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LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care

Primary Purpose

HIV/AIDS

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LinkPositively
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV/AIDS focused on measuring HIV Care Continuum, Mobile Apps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Female Gender
  • Black or African-American racial/ethnic background
  • Aged 18 years or older
  • HIV-positive status
  • Ever experienced physical, sexual, and/or psychological abuse by a current or former partner or non-partner (e.g., relative, friend, stranger)
  • Owner of a smartphone with internet browsing capabilities
  • English speaking

Exclusion Criteria:

  • Male Gender
  • Aged 17 or younger
  • HIV-negative status

Sites / Locations

  • UCSD AntiViral Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

LinkPositively Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Retention in HIV Care
Having two or more laboratory test for CD4 count AND/OR viral load at least 90 days apart
Change in Retention in HIV Care
Having two or more laboratory test for CD4 count AND/OR viral load at least 90 days apart
Change in ART Adherence
Greater or less than 90% adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples
Change in ART Adherence
Greater or less than 90% adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples
Change in Viral Suppression
Undetectable viral load OR fewer than 200 copies/mL
Change in Viral Suppression
Undetectable viral load OR fewer than 200 copies/mL

Secondary Outcome Measures

Full Information

First Posted
December 9, 2019
Last Updated
January 12, 2023
Sponsor
University of California, San Diego
Collaborators
San Diego State University, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04199052
Brief Title
LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care
Official Title
LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care Across the Continuum for Black Women Affected by Interpersonal Violence
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 14, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
San Diego State University, National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) GPS-enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system. The study will be conducted in 2 phases with corresponding aims. In Phase 1 (Aim 1), 4 focus groups with Black WLHA with experiences of interpersonal violence, one focus group with peer navigators, and 4-6 key informant interviews with providers will be conducted to determine which app features, content, and functions are most likely to support downloading, initiating use, and sustaining engagement over time. Aim 1 will culminate in usability testing by Black WLHA affected by interpersonal violence (n=8), to finalize intervention components and procedures. In Phase 2 (Aim 2), investigators will pilot test LinkPositively to assess feasibility and acceptability and determine preliminary effects of the intervention on HIV care outcomes (i.e., retention in care, ART adherence, viral suppression) and mechanism of change variables (i.e., social support, self-efficacy). Through a randomized control trial (RCT), participants will be randomly assigned to either the intervention arm (n=40) or control arm (Ryan White standard of care, n=40), with follow-up at 3- and 6- months. This study will benefit the advancement of HIV prevention science by harnessing technology to promote engagement in HIV care, while improving social support through peers and social networking-all under the auspices of being trauma-informed for Black WLHA with experiences of interpersonal violence.
Detailed Description
In the US, Black women living with HIV/AIDS (WLHA) are less likely to be engaged in care, adherent to antiretroviral therapy (ART), and virally suppressed compared to White WLHA. Black women are also disproportionately affected by interpersonal violence - physical, sexual, and/or psychological abuse by a current or former intimate partner or non-intimate partner - which may co-occur with poor mental health and/or substance use, further contributing to ART non-adherence, lower CD4 counts, and reduced viral suppression. Peer Navigation, while highlighted as a successful model of care in improving HIV care outcomes, requires resources that HIV service agencies often lack. A scalable and sustainable solution is the use of mobile health (mHealth) smartphone applications ("apps"). Although there has been an increase in mHealth interventions developed for HIV prevention and care among at-risk and HIV-positive men who have sex with men (MSM) and youth, investigators are unaware of any to improve retention in care, ART adherence, and viral suppression among Black WLHA, nor any mHealth interventions that are responsive to Black women's experiences with interpersonal violence. To address this gap, investigators will develop and pilot test a culturally tailored, trauma-informed smartphone app, called LinkPositively, for Black WLHA affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) GPS-enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system. Guided by the Theory of Triadic Influences and Syndemic Theory, the study will be conducted in 2 phases with corresponding aims. In Aim 1, 4 focus groups with Black WLHA with experiences of interpersonal violence, one focus group with peer navigators, and 4-6 key informant interviews with providers will be conducted to determine which app features, content, and functions are most likely to support downloading, initiating use, and sustaining engagement over time. Aim 1 will culminate in usability testing by Black WLHA affected by interpersonal violence (n=5), to finalize intervention components and procedures. In Aim 2, investigators will pilot test LinkPositively to assess feasibility and acceptability and determine preliminary effects of the intervention on HIV care outcomes (i.e., retention in care, ART adherence, viral suppression) and mechanism of change variables (i.e., social support, self-efficacy). Participants will be randomly assigned to either the intervention (n=40) or control (Ryan White standard of care, n=40) arm, with follow-up at 3- and 6- months. This study will benefit the advancement of HIV prevention science by harnessing technology to promote engagement in HIV care, while improving social support through peers and social networking - all under the auspices of being trauma-informed for Black WLHA with experiences of interpersonal violence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
HIV Care Continuum, Mobile Apps

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Arm Title
LinkPositively Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
LinkPositively
Intervention Description
LinkPositively is a culturally tailored, trauma-informed smartphone app for Black women living with HIV/AIDS affected by interpersonal violence. Core components of LinkPositively include: a) Virtual Peer Navigation that includes phone and text check-ins and 4 weekly one-on-one video sessions to build skills to cope with barriers and navigate care; b) Social Networking platform to receive peer support; c) Educational and Self-care database with healthy living and self-care tips; d) GPS-enabled Resource Locator for HIV care and ancillary support service agencies; and e) ART self-monitoring and reminder system.
Primary Outcome Measure Information:
Title
Change in Retention in HIV Care
Description
Having two or more laboratory test for CD4 count AND/OR viral load at least 90 days apart
Time Frame
3 Months Post-Baseline
Title
Change in Retention in HIV Care
Description
Having two or more laboratory test for CD4 count AND/OR viral load at least 90 days apart
Time Frame
6 Months Post-Baseline
Title
Change in ART Adherence
Description
Greater or less than 90% adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples
Time Frame
3 Months Post-Baseline
Title
Change in ART Adherence
Description
Greater or less than 90% adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples
Time Frame
6 Months Post-Baseline
Title
Change in Viral Suppression
Description
Undetectable viral load OR fewer than 200 copies/mL
Time Frame
3 Months Post-Baseline
Title
Change in Viral Suppression
Description
Undetectable viral load OR fewer than 200 copies/mL
Time Frame
6 Months Post-Baseline

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Female gender identifying
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female Gender Black or African-American racial/ethnic background Aged 18 years or older HIV-positive status Ever experienced physical, sexual, and/or psychological abuse by a current or former partner or non-partner (e.g., relative, friend, stranger) Owner of a smartphone with internet browsing capabilities English speaking Exclusion Criteria: Male Gender Aged 17 or younger HIV-negative status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine M. Anderson, MPH
Phone
619-471-3884
Email
k4anderson@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jamila K. Stockman, PhD, MPH
Phone
858-822-4652
Email
jstockman@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamila K. Stockman, PhD, MPH
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keith J. Horvath, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD AntiViral Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
KATHERINE M ANDERSON, MPH
Phone
619-471-3884
Email
k4anderson@ucsd.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No current plan

Learn more about this trial

LinkPositively: A Technology-Delivered Peer Navigation and Social Networking Intervention to Improve HIV Care

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