Availability is Not Access:Recently Incarcerated Women, HIV Risk, and Substance Use Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 82
- Locations
- 2
- Primary Endpoint
- Preliminary effectiveness of WISH to improve engagement in and adherence to needed treatments and associated outcomes
Study Overview
Brief Summary
Women recently released (RR women) from incarceration constitute a vulnerable group characterized by high rates of untreated HIV and sexually transmitted infections (STIs), substance use disorder (SUD), mental health (MH) disorders and trauma. This interconnected syndemic requires helping RR women to overcome multiple internal and structural care barriers. This R34 builds on work conducted by the PI in a NIDA-funded K23 project, in which an intervention called Women's Initiative Supporting Health (WISH) was developed to improve RR women's engagement in HIV, Hepatitis C (HCV), and primary medical care using Self Determination Theory (SDT). The proposed R34 project, a natural extension of this prior work, will conduct a pilot randomized controlled trial (RCT) of the WISH intervention to examine feasibility, acceptability, and preliminary effectiveness.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Preliminary effectiveness of WISH to improve engagement in and adherence to needed treatments and associated outcomes
Time Frame: 3 years
The investigator will qualitatively analyze intervention/interview sessions using Atlas.ti to organize thematic content complemented by framework analysis. This is one assessment.
Secondary Outcomes
- Explore biomarker levels in relation to intervention.(3 years)
- Explore serum levels of CRP(3 years)
- Linkage to prevention program.(3 years)
- HIV prevention behaviors(3 years)
- Explore impact of WISH on inflammatory biomarker(3 years)
- Explore inflammation biomarkers outcomes of WISH(3 years)
- Linkage to HIV prevention services; HIV risk behaviors(3 years)
- HIV risk behavior(3 years)
Investigators
Diane Morse
Associate Professor of Psychiatry and Medicine
University of Rochester