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

Trial Summary

What is the purpose of this trial?

The investigative team will conduct a 2-arm randomized control trial to examine the preliminary effect of LinkPositively+ (LPP) an enhanced version of LinkPositively (LP) mobile app on improved HIV care outcomes including improved retention in HIV care, ART adherence, and viral suppression using hair sample analysis and passive electronic, medical record review, and secondarily, self-reported increased social support via activation of social support networks (i.e., assessed by utilization), self-efficacy, and utilization of ancillary support services at baseline, 3- and 6-month post enrollment. Black women living with HIV (WLHA) with a lifetime history of interpersonal violence, who have been linked to care but may have fallen out of care in the past year will be randomized 1:1 to either the LP arm or the LPP arm.

Eligibility Criteria

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

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.

HIV negative serostatus

Timeline

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

Treatment Details

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.

Participant Groups

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+