University of California San Diego
La Jolla, California, 92093, United States
NCT Number: NCT06068283
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 opening soon.
Get Notified18 year and older
Female
Interventional
Not applicable
La Jolla, California, 92093, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months
The feasibility of the LOTUS mHealth intervention will be measured by participant retention and via intervention use data.
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.
Time frame: 6 months
The percentage of participants who report obtaining an HIV/STI test and/or initiating PrEP
Time frame: 6 months
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.
Contact information is provided by the study sponsor or research team.
University of California, San Diego
Other
LOTUS: An mHealth Intervention to Improve HIV Prevention Service Engagement Among People Who Use Drugs
Acronym: LOTUS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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