Tele-PrEP Intervention for HIV Infections

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Mississippi Medical Center, Jackson, MS
HIV Infections+2 More
Tele-PrEP Intervention - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
HIV Infections

Study Summary

This study is evaluating whether a program which delivers PrEP care through telemedicine can help improve outcomes for individuals at risk for HIV.

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Eligible Conditions

  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Human Immunodeficiency Virus Infection(HIV)/Acquired Immunodeficiency Syndrome (AIDS)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Tele-PrEP Intervention will improve 7 primary outcomes and 4 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of Assessed at 6 months.

Assessed at 3 months
Appointment attendance at 3 months post-intervention (electronic medical record extraction)
Number of PrEP medication refills at 3 months (electronic medical record extraction)
Receipt of PrEP medication prescription at 3 months (electronic medical record extraction)
Month 6
Change in adherence to PrEP (self-report)
Intervention acceptability (CSQ-8)
Intervention acceptability (SEF)
Assessed at 6 months
Appointment attendance at 6 months post-intervention (electronic medical record extraction)
Number of PrEP medication refills at 6 months (electronic medical record extraction)
Receipt of PrEP medication prescription at 6 months (electronic medical record extraction)
Month 6
Motivational readiness for PrEP and PrEP-related care
PrEP knowledge

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Tele-PrEP Intervention

This trial requires 75 total participants across 2 different treatment groups

This trial involves 2 different treatments. Tele-PrEP Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Tele-PrEP Intervention
Behavioral
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.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: assessed at 3 months and 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly assessed at 3 months and 6 months for reporting.

Who is running the study

Principal Investigator
D. L. K. B.
Dr. Larry K. Brown, MD
Rhode Island Hospital

Closest Location

University of Mississippi Medical Center - Jackson, MS

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for hiv infections?

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Most HIV-positive individuals are treated for common infections, such as respiratory and digestive problems. Treatment is frequently repeated in the context of a clinical trial. Some common treatment options for HIV infection include antiretroviral therapy, antiinflammatory therapies, and immunization. HIV may be transmitted through blood donations and through homosexual and heterosexual sexual transmission.

Unverified Answer

Can hiv infections be cured?

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If the patient is highly symptomatic and if there are [HIV-1 RNA<50copy/mL] blood tests show treatment is necessary and appropriate. Some patients need a course of a single day of TDF +3TC. A few patients need several weeks of suppressive antivirals to eradicate infected lymphocytes.(https://ghr.nlm.nih.gov/cdrh/trivial/r1517_p.html). [https://ghr.nlm.nih.gov/cdrh/trivial/r1517_q.

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How many people get hiv infections a year in the United States?

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Each year in the US, around 703,000 new HIV infections occur, which accounts for almost 70% of all newly registered HIV cases and HIV new diagnoses.

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What causes hiv infections?

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The cause of hiv infection is thought to be sexual contact with a sexually active homosexual partner. Individuals have no control over being infected and are therefore vulnerable to infection. There is no known vaccine to prevent HIV infection. To decrease the incidence of HIV, prevention programs should focus on increasing the knowledge and practices of HIV-positive people's partners, as well as educating physicians, the media, law enforcement agencies, and the public about hiv transmission and ways to prevent the infection. Vaccine development is needed as a secondary preventive measure.

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What is hiv infections?

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In 2011 the estimated U.S. prevalence of HIV infections was 0.9%. This estimate has declined by more than 75% since the early 1990s, although the increase has been disproportionately concentrated in populations of blacks and Hispanics at high risk of HIV infection; this disparity also persists in state and regional demographic analyses. The rate of HIV infection among racial and ethnic minorities, however, continues to increase. The U.S. HIV surveillance system has been well preserved, as has documentation of the prevalence of HIV seropositivity, by race/ethnicity, but not by sex or age—as it is for the general population.

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What are the signs of hiv infections?

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The signs of HIV infections manifest as swelling, soreness, pain, itching, rash, itchiness, and a rash. Many signs are usually due to more serious, life-threatening, complications.\n

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Who should consider clinical trials for hiv infections?

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We conclude that the risk of clinical trials for AIDS or HIV infection should be evaluated individually for every patient, based on the type of trial and the patient's own risk, as well as by age and other medical condition.

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What does tele-prep intervention usually treat?

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The most salient finding of this study is a high prevalence of poor health communication behaviours among participants and an absence of evidence for intervention effects. Future studies should explore whether improving these practices in HIV positive men increases men's health literacy and self-efficacy for healthier lifestyles and can reduce HIV transmission risk behaviors.

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How serious can hiv infections be?

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Even in the absence of clinical symptoms, HIV infection is accompanied by an increased risk of subsequent infection and death. These higher risks are most salient among younger individuals; those with less education at the time of infection; those who acquire the disease later in life; and those who develop AIDS. Therefore, it is of critical importance to prevent HIV-1 from entering the body through injection drug use and to protect against potential viral transmission among individuals with multiple partners, especially those who have not used condoms in the past year.

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What are the common side effects of tele-prep intervention?

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Tele-prep has several important advantages, which will help to improve adherence and retention rates of participants. Tele-prep can be considered a powerful tool for HIV prevention.

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What is the average age someone gets hiv infections?

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For the purpose of surveillance and prevention programmes, age at infection should not be used as a surrogate for sexual behaviour as the behaviour of the age-mates is also of importance.

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Is tele-prep intervention typically used in combination with any other treatments?

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Tele-prep intervention was most commonly used with other complementary and alternative therapy treatments among those with moderate-severe depressive symptoms. Tele-prep may be another potentially complementary and alternative option for helping patients with clinically-defined depression manage multiple stresses.

Unverified Answer
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