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

ConditionHIV/AIDS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, San Diego

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Women SHINE

    Behavioral

    Minimum of nine weekly one-on-one peer navigation sessions and 7 weekly psychoeducation support group sessions.

  • Control

    Behavioral

    Single group session and access to website

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Control ArmPlacebo comparator 1 intervention
Group B: Women SHINEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in ART Adherence

Adherence to ART regime measured by tenofovir (TFV), emtricitabine (FTC) concentration in hair samples

Time frame
4-, 8-, and 12-month post-randomization
2

Change in ART Adherence

Validated self-report measure of ART adherence (3 items)

Time frame
4-, 8-, and 12-month post-randomization
3

Change in PTSD Symptoms

Validated self-report measure of PTSD (9 items;PCL-5)

Time frame
4-, 8-, and 12-month post-randomization
4

Change in Emotion Regulation

Validated self-report measure of emotion regulation (16 items; DERS-16)

Time frame
4-, 8-, and 12-month post-randomization

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of California, San Diego

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator