Clinical trial NCT06068283: An MHealth Intervention to Improve HIV Prevention Service Engagement Among Racially Diverse Women Who Use Drugs
Official title: LOTUS: an MHealth Intervention to Improve HIV Prevention Service Engagement Intersectional Stigma Among Racially and Ethnically Diverse Women Who Use Drugs
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Infections
Keywords: Stigma
Women
Drug Use
mHealth
HIV Prevention
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-10-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: LOTUS Feasibility
timeFrame: 6 months
measure: LOTUS Acceptability
timeFrame: 6 months
measure: HIV Prevention Service Engagement
timeFrame: 6 months
Secondary outcomes:
measure: Stigma
timeFrame: 6 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
References: