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Women's Initiative Supporting Health Increasing Healthcare Access (WISH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02964845
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : February 15, 2019
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Diane Morse, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Behavioral: WISH with CHW and referral to HFM Other: Enhanced Treatment as Usual Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Availability is Not Access:Recently Incarcerated Women, HIV Risk, and Substance Use Disorders
Actual Study Start Date : July 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse HIV/AIDS

Arm Intervention/treatment
Experimental: WISH with CHW and referral to HFM
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
6 intervention counseling sessions with a peer CHW, as well as CHW facilitated linkage to primary care and HIV risk reduction.

Enhanced Treatment as Usual control
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
Linkage to Primary care.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Explore inflammation biomarkers outcomes of WISH [ Time Frame: 3 years ]
    The investigator will examine serum levels of IL-6.

  2. Explore impact of WISH on inflammatory biomarker [ Time Frame: 3 years ]
    The investigator will examine serum levels of IL-8.

  3. Explore biomarker levels in relation to intervention. [ Time Frame: 3 years ]
    The investigator will examine serum levels of D-dimer.

  4. Explore serum levels of CRP [ Time Frame: 3 years ]
    The investigator will examine serum levels of CRP.

  5. Linkage to HIV prevention services; HIV risk behaviors [ Time Frame: 3 years ]
    Success will be measured by demonstrated awareness of and willingness to participate.

  6. Linkage to prevention program. [ Time Frame: 3 years ]
    Success will also be measured by if subjects made an HIV prevention appointment.

  7. HIV prevention behaviors [ Time Frame: 3 years ]
    Adherence to HIV prevention strategies will be measured.

  8. HIV risk behavior [ Time Frame: 3 years ]
    Changes in HIV risk behavior scale scores will also be measured.

Other Outcome Measures:
  1. Substance Use Disorder treatment engagement [ Time Frame: 3 years ]
    The investigator will measure substance use as a behavioral and biological outcome.

  2. Mental health treatment engagement [ Time Frame: 3 years ]
    The investigator will report initiation rate, engagement rate and number of services received after initiation as a singular measure for continuity of care.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02964845

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Contact: Diane Morse, MD 585-275-6484

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United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Diane Morse, MD    585-275-6484   
Sponsors and Collaborators
University of Rochester
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Diane Morse, MD University of Rochester
Study Director: Amali Epa-Llop, PHD University of Rochester

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Responsible Party: Diane Morse, Associate Professor of Psychiatry and Medicine, University of Rochester Identifier: NCT02964845     History of Changes
Other Study ID Numbers: RSRB#63032
1R34DA041240-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 16, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders