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

NCT06068283 | Not Yet Recruiting

• 2 other identifiers: 310548-00001K01DA055983
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Stigma; Women; Drug Use; mHealth; HIV Prevention

Outcome Measures

Primary Outcomes (3)

• LOTUS Feasibility

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

  6 months

• LOTUS Acceptability

  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

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

  6 months

Secondary Outcomes (1)

• Stigma

  6 months

Study Arms (2)

LOTUS Intervention Arm

EXPERIMENTAL

A mobile, WebApp-based platform to access the LOTUS intervention content.

Behavioral: LOTUS mHealth Intervention Group

Informational Control Arm

ACTIVE COMPARATOR

An information-only website, with content on HIV transmission, PrEP, harm reduction, and resources for women.

Behavioral: LOTUS Control Group

Interventions

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, 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.

LOTUS Intervention Arm

LOTUS Control Group BEHAVIORAL

Access to an information-only website with content on HIV transmission, PrEP, harm reduction, and resources for women.

Informational Control Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: To be eligible for participation, participants must report being assigned female at birth and current female identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

HIV Infections; Social Stigma

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior

Central Study Contacts

Stephanie A Meyers-Pantele, PhD

CONTACT

619-880-9588; s3meyers@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 19, 2023
• First Posted: October 5, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)