HIV/AIDS
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALTele-PrEP Intervention
Telemedicine conferences with PrEP-specialists
Sponsors
University of Mississippi Medical Center
Rhode Island Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years old or older * Presented at a collaborating CBO for HIV testing during trial months * PrEP eligible based on HIV Risk Checklist * Able to read and speak English * Able to give meaningful consent as determined by research staff * No known HIV infection
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record) | Assessed at 6 months | Number of Participants With 0-2 PrEP Refills in past 3 months (extracted from electronic medical record at 6-month follow-up). |
| Number of Participants Who Received a PrEP Medication Prescription at 6 Months (Electronic Medical Record Extraction) | Assessed at 6 months | 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. |
| Adherence to PrEP (Self-report) | Assessed at 3 months and 6 months | Self-reported number of days a PrEP dose was missed in the past 30 days. Ranging from 0 to 30. |
| Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record ) | Assessed at 3 months | Number of participants with 0-2 PrEP medication refills in past 3 months (extracted from electronic medical record at 3-month follow-up). |
| Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction) | Assessed at 3 months | 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. |
| Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 6 Months Post-intervention (Electronic Medical Record Extraction) | Assessed at 6 months | 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. |
| Number of Participants Who Received a PrEP Medication Prescription at 3 Months (Electronic Medical Record Extraction) | Assessed at 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motivational Readiness for PrEP and PrEP-related Care | Assessed at 3 months and 6 months | 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. |
| Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8) | Assessed at 3 months and 6 months | 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. |
| PrEP Knowledge | Assessed at 3 months and 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 63 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 11 |
Baseline characteristics
| Characteristic | Tele-PrEP Intervention |
|---|---|
| Age, Continuous | 30.3 years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Motivational readiness for PrEP and PrEP-related care | 25.07 score on a scale STANDARD_DEVIATION 4.37 |
| PrEP knowledge | 2.63 score on a scale STANDARD_DEVIATION 1.72 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 63 |
| other Total, other adverse events | 0 / 63 |
| serious Total, serious adverse events | 0 / 63 |
Outcome results
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.
Time frame: Assessed at 3 months and 6 months
Population: Only participants who self-reported current PrEP use were included in these analyses.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-PrEP Intervention | Adherence to PrEP (Self-report) | Missed Doses at 3-Months | 2.07 missed PrEP doses | Standard Deviation 3.03 |
| Tele-PrEP Intervention | Adherence to PrEP (Self-report) | Missed Doses at 6-Months | 18.75 missed PrEP doses | Standard Deviation 13.5 |
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.
Time frame: Assessed at 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tele-PrEP Intervention | Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction) | 8 Participants |
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.
Time frame: Assessed at 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tele-PrEP Intervention | Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 6 Months Post-intervention (Electronic Medical Record Extraction) | 2 Participants |
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.
Time frame: Assessed at 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tele-PrEP Intervention | Number of Participants Who Received a PrEP Medication Prescription at 3 Months (Electronic Medical Record Extraction) | 22 Participants |
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.
Time frame: Assessed at 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tele-PrEP Intervention | Number of Participants Who Received a PrEP Medication Prescription at 6 Months (Electronic Medical Record Extraction) | 17 Participants |
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).
Time frame: Assessed at 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tele-PrEP Intervention | Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record ) | 0 Refills | 43 Participants |
| Tele-PrEP Intervention | Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record ) | 1 Refill | 11 Participants |
| Tele-PrEP Intervention | Number of Participants With 0-2 PrEP Refills at 3 Months (Electronic Medical Record ) | 2 Refills | 9 Participants |
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).
Time frame: Assessed at 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tele-PrEP Intervention | Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record) | 0 Refills | 46 Participants |
| Tele-PrEP Intervention | Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record) | 1 Refill | 12 Participants |
| Tele-PrEP Intervention | Number of Participants With 0-2 PrEP Refills at 6 Months (Electronic Medical Record) | 2 Refills | 5 Participants |
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.
Time frame: Assessed at 3 months and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-PrEP Intervention | Motivational Readiness for PrEP and PrEP-related Care | Score at 3-Months | 25.95 score on a scale | Standard Deviation 4.69 |
| Tele-PrEP Intervention | Motivational Readiness for PrEP and PrEP-related Care | Score at 6-Months | 26.50 score on a scale | Standard Deviation 4.11 |
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.
Time frame: Assessed at 3 months and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-PrEP Intervention | Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8) | Score at 3-Months | 7.27 score on a scale | Standard Deviation 1.27 |
| Tele-PrEP Intervention | Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8) | Score at 6-Months | 7.50 score on a scale | Standard Deviation 1 |
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.
Time frame: Assessed at 3 months and 6 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tele-PrEP Intervention | PrEP Knowledge | Score at 3-months | 2.89 score on a scale | Standard Deviation 1.84 |
| Tele-PrEP Intervention | PrEP Knowledge | Score at 6-months | 2.93 score on a scale | Standard Deviation 1.64 |