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LinkPositively for HIV/AIDS
N/A
Waitlist Available
Led By Jamila K. Stockman, PhD, MPH
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months post-baseline
Awards & highlights
Study Summary
This trial will develop and test a smartphone app called LinkPositively to help Black women living with HIV who have experienced interpersonal violence. The app will include features like virtual peer navigation, a social networking platform, and an educational database. The study will be conducted in 2 phases with corresponding aims. In Phase 1, focus groups and key informant interviews will be conducted to determine which app features, content, and functions are most likely to support downloading, initiating use, and sustaining engagement over time. In Phase 2, the investigators will pilot test LinkPositively to assess feasibility and acceptability and determine preliminary effects of the intervention on HIV care outcomes and mechanism
Who is the study for?
This trial is for English-speaking Black women living with HIV/AIDS, aged 18 or older, who have experienced interpersonal violence and own a smartphone. It's not for men, those under 18, or anyone without an HIV-positive status.Check my eligibility
What is being tested?
The LinkPositively app is being tested to see if it helps improve HIV care. The app offers virtual peer navigation, social networking for support, health tips, local resource mapping, and medication reminders. Participants will be randomly assigned to use the app or receive standard care in a pilot study.See study design
What are the potential side effects?
Since this intervention involves using a smartphone application rather than medication there are no direct medical side effects; however participants may experience emotional discomfort discussing personal experiences during sessions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post-baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post-baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in ART Adherence
Change in Retention in HIV Care
Change in Viral Suppression
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: LinkPositively InterventionExperimental Treatment1 Intervention
Women assigned to the LinkPositively intervention 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.
Group II: Standard of CareActive Control1 Intervention
Women assigned to the control arm will receive self-directed (non-Virtual Peer Navigator (PN) supported) treatment as usual at the HIV care service provider of choice following the Ryan White standard of care (i.e., referrals to physical, dental and mental health services; case management; and ancillary services. Annual assessments (e.g., updates on insurance, housing, referrals needed, behavioral assessment [e.g., depression, substance use]) are conducted by a case manager. For women who have fallen out of care and re-engage care, case management begins with an interview and assessment of current needs. Goals are set to create an individual care plan related to medical care, housing, and other resources, as needed. Referrals are made to appropriate services (e.g., primary care, housing, benefits counseling, food, support services) based on the intake assessment. It is important to note that the case management approach is self-guided versus intensive virtual PN assistance.
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Who is running the clinical trial?
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,565 Total Patients Enrolled
San Diego State UniversityOTHER
152 Previous Clinical Trials
86,311 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,782 Previous Clinical Trials
2,689,037 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 17 years old or younger.I am female.I am male.I am 18 years old or older.I am HIV-positive.
Research Study Groups:
This trial has the following groups:- Group 1: LinkPositively Intervention
- Group 2: Standard of Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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