Women's Initiative Supporting Health Increasing Healthcare Access

NCT02964845 | Completed DMC

• 2 other identifiers: RSRB#630321R34DA041240-01A1
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance-Related Disorders

Outcome Measures

Primary Outcomes (1)

• Preliminary effectiveness of WISH to improve engagement in and adherence to needed treatments and associated outcomes

  The investigator will qualitatively analyze intervention/interview sessions using Atlas.ti to organize thematic content complemented by framework analysis. This is one assessment.

  3 years

Secondary Outcomes (8)

• Explore inflammation biomarkers outcomes of WISH

  3 years

• Explore impact of WISH on inflammatory biomarker

  3 years

• Explore biomarker levels in relation to intervention.

  3 years

• Explore serum levels of CRP

  3 years

• Linkage to HIV prevention services; HIV risk behaviors

  3 years

Other Outcomes (2)

• Substance Use Disorder treatment engagement

  3 years

• Mental health treatment engagement

  3 years

Study Arms (2)

WISH with CHW and referral to HFM

EXPERIMENTAL

Subjects will be assigned a CHW for intervention sessions along with receiving primary care from Highland Family Medicine. CHWs will use the SDT-based, trauma-specific motivational approach in the intervention to engage women during 6 sessions. The duration of the intervention is 3 months. Each session will last 1 hour and will take place in a community location. CHW's will also help facilitate primary care by linking subjects to primary care and will use electronic records to update and receive input from medical providers, and support treatment recommendations from Trillium Health. CHWs will empower women to convey their needs to providers for HIV risk reduction, SUD, co-morbidity (MH, IPV) treatment and will support autonomy and competence for treatment in the intervention sessions.

Behavioral: WISH with CHW and referral to HFM

Enhanced Treatment as Usual control

OTHER

eTAU participants will be given an HIV risk reduction information sheet made in cooperation with Trillium Health, HIV health providers. The sheet will include sex and drug behavioral risk reduction strategies and information on obtaining PrEP. The eTAU group is also facilitated to receive healthcare by having a cell phone, a primary care clinic which accepts patients, and bus passes.

Other: Enhanced Treatment as Usual

Interventions

WISH with CHW and referral to HFM BEHAVIORAL

6 intervention counseling sessions with a peer CHW, as well as CHW facilitated linkage to primary care and HIV risk reduction.

WISH with CHW and referral to HFM

Enhanced Treatment as Usual OTHER

Linkage to Primary care.

Enhanced Treatment as Usual control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Diane Morse, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

• Amali Epa-Llop, PHD

  University of Rochester

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Medicine

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 16, 2016
• Study Start: January 13, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)