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| Name | Class |
|---|---|
| University of Mississippi Medical Center | OTHER |
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This study will develop and test a program to deliver PrEP care in underserved communities in Mississippi (MS) through telemedicine, distance-based, clinical care delivered in local community based organizations (CBOs). The intervention will be developed in collaboration with medical specialists at the University of Mississippi Medical Center (UMMC) and local CBO stakeholders (providers, administrators and patients). Approximately 75 individuals will be recruited from CBOs in MS. Participants will be able to receive PrEP counseling in the CBO and PrEP care via telemedicine from a PrEP specialist at UMMC. Participants will complete three assessments in the six months after enrolling. Our study will provide a wealth of information about PrEP-related outcomes and HIV testing among MS residents living in underserved communities. If successful, this program will be able to be disseminated to other CBOs in the South.
Uptake of PrEP in the southern United States has been slow, especially in areas distant from academic medical centers that provide PrEP care. Despite underserved populations in the South having alarmingly high rates of HIV, a large percentage of at-risk individuals are not engaged in PrEP care due to limited access to academic medical centers. Mississippi (MS), the site of this proposed project, has the seventh highest incidence of HIV of any state and CBOs that provide HIV/STI testing outside of urban areas report that very few of their at-risk individuals use PrEP. Unfortunately, physicians outside of academic centers are often reluctant to prescribe PrEP because they lack the expertise, training, and the support necessary to provide comprehensive HIV prevention care. Those are at-risk do not seek PrEP from academic centers because of stigma, travel burdens, and financial concerns. To overcome these barriers, this project will develop and pilot test a program to deliver PrEP care in underserved remote communities in MS through telemedicine clinical care delivered in local CBOs. Telemedicine will allow specialists to provide care at a distance and while simultaneously enhancing the capacity of local CBOs to provide quality HIV testing and counseling, PrEP treatment, and linkage to HIV care if needed. It will allow patients to receive the highest level of medical care from trusted CBOs within their local communities. It will also enhance the CBO's mission by allowing it to provide a new, high-quality medical service.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-PrEP Intervention | Experimental | The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-PrEP Intervention | Behavioral | Telemedicine conferences with PrEP-specialists |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction) | Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 3 months post-intervention. | Assessed at 3 months |
| Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 6 Months Post-intervention (Electronic Medical Record Extraction) | Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 6 months post-intervention. | Assessed at 6 months |
| Number of Participants Who Received a PrEP Medication Prescription at 3 Months (Electronic Medical Record Extraction) | Number of participants who received a PrEP medication prescription in past 3 months, extracted from patient's electronic medical record at 3-month follow-up. | Assessed at 3 months |
| Number of Participants Who Received a PrEP Medication Prescription at 6 Months (Electronic Medical Record Extraction) | Number of participants who received a PrEP medication prescription in past 3 months, extracted from patient's electronic medical record at 6-month follow-up. | Assessed at 6 months |
| Adherence to PrEP (Self-report) | Self-reported number of days a PrEP dose was missed in the past 30 days. Ranging from 0 to 30. | Assessed at 3 months and 6 months |
| Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record ) |
| Measure | Description | Time Frame |
|---|---|---|
| PrEP Knowledge | This 5-item measure was used to assess knowledge (true/false/don't know) based on facts from the CDC and the San Francisco AIDS Foundation websites concerning PrEP. Scores for the measure could range from 0 to 5 with higher scores indicating greater PrEP knowledge. | Assessed at 3 months and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Larry K Brown, MD | Rhode Island Hospital | Principal Investigator |
| James B Brock, MD | University of Mississippi Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tele-PrEP Intervention | The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Participants who completed the baseline assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Tele-PrEP Intervention | The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction) | Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 3 months post-intervention. | Posted | Count of Participants | Participants | Assessed at 3 months |
|
Adverse event data were collected over the 6 month study duration.
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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 | Tele-PrEP Intervention | The telemedicine intervention will allow participants to discuss HIV prevention and PrEP with PrEP specialists at an academic medical center via videoconference from their local community based organization (CBO). During the intervention, participants will gain information related to HIV and PrEP, view a video to improve motivation for engagement in PrEP related care, and receive resources to address barriers to care. Tele-PrEP Intervention: Telemedicine conferences with PrEP-specialists |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Larry Brown | Rhode Island Hospital | +1 (401) 793-8808 | lkbrown@lifespan.org |
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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 | Jul 12, 2021 | Oct 13, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 27, 2021 | Oct 13, 2022 | 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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Number of participants with 0-2 PrEP medication refills in past 3 months (extracted from electronic medical record at 3-month follow-up). |
| Assessed at 3 months |
| Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record) | Number of Participants With 0-2 PrEP Refills in past 3 months (extracted from electronic medical record at 6-month follow-up). | Assessed at 6 months |
| Motivational Readiness for PrEP and PrEP-related Care |
This measure was a subscale adapted from The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ), 2006. The motivational readiness to engage in PrEP care subscale consisted of eight items with 4-point Likert responses. The possible score range for this subscale is 8 to 32, with higher scores indicating higher motivation to engage in PrEP care. |
| Assessed at 3 months and 6 months |
| Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8) | Patients' perspective on the acceptability of using telemedicine for PrEP care was assessed with a modified version of the Client Satisfaction Questionnaire (CSQ-8). This measure was only given to participants who attended a PrEP-related telemedicine appointment. Scores for this measure could range from 2 to 8, with higher scores indicating greater satisfaction. | Assessed at 3 months and 6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| PrEP knowledge | 5-item questionnaire to assess knowledge (true/false/don't know) based on facts from the CDC and the San Francisco AIDS Foundation websites concerning PrEP. The score of this measure ranges from 0 to 5, with 5 indicating higher levels of PrEP knowledge. | Mean | Standard Deviation | score on a scale |
|
| Motivational readiness for PrEP and PrEP-related care | This measure was a subscale adapted from The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ), 2006. The motivational readiness to engage in PrEP care subscale consisted of eight items with 4-point Likert responses. The possible score range for this subscale is 8 to 32, with higher scores indicating higher motivation to engage in PrEP care. | Only those who completed 80% of the scale or more are included in the analyses. This explains why the number analyzed for this measure is lower than the overall number of baseline participants. | Mean | Standard Deviation | score on a scale |
|
|
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| Primary | Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 6 Months Post-intervention (Electronic Medical Record Extraction) | Number of participants who attended one or more PrEP telemedicine appointments with a UMMC PrEP specialist, in the past 3 months, extracted from patient's electronic medical record at 6 months post-intervention. | Posted | Count of Participants | Participants | Assessed at 6 months |
|
|
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| Primary | Number of Participants Who Received a PrEP Medication Prescription at 3 Months (Electronic Medical Record Extraction) | Number of participants who received a PrEP medication prescription in past 3 months, extracted from patient's electronic medical record at 3-month follow-up. | Posted | Count of Participants | Participants | Assessed at 3 months |
|
|
|
| Primary | Number of Participants Who Received a PrEP Medication Prescription at 6 Months (Electronic Medical Record Extraction) | Number of participants who received a PrEP medication prescription in past 3 months, extracted from patient's electronic medical record at 6-month follow-up. | Posted | Count of Participants | Participants | Assessed at 6 months |
|
|
|
| Primary | Adherence to PrEP (Self-report) | Self-reported number of days a PrEP dose was missed in the past 30 days. Ranging from 0 to 30. | Only participants who self-reported current PrEP use were included in these analyses. | Posted | Mean | Standard Deviation | missed PrEP doses | Assessed at 3 months and 6 months |
|
|
|
| Primary | Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record ) | Number of participants with 0-2 PrEP medication refills in past 3 months (extracted from electronic medical record at 3-month follow-up). | Posted | Count of Participants | Participants | Assessed at 3 months |
|
|
|
| Primary | Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record) | Number of Participants With 0-2 PrEP Refills in past 3 months (extracted from electronic medical record at 6-month follow-up). | Posted | Count of Participants | Participants | Assessed at 6 months |
|
|
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| Secondary | PrEP Knowledge | This 5-item measure was used to assess knowledge (true/false/don't know) based on facts from the CDC and the San Francisco AIDS Foundation websites concerning PrEP. Scores for the measure could range from 0 to 5 with higher scores indicating greater PrEP knowledge. | Only those who completed 80% of the scale or more are included in the analyses. This is why only 57 and 54 participants were included in the 3-month and 6-month analysis, respectively. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 3 months and 6 months |
|
|
|
| Secondary | Motivational Readiness for PrEP and PrEP-related Care | This measure was a subscale adapted from The LifeWindows Information Motivation Behavioral Skills ART Adherence Questionnaire (LW-IMB-AAQ), 2006. The motivational readiness to engage in PrEP care subscale consisted of eight items with 4-point Likert responses. The possible score range for this subscale is 8 to 32, with higher scores indicating higher motivation to engage in PrEP care. | Only those who completed 80% of the scale or more are included in the analyses. This is why only 57 and 54 participants were included in the 3-month and 6-month analysis, respectively. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 3 months and 6 months |
|
|
|
| Secondary | Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8) | Patients' perspective on the acceptability of using telemedicine for PrEP care was assessed with a modified version of the Client Satisfaction Questionnaire (CSQ-8). This measure was only given to participants who attended a PrEP-related telemedicine appointment. Scores for this measure could range from 2 to 8, with higher scores indicating greater satisfaction. | Only those who attended a telemedicine for PrEP appointment and completed this measure on the survey were included in the analyses. By 3-month follow-up, 11 of 63 participants used telemedicine for PrEP care. By 6-month follow-up, 1 additional participant used telemedicine for PrEP care. This explains why the overall number of participants analyzed for this measure was 12, as opposed to 63. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 3 months and 6 months |
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| 0 |
| 63 |
| 0 |
| 63 |
| 0 |
| 63 |
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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 |
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