Substance-Related Disorders Clinical Trial
— WISHOfficial title:
Availability is Not Access:Recently Incarcerated Women, HIV Risk, and Substance Use Disorders
Verified date | November 2019 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | July 31, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Substance Use Disorder treatment engagement | The investigator will measure substance use as a behavioral and biological outcome. | 3 years | |
Other | Mental health treatment engagement | The investigator will report initiation rate, engagement rate and number of services received after initiation as a singular measure for continuity of care. | 3 years | |
Primary | 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 | Explore inflammation biomarkers outcomes of WISH | The investigator will examine serum levels of IL-6. | 3 years | |
Secondary | Explore impact of WISH on inflammatory biomarker | The investigator will examine serum levels of IL-8. | 3 years | |
Secondary | Explore biomarker levels in relation to intervention. | The investigator will examine serum levels of D-dimer. | 3 years | |
Secondary | Explore serum levels of CRP | The investigator will examine serum levels of CRP. | 3 years | |
Secondary | Linkage to HIV prevention services; HIV risk behaviors | Success will be measured by demonstrated awareness of and willingness to participate. | 3 years | |
Secondary | Linkage to prevention program. | Success will also be measured by if subjects made an HIV prevention appointment. | 3 years | |
Secondary | HIV prevention behaviors | Adherence to HIV prevention strategies will be measured. | 3 years | |
Secondary | HIV risk behavior | Changes in HIV risk behavior scale scores will also be measured. | 3 years |
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