Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06068283

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego

La Jolla, California, 92093, United States

Location contact

Stephanie Meyers-Pantele, PhD

CONTACT

[email protected]

619-880-9588

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LOTUS mHealth Intervention Group

Behavioral

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.

Primary outcomes

  1. LOTUS Feasibility

    Time frame: 6 months

    The feasibility of the LOTUS mHealth intervention will be measured by participant retention and via intervention use data.

  2. LOTUS Acceptability

    Time frame: 6 months

    The 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.

  3. HIV Prevention Service Engagement

    Time frame: 6 months

    The percentage of participants who report obtaining an HIV/STI test and/or initiating PrEP

Secondary outcomes

  1. Attitudes and Perceptions

    Time frame: 6 months

    Attitudes 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie A Meyers-Pantele, PhD

CONTACT

[email protected]

619-880-9588

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: LOTUS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Oct 5, 2023
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.