Digital Intervention for HIV/STI Testing in Black Women

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

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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 sexually transmitted infections (STIs) in a HIV hotspot in the South. The intervention will promote using the home test, linkage to care, and linkage to pre-exposure prophylaxis (PrEP) evaluation. The intervention has the potential to be implemented on a large scale and tailored based on location and population to increase testing, treatment, and PrEP adoption.

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 data supports the effectiveness of the treatment Empowered to Test Yourself, Digital Intervention for HIV/STI Home Testing?

Research shows that digital interventions for HIV self-testing can improve access to testing and link users to care, making it easier for people to test themselves at home. These digital supports have been shown to be effective in increasing testing rates and ensuring that people who test positive can quickly get the care they need. ^{1 2 3 4 5}

Is the digital intervention for HIV/STI testing safe for humans?

The digital intervention for HIV/STI testing, including self-testing kits, has been widely studied and is generally considered safe. The World Health Organization recommends HIV self-testing, and digital interventions have been developed to improve the testing experience and link users to care. ^{2 4 6 7 8}

How is the 'Empowered to Test Yourself' treatment different from other treatments for HIV/STI testing?

The 'Empowered to Test Yourself' treatment is unique because it uses digital interventions to facilitate home testing for HIV/STIs, allowing individuals to self-test and manage their sexual health more independently. This approach leverages technology to enhance accessibility and convenience, which is different from traditional in-person testing methods. ^{2 5 9 10 11}

Research Team

Liesl A Nydegger, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Acceptability and Feasibility of a Telehealth Intervention for STI Testing Among Male Couples. [2021]

2. Australia pubmed.ncbi.nlm.nih.gov

Digital sexually transmitted infection and HIV services across prevention and care continuums: evidence and practical resources. [2022]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

The evolution of HIV self-testing and the introduction of digital interventions to improve HIV self-testing. [2023]

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

HIV self-testing with digital supports as the new paradigm: A systematic review of global evidence (2010-2021). [2022]

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

Acceptability of using electronic vending machines to deliver oral rapid HIV self-testing kits: a qualitative study. [2022]

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

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

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

Strategies to Improve HIV Testing in African Americans. [2022]

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

HealthMpowerment.org: development of a theory-based HIV/STI website for young black MSM. [2022]

10. England 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. [2021]

11. Canada pubmed.ncbi.nlm.nih.gov

Using ADAPT-ITT to Modify a Telephone-Based HIV Prevention Intervention for SMS Delivery: Formative Study. [2020]