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An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs

LOTUS: An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06068283
Acronym
LOTUS
Enrollment
40
Registered
2023-10-05
Start date
2026-07-01
Completion date
2027-07-30
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Women, Drug Use, mHealth, HIV Prevention

Brief summary

The goal of this single arm pre-post study is to assess the feasibility, acceptability, and preliminary impact of the LOTUS intervention to improve HIV prevention service engagement among people 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 a virtual space to have questions answered by health care professionals.

Detailed description

The LOTUS intervention is a technology-delivered intervention to improve HIV prevention service engagement for people who use drugs. LOTUS 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 a virtual space to have questions answered by health care professionals. Given the disproportionate HIV-related harms people who use drugs face, and critical need for HIV prevention mHealth interventions tailored to the unique needs of this population, the current study seeks to accomplish the following aim. The primary aim is to assess the feasibility, acceptability, and preliminary impact of the LOTUS intervention in a single arm pre-post study. People who use drugs residing in Southern California (n = 40) will receive the LOTUS intervention for 6-months. The proportion of participants retained, intervention use data, and validated self-reported usability and HIV prevention service (e.g., HIV/STI testing, PrEP) knowledge, motivation, and use measures will be collected at baseline, 3-, and 6-months to assess LOTUS feasibility, acceptability, and preliminary impact. The investigators hypothesize that participants in the LOTUS intervention will find the intervention to be feasible and usable, and that they will demonstrate significant improvements in HIV prevention service use at each follow-up time point when compared to baseline. The investigators will also conduct exit interviews with LOTUS participants (n = 20) to gain feedback on the intervention characteristics, as defined by the Consolidated Framework for Implementation Research, and to elicit suggestions for improvement in anticipation of a future large-scale randomized controlled trial.

Interventions

BEHAVIORALLOTUS mHealth Intervention Group

A mobile, WebApp-based intervention comprised of tips for HIV prevention, a community wall for peer interaction and support, HIV prevention monitoring and reminders, a virtual space to have questions answered by a healthcare professional, a resource database, and a personalized profile. Intervention components are designed to promote HIV prevention service use and improve social support, coping strategies, and positive affect.

Sponsors

University of California, San Diego
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

All participants in this single arm pre-post study will receive the LOTUS mHealth intervention. Participants will receive access to the LOTUS intervention for 6-months and will be assessed at baseline and at 3-month and 6-month follow-up timepoints.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 18 years of age or older * Report weekly or daily use of opioids and/or stimulants in the past 6 months * Meet current CDC eligibility criteria for PrEP * Report low levels of HIV prevention service engagement in the past 6 months * Not currently, or planning on becoming, pregnant during the study * Owns a smartphone with internet web-browsing capabilities

Exclusion criteria

* 17 years of age or younger * 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 * Report high levels of HIV prevention service engagement in the past 6 months * Currently, or planning on becoming, pregnant during the study * Does not own a smartphone with internet web-browsing capabilities

Design outcomes

Primary

MeasureTime frameDescription
LOTUS Feasibility6 monthsThe feasibility of the LOTUS mHealth intervention will be measured by participant retention and via intervention use data.
LOTUS Acceptability6 monthsThe acceptability of the LOTUS mHealth intervention will be measured via the System Usability Scale (SUS), with possible scores ranging from 10-50 and higher scores indicating higher acceptability.
HIV Prevention Service Engagement6 monthsThe percentage of participants who report obtaining an HIV/STI test and/or initiating PrEP

Secondary

MeasureTime frameDescription
Attitudes and Perceptions6 monthsAttitudes and perceptions will be measured via the validated InDI measure, which is comprised of three subscales: anticipated, day-to-day, and major. Anticipated scores range from 0-4, day-to-day scores range from 0-18, and major scores range from 0-13.

Countries

United States

Contacts

CONTACTStephanie A Meyers-Pantele, PhD
s3meyers@health.ucsd.edu619-880-9588

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026