Mobile Health App for HIV/AIDS

(LPP Plus Trial)

Recruiting at 2 trial locations

Overseen By Jamila K Stockman, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Guiding Right, Inc.

Disqualifiers: Male gender, HIV negative, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health app called LinkPositively (LP) to determine its effectiveness in helping Black women living with HIV adhere to their treatment and improve their health. The study compares a standard version of the app with an enhanced version featuring mindfulness elements to identify which is more effective. Women who have experienced violence, have HIV, and have previously used health services but may have recently stopped, are well-suited for this study. Participants will use the app to connect with support services and receive assistance with healthcare appointments and emotional support. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance support for Black women living with HIV.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the LinkPositively (LP) app has been successfully used in past studies with Black women living with HIV/AIDS. The app offers support through peer guidance and addresses trauma and cultural needs. In these studies, participants reported no serious safety issues and generally found the app easy to use.

The improved version, LinkPositively+ (LPP+), includes mindfulness videos and extra support sessions. While specific data on LPP+ is not yet available, it builds on the LP app, which has been safe in previous studies. Since LPP+ simply adds more features to an already safe app, it is likely to be well-received. Participants in past studies did not report major problems with the LP app, indicating its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel way to support women living with HIV/AIDS using a mobile health app called LinkPositively. Unlike standard HIV care, which often focuses on medication adherence and medical appointments, this approach incorporates virtual peer support and mindfulness practices to address emotional, mental, and social needs. The LinkPositively+ arm adds unique features like mindfulness videos and culturally tailored meditation sessions, helping participants build resilience and self-pride in a personalized and accessible manner. This trial aims to enhance traditional HIV treatment by integrating holistic support, potentially improving overall well-being and engagement in care for women with HIV.

What evidence suggests that this trial's treatments could be effective for improving HIV care outcomes?

Research shows that the LinkPositively (LP) app, used by participants in the control arm of this trial, can improve HIV care for Black women living with HIV/AIDS. Studies have found that it keeps people engaged in their HIV care, enhances medication adherence, and helps reduce the virus to undetectable levels. Participants in the intervention arm will use the new version, LinkPositively+ (LPP+), which includes mindfulness meditation and cultural content to potentially further support mental health and coping skills. This combination aims to boost confidence in managing HIV and increase social support. Early findings suggest these digital tools can help overcome barriers to healthcare and provide essential emotional and informational support. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for Black women living with HIV who have experienced interpersonal violence and may have had gaps in their HIV care within the past year. Participants should be currently linked to some form of HIV care.

Inclusion Criteria

Black or African American racial/ethnic identity

Living with HIV/AIDS

I identify as a woman, whether cisgender or transgender.

Exclusion Criteria

HIV negative serostatus

I am not willing to participate in the study.

I do not have any cognitive issues that would stop me from following the study's procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessment including needs assessment and app training

1 week

1 visit (in-person or virtual)

Intervention

Participants receive the LinkPositively or LinkPositively+ intervention, including app usage and mindfulness sessions

6 months

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3- and 6-month post enrollment assessments

What Are the Treatments Tested in This Trial?

Interventions

• LP
• LPP+

Trial Overview The study is testing an enhanced mobile app called LinkPositively+ (LPP) against a standard version (LP). The goal is to see if LPP improves staying on track with HIV treatment, medication adherence, and viral suppression through features like mindfulness meditation.

How Is the Trial Designed?

Group I: Intervention Arm: LinkPositively+ Experimental Treatment 1 Intervention

Women assigned to the LPP+ arm will receive all components of the LP arm plus access to mindfulness videos via the app, in addition to participating in a virtual 6-session weekly, PN led mindfulness meditation enhanced intervention. The sessions will be delivered in real time, by PNs and will involve 1 on 1 discussions on a) the principles and health benefits of mindfulness meditation, b) lived experiences of women living with HIV and intersectional identities of being Black, and doubling identifying as women, c) experiencing trauma in personal relationships, d) ethnic pride, e) sex/gender pride, and f) positive self-affirmations. Sessions will be conducted online, in-app, and include culturally congruent video clips, role playing, and skills building activities that enhance self-pride and coping during stressful situations.

Group II: Control Arm: LinkPositively Active Control 1 Intervention

Women assigned to the LinkPositively arm will have access to all four components of the LinkPositively app. Women will be scheduled for a session with staff to inform them of their assigned virtual Peer Navigator (PN). Staff will train participants on how to download the app, explain the five components, using each component, and contacting their PN. Within the first week after, virtual PNs will complete a one-on-one, in-person or phone intake session with the participant, based on the participant's preference. During this intake session, the PN will conduct a participant needs assessment to connect her to HIV medical care via local health clinics and identify other areas of need, services of need, and assisted referrals (domestic violence services, mental health care, substance abuse treatment, housing and legal support, etc.). PNs will provide trauma-informed emotional and informational support, including guidance on accessing information about referred services.

LP is already approved in United States for the following indications:

Approved in United States as LinkPositively for:

• Improving HIV care outcomes among Black women affected by interpersonal violence and mental health issues

Who Is Running the Clinical Trial?

Guiding Right, Inc.

Lead Sponsor

Trials

1

Recruited

60+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8687146/

LinkPositively: A Trauma-Informed Peer Navigation and Social ... In the U.S., Black women living with HIV/AIDS (WLHA) are affected disproportionately by interpersonal violence, which often co-occurs with adverse mental health ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06458660?term=Lpp&viewType=Table&rank=3

LinkPositively+ A Mobile Health App Delivered Intervention to ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06458660/linkpositively-a-mobile-health-app-delivered-intervention-to-improve-hiv-care-outcomes-among-black-women-affected-by-mental-health-and-violence?page=1&id=2&slug=aids-and-aids-related-infections

LinkPositively+ A Mobile Health App Delivered Intervention ... LP aims to improve HIV care outcomes including improved retention in HIV care, ART adherence, and to ultimately achieve viral suppression among ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04199052

LinkPositively: A Technology-Delivered Peer Navigation ... LinkPositively is a culturally tailored, trauma-informed smartphone app for Black women living with HIV/AIDS affected by interpersonal violence. Core components ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10357377/

A Trauma-Informed HIV Intervention (LinkPositively) to ... The substance use, violence, and HIV/AIDS syndemic is the overlapping and synergistic intersection of these conditions [5]; in addition, mental ...

6. istriveresearchlab.com istriveresearchlab.com/linkpositively-2/

LinkPositively: A Technology-Delivered Peer Navigation ... This study will benefit the advancement of HIV prevention science by harnessing technology to promote engagement in HIV care, while improving social support ...