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Behavioral Intervention

Mobile Health App for HIV/AIDS (LPP Plus Trial)

N/A

Recruiting

Research Sponsored by Guiding Right, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18 years or older

Cisgender or transgender woman

Must not have

Unwillingness to participate in the study

Cognitive impairment that would limit participation with study procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3- and 6-month post baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new version of a mobile app called LinkPositively+ on improving HIV care outcomes in Black women living with HIV. The study will look at whether the app helps with staying

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves a mobile health app intervention rather than medication, traditional physical side effects are not expected. However, participants might experience emotional or psychological responses to the content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I identify as a woman, whether cisgender or transgender.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not willing to participate in the study.

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

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I am male.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3- and 6-month post baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3- and 6-month post baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3- and 6-month post baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Preliminary effect of LPP+ to improve HIV care outcomes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Arm: LinkPositively+Experimental Treatment1 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: LinkPositivelyActive Control1 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.

0 / 5Eligibility criteria met