An MHealth Intervention to Improve HIV Prevention Service Engagement Among Racially Diverse Women Who Use Drugs (LOTUS)

February 28, 2025 updated by: Stephanie Meyers, University of California, San Diego

LOTUS: an MHealth Intervention to Improve HIV Prevention Service Engagement Intersectional Stigma Among Racially and Ethnically Diverse Women Who Use Drugs

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The LOTUS intervention is a technology-delivered intervention to improve HIV prevention service engagement and reduce intersectional stigma, guided by the Health Stigma and Discrimination Framework and the Theory of Triadic Influences, for racially and ethnically diverse women 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 virtual guided discussions with health care professionals. Given the disproportionate HIV-related harms racially and ethnically diverse women 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 pilot randomized controlled trial. Racially and ethnically diverse women who use drugs residing in Southern California (n = 60) will be randomized (2:1) to receive the LOTUS intervention or an informational control for 6-months. The proportion of participants retained, intervention use data, and validated self-reported usability, HIV/STI testing, PrEP use, and intersectional stigma 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 and intersectional stigma at each follow-up time point when compared to control participants. The investigators will also conduct exit interviews with every other participant randomized to LOTUS (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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University Of California San Diego
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 18 years of age or older
  • Current female identity
  • Assigned female at birth
  • 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
  • Current gender identity other than female
  • Not assigned female at birth
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LOTUS Intervention Arm
A mobile, WebApp-based platform to access the LOTUS intervention content.
Behavioral: LOTUS 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, guided discussions with a health care professional, a resource database, and a personalized profile. Intervention components are designed to promote HIV prevention service use, reduce stigma and improve social support, coping strategies, and positive affect.
Active Comparator: Informational Control Arm
An information-only website, with content on HIV transmission, PrEP, harm reduction, and resources for women.
Behavioral: LOTUS Control Group
Access to an information-only website with content on HIV transmission, PrEP, harm reduction, and resources for women.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LOTUS Feasibility
Time Frame: 6 months
The feasibility of the LOTUS mHealth intervention will be measured by participant retention and via intervention use data.
6 months
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.
6 months
HIV Prevention Service Engagement
Time Frame: 6 months
The percentage of participants who report obtaining an HIV/STI test and/or initiating PrEP
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stigma
Time Frame: 6 months
Intersectional stigma will be measured via the Intersectional Discrimination Index (InDI), which is comprised of three subscales: anticipated discrimination, day-to-day discrimination, and major discrimination. Anticipated discrimination scores range from 0-4, day-to-day discrimination scores range from 0-18, and major discrimination scores range from 0-13. Higher scores on all subscales indicate higher levels of anticipated or experienced discrimination.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 28, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 310548-00001
  • K01DA055983 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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