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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH118044-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Beth Israel Deaconess Medical Center | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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The objective of this application is to increase PrEP uptake among women vulnerable to HIV acquisition in the rural South, specifically those seeking care at Federally Qualified Healthcare Centers (FQHC) in rural Alabama.
The investigators will use a mixed-methods approach to adapt and pilot test a patient-provider communication tool from the Centers for Disease Control and Prevention (CDC) PrEP toolkit that focuses on the first three steps of the PrEP cascade (e.g., recognizing HIV risk, identifying as a PrEP candidate, and interested in PrEP) to increase PrEP uptake via referrals to local PrEP clinics.
Investigators completed formative qualitative research to explore the HIV risk perceptions of African American or Black (AA) women with recent PrEP use, AA women who are candidates for PrEP, and providers and to identify preferences around patient-provider communication about HIV risk and PrEP services (Aim 1).
The investigators then systematically adapted a patient-provider communication tool to increase PrEP uptake at federally qualified health centers in Alabama, using an iterative implementation process (Aim 2A), and assessed the feasibility, acceptability, and preliminary impact of the patient-provider communication intervention on PrEP uptake among women in a pilot pre-/post-intervention design (Aim 2B).
Provider training completion rates and satisfaction with the communication tool were assessed to evaluate implementation feasibility and intervention delivery. The study systematically documented and evaluated reasons for declining PrEP referrals, incomplete referrals, failure to initiate PrEP after successful referral, and ongoing PrEP use at 3 and 12 months post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient: cultural adaptation of a patient-provider communication tool | Experimental | Strengthening of the PrEP care continuum by developing and testing an intervention designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at substantial risk for HIV infection; developing and testing an intervention to reduce racial/disparities in PrEP uptake and use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cultural adaptation of a patient-provider communication tool | Behavioral | Adaptation of a patient-provider communication tool for PrEP uptake utilized among women and their providers in a pilot pre/post-intervention design. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened | To determine intervention feasibility through analysis of enrollment rates (i.e., proportion of eligible patient participants who consent to participate, decline, or are lost to follow-up over the total number of eligible patient participants screened) and reasons for declining enrollment. | Throughout recruitment period (approximately 24 months) |
| Intervention Feasibility: Intervention Completion Rates Among Enrolled Patients | To determine intervention feasibility through the analysis of intervention completion rates (i.e., proportion of enrolled patient participants who completed the intervention) and reasons for incomplete intervention | Throughout recruitment period (approximately 24 months) |
| Intervention Feasibility: 3-month Follow-up Completion Rates Among Patients With Completed Intervention | To determine intervention feasibility through the analysis of 3-month follow-up completion rates (i.e., proportion of enrolled patient participants with complete interventions with complete 3-month follow-up data) | Throughout recruitment and follow-up period (approximately 24 months) |
| Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention | To determine intervention feasibility through the analysis of PrEP referral acceptance rates (i.e., proportion accepting PrEP referral among those offered) and reasons for declining a referral | Throughout recruitment period and follow-up period (approximately 24 months) |
| Intervention Acceptability: Client Satisfaction Among Patients With Completed Intervention | To determine intervention acceptability using the Client Satisfaction Questionnaire (CSQ-8), an 8-item instrument that measures patient participants' perceived value of the intervention. The CSQ-8 generates a total score by summing individual item responses, with possible scores ranging from 8 to 32, where higher scores reflect greater treatment satisfaction. |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2 | To determine PrEP medication regimen adherence, patient participants completed an adherence questionnaire using a 6-point Likert scale to self-report their perceived ability to take their PrEP medication as prescribed over the last 4 weeks. The scale ranged from excellent to very poor. |
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Inclusion/Exclusion Criteria
Patients
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| Name | Affiliation | Role |
|---|---|---|
| Mirjam-Colette Kempf, PhD, MPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37286316 | Result | Psaros C, Goodman GR, McDonald VW, Ott C, Blyler A, Rivas A, Shan L, Campbell M, Underwood E, Krakower D, Elopre L, Kudroff K, Sherr KH, Kempf MC. Protocol for WeExPAnd: a prospective, mixed-methods pilot demonstration study to increase access to pre-exposure prophylaxis among women vulnerable to HIV infection in the Southern USA. BMJ Open. 2023 Jun 7;13(6):e075250. doi: 10.1136/bmjopen-2023-075250. |
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Our data sharing plans will be discussed with our NIH program officer and based on their feedback, may be altered. Our current plans call for the results of the process and outcome evaluations collected as part of this project will be shared via professional presentations and publications, and will also be shared upon request. De-identified data will also be electronically encrypted and archived for use by others who are interested in using this data. New procedures, protocols, data collection instruments and analytic routines will be made available to interested investigators.
Data will be available after analysis is completed.
Only de-identified information will be available.
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Patient participants were recruited from a Federally Qualified Health Care Center (FQHC) (Site 1) and an HIV and sexually transmitted infection (STI) clinic (Site 2) in Tuscaloosa, Alabama from March 2022-June 2024. First patient participant was enrolled March 7, 2022; last participant was enrolled in June 27, 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient: Cultural Adaptation of a Patient-Provider Communication Tool | The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use. Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient: Cultural Adaptation of a Patient-Provider Communication Tool | The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted patient-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use. Each enrolled patient participant took part in a pilot study evaluating a patient-provider communication tool adapted for PrEP uptake among American women and their healthcare providers, using a pre-post intervention design. Participating healthcare providers discussed PrEP with participants using the communication tool. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intervention Feasibility: Enrollment Rates Among Eligible Patients Screened | To determine intervention feasibility through analysis of enrollment rates (i.e., proportion of eligible patient participants who consent to participate, decline, or are lost to follow-up over the total number of eligible patient participants screened) and reasons for declining enrollment. | HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months | Posted | Count of Participants | Participants | Throughout recruitment period (approximately 24 months) |
|
2 years, 3 months
Adverse events are harmful occurrences to study participants, either study-related or non-study related.
Study participation reflected a unique opportunity to provide referrals for social services as we collected data on depressive symptoms and intimate partner violence. Any participant who endorsed significant symptoms on either of these measures (or a participant who spontaneously reported these problems) was provided with a referral for services from the partnering clinic.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cultural Adaptation of a Client-Provider Communication Tool | The goal of the intervention is to strengthen the PrEP care continuum by developing and testing a culturally adapted client-provider communication tool designed to improve PrEP awareness, screening, engagement, retention, adherence, and persistence among individuals at increased risk for HIV seroconversion. Specifically, the intervention aims to reduce racial and gender disparities in PrEP uptake and use. Each enrolled participant took part in a pilot study evaluating the client-provider communication tool adapted for PrEP uptake among Black or African American cis-gender women and their healthcare providers in a pre-post intervention design. Eligibility criteria was expanded to include women of any race/ethnicity. Participating healthcare providers discussed PrEP with participants using the communication tool. |
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Target enrollment was not met due to recruitment challenges, which limited the study's statistical power to detect intervention effects.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mirjam-Colette Kempf | University of Alabama at Birmingham | 205-934-9333 | MKempf@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2024 | Jun 13, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 2, 2024 | Jun 13, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| On intervention day, directly after intervention delivery |
| Preliminary Effectiveness: PrEP Uptake Among Eligible Patients Post-Intervention | To determine preliminary effectiveness through PrEP uptake (i.e., proportion of patient participants who initiated PrEP (i.e., got PrEP prescription) over the number of eligible patients referred to PrEP) in the participating clinic post-intervention. | Enrollment to 3 months post-intervention |
| 3-month Follow-up |
| PrEP Medication Adherence: Self-Reported PrEP Prescription Dosage Adherence Among Participants Who Initiated Oral PrEP at Both Site 1 and Site 2 | To determine PrEP medication dosage adherence, patients completed an adherence questionnaire to self-report the percentage of PrEP medication they have taken in the last 4 weeks. | 3-Month Follow-up |
| PrEP Clinic Visit Adherence at 3-months: Percentage of Scheduled PrEP Visits Attended Among Patients Who Initiated Oral or Injection PrEP at Both Site 1 and Site 2 | To determine PrEP clinic visit adherence, we calculated the average percentage of PrEP visits attended among patient participants who initiate PrEP, compared to the number of PrEP visits scheduled. Visit data was extracted from patients' electronic medical records. | From enrollment to 3-months post-enrollment |
| PrEP Clinic Visit Adherence at 12-months: Percentage of Scheduled PrEP Visits Attended Among Patients Who Initiated Oral or Injection PrEP at Site 1 | To determine PrEP clinic visit adherence, we calculated the average percentage of PrEP visits attended among patient participants who initiated PrEP, compared to the number of PrEP visits scheduled. Visit data was extracted from patients' electronic medical records. | From enrollment to 12-months post-enrollment |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Religion | Count of Participants | Participants |
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| Household Income | Count of Participants | Participants |
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| Primary Insurance | Count of Participants | Participants |
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| Housing | Count of Participants | Participants |
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| Have household members living with HIV | Count of Participants | Participants |
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| Relationship Status | Count of Participants | Participants |
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| Children | Count of Participants | Participants |
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| Have you heard of a daily pill that an HIV-negative person can take to prevent getting HIV? | Count of Participants | Participants |
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| How likely would you be to take this HIV prevention pill if it were available to you for free? | Count of Participants | Participants |
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| Do you plan to start taking PrEP as an HIV prevention method? | Count of Participants | Participants |
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| Occupation/Income Source | Count of Participants | Participants |
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| Have you ever taken Pre-exposure Prophylaxis (PrEP) to prevent HIV infection? | Count of Participants | Participants |
|
|
|
| Primary | Intervention Feasibility: Intervention Completion Rates Among Enrolled Patients | To determine intervention feasibility through the analysis of intervention completion rates (i.e., proportion of enrolled patient participants who completed the intervention) and reasons for incomplete intervention | HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months | Posted | Count of Participants | Participants | Throughout recruitment period (approximately 24 months) |
|
|
|
| Primary | Intervention Feasibility: 3-month Follow-up Completion Rates Among Patients With Completed Intervention | To determine intervention feasibility through the analysis of 3-month follow-up completion rates (i.e., proportion of enrolled patient participants with complete interventions with complete 3-month follow-up data) | HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months | Posted | Count of Participants | Participants | Throughout recruitment and follow-up period (approximately 24 months) |
|
|
|
| Primary | Intervention Feasibility: PrEP Referral Acceptance Among Patients With Completed Intervention | To determine intervention feasibility through the analysis of PrEP referral acceptance rates (i.e., proportion accepting PrEP referral among those offered) and reasons for declining a referral | HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months | Posted | Count of Participants | Participants | Throughout recruitment period and follow-up period (approximately 24 months) |
|
|
|
| Primary | Intervention Acceptability: Client Satisfaction Among Patients With Completed Intervention | To determine intervention acceptability using the Client Satisfaction Questionnaire (CSQ-8), an 8-item instrument that measures patient participants' perceived value of the intervention. The CSQ-8 generates a total score by summing individual item responses, with possible scores ranging from 8 to 32, where higher scores reflect greater treatment satisfaction. | HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months | Posted | Mean | Standard Deviation | score on a scale | On intervention day, directly after intervention delivery |
|
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| Primary | Preliminary Effectiveness: PrEP Uptake Among Eligible Patients Post-Intervention | To determine preliminary effectiveness through PrEP uptake (i.e., proportion of patient participants who initiated PrEP (i.e., got PrEP prescription) over the number of eligible patients referred to PrEP) in the participating clinic post-intervention. | The overall number of participants analyzed for this outcome measure includes the number of eligible patients referred to PrEP at our primary partnering clinic site (i.e., Site 1) after the intervention as part of the study (n = 17). Data from our secondary clinic site (Site 2) were excluded from the pre-post comparison due to insufficient sample size. | Posted | Number | 95% Confidence Interval | percentage of patients initiating PrEP | Enrollment to 3 months post-intervention |
|
|
|
| Secondary | PrEP Medication Adherence: Self-Reported PrEP Prescription Regimen Adherence Among Patients Who Initiated Oral PrEP at Both Site 1 and Site 2 | To determine PrEP medication regimen adherence, patient participants completed an adherence questionnaire using a 6-point Likert scale to self-report their perceived ability to take their PrEP medication as prescribed over the last 4 weeks. The scale ranged from excellent to very poor. | HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months; specifically, the Number of Participants Analyzed for this measure is a subset of the total number of participants who completed 3-month follow-up (n=53) and both accepted a PrEP referral and initiated oral PrEP medication after the intervention at both Site 1 and Site 2 (n=7). | Posted | Count of Participants | Participants | 3-month Follow-up |
|
|
|
| Secondary | PrEP Medication Adherence: Self-Reported PrEP Prescription Dosage Adherence Among Participants Who Initiated Oral PrEP at Both Site 1 and Site 2 | To determine PrEP medication dosage adherence, patients completed an adherence questionnaire to self-report the percentage of PrEP medication they have taken in the last 4 weeks. | HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months; specifically, the Number of Participants Analyzed for this measure is a subset of the total number of participants who completed 3-month follow-up (n=53) and both accepted a PrEP referral and initiated oral PrEP medication after the intervention at both Site 1 and Site 2 (n=7). | Posted | Mean | Standard Deviation | percentage of medication taken | 3-Month Follow-up |
|
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| Secondary | PrEP Clinic Visit Adherence at 3-months: Percentage of Scheduled PrEP Visits Attended Among Patients Who Initiated Oral or Injection PrEP at Both Site 1 and Site 2 | To determine PrEP clinic visit adherence, we calculated the average percentage of PrEP visits attended among patient participants who initiate PrEP, compared to the number of PrEP visits scheduled. Visit data was extracted from patients' electronic medical records. | HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months; specifically, the Number of Participants Analyzed for this measure is a subset of the total number of participants who completed 3-month follow-up (n=53) and both accepted a PrEP referral and initiated oral or injection PrEP medication after the intervention (n=8) at both Site 1 and Site 2. | Posted | Mean | Standard Deviation | percentage of PrEP visits attended | From enrollment to 3-months post-enrollment |
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|
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| Secondary | PrEP Clinic Visit Adherence at 12-months: Percentage of Scheduled PrEP Visits Attended Among Patients Who Initiated Oral or Injection PrEP at Site 1 | To determine PrEP clinic visit adherence, we calculated the average percentage of PrEP visits attended among patient participants who initiated PrEP, compared to the number of PrEP visits scheduled. Visit data was extracted from patients' electronic medical records. | HIV-uninfected women aged 18 years or older who are English-speaking and report sexual activity or anticipate sexual activity within 6 months; specifically, the Number of Participants Analyzed for this measure is a subset of the total number of participants who completed 12-month follow-up (n=48) and both accepted a PrEP referral and initiated oral or injection PrEP medication after the intervention at Site 1 (n=7). No 12-month data was collected from Site 2. | Posted | Mean | Standard Deviation | percentage of PrEP visits attended | From enrollment to 12-months post-enrollment |
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|
| 0 |
| 67 |
| 0 |
| 67 |
| 0 |
| 67 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Declined PrEP: Need for more information/consideration time |
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| Declined PrEP: Logistical/timing concerns |
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| Declined PrEP: Delayed PrEP referral acceptance after intervention |
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| Declined PrEP: Reason unknown |
|
| Fair |
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| Poor |
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| Very Poor |
|