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

Not Applicable

Not yet recruiting

• Conditions: HIV Infections
• Interventions: Behavioral: LOTUS Control Group; Behavioral: LOTUS mHealth Intervention Group

• Registration Number: NCT06068283
• Lead Sponsor: University of California, San Diego

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-28
• Study First Posted: 2023-10-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Study Start: 2025-06
• Primary Completion: 2026-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Informational Control Arm	LOTUS Control Group	An information-only website, with content on HIV transmission, PrEP, harm reduction, and resources for women.
LOTUS Intervention Arm	LOTUS mHealth Intervention Group	A mobile, WebApp-based platform to access the LOTUS intervention content.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Stigma	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.

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 La Jolla, California, United States