LOTUS mHealth Intervention for HIV Prevention

(LOTUS Trial)

Overseen By Stephanie A Meyers-Pantele, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Must be taking: PrEP

Disqualifiers: Pregnancy, Male identity, others

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

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile app designed to help women who use drugs engage more with HIV prevention services and manage stigma. Participants will use either a full-featured app, the LOTUS mHealth Intervention, which includes information, peer support, and health reminders, or a simpler website with basic HIV information, known as the LOTUS Control Group. The trial seeks women who regularly use opioids or stimulants, have not been active in HIV prevention services recently, and own a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for HIV prevention and support.

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 the LOTUS mHealth intervention is safe for use in HIV prevention?

Research has shown that the LOTUS mHealth Intervention is a technology-based tool to help prevent HIV. This tool is a mobile app offering features like educational content, peer support, and reminders for testing and medication adherence.

While specific safety data for the LOTUS mHealth Intervention is not available, it is important to note that it is a digital tool, not a drug or medical procedure, making physical harm unlikely. The app is designed to provide information and support, generally involving minimal risk to users.

In summary, as a mobile app offering educational content and support, the LOTUS intervention is expected to be safe and well-received, with no major safety concerns reported in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LOTUS mHealth Intervention for HIV prevention because it uses a mobile, WebApp-based platform to deliver its content, making it more accessible and engaging for users. Unlike traditional methods that might rely on in-person consultations or static websites, this intervention offers a dynamic, interactive experience that can be accessed anytime and anywhere. This approach is particularly promising for reaching women who may face barriers to accessing traditional healthcare resources. By integrating technology into HIV prevention, the intervention has the potential to enhance user engagement and improve health outcomes in ways that standard information-only websites may not achieve.

What evidence suggests that the LOTUS mHealth Intervention is effective for HIV prevention?

Research has shown that mobile health programs, such as the LOTUS mHealth Intervention, can enhance HIV prevention and care. For instance, a similar program, PositiveLinks, increased the retention of people with HIV in care from 51% to 88% within six months. Another mobile health program reduced the amount of HIV in the blood, indicating improved health. These programs often provide crucial tools like medication and testing reminders, along with support from peers and professionals. Overall, early evidence suggests that the LOTUS mHealth Intervention could engage diverse women who use drugs in HIV prevention and reduce stigma. Meanwhile, participants in the control arm will access an information-only website with content on HIV transmission, PrEP, harm reduction, and resources for women. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for women over 18 who use opioids/stimulants weekly or daily, have low HIV prevention service engagement, and are eligible for PrEP according to CDC guidelines. Participants must own a smartphone with internet access and not be pregnant nor plan to become pregnant during the study.

Inclusion Criteria

I identify as female.

I was assigned female at birth.

I have used opioids or stimulants weekly or daily in the past 6 months.

Exclusion Criteria

Does not report weekly or daily use of opioids and/or stimulants in the past 6 months

Does not meet current CDC eligibility criteria for PrEP

My current gender identity is not female.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the LOTUS intervention or an informational control for 6 months

6 months

Baseline, 3-month, and 6-month assessments

Follow-up

Participants are monitored for HIV prevention service engagement and intersectional stigma

6 months

What Are the Treatments Tested in This Trial?

Interventions

• LOTUS Control Group
• LOTUS mHealth Intervention

Trial Overview The LOTUS mHealth intervention is being tested. It's a tech-based program offering HIV prevention info, peer support, resource locating, reminders for testing and PrEP doses, plus virtual talks with healthcare pros. The control group doesn't receive these features.

How Is the Trial Designed?

Group I: LOTUS Intervention Arm Experimental Treatment 1 Intervention

A mobile, WebApp-based platform to access the LOTUS intervention content.

Group II: Informational Control Arm Active Control 1 Intervention

An information-only website, with content on HIV transmission, PrEP, harm reduction, and resources for women.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Mobile health technology (mHealth) shows promise in supporting key aspects of HIV care, such as linking patients to care, retaining them in treatment, and improving adherence to antiretroviral therapy, based on a systematic review of 62 articles.

Despite the rapid evolution of mHealth tools, there is still a lack of rigorous evidence specifically addressing the needs of vulnerable populations, indicating a need for more targeted research and implementation in these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth for HIV Treatment & Prevention: A Systematic Review of the Literature. Catalani, C., Philbrick, W., Fraser, H., et al.[2022]

The PositiveLinks mobile health intervention significantly improved retention in care for People Living with HIV, increasing from 51% at baseline to 88% at 6 months and 81% at 12 months, indicating its effectiveness in keeping patients engaged with their healthcare.

Participants also experienced notable clinical improvements, with viral load suppression rising from 47% at baseline to 87% at 6 months, and mean CD4 counts increasing significantly, demonstrating the intervention's potential to enhance health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PositiveLinks: A Mobile Health Intervention for Retention in HIV Care and Clinical Outcomes with 12-Month Follow-Up. Dillingham, R., Ingersoll, K., Flickinger, TE., et al.[2019]

The iReach randomized controlled trial successfully identified and prevented 624 cases of potential fraudulent or ineligible enrollment among same-sex attracted, cisgender males aged 13-18, using a combination of electronic and manual authentication strategies.

79% of these cases were detected through electronic methods, highlighting the effectiveness of technology in maintaining data integrity and reducing the need for extensive manual reviews in web-based trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methods for Authenticating Participants in Fully Web-Based Mobile App Trials from the iReach Project: Cross-sectional Study. Guest, JL., Adam, E., Lucas, IL., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06068283

An MHealth Intervention to Improve HIV Prevention Service ... The LOTUS intervention is a technology-delivered intervention to improve HIV prevention service engagement and reduce intersectional stigma, guided by the ...

2. withpower.com withpower.com/trial/phase-hiv-infections-6-2025-09a3d

LOTUS mHealth Intervention for HIV Prevention ... The PositiveLinks mobile health intervention significantly improved retention in care for People Living with HIV, increasing from 51% at baseline to 88% at 6 ...

3. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT06068283

MHealth Intervention to Improve HIV Prevention Service ... The LOTUS intervention is a technology-delivered intervention to improve HIV prevention service engagement and reduce intersectional stigma.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5889341/

Mobile Health Intervention to Reduce HIV Transmission Eighty-six percent of the cohort was retained for 12-months follow-up. The B-TasP intervention demonstrated significantly lower HIV RNA, OR = 0.56, p=.01, ...

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

HIV interventions across the care continuum for ... Our data demonstrate several evidence-based interventions that can enhance adolescent HIV outcomes across the care continuum.

6. reporter.nih.gov reporter.nih.gov/project-details/8629777

Project Details - NIH RePORTER Thus, we propose to conduct a series of experiments that will result in improved knowledge of how to conduct internet-based HIV prevention research with young ...

7. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/hiv-aids

UCSD HIV/AIDS Clinical Trials for 2025 — San Diego MHealth Intervention to Improve HIV Prevention Service Engagement Among Racially Diverse Women Who Use Drugs ... (LOTUS) intervention to ...