HIV InfectionsLOTUSNCT06068283
An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs
A study testing LOTUS mHealth Intervention Group in people with HIV Infections, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- LOTUS mHealth Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 30 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 17 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California San Diego
La Jolla, California, 92093
Stephanie Meyers-Pantele, PhD, 619-880-9588, s3meyers@health.ucsd.edu
About this study
Official title: LOTUS: An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs
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.
Read the detailed description
The LOTUS intervention is a technology-delivered intervention to improve HIV prevention service engagement for people 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 a virtual space to have questions answered by health care professionals. Given the disproportionate HIV-related harms people 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 single arm pre-post study. People who use drugs residing in Southern California (n = 40) will receive the LOTUS intervention for 6-months. The proportion of participants retained, intervention use data, and validated self-reported usability and HIV prevention service (e.g., HIV/STI testing, PrEP) knowledge, motivation, and use 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 at each follow-up time point when compared to baseline. The investigators will also conduct exit interviews with LOTUS participants (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.
- Conditions
- HIV Infections
- Being tested
- LOTUS mHealth Intervention Group
- Keywords
- Women, Drug Use, mHealth, HIV Prevention
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOTUS mHealth Intervention GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| LOTUS Intervention Arm | Experimental | A mobile, WebApp-based platform to access the LOTUS intervention content. Receives: Behavioral: LOTUS mHealth Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
LOTUS Feasibility
The feasibility of the LOTUS mHealth intervention will be measured by participant retention and via intervention use data.
Measured: 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.
Measured: 6 months
HIV Prevention Service Engagement
The percentage of participants who report obtaining an HIV/STI test and/or initiating PrEP
Measured: 6 months
Secondary outcomes (1)
Attitudes and Perceptions
Attitudes and perceptions will be measured via the validated InDI measure, which is comprised of three subscales: anticipated, day-to-day, and major. Anticipated scores range from 0-4, day-to-day scores range from 0-18, and major scores range from 0-13.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start1 Jul 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Stephanie Meyers, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068283
- Sponsor's protocol ID
- 310548-00001
- Other IDs
- K01DA055983
- Acronym
- LOTUS
- Status last verified
- Jun 2026
- First submitted
- 19 Sep 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LOTUS: An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs
- ClinicalTrials.gov ID
- NCT06068283
- Acronym / sponsor ID
- LOTUS / 310548-00001
- Conditions
- HIV Infections
- Keywords
- Women, Drug Use, mHealth, HIV Prevention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Jul 2027 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The LOTUS intervention is a technology-delivered intervention to improve HIV prevention service engagement for people 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 a virtual space to have questions answered by health care professionals. Given the disproportionate HIV-related harms people 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 single arm pre-post study. People who use drugs residing in Southern California (n = 40) will receive the LOTUS intervention for 6-months. The proportion of participants retained, intervention use data, and validated self-reported usability and HIV prevention service (e.g., HIV/STI testing, PrEP) knowledge, motivation, and use 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 at each follow-up time point when compared to baseline. The investigators will also conduct exit interviews with LOTUS participants (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
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| LOTUS Intervention Arm | Experimental | Behavioral: LOTUS mHealth Intervention GroupA mobile, WebApp-based platform to access the LOTUS intervention content. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 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
Key exclusion criteria (6 listed)
- 17 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOTUS mHealth Intervention GroupA 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. | Behavioural | LOTUS Intervention Arm |
Primary outcome
LOTUS Feasibility
Time frame: 6 months
The feasibility of the LOTUS mHealth intervention will be measured by participant retention and via intervention use data.
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.
HIV Prevention Service Engagement
Time frame: 6 months
The percentage of participants who report obtaining an HIV/STI test and/or initiating PrEP
1 secondary outcome
Attitudes and Perceptions
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOTUS mHealth Intervention Group in people with HIV Infections, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie A Meyers-Pantele, PhD (619-880-9588, s3meyers@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LOTUS Feasibility (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.