Women's Initiative Supporting Health Increasing Healthcare Access

The PI identified two priority needs of RR women: (1) adequate HIV/HCV prevention counseling
and services, including HIV pre-exposure prophylaxis (PrEP) medications for women at high
risk, and (2) primary care as an avenue to address co-occurring SUD, MH disorders, and trauma
that interfere with HIV preventive care. WISH is a gender, trauma, and culturally-specific,
peer-delivered intervention designed to improve health services utilization and health
behaviors. The proposed pilot RCT will examine the feasibility, acceptability and preliminary
effectiveness of the WISH intervention in a community setting.

The WISH intervention is grounded in Self-Determination Theory (SDT), which shows that
support for autonomy increases autonomous regulation and perceived competence which mediate
engagement in healthy behaviors by overcoming internal and structural barriers. A novel and
exploratory aim of the proposed study is to examine whether related biologic changes vary in
association with SDT mediation measures. Serum inflammatory biomarkers interleukin (IL) -6,
IL-8, C-reactive protein (CRP) and coagulation marker D-dimer variations are associated with
HIV vulnerability and depression, and these biomarkers have not been studied in relation to
SDT.

This study will randomize RR women to the WISH intervention or enhanced treatment-as-usual
(eTAU) control. WISH peer community health workers (CHW) will conduct SDT-based individual
sessions with women addressing autonomy and competence regarding linkage to HIV risk
reduction treatment, SUD treatment, primary care, and structural empowerment. Structurally,
the peers will be a part of the primary care medical team to: (1) inform providers regarding
women's treatment needs and readiness; (2) navigate RR women to link with HIV risk reduction
services including prophylaxis providers; and (3) help women overcome systemic barriers to
care. The investigator will examine SDT mediation measures, associated internal and
structural barriers, treatment engagement and adherence, HIV risk behaviors, and
inflammation. Specific aims are as follows:

Aim 1: Evaluate the feasibility and acceptability of the WISH intervention in a community
setting:

Aim 1 Outcomes: Participant mixed method feedback for all study and intervention procedures.

Aim 2: Assess the preliminary effectiveness of WISH to improve engagement in and adherence to
needed treatments and associated outcomes

1. Linkage to HIV prevention services; HIV risk behaviors: Assess WISH intervention effects
on HIV prevention services engagement as primary outcome, adherence, and reductions in
HIV risk behaviors 2a. Hypothesis: WISH intervention will show preliminary effectiveness
to improve use of preventative services, including pre-exposure prophylaxis,
self-reported HIV risk behaviors, and STIs

2. SUD and other tx: Examine engagement and adherence for treatment as secondary WISH
outcome. Hypothesis: WISH intervention will show preliminary effectiveness to increase
SUD, primary care, and MH treatment initiation, engagement, and continuity of care, and
reduced substance use & MH symptoms.

Aim 3: Assess WISH mechanisms of action: Assess preliminary effect differences in known SDT
mediators in relation to Aim 2 outcomes. Hypothesis: SDT measures will mediate relationship
between the intervention and Aim 2 outcomes.

Exploratory Aim: Explore inflammatory biomarker outcomes of WISH: Measure serum IL-6, IL-8,
CRP, and D-dimer and associated SDT mediators in intervention and control subjects.
Hypotheses: IL-6, IL-8, CRP, and D-dimer levels and associated SDT mediators will correlate.

Implications: RR women are at high risk for syndemic risk factors of HIV/HCV, SUD, mental
health disorders, and trauma. Yet, engagement in needed care in this group is exceedingly low
and innovative interventions are needed to address this problem. To the investigator's
knowledge, this is the first study to assess a SDT-based intervention designed to address
urgently needed improvements in the provision and utilization of HIV and primary care
services for RR persons. The intervention incorporates health behavior change, CHW training,
peer-navigation, and targets biological and behavioral mechanisms of changes in HIV risk. It
further develops community and training infrastructures which will lead to reduced
disparities in HIV acquisition

Inclusion Criteria:

- English-speaking

- >18 years old female by birth biologically

- Any HIV risk and SUD in the year prior (adjusting for incarceration during which they
may have had fewer HIV risk behaviors and less access to drugs or alcohol)

- HIV/HCV negative

- Released from incarceration within the prior 1 year or to be released within 2 weeks

- Agree to release all medical/mental health/SUD treatment records for research access

- Agree to become a patient at Highland Family Medicine for primary care

Exclusion Criteria:

- Non-English speaking

- < 18 year old

- Not biologically female

- Score <2 on the Six-Item Screener (derived from the Mini-Mental Status Examination )

- Decline HIV/HCV assessment.

- Refusal to obtain primary medical care from Highland Family Medicine.

- The inability to speak or comprehend English with sufficient skill to give consent or
understand interviewers.

- Apparent intoxication; psychotic behavior or the presence of severe illness or pain
that interferes with participation as determined with exclusion criteria score < 2 on
the Six-Item Screener