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Behavioral Intervention

LOTUS mHealth Intervention for HIV Prevention (LOTUS Trial)

N/A
Waitlist Available
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Assigned female at birth
Report weekly or daily use of opioids and/or stimulants in the past 6 months
Must not have
Current gender identity other than female
Not assigned female at birth
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess the impact of a technology-delivered intervention to improve HIV prevention service engagement and reduce stigma among racially diverse women who use drugs.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves an informational and support intervention rather than medication, traditional side effects aren't expected. However, participants may experience discomfort or stress related to discussing personal health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I was assigned female at birth.
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I have used opioids or stimulants weekly or daily in the past 6 months.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My current gender identity is not female.
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I was not assigned female at birth.
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I am 17 years old or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
HIV Prevention Service Engagement
LOTUS Acceptability
LOTUS Feasibility
Secondary study objectives
Stigma

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: LOTUS Intervention ArmExperimental Treatment1 Intervention
A mobile, WebApp-based platform to access the LOTUS intervention content.
Group II: Informational Control ArmActive Control1 Intervention
An information-only website, with content on HIV transmission, PrEP, harm reduction, and resources for women.

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor
1,180 Previous Clinical Trials
1,574,986 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,586 Previous Clinical Trials
3,328,476 Total Patients Enrolled
~40 spots leftby Jul 2026
Unbiased ResultsWe believe in providing patients with all the options.
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