Mobile Technology for HIV Prevention

(YouthHealth Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: New York State Psychiatric Institute

Disqualifiers: Age, Location, Phone ownership, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to explore how mobile phones can help prevent HIV and improve related health issues, such as sexual and mental health, among adolescents. It will test an adapted text-message and voice system, originally developed by FHI 360, called Youth Health SMS, to determine its effectiveness in supporting HIV prevention and connecting users to health resources. The trial consists of two parts: one group will use this mobile-based intervention, while the other will receive standard care. Adolescents aged 15-19 living in the greater Masaka region in Uganda with a mobile phone may be eligible to participate. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative research that could enhance health outcomes for adolescents.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using mobile technology for HIV prevention, so it's best to ask the study team directly for guidance.

What prior data suggests that this mobile technology is safe for HIV prevention among adolescents?

Research shows that mobile phone programs like the Youth Health SMS system are generally safe. Past studies have found these programs to be popular and easy to use. For example, a similar program called Kirabo SMS was both well-received by users and effective in sharing health information.

Specific safety data for the Youth Health SMS system is not yet available, but using text messages and voice technology for health purposes is common and typically very safe. These tools often send reminders, share educational content, and assist in habit changes without causing harm. Based on similar programs, participants can expect this approach to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Youth Health SMS program because it represents a novel approach to HIV prevention by leveraging mobile technology. Unlike traditional methods that often rely on in-person education and counseling, this intervention uses text messages to reach young people directly and consistently on their phones. This method not only increases accessibility and engagement but also provides timely and personalized health information. By integrating these elements, the Youth Health SMS program aims to enhance preventive behaviors among youth, potentially leading to a significant reduction in HIV risk.

What evidence suggests that this mobile technology is effective for HIV prevention?

Research has shown that mobile health tools, like text message systems, can help prevent HIV among teenagers. In this trial, participants in the intervention arm will receive the mobile phone-based intervention, Youth Health SMS, designed to enhance HIV prevention efforts. Studies have found that these tools can boost teens' confidence in preventing HIV. Evidence also suggests they can lead to more HIV testing and increased condom use, both crucial for prevention. Although data on whether these tools increase PrEP use (a medication to prevent HIV) is limited, early results appear promising. Overall, mobile technology for health information shows promise in supporting HIV prevention and related health issues. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for adolescents aged 15-19 living in the greater Masaka region of southern Uganda who own a mobile phone and can consent to participate. They should not have taken part in Phase I of the study, ensuring new participants for Phase II.

Inclusion Criteria

I understand and can agree to the study's consent forms on my own.

For Phase II, did not participate. In Phase I: Review of study records

Own a mobile phone self-report during enrollment and confirmed visually by project director or research assistant

Exclusion Criteria

I am not between the ages of 15 and 19.

People who do not own a mobile phone self-report during enrollment and confirmed visually by project director or research assistant

People who do not reside in the greater Masaka region in southern Uganda self-report during enrollment and confirmed by school personnel or local community leader

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Theater Pretesting and Focus Groups

Theater pretesting involves developing the messages and concepts of an intervention and exploring them with intended audiences, followed by focus groups to gather feedback.

3 months

Daily interactions for 1 week, followed by focus groups

Phase 2: Randomized Control Trial

Participants are randomized into two arms to evaluate the mobile phone-based intervention versus standard of care.

5 weeks

Weekly interactions via mobile phone

Follow-up

Participants are monitored for outcomes such as HIV testing, mental health, and substance use.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Youth Health SMS

Trial Overview The study tests an adapted text-message and interactive voice response (IVR) system aimed at preventing HIV and addressing sexual, mental health, and alcohol use issues among youth. Participants will be randomly assigned to receive this mobile intervention or standard care.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Participants in this arm will receive the mobile phone-based intervention.

Group II: Standard of care Active Control 1 Intervention

Participants in this arm will receive only standard of care.

Who Is Running the Clinical Trial?

New York State Psychiatric Institute

Lead Sponsor

Trials

481

Recruited

154,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38113102/

Protocol for a Pilot Randomized Controlled Trial - PubMed - NIH Objective: This study aims to evaluate the acceptability and feasibility of Kirabo, an SMS text message intervention informed by the information ...

2. researchprotocols.org researchprotocols.org/2023/1/e49352/

Mobile Phone Technology for Preventing HIV and Related ... We posit that SMS text messaging via the platform will increase adolescents' self-efficacy by providing them with simple and direct information ...

3. mhealth.jmir.org mhealth.jmir.org/2025/1/e60819

Mobile Health Intervention Tools Promoting HIV Pre-Exposure ... Overall, the reviews found limited data on the effectiveness of current interventions (including mHealth tools) to increase PrEP uptake and ...

4. jahonline.org jahonline.org/article/S1054-139X(24)00586-X/fulltext

Outcomes of a Novel HIV and STI Prevention Intervention ... The TAKE Steps intervention led to increases in HIV and STI prevention self-efficacy among youth with recent STIs. We also found significantly higher rates ...

5. implementationsciencecomms.biomedcentral.com implementationsciencecomms.biomedcentral.com/articles/10.1186/s43058-021-00230-w

Mobile health interventions for HIV/STI prevention among ... Studies evaluating the effectiveness of mhealth interventions have also shown promising results such as increase in HIV testing, condom use, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10762611/

Mobile Phone Technology for Preventing HIV and Related ... This study aims to evaluate the acceptability and feasibility of Kirabo, an SMS text message intervention informed by the information, motivation, and behavior ...

7. researchprotocols.org researchprotocols.org/2025/1/e63114

Adolescent Youth Survey on HIV Prevention and Sexual ... In this study, we aim to elucidate knowledge, beliefs, and preferences related to HIV and STI prevention among sexual and gender minority ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4620570/

Social media interventions to prevent HIV: A review of ... We review recent research using social media behavioral interventions to prevent HIV. These interventions promote safe sex, HIV testing and safe injection use.

9. sciencedirect.com sciencedirect.com/science/article/pii/S2589537024005686

HIV interventions across the care continuum for ... Adolescents (10–19 years old) have poor outcomes across the prevention-to-treatment HIV care continuum, leading to significant mortality and morbidity.

10. journals.uchicago.edu journals.uchicago.edu/doi/full/10.1086/712479

Case Managers, HIV-Positive Youth, and a Text Messaging ... We developed and implemented the E-VOLUTION text messaging program to improve health outcomes among youths (ages 18–29) with HIV, with the goals of improving ...