PrEP Master Adherence Intervention for HIV, Prevention

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Florida International University Biscayne Bay Campus, North Miami, FL
HIV, Prevention
PrEP Master Adherence Intervention - Behavioral
Eligibility
18 - 65
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a medication may help reduce the risk of HIV infection for women.

See full description

Treatment Effectiveness

Study Objectives

This trial is evaluating whether PrEP Master Adherence Intervention will improve 4 primary outcomes in patients with HIV, Prevention. Measurement will happen over the course of 3 months.

3 months
Number of Participants receiving 3 Medication Appointments
Number of Participants reporting Adherence to HIV testing recommendation
Percentage Adherence to PrEP Medication
Self reported PrEP Adherence

Trial Safety

Trial Design

1 Treatment Group

PrEP Master Adherence Intervention
1 of 1
Experimental Treatment

This trial requires 120 total participants across 1 different treatment group

This trial involves a single treatment. PrEP Master Adherence 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.

PrEP Master Adherence Intervention
Behavioral
The intervention consists of an introductory session and 4 individual sessions led by the PrEP Master, over an 8 week period. Between the sessions, the PrEP Master will conduct weekly check-in calls to participants to encourage adherence and assist with difficulties. During the weekly check-in, side effects and their impact will be assessed using assessment measures.

Trial Logistics

Trial Timeline

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

Who is running the study

Principal Investigator
j. g. d.
jessy g devieux, Principal Investigator
Florida International University

Closest Location

Florida International University Biscayne Bay Campus - North Miami, FL

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
I identify as an African American, Hispanic/Latina, or Haitian. show original
having a child The text discusses how sexual risk affects having a child show original
At least 18 years old. show original
born female;
identifies as a woman The individual identifies as a woman. show original
Able to understand what they are consenting to. show original
HIV uninfected;
History of alcohol or drug use in last 3 months;
ongoing HIV monitoring There are no uncleared PrEP contraindications show original
This person does not have a psychosis. show original

Patient Q&A Section

Can hiv, prevention be cured?

"It is highly uncertain whether can be cured. However, there are many elements of prevention that can easily be achieved, particularly for those at high risk for hiv." - Anonymous Online Contributor

Unverified Answer

What are the signs of hiv, prevention?

"Significant signs of HIV and AIDS include: erythema, skin changes such as itching, dryness and cracking of the skin; fatigue; malaise; weight loss; cough; hoarseness; a dry and cracking mouth; hair loss or loss of hair color; and swollen lymph nodes in the neck, or the throat. The diagnosis of HIV also includes a positive result for HIV antibodies in the bloodstream, which indicates long-term exposure to HIV and a greater risk of developing AIDS." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hiv, prevention?

"Some treatments for hiv and/or pre-exposure prophylaxis (PEP) include supplements for various nutrient deficiencies and drugs that alter immune function or replication of the virus such as anti-retroviral drugs or integrase inhibitors. It is necessary to continue to develop more-selective, non-nucleoside reverse transcriptase inhibitors (NNRTI) that increase the durability of treatment. Also, new drugs such as fusion inhibitors and other biologics would offer an option for patients whose immune system is compromised, but who do not benefit from NNRTI therapy. More so, vaccines remain an option for preventing HIV exposure." - Anonymous Online Contributor

Unverified Answer

What is hiv, prevention?

"HIV prevention does not guarantee a reduction in HIV transmission. The best way of reducing HIV transmission is to prevent men having sex with other men. However, condom use between men who have sex with men and between sex partners is critical if HIV is going to be effectively controlled. The use of condoms both in men who have sex with men and in those who have relationships with men would not only increase the health and sexual satisfaction of these men, but would also reduce the number of young people who acquire AIDS through exposure to HIV." - Anonymous Online Contributor

Unverified Answer

What causes hiv, prevention?

"A large proportion of people living with HIV do not understand the basic principles of oral sex and how it is spread. There is a need for public health campaigns to increase awareness on the key principles of oral health precautions and HIV transmission." - Anonymous Online Contributor

Unverified Answer

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

"Estimates vary widely of numbers who would get infected with HIV every year in the United States. Preventive efforts and health care need must be tailored to the population in question. There is no single answer to these crucial questions that will work for all jurisdictions. There are also differences in the way the questions may be posed to respondents of different racial-ethnic groups and other demographic subgroups. Using the data in this study, we can make some estimates, but not all, of the number of people getting AIDS in any given year in the U.S. The estimates can help health officials planning programs. They can help states allocate funds for those services." - Anonymous Online Contributor

Unverified Answer

Is prep master adherence intervention safe for people?

"Prep master adherence intervention is a safe, feasible, effective, and acceptable model of care for enhancing the HIV preventive practices of men who have sex with men for 2 years." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for hiv, prevention?

"In the current era, the decision to enroll in clinical trials is often based on personal desire and fear of adverse effects of new drugs. In addition to this, current research on clinical trials shows limited results for hiv, prevention trials that involve immunizations. Moreover, while the majority of men will be infected with hiv, men are in more control of their personal health than the disease. These men are in more control of their lifestyle choices, making it more difficult for them to be interested in trials. In the future, [HIV, prevention trials] could address the fears of the majority of men and the desires of the majority of women, if more research is done on the long-term safety of new drugs." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in prep master adherence intervention for therapeutic use?

"There are still many unanswered questions and ethical considerations about delivering MMI to a population of clients who have already undergone prolonged abstinence from substances for many months." - Anonymous Online Contributor

Unverified Answer

How serious can hiv, prevention be?

"The prevalence and severity of STIs are increasing among U.S. men who have sex with men. In addition, the proportion of infected individuals who seek treatment for their condition is also increasing sharply. Effective treatment and prevention programs are urgently needed. HIV prevention, testing, and counseling should be implemented within health-care delivery systems." - Anonymous Online Contributor

Unverified Answer

Does prep master adherence intervention improve quality of life for those with hiv, prevention?

"Prepmaster is associated with increased knowledge and satisfaction concerning HIV risk behaviors among young people, but this advantage is not reflected in improvements in global physical or psychological functioning." - Anonymous Online Contributor

Unverified Answer

What is prep master adherence intervention?

"To our knowledge, this is the first study to illustrate the utility and potential effectiveness of a master-training program for a behavioral drug regimen that is not widely available in the clinical setting. The P-MART intervention was successfully implemented, provided a strong impact on improved retention, and resulted in improved adherence. There are many potential advantages of this approach to enhancing adherence to other medications." - Anonymous Online Contributor

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