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Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement

Primary Purpose

HIV/AIDS

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

About this trial

This is an interventional supportive care trial for HIV/AIDS focused on measuring HIV Care Continuum, Psychoeducation

Eligibility Criteria

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

Inclusion Criteria:

  • Cisgender female
  • Diagnosis of HIV by a physician, healthcare provider, or community health worker
  • Aged 18 years or older
  • Speaking and reading English or Spanish
  • Adulthood experiences of interpersonal violence
  • Currently prescribed ART
  • Self-report of <90% past-month ART adherence
  • Not currently participating in another adherence intervention
  • Access to an internet browser

Exclusion Criteria:

  • Unwillingness to participate in the intervention
  • Transgender female
  • No diagnosis of HIV by a physician, healthcare provider, or community health worker
  • Aged less than 18 years
  • Not speaking and reading English or Spanish
  • Not currently prescribed ART
  • Self-report of >= 90% past-month ART adherence
  • Currently participating in another adherence intervention
  • No access to an internet browser
  • Cognitive impairment limiting the ability to provide informed consent
  • Experiencing only childhood experiences of interpersonal violence
  • Inability to safely participate in the study based on secondary screener

Sites / Locations

  • The Regents of the Univ. of Calif., U.C. San DiegoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Arm

Women SHINE

Arm Description

Women assigned to the control arm (n=180) will receive one 60-minute group session facilitated by the licensed clinical therapist (LCT) on self-care and well-being as it relates to HIV, interpersonal violence, trauma, adverse mental health, and substance use. During this session, women will be provided with resources to HIV care, interpersonal violence, trauma, mental health, and substance use, through a static website created for Women SHINE. The content will include: 1) names and locations of clinics and organizations, services provided, and contact information; 2) links to support websites and hotlines and 3) testimonials from WLHA.

Women SHINE consists of a four-month intervention that includes video-based one-on-one peer navigation and 7 weekly psycho-education support group sessions co-facilitated by a licensed clinical therapist (LCT) and peer navigator (PN). 180 women will be enrolled in the Women SHINE intervention and will remain in their assigned psycho-education support group sessions with the same members over the course of the intervention.

Outcomes

Primary Outcome Measures

Change in ART Adherence
Adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples
Change in ART Adherence
Validated self-report measure of ART adherence (3 items)
Change in PTSD Symptoms
Validated self-report measure of PTSD (9 items;PCL-5)
Change in Emotion Regulation
Validated self-report measure of emotion regulation (16 items; DERS-16)
Change in Individual and Socio-Structural Mechanisms of Change
Validated self-report measure of retention in HIV care
Change in Individual and Socio-Structural Mechanisms of Change
Validated self-report measure of coping self-efficacy (26 items; CSE)
Change in Individual and Socio-Structural Mechanisms of Change
Validated self-report measure of social support (8 items; mMOS-SS)
Change in Individual and Socio-Structural Mechanisms of Change
Validated self-report measure of ancillary support utilization (26 items; adapted from CDC medical monitoring project), HIV stigma (30 items), and medical mistrust (12 items; GBMMS)
Change in Individual and Socio-Structural Mechanisms of Change
Validated self-report measure of HIV stigma (30 items), and medical mistrust (12 items; GBMMS)
Change in Individual and Socio-Structural Mechanisms of Change
Validated self-report measure of medical mistrust (12 items; GBMMS)

Secondary Outcome Measures

Full Information

First Posted
July 26, 2022
Last Updated
March 15, 2023
Sponsor
University of California, San Diego
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05509959
Brief Title
Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement
Official Title
Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
November 28, 2025 (Anticipated)
Study Completion Date
November 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
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
A two-arm RCT will be conducted to test the efficacy of Women SHINE, a web-based trauma-informed peer navigation-social support intervention (Figure 2). A total of 360 women living with HIV/AIDS (WLHA) with a history of adulthood interpersonal violence who have been prescribed ART but are non-adherent (< 90% ART adherent in the last 4 weeks) will be enrolled in the study. WLHA will be randomized (1:1) into one of the following conditions: 1) Women SHINE intervention arm (n=180) or 2) Control arm (n=180). The Women SHINE intervention arm will receive a four-month intervention including peer navigator (PN) one-on-one sessions, phone/text-based check-ins, 7 psychoeducation weekly support group sessions (120 mins.) co-facilitated by a licensed therapist and PN, and access to a static website with resources for HIV care, interpersonal violence, trauma, mental health, and substance use. The control arm will receive one group session (60 mins.) on self-care and well-being and access to the aforementioned website with resources. Women will complete a video-based survey and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization, to evaluate improvements in ART adherence (Aim 1), emotion regulation, and PTSD symptoms (Aim 2). Investigators will examine the mediating effect of individual (retention in HIV care, coping self-efficacy, social support, ancillary support services use) and socio-structural (stigma, medical mistrust) mechanisms of change on the efficacy of Women SHINE (Aim 3).
Detailed Description
In the US, women living with HIV/AIDS (WLHA) are less likely to be adherent to antiretroviral therapy (ART) and virally suppressed compared to men living with HIV/AIDS. Concurrently, WLHA experience high rates of interpersonal violence - physical, sexual, and/or psychological abuse in childhood or adulthood - which often results in trauma (e.g., post-traumatic stress disorder [PTSD]) and other adverse mental health, further contributing to ART non-adherence. Additionally, the confluence of syndemic or co-occurring adverse mental health, substance use, and socio-structural factors (e.g., HIV stigma, medical mistrust) further contribute to poor HIV outcomes. Social support through peer navigation and networks has been shown to counter these effects and improve HIV outcomes among WLHA. Likewise, psychoeducation addressing affective distress to improve mood and emotion management and relationship skills has been shown to reduce PTSD and depression. However, limited resources at HIV service agencies combined with socio-structural barriers (e.g., social isolation, lack of transportation) impede the potential effectiveness of in-person peer navigation. A scalable and sustainable solution is the use of technology in the form of web-based video interaction. Building on these promising pilot findings, investigators propose to conduct a randomized clinical trial of Women SHINE (new name) to improve ART adherence among WLHA affected by interpersonal violence in California. Participants will be randomized to either: a) the intervention arm (n=180) where they will receive a 4-month program comprised of video-based peer navigation support via one-on-one sessions, 7 psychoeducation weekly support group sessions, and access to a static Women SHINE website with statewide resources for HIV care, interpersonal violence, trauma, mental health, and substance use; or b) the control arm (n=180) where they will receive a single group session on self-care and well-being, with access to the static Women SHINE website. Women will complete video-based survey assessments and mailed hair sample self-collection at baseline, 4-, 8-, and 12-months post-randomization. Compared to the control arm, investigators will determine if Women SHINE is associated with improvements in ART adherence (Aim 1) and PTSD symptoms and emotion regulation (Aim 2). Investigators will also examine individual (e.g., self-efficacy for coping, social support networks) and socio-structural (e.g., HIV stigma, medical mistrust) mechanisms of change in the efficacy of Women SHINE (Aim 3). If efficacious, investigators will conduct subsequent research to determine effective and feasible methods for intervention implementation nationwide to improve HIV outcomes among WLHA.

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, Psychoeducation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
Placebo Comparator
Arm Description
Women assigned to the control arm (n=180) will receive one 60-minute group session facilitated by the licensed clinical therapist (LCT) on self-care and well-being as it relates to HIV, interpersonal violence, trauma, adverse mental health, and substance use. During this session, women will be provided with resources to HIV care, interpersonal violence, trauma, mental health, and substance use, through a static website created for Women SHINE. The content will include: 1) names and locations of clinics and organizations, services provided, and contact information; 2) links to support websites and hotlines and 3) testimonials from WLHA.
Arm Title
Women SHINE
Arm Type
Experimental
Arm Description
Women SHINE consists of a four-month intervention that includes video-based one-on-one peer navigation and 7 weekly psycho-education support group sessions co-facilitated by a licensed clinical therapist (LCT) and peer navigator (PN). 180 women will be enrolled in the Women SHINE intervention and will remain in their assigned psycho-education support group sessions with the same members over the course of the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Women SHINE
Intervention Description
Minimum of nine weekly one-on-one peer navigation sessions and 7 weekly psychoeducation support group sessions.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Single group session and access to website
Primary Outcome Measure Information:
Title
Change in ART Adherence
Description
Adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples
Time Frame
4-, 8-, and 12-month post-randomization
Title
Change in ART Adherence
Description
Validated self-report measure of ART adherence (3 items)
Time Frame
4-, 8-, and 12-month post-randomization
Title
Change in PTSD Symptoms
Description
Validated self-report measure of PTSD (9 items;PCL-5)
Time Frame
4-, 8-, and 12-month post-randomization
Title
Change in Emotion Regulation
Description
Validated self-report measure of emotion regulation (16 items; DERS-16)
Time Frame
4-, 8-, and 12-month post-randomization
Title
Change in Individual and Socio-Structural Mechanisms of Change
Description
Validated self-report measure of retention in HIV care
Time Frame
4-, 8-, and 12-month post-randomization
Title
Change in Individual and Socio-Structural Mechanisms of Change
Description
Validated self-report measure of coping self-efficacy (26 items; CSE)
Time Frame
4-, 8-, and 12-month post-randomization
Title
Change in Individual and Socio-Structural Mechanisms of Change
Description
Validated self-report measure of social support (8 items; mMOS-SS)
Time Frame
4-, 8-, and 12-month post-randomization
Title
Change in Individual and Socio-Structural Mechanisms of Change
Description
Validated self-report measure of ancillary support utilization (26 items; adapted from CDC medical monitoring project), HIV stigma (30 items), and medical mistrust (12 items; GBMMS)
Time Frame
4-, 8-, and 12-month post-randomization
Title
Change in Individual and Socio-Structural Mechanisms of Change
Description
Validated self-report measure of HIV stigma (30 items), and medical mistrust (12 items; GBMMS)
Time Frame
4-, 8-, and 12-month post-randomization
Title
Change in Individual and Socio-Structural Mechanisms of Change
Description
Validated self-report measure of medical mistrust (12 items; GBMMS)
Time Frame
4-, 8-, and 12-month post-randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cisgender female Diagnosis of HIV by a physician, healthcare provider, or community health worker Aged 18 years or older Speaking and reading English or Spanish Adulthood experiences of interpersonal violence Currently prescribed ART Self-report of <90% past-month ART adherence Not currently participating in another adherence intervention Access to an internet browser Exclusion Criteria: Unwillingness to participate in the intervention Transgender female No diagnosis of HIV by a physician, healthcare provider, or community health worker Aged less than 18 years Not speaking and reading English or Spanish Not currently prescribed ART Self-report of >= 90% past-month ART adherence Currently participating in another adherence intervention No access to an internet browser Cognitive impairment limiting the ability to provide informed consent Experiencing only childhood experiences of interpersonal violence Inability to safely participate in the study based on secondary screener
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Fernandez DeSoto, MPH
Phone
(858) 354-0381
Email
alf013@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
Facility Information:
Facility Name
The Regents of the Univ. of Calif., U.C. San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamila K Stockman, PhD
Phone
858-822-4652
Email
jstockman@ucsd.edu
First Name & Middle Initial & Last Name & Degree
Jamila K Stockman, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Women SHINE: Addressing Syndemics and HIV Among Women Through Tech-Based Peer Engagement

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