NCT06068283

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for not_applicable hiv-infections

Timeline
12mo left

Started Jul 2026

Shorter than P25 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jul 2026Jul 2027

First Submitted

Initial submission to the registry

September 19, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
2.7 years until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2027

Last Updated

June 26, 2026

Status Verified

June 1, 2026

Enrollment Period

10 months

First QC Date

September 19, 2023

Last Update Submit

June 22, 2026

Conditions

HIV Infections

Keywords

WomenDrug UsemHealthHIV 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)

  • Attitudes and Perceptions

    6 months

Study Arms (1)

LOTUS Intervention Arm

EXPERIMENTAL

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

Behavioral: LOTUS mHealth Intervention Group

Interventions

LOTUS mHealth Intervention GroupBEHAVIORAL

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.

LOTUS Intervention Arm

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsTo be eligible for participation, participants must report being assigned female at birth and current female identity.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Central Study Contacts

Stephanie A Meyers-Pantele, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: All participants in this single arm pre-post study will receive the LOTUS mHealth intervention. Participants will receive access to the LOTUS intervention for 6-months and will be assessed at baseline and at 3-month and 6-month follow-up timepoints.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 5, 2023

Study Start

July 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

July 30, 2027

Last Updated

June 26, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)