RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2022-11-15
Study Completion:2025-11-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05509959

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Cisgender female
  2. * Diagnosis of HIV by a physician, healthcare provider, or community health worker
  3. * Aged 18 years or older
  4. * Speaking and reading English or Spanish
  5. * Adulthood experiences of interpersonal violence
  6. * Currently prescribed ART
  7. * Self-report of \<90% past-month ART adherence
  8. * Not currently participating in another adherence intervention
  9. * Access to an internet browser
  1. * Unwillingness to participate in the intervention
  2. * Transgender female
  3. * No diagnosis of HIV by a physician, healthcare provider, or community health worker
  4. * Aged less than 18 years
  5. * Not speaking and reading English or Spanish
  6. * Not currently prescribed ART
  7. * Self-report of \>= 90% past-month ART adherence
  8. * Currently participating in another adherence intervention
  9. * No access to an internet browser
  10. * Cognitive impairment limiting the ability to provide informed consent
  11. * Experiencing only childhood experiences of interpersonal violence
  12. * Inability to safely participate in the study based on secondary screener

Contacts and Locations

Study Contact

Cassandra Cyr, MPH
CONTACT
(858) 534-7979
clcyr@health.ucsd.edu
Jamila K Stockman, PhD, MPH
CONTACT
(858) 822-4652
jstockman@health.ucsd.edu

Principal Investigator

Jamila K Stockman, PhD, MPH
PRINCIPAL_INVESTIGATOR
University of California, San Diego

Study Locations (Sites)

The Regents of the Univ. of Calif., U.C. San Diego
La Jolla, California, 92093
United States

Collaborators and Investigators

Sponsor: University of California, San Diego

  • Jamila K Stockman, PhD, MPH, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-15
Study Completion Date2025-11-28

Study Record Updates

Study Start Date2022-11-15
Study Completion Date2025-11-28

Terms related to this study

Keywords Provided by Researchers

  • HIV Care Continuum
  • Psychoeducation

Additional Relevant MeSH Terms

  • HIV/AIDS