Substance-Related DisordersWISHNCT02964845
Women's Initiative Supporting Health Increasing Healthcare Access
A study testing WISH with CHW and referral to HFM and Enhanced Treatment as Usual in people with Substance-Related Disorders, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- WISH with CHW and referral to HFM and Enhanced Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Availability is Not Access:Recently Incarcerated Women, HIV Risk, and Substance Use Disorders
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.
Read the 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.
Aim 2: Assess the preliminary effectiveness of WISH to improve engagement in and adherence to needed treatments and associated outcomes
- Linkage to HIV prevention services; HIV risk behaviors: Assess WISH intervention effects on HIV prevention services engagement as primary outcome, adherence, and reductions in HIV risk behaviors 2a. Hypothesis: WISH intervention will show preliminary effectiveness to improve use of preventative services, including pre-exposure prophylaxis, self-reported HIV risk behaviors, and STIs
- SUD and other tx: Examine engagement and adherence for treatment as secondary WISH outcome. Hypothesis: WISH intervention will show preliminary effectiveness to increase SUD, primary care, and MH treatment initiation, engagement, and continuity of care, and reduced substance use \& MH symptoms.
Aim 3: Assess WISH mechanisms of action: Assess preliminary effect differences in known SDT mediators in relation to Aim 2 outcomes. Hypothesis: SDT measures will mediate relationship between the intervention and Aim 2 outcomes.
Exploratory Aim: Explore inflammatory biomarker outcomes of WISH: Measure serum IL-6, IL-8, CRP, and D-dimer and associated SDT mediators in intervention and control subjects. Hypotheses: IL-6, IL-8, CRP, and D-dimer levels and associated SDT mediators will correlate.
Implications: RR women are at high risk for syndemic risk factors of HIV/HCV, SUD, mental health disorders, and trauma. Yet, engagement in needed care in this group is exceedingly low and innovative interventions are needed to address this problem. To the investigator's knowledge, this is the first study to assess a SDT-based intervention designed to address urgently needed improvements in the provision and utilization of HIV and primary care services for RR persons. The intervention incorporates health behavior change, CHW training, peer-navigation, and targets biological and behavioral mechanisms of changes in HIV risk. It further develops community and training infrastructures which will lead to reduced disparities in HIV acquisition
- Conditions
- Substance-Related Disorders
- Being tested
- WISH with CHW and referral to HFM, Enhanced Treatment as Usual
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WISH with CHW and referral to HFMBehavioural
6 intervention counseling sessions with a peer CHW, as well as CHW facilitated linkage to primary care and HIV risk reduction.
Enhanced Treatment as UsualOther
Linkage to Primary care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enhanced Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (8)
Explore inflammation biomarkers outcomes of WISH
The investigator will examine serum levels of IL-6.
Measured: 3 years
Explore impact of WISH on inflammatory biomarker
The investigator will examine serum levels of IL-8.
Measured: 3 years
Explore biomarker levels in relation to intervention.
The investigator will examine serum levels of D-dimer.
Measured: 3 years
Explore serum levels of CRP
The investigator will examine serum levels of CRP.
Measured: 3 years
Linkage to HIV prevention services; HIV risk behaviors
Success will be measured by demonstrated awareness of and willingness to participate.
Measured: 3 years
Linkage to prevention program.
Success will also be measured by if subjects made an HIV prevention appointment.
Measured: 3 years
HIV prevention behaviors
Adherence to HIV prevention strategies will be measured.
Measured: 3 years
HIV risk behavior
Changes in HIV risk behavior scale scores will also be measured.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study start13 Jan 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-Related DisordersStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Diane Morse, University of Rochester
- Investigators
- Diane Morse, MD, Principal investigator, University of RochesterAmali Epa-Llop, PHD, Study director, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02964845
- Sponsor's protocol ID
- RSRB#63032
- Other IDs
- 1R34DA041240-01A1
- Acronym
- WISH
- Status last verified
- Nov 2019
- First submitted
- 31 Oct 2016
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Availability is Not Access:Recently Incarcerated Women, HIV Risk, and Substance Use Disorders
- ClinicalTrials.gov ID
- NCT02964845
- Acronym / sponsor ID
- WISH / RSRB#63032
- Conditions
- Substance-Related Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 13 Jan 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Aim 2: Assess the preliminary effectiveness of WISH to improve engagement in and adherence to needed treatments and associated outcomes
- Linkage to HIV prevention services; HIV risk behaviors: Assess WISH intervention effects on HIV prevention services engagement as primary outcome, adherence, and reductions in HIV risk behaviors 2a. Hypothesis: WISH intervention will show preliminary effectiveness to improve use of preventative services, including pre-exposure prophylaxis, self-reported HIV risk behaviors, and STIs
- SUD and other tx: Examine engagement and adherence for treatment as secondary WISH outcome. Hypothesis: WISH intervention will show preliminary effectiveness to increase SUD, primary care, and MH treatment initiation, engagement, and continuity of care, and reduced substance use \& MH symptoms.
Aim 3: Assess WISH mechanisms of action: Assess preliminary effect differences in known SDT mediators in relation to Aim 2 outcomes. Hypothesis: SDT measures will mediate relationship between the intervention and Aim 2 outcomes.
Exploratory Aim: Explore inflammatory biomarker outcomes of WISH: Measure serum IL-6, IL-8, CRP, and D-dimer and associated SDT mediators in intervention and control subjects. Hypotheses: IL-6, IL-8, CRP, and D-dimer levels and associated SDT mediators will correlate.
Implications: RR women are at high risk for syndemic risk factors of HIV/HCV, SUD, mental health disorders, and trauma. Yet, engagement in needed care in this group is exceedingly low and innovative interventions are needed to address this problem. To the investigator's knowledge, this is the first study to assess a SDT-based intervention designed to address urgently needed improvements in the provision and utilization of HIV and primary care services for RR persons. The intervention incorporates health behavior change, CHW training, peer-navigation, and targets biological and behavioral mechanisms of changes in HIV risk. It further develops community and training infrastructures which will lead to reduced disparities in HIV acquisition
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WISH with CHW and referral to HFM | Experimental | Behavioral: WISH with CHW and referral to HFMSubjects 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. |
| Enhanced Treatment as Usual control | Other | Other: Enhanced Treatment as UsualeTAU 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WISH with CHW and referral to HFM6 intervention counseling sessions with a peer CHW, as well as CHW facilitated linkage to primary care and HIV risk reduction. | Behavioural | WISH with CHW and referral to HFM |
| Enhanced Treatment as UsualLinkage to Primary care. | Other | Enhanced Treatment as Usual control |
Primary outcome
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.
8 secondary outcomes
Explore inflammation biomarkers outcomes of WISH
Time frame: 3 years
Explore impact of WISH on inflammatory biomarker
Time frame: 3 years
Explore biomarker levels in relation to intervention.
Time frame: 3 years
Explore serum levels of CRP
Time frame: 3 years
Linkage to HIV prevention services; HIV risk behaviors
Time frame: 3 years
Linkage to prevention program.
Time frame: 3 years
HIV prevention behaviors
Time frame: 3 years
HIV risk behavior
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diane Morse, MD principal investigator
University of Rochester
Amali Epa-Llop, PHD study director
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WISH with CHW and referral to HFM and Enhanced Treatment as Usual in people with Substance-Related Disorders, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary effectiveness of WISH to improve engagement in and adherence to needed treatments and associated outcomes (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.