HIV/AIDSTele-PrEPNCT03840382
Telemedicine for PrEP Throughout Mississippi
A study testing Tele-PrEP Intervention in people with HIV/AIDS, run by Rhode Island Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Tele-PrEP Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 4 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
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.
Read the 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.
- Conditions
- HIV/AIDS
- Being tested
- Tele-PrEP Intervention
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-PrEP InterventionBehavioural
Telemedicine conferences with PrEP-specialists
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Tele-PrEP Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at 3 months and 6 months
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).
Measured: 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).
Measured: Assessed at 6 months
Secondary outcomes (3)
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.
Measured: Assessed at 3 months and 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.
Measured: 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.
Measured: Assessed at 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start19 Dec 2019
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Mississippi Medical Center
- Responsible party
- Principal investigator, Dr. Larry K. Brown, Rhode Island Hospital
- Investigators
- Larry K Brown, MD, Principal investigator, Rhode Island HospitalJames B Brock, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03840382
- Sponsor's protocol ID
- 407618
- Acronym
- Tele-PrEP
- Status last verified
- Nov 2023
- First submitted
- 28 Jan 2019
- Last updated
- 29 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine for PrEP Throughout Mississippi
- ClinicalTrials.gov ID
- NCT03840382
- Acronym / sponsor ID
- Tele-PrEP / 407618
- Conditions
- HIV/AIDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- University of Mississippi Medical Center
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Posted 29 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tele-PrEP Intervention | Experimental | Behavioral: Tele-PrEP InterventionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Tele-PrEP InterventionTelemedicine conferences with PrEP-specialists | Behavioural | Tele-PrEP Intervention |
Primary outcome
Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Number of Participants Who Received a PrEP Medication Prescription at 6 Months (Electronic Medical Record Extraction)
Time frame: 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)
Time frame: 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 )
Time frame: 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 With 0-2 PrEP Refills at 6 Months (Electronic Medical Record)
Time frame: 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).
3 secondary outcomes
PrEP Knowledge
Time frame: Assessed at 3 months and 6 months
Motivational Readiness for PrEP and PrEP-related Care
Time frame: Assessed at 3 months and 6 months
Patient Acceptability Score Regarding the Use of Telemedicine for PrEP Care (CSQ-8)
Time frame: Assessed at 3 months and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for HIV/AIDS
Not yet recruitingPhase 1
huCART19-IL18-CD428z Cells for the Treatment of Patients With HIV With CD19+ Cancers
Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia
Enrolling by invitation
Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
HIV Infections
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
Not yet recruitingPhase 4
Study of BIC/LEN FDC Versus Stable Baseline Regimens in Virologically Suppressed People With HIV
HIV-1 Infection
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.
Larry K Brown, MD principal investigator
Rhode Island Hospital
James B Brock, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-PrEP Intervention in people with HIV/AIDS, run by Rhode Island Hospital 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 6 inclusion and 1 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 29 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Attended One or More PrEP Telemedicine Appointments at 3 Months Post-intervention (Electronic Medical Record Extraction) (time frame: Assessed at 3 months). The study lists 7 primary outcomes in all. 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 29 Apr 2024.