LOTUS mHealth Intervention for HIV Prevention
(LOTUS Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of California, San Diego

No Placebo Group

Trial Summary

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.

+5 more

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.

+5 more

Participant Groups

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.

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.