Text Messaging for HIV Testing

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Must not be taking: PrEP

Disqualifiers: HIV positive, Cisgender female, others

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will test the effectiveness of a text message-based intervention on human immunodeficiency virus (HIV) testing behaviors among adolescent (13-18 year old) sexual minority men and transgender and gender diverse teens (ASMM/TGD). To test the effectiveness on HIV testing behaviors we will randomize participants to the treatment or an attention matched information only control arm and asses our primary effectiveness outcome of objective HIV testing (e.g., photo of test results).

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 text messaging treatment for HIV testing?

Research shows that text messaging can improve health outcomes and support behavior change in people living with HIV and other chronic diseases. Text messaging is widely available, inexpensive, and has been effective in disease management and prevention. ^{1 2 3 4 5}

Is text messaging for health interventions safe for humans?

Research shows that using text messaging for health interventions, like reminders and behavior change support, is generally safe. There have been no reports of harmful effects, such as misreading messages or privacy issues, when using text messaging in these contexts. ^{1 3 6 7 8}

How does the Text Messaging Intervention for HIV testing differ from other treatments?

The Text Messaging Intervention is unique because it uses mobile phone text messages to support behavior change and improve health outcomes, offering a low-cost, widely accessible, and instant method to encourage HIV testing and adherence to treatment, unlike traditional in-person or medication-based approaches. ^{1 3 9 10 11}

Research Team

Eligibility Criteria

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 am between 13 and 18 years old.

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

Trial Timeline

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

Treatment Details

Interventions

• Text Messaging Intervention (Behavioral 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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Dr. Jeanne Marrazzo

National Institutes of Health (NIH)

Chief Medical Officer

MD from University of California, Los Angeles

Dr. Jay Bhattacharya

National Institutes of Health (NIH)

Chief Executive Officer

MD, PhD from Stanford University

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Dr. Joshua A. Gordon

National Institute of Mental Health (NIMH)

Chief Executive Officer since 2016

MD, PhD

Dr. Shelli Avenevoli

National Institute of Mental Health (NIMH)

Chief Medical Officer

PhD

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. England 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. [2022]

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

Text messaging as a tool for behavior change in disease prevention and management. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Developing and Pretesting a Text Messaging Program for Health Behavior Change: Recommended Steps. [2022]

5. Canada 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. [2022]

6. Switzerland 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. [2020]

7. Canada 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. [2020]

8. Canada pubmed.ncbi.nlm.nih.gov

Design considerations in developing a text messaging program aimed at smoking cessation. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Use of mobile phone text message reminders in health care services: a narrative literature review. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Text Message Behavioral Interventions: From Here to Where? [2022]

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

Patient and health-care worker experiences of an HIV viral load intervention using SMS: A qualitative study. [2020]