Text Messaging for HIV Testing

Overseen By Andrés Alvarado Avila, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: PrEP

Disqualifiers: HIV positive, Cisgender female, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of text messages (Text Messaging Intervention) to encourage HIV testing among teenagers. Participants will receive either motivational and skill-based messages to promote testing or general health information for comparison. The main goal is to determine if these texts can increase the likelihood of getting tested for HIV. Teens aged 13-18 who have had sex but haven't been tested for HIV or other STIs are suitable for this study. Participants need an unlimited text plan and should live in the U.S. or its territories.

As an unphased trial, this study offers a unique opportunity for teens to contribute to innovative research that could enhance public health strategies.

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 text messaging intervention is safe for adolescents?

Research has shown that text messaging is a safe method to assist individuals with health issues, including HIV. One study found that text messages can help people remember to take their HIV prevention medicine, which is crucial for preventing HIV infection.

Text messaging programs have been tested in various locations and have shown no major safety problems, indicating that recipients typically do not experience harmful effects from these messages. The studies primarily focus on the effectiveness of the messages rather than any potential harm.

In summary, using text messages to encourage HIV testing and other healthy actions is considered safe, with no reports of serious issues from similar past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the text messaging intervention for HIV testing because it offers a fresh approach by leveraging digital communication to increase HIV testing rates. Unlike traditional methods that rely on in-person consultations or static educational materials, this intervention uses engaging and interactive text messages to provide information, motivation, and skill-building over a period of six weeks. Participants receive daily messages and have access to interactive features like quizzes and group chats, which aim to boost engagement and facilitate discussions about HIV prevention and care. This approach could lead to more frequent HIV testing and better prevention practices, making it a promising tool in the ongoing fight against HIV.

What evidence suggests that this text messaging intervention is effective for increasing HIV testing among adolescents?

Research has shown that sending text messages can effectively encourage people to get tested for HIV and improve their health habits. In this trial, participants in the active treatment arm will receive text messages with information, motivation, and behavioral skills to increase HIV testing. Studies have found that such programs help people stick to their treatment plans and take preventive steps for HIV and other sexually transmitted infections (STIs). A review of multiple studies found that text messaging is a helpful tool for supporting HIV prevention and treatment. Additionally, past programs have boosted people's confidence in managing their health and reduced risky behaviors related to HIV. These findings suggest that using text messages could be a promising way to encourage HIV testing among teens. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for male teens aged 13-18 who identify as part of the sexual and gender minority (SGM) community or are questioning their sexuality, have had penetrative sex with a partner assigned male at birth in the past year, can read English at an 8th-grade level, are HIV negative or unsure of their status, own a cell phone with unlimited texting, and live in the U.S. Cisgender heterosexual males who've had male partners may also qualify.

Inclusion Criteria

I am male or was assigned male at birth.

I have had penetrative sex with male partners in the last year.

You are proficient in English at an 8th grade level.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 8-10 text messages per day for 6 weeks, with a focus on information, motivation, and behavioral skills to increase HIV testing

6 weeks

Daily virtual engagement

Booster Session

Participants receive a 1-week booster session of text messages to reinforce the intervention

1 week

Daily virtual engagement

Follow-up

Participants are monitored for HIV/STI testing outcomes and other secondary measures at 3 and 6 months post-intervention

6 months

3-month and 6-month virtual follow-up surveys

What Are the Treatments Tested in This Trial?

Interventions

• Text Messaging Intervention

Trial Overview The study is testing if text messages can help encourage SGM teens to get tested for HIV. Participants will be randomly placed into two groups: one receives texts designed to inform, motivate and build skills related to HIV testing; the other gets only information texts. The main goal is to see if these messages increase actual HIV testing.

How Is the Trial Designed?

Group I: Information, motivation, behavioral skills treatment arm Experimental Treatment 1 Intervention

The active treatment arm consists of text messages with information, motivation, and behavioral skill based text messages aimed at increasing HIV testing, our primary outcome. Secondary outcomes include STI testing, PrEP uptake, condomless sex, and discussions with providers about PrEP/HIV care. Hypothesized mediators of HIV testing include testing/prevention information, motivation, and behavioral skills. All participants will receive 8-10 messages/day for 6 weeks, with a 1 week booster session following the intervention. In the active treatment arm, participants will have full access to interactive features such as quizzes, badges, an external chatbot feature, a website with sexual health resources, and a group chat feature (a group of 3-5 total participants with whom participants can discuss program content) to promote engagement and enhance learning and skills acquisition.

Group II: Information only control Placebo Group 1 Intervention

The attention matched control arm will include information based text messages about general health and sexual health topics such as human immunodeficiency virus (HIV), sexually transmitted infections (STIs), relationships, and biomedical methods of HIV prevention (e.g., Pre-exposure prophylaxis (PrEP), Post-exposure prophylaxis (PEP)). No motivational or behavioral skill based text messages aimed at increasing HIV testing or reducing HIV risk behavior will be included. All participants will receive 8-10 messages/day for 6 weeks, with a 1 week booster. Participants in the control arm will have modified access to the interactive features such as quizzes, badges, an external chatbot feature, a website with sexual health resources and a group chat feature (a group of 3-5 total participants with whom participants can discuss program content).

Text Messaging Intervention is already approved in United States, Canada for the following indications:

Approved in United States as Text Messaging Intervention for:

• Perinatal Depression Risk Reduction

Approved in Canada as Text Messaging Intervention for:

• Perinatal Depression Risk Reduction

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

The study analyzed 1550 SMS messages and 4071 participant replies, finding that supportive and informative messages significantly reduced the likelihood of participants prematurely stopping the program, while notification messages increased the chance of stopping.

Machine learning models effectively categorized message intent and participant replies, showing that informative and instructional messages boosted engagement, while motivational messages did not have a significant impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Message Analysis Using Machine Learning to Assess Predictors of Engagement With Mobile Health Chronic Disease Prevention Programs: Content Analysis. Klimis, H., Nothman, J., Lu, D., et al.[2022]

Text messaging (SMS) is a highly effective and personal way to deliver behavioral health interventions remotely, leveraging the widespread use of cell phones globally.

Current studies indicate that SMS interventions can successfully promote healthy behaviors and may be more effective than other computerized methods, highlighting the need for future research to optimize SMS features for individual user engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Message Behavioral Interventions: From Here to Where? Suffoletto, B.[2022]

A mobile text messaging intervention for HIV prevention was successfully implemented among 464 employees in the construction industry, achieving a high message delivery rate of 91.6% and 100% read rate, indicating strong engagement.

The intervention led to 21.6% of participants reporting they had taken an additional HIV test since the initial workplace testing, suggesting that SMS messaging can effectively promote HIV testing and awareness even during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test@Work Texts: Mobile Phone Messaging to Increase Awareness of HIV and HIV Testing in UK Construction Employees during the COVID-19 Pandemic. Middleton, M., Somerset, S., Evans, C., et al.[2020]

This study aims to evaluate the effectiveness of different reminder methods (text messages, reminder calls, or both) in increasing the use of service referrals among 300 participants from community outreach programs.

The research will help determine how mobile phone-based interventions can enhance community engagement and service utilization, potentially guiding future reminder protocols for similar programs across the country.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Research Protocol to Test the Effectiveness of Text Messaging and Reminder Calls to Increase Service Use Referrals in a Community Engagement Program. Varma, DS., Hart, M., McIntyre, DS., et al.[2020]

Text messaging interventions have been shown to effectively improve adherence to antiretroviral therapy and increase appointment attendance among people living with HIV, based on a systematic review of nine high-quality reviews involving 37 studies across 19 countries.

There are significant knowledge gaps regarding long-term outcomes and patient satisfaction with text messaging interventions, indicating a need for further research to fully understand their impact and potential in managing other chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone text messaging interventions for HIV and other chronic diseases: an overview of systematic reviews and framework for evidence transfer. Mbuagbaw, L., Mursleen, S., Lytvyn, L., et al.[2022]

A systematic review of 60 studies found that mobile text message reminders significantly improved health outcomes, with 77% of studies reporting benefits such as better medication adherence and reduced missed appointments.

Despite the positive results, the use of SMS reminders in healthcare lacks rigorous randomized controlled trials, indicating a need for more systematic research to validate their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of mobile phone text message reminders in health care services: a narrative literature review. Kannisto, KA., Koivunen, MH., Välimäki, MA.[2022]

A review of 51 studies highlighted the importance of developing SMS content for mHealth initiatives aimed at supporting HIV/AIDS treatment adherence, emphasizing the need for formative research and grounding messages in behavior change theory.

Best practices for creating effective SMS messages include consulting with experts and using established behavior change frameworks to enhance the effectiveness of mobile health interventions in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content guidance for mobile phones short message service (SMS)-based antiretroviral therapy adherence and appointment reminders: a review of the literature. Kerrigan, A., Kaonga, NN., Tang, AM., et al.[2023]

The SMS intervention for managing HIV Viral Load results in Zimbabwe was found to be acceptable to both patients and healthcare workers, improving adherence and management of results despite some implementation challenges.

While the intervention has the potential to reduce unnecessary clinic visits and enhance patient engagement in their HIV care, it requires clear communication and counseling to address concerns about message clarity and privacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and health-care worker experiences of an HIV viral load intervention using SMS: A qualitative study. Venables, E., Ndlovu, Z., Munyaradzi, D., et al.[2020]

The SMS Turkey program, designed for smoking cessation in Turkey, emphasizes that the content of text messaging interventions is crucial for behavior change, not just the technology itself.

The development of the program involved careful consideration of cultural factors and evidence-based smoking cessation theories, leading to tailored messaging strategies that align with participants' quitting progress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design considerations in developing a text messaging program aimed at smoking cessation. Ybarra, ML., Holtrop, JS., Bağci Bosi, AT., et al.[2022]

Text messaging programs can effectively help individuals change health behaviors, leveraging automated and interactive messages to guide users through the behavior change process.

The authors provide a structured guide for developing these programs, emphasizing the importance of formative research, design, pretesting, and revision to ensure the program meets the needs of the target audience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and Pretesting a Text Messaging Program for Health Behavior Change: Recommended Steps. Abroms, LC., Whittaker, R., Free, C., et al.[2022]

A systematic review of 12 studies involving text messaging interventions for behavior change found that 8 out of 9 sufficiently powered studies supported its effectiveness in promoting health behavior changes over periods ranging from 3 to 12 months.

The review highlighted the need for more research in developing countries, as most studies were conducted in developed nations, despite the potential for text messaging to be a low-cost health intervention globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text messaging as a tool for behavior change in disease prevention and management. Cole-Lewis, H., Kershaw, T.[2022]

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