Women's Initiative Supporting Health Increasing Healthcare Access (WISH)
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|ClinicalTrials.gov Identifier: NCT02964845|
Recruitment Status : Recruiting
First Posted : November 16, 2016
Last Update Posted : February 15, 2019
|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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
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.
- 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.
- Explore inflammation biomarkers outcomes of WISH [ Time Frame: 3 years ]The investigator will examine serum levels of IL-6.
- Explore impact of WISH on inflammatory biomarker [ Time Frame: 3 years ]The investigator will examine serum levels of IL-8.
- Explore biomarker levels in relation to intervention. [ Time Frame: 3 years ]The investigator will examine serum levels of D-dimer.
- Explore serum levels of CRP [ Time Frame: 3 years ]The investigator will examine serum levels of CRP.
- Linkage to HIV prevention services; HIV risk behaviors [ Time Frame: 3 years ]Success will be measured by demonstrated awareness of and willingness to participate.
- Linkage to prevention program. [ Time Frame: 3 years ]Success will also be measured by if subjects made an HIV prevention appointment.
- HIV prevention behaviors [ Time Frame: 3 years ]Adherence to HIV prevention strategies will be measured.
- HIV risk behavior [ Time Frame: 3 years ]Changes in HIV risk behavior scale scores will also be measured.
- Substance Use Disorder treatment engagement [ Time Frame: 3 years ]The investigator will measure substance use as a behavioral and biological outcome.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02964845
|Contact: Diane Morse, MD||585-275-6484||Diane_Morse@urmc.rochester.edu|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Diane Morse, MD 585-275-6484 Diane_Morse@urmc.rochester.edu|
|Principal Investigator:||Diane Morse, MD||University of Rochester|
|Study Director:||Amali Epa-Llop, PHD||University of Rochester|