LOTUS: An mHealth Intervention to Improve HIV Prevention Service Engagement Among Racially Diverse Women Who Use Drugs

Sponsor

University of California, San Diego (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06068283

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Behavioral: LOTUS mHealth Intervention Group Behavioral: LOTUS Control Group	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomized 2:1 to either the LOTUS mHealth intervention or an informational control. Participants randomized to the treatment arm will receive access to the LOTUS intervention for 6-months. Participants in the control arm will, in parallel, receive access to an information-only website for 6-months.Participants will be randomized 2:1 to either the LOTUS mHealth intervention or an informational control. Participants randomized to the treatment arm will receive access to the LOTUS intervention for 6-months. Participants in the control arm will, in parallel, receive access to an information-only website for 6-months.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2025

Anticipated Primary Completion Date :

Jul 1, 2026

Anticipated Study Completion Date :

Jul 1, 2027

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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