaths, highlighting a critical need for increased HIV testing in this group.

Focus groups revealed that community health workers, when paired with the home-based HIV rapid test (OraQuick®), could effectively increase testing rates by addressing misconceptions and providing culturally appropriate support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to Improve HIV Testing in African Americans. Kenya, S., Okoro, I., Wallace, K., et al.[2022]

A pilot study successfully adapted a health intervention for African American adolescent females by transforming a telephone-based preventive maintenance intervention into a text messaging format, using the ADAPT-ITT framework.

Feedback from an advisory board of young African American women helped refine the text messages, emphasizing the importance of context and personal narratives in enhancing the effectiveness of STI and HIV prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using ADAPT-ITT to Modify a Telephone-Based HIV Prevention Intervention for SMS Delivery: Formative Study. Davis, T., DiClemente, RJ., Prietula, M.[2020]

HIV self-testing (HIVST) with digital supports, such as web-based tools and social media, has been shown to be highly acceptable and effective, with 77-97% of users finding it preferable to in-person options, and it significantly increases linkage to care for users.

Digital vending machines (VMs) for HIVST resulted in a sixfold increase in uptake compared to traditional distribution methods, highlighting their potential to reach hard-to-access populations and improve overall testing rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HIV self-testing with digital supports as the new paradigm: A systematic review of global evidence (2010-2021). McGuire, M., de Waal, A., Karellis, A., et al.[2022]

Digital STI/HIV services are becoming increasingly important for promoting and facilitating testing, clinical management, and prevention strategies, especially as self-testing technologies advance.

While there is a growing body of evidence supporting these digital services, most studies have been conducted in high-income countries, highlighting a need for more research focused on low- and middle-income countries where STI/HIV burdens are significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital sexually transmitted infection and HIV services across prevention and care continuums: evidence and practical resources. Tucker, JD., Hocking, J., Oladele, D., et al.[2022]

A study involving African American and Latino men who have sex with men (MSM) found that dispensing HIV self-testing kits through electronic vending machines was generally accepted, with participants appreciating the novelty and convenience of this method.

The acceptability of using vending machines for HIV testing was linked to factors like credibility, confidentiality, and convenience, highlighting the need for further research to address potential user errors and costs before wider implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of using electronic vending machines to deliver oral rapid HIV self-testing kits: a qualitative study. Young, SD., Daniels, J., Chiu, CJ., et al.[2022]

Citations

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Increasing HIV/STI Home Testing Via a Digital Intervention ... The proposed intervention is a web-based intervention guided by theoretical components to increase HIV home testing among Black women at risk for HIV and ...

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HIV self-testing with digital supports as the new paradigm HIVST with digital supports strategies reported successes in uptake, participant preference, and linkage to care in key and general populations. Digital ...

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Evidence on Digital HIV Self-Testing From Accuracy to Impact Conclusions: Digital innovations improved the accuracy of HIV self-test results, and were well-accepted and preferred by participants.

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Digital Intervention Services to Promote HIV Self-Testing and ... The study aims to provide an overview of the scientific production and research trends in digital intervention, HIV self-testing, ...

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HIV self-testing with digital supports as the new paradigm HIVST with digital supports was deemed feasible, acceptable, preferable, and was shown to increase uptake, engage first-time testers and hard-to ...

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Digital Intervention Services to Promote HIV Self-Testing and ... The content analysis reveals that digital interventions have shown promise in improving HIV testing rates and facilitating linkage to care. Some ...

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HIV, hepatitis, and syphilis self-testing among adolescents ... Self-testing is a safe, acceptable and effective way to increase access to HIV, hepatitis and syphilis testing in AYA.