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

60 Participants Needed

Trial Summary

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 LOTUS mHealth Intervention treatment for HIV prevention?

Research shows that mobile health (mHealth) tools, like smartphone apps, can help people with HIV stay in care and stick to their treatment plans. These tools have been found to improve safe behavior knowledge, increase condom use, and reduce risky behaviors, making them promising for HIV prevention. ^{1 2 3 4 5}

Is the LOTUS mHealth Intervention for HIV Prevention safe for humans?

The available research does not provide specific safety data for the LOTUS mHealth Intervention, but it focuses on using mobile apps to support HIV prevention efforts, which generally involve low-risk activities like messaging and education. ^{6 7 8 9 10}

How is the LOTUS mHealth Intervention treatment for HIV prevention different from other treatments?

The LOTUS mHealth Intervention is unique because it uses mobile health technology to support HIV prevention by providing alerts, reminders, educational messaging, and direct communication, which can improve adherence to prevention strategies and engagement in care, especially for populations with limited access to traditional healthcare services. ^{1 2 3 6 9}

What is the purpose of this trial?

The goal of this pilot randomized controlled trial is to assess the feasibility, acceptability, and preliminary impact of the mHeaLth interventiOn To redUce Stigma (LOTUS) intervention to improve HIV prevention service engagement and reduce intersectional stigma among racially diverse women who use drugs. LOTUS is a technology-delivered intervention that provides HIV prevention informational content and tips, peer social support and social networking features, a resource locator, HIV prevention monitoring and reminders (e.g., reminders for HIV/STI testing and PrEP doses), and virtual guided discussions with health care professionals.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United Arab Emirates pubmed.ncbi.nlm.nih.gov

mHealth for HIV Treatment & Prevention: A Systematic Review of the Literature. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Scaled-Up Mobile Phone Intervention for HIV Care and Treatment: Protocol for a Facility Randomized Controlled Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A systematic review of mHealth interventions for HIV prevention and treatment among gay, bisexual, and other men who have sex with men. [2021]

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

PositiveLinks: A Mobile Health Intervention for Retention in HIV Care and Clinical Outcomes with 12-Month Follow-Up. [2019]

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

Effects of mobile health on HIV risk reduction for men who have sex with men. [2020]

6. Canada pubmed.ncbi.nlm.nih.gov

HIV Prevention Via Mobile Messaging for Men Who Have Sex With Men (M-Cubed): Protocol for a Randomized Controlled Trial. [2020]

7. Canada pubmed.ncbi.nlm.nih.gov

Privacy and Confidentiality Concerns Related to the Use of mHealth Apps for HIV Prevention Efforts Among Malaysian Men Who Have Sex With Men: Cross-sectional Survey Study. [2022]

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

Paradata Analysis of an eHealth HIV Testing Intervention for Young Men Who Have Sex With Men. [2021]

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

Building a Mobile HIV Prevention App for Men Who Have Sex With Men: An Iterative and Community-Driven Process. [2018]

10. Canada pubmed.ncbi.nlm.nih.gov

Methods for Authenticating Participants in Fully Web-Based Mobile App Trials from the iReach Project: Cross-sectional Study. [2021]