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

HIV/AIDS Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04199052
• Other study ID #: 191398
• Secondary ID: R34MH122014-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 14, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: June 30, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Intervention

Behavioral:
• LinkPositively
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.

Locations

Country	Name	City	State
United States	UCSD AntiViral Research Center	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	National Institute of Mental Health (NIMH), San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Retention in HIV Care	Having two or more laboratory test for CD4 count AND/OR viral load at least 90 days apart	3 Months Post-Baseline
Primary	Change in Retention in HIV Care	Having two or more laboratory test for CD4 count AND/OR viral load at least 90 days apart	6 Months Post-Baseline
Primary	Change in ART Adherence	Greater or less than 90% adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples	3 Months Post-Baseline
Primary	Change in ART Adherence	Greater or less than 90% adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples	6 Months Post-Baseline
Primary	Change in Viral Suppression	Undetectable viral load OR fewer than 200 copies/mL	3 Months Post-Baseline
Primary	Change in Viral Suppression	Undetectable viral load OR fewer than 200 copies/mL	6 Months Post-Baseline