PrEPmate for HIV Infections

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Whitman-Walker Health, Washington, United States
HIV Infections+1 More
PrEPmate - Other
Eligibility
Any Age
All Sexes
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Study Summary

This study is evaluating whether text messages or a mobile app may help people take HIV medications as directed.

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Eligible Conditions

  • HIV Infections
  • Sexually Transmitted Diseases

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether PrEPmate will improve 3 primary outcomes and 3 secondary outcomes in patients with HIV Infections. Measurement will happen over the course of Adherence self-efficacy measured through 12 months.

Month 12
Adherence self-efficacy
Month 12
PrEP adherence as measured by tenofovir diphosphate levels in dried blood spots
Month 12
Patient engagement
Month 12
PrEP continuation based on medication refills
Month 12
Satisfaction with medical care
Month 12
Sexual satisfaction

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Dot Diary mobile application
1 of 2
PrEPmate
1 of 2
Experimental Treatment

This trial requires 300 total participants across 2 different treatment groups

This trial involves 2 different treatments. PrEPmate is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Dot Diary mobile application
Device
Participants randomized to this study arm will download and use the Dot Diary mobile application on a personal device, to support PrEP adherence and continuation.
PrEPmate
Other
Participants randomized to this study arm will receive the PrEPmate mHealth intervention (bi-directional text messaging with PrEP navigators/clinic staff) to support PrEP adherence and continuation.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: dbs measured through 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly dbs measured through 12 months for reporting.

Who is running the study

Principal Investigator
A. L.
Albert Liu, Clinical Research Director
Public Health Foundation Enterprises, Inc.

Closest Location

Whitman-Walker Health - Washington, United States

Eligibility Criteria

This trial is for patients born any sex of any age. There are 7 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Self-identifies as a cisgender man, transgender man (assigned female at birth, trans-masculine spectrum), or transgender woman (assigned male sex at birth, trans-feminine spectrum)
Report sex with a cisgender man or transgender woman or any individual assigned male sex at birth in the past 12 months
Age 15 years or older
Willing and able to provide written informed consent
Owns an iOS or Android mobile phone and able to access the internet and send and receive text messages
Able to understand, read, and speak English or Spanish
Initiated PrEP within the past 6 months, or Has any of the following risk factors for PrEP discontinuation: missed clinic visits; age < 30; African-American or Latino; transgender gender identity; or self-reported illicit substance use

Patient Q&A Section

How many people get sexually transmitted diseases a year in the United States?

"The [Federal Center for Disease Control]] estimates that at least 9% of adults have a sexually transmitted diseases in the United States. It is imperative to have a good understanding of the prevalence of sexually transmitted diseases in the United States because these rates are difficult to obtain." - Anonymous Online Contributor

Unverified Answer

What are the signs of sexually transmitted diseases?

"Sexual activity can be associated with the development of genital infection with sexually transmitted infections. The following sexual act associated with infection with sexually transmitted infections is unprotected oral sex: A recent history of genital injury with or without signs of infection, non-regular partner of the last partner, or a spouse with a history of HIV/AIDS. Previous infection with a sexually transmitted infection can also be associated with sexual activity associated with an increased risk of infection with sexually transmitted infections, but to less than 10%." - Anonymous Online Contributor

Unverified Answer

What is sexually transmitted diseases?

"STDs can be acquired from a person's partner or others close to them. Most of the STDs can be prevented through screening people for STDs who have sex with men, including HIV and other sexually transmitted diseases. Preventive interventions that do not rely on screening are not effective for preventing HIV. STDs are often spread through intercourse; condoms or abstinence are usually the most effective ways to prevent them. Many other STDs can be prevented by avoiding a sexually active lifestyle." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sexually transmitted diseases?

"Many sexual partners treat themselves with barrier contraception to prevent pregnancy, while many couples also consider partner condoms. Vaccinations are recommended for hepatitis A, typhoid, tetanus, diphtheria and pertussis. Oral sex has been shown to be a risk factor for HIV infection, but is being used as a method of transmission. Inappropriate treatment of sexually transmitted infections is a major risk factor for transmission of HIV to partners. Gender-specific preventive methods have been shown to be protective, such as male condoms. It is unclear if the use of male contraceptive condoms is safer than female barrier contraception for women at high enough risk for HIV infection." - Anonymous Online Contributor

Unverified Answer

What causes sexually transmitted diseases?

"Most STDs begin during adolescence. Infection is not spread from one person to another. Genital infection is common and often unrecognized. Sexual partners often are a vector for STDs. Many STDs are easily preventable. STDs can be minimized by using condoms consistently, correctly and consistently during and after sexual intercourse, use of other non-penetrative male contraceptives, not having multiple sex partners and receiving regular health care.\n\nFactors that increase the likelihood that a pregnant woman will have complications: Age, preexisting chronic illnesses, chronic exposure to various types of drugs and/or pollutants like tobacco." - Anonymous Online Contributor

Unverified Answer

Can sexually transmitted diseases be cured?

"It is likely that, in clinical practice, the possibility of healing STDs is minimal. Nevertheless, it is possible to prevent them in populations where they are common. Because people are very attached to the idea that they could be cured of STDs, if the notion that this is possible is raised, their fear, insecurity and mistrust are increased, leading to an increase of disease in other circumstances. This may be a barrier for implementing programmes to prevent STDs." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving prepmate?

"There have been a small number of clinical trials carried out with "premate" as a study adjuvant. These include 2 "premate vs. placebo" trials and 3 studies using non-sterile penile implants. A systematic review and meta-analyse were also conducted in 2008 involving the study of oral premate and a meta-analysis involving premate vs placebo also yielded similar results. Oral premate did not appear to result in benefits of treating "non-infectious" symptoms for "sexually active" or "homosexual" patients." - Anonymous Online Contributor

Unverified Answer

What does prepmate usually treat?

"In the UK, most doctors treat sexually transmitted infections (STI) by using [the STI first-line treatment for men and women] or 'do no harm' practices that focus on symptomatic treatment of people without STI." - Anonymous Online Contributor

Unverified Answer

Has prepmate proven to be more effective than a placebo?

"The use of a placebo on the other hand may have an impact on the results of the study. In our study, the prevalence of genital ulcer infection was similar to the one seen with the control group. A longer duration of the study and more subjects might probably provide more reliable data. However, in conclusion, there is no definite proof of the superiority of a steroid cream preparation over a placebo in the treatment of genital ulcer on the other hand there is no proof for the superiority of one preparation over another and in the present study no conclusion can be drawn on the treatment of genital ulcer (Tab. 5, Fig. 6, Ref. 29)." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for sexually transmitted diseases?

"Almost four-fifths of sexually active women reported being concerned about the possibility that they or their partner might have a STI. A significant number (22%) of women reported being “very” or “fairly” concerned about developing an STI. Women and men should be able to be adequately educated about the risk of contracting an STI, as well as risk factors for infection. Many women reported that they would definitely like to take part in a trial of an STI vaccine." - Anonymous Online Contributor

Unverified Answer

Does sexually transmitted diseases run in families?

"This first cross-generational examination of the relative frequency of STD in first-degree relatives of subjects with a diagnosis of STI suggests that STDs are not significantly associated with familial occurrence of STI. In contrast, there may be a significant association between low relative frequency and a lower prevalence of a prior STD." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of sexually transmitted diseases?

"More than half of sexually active young women have a sexually transmitted disease infection. In some instances, men can be found to be the primary source of infection. Most women may not be aware of the health issue. Appropriate education about safe sexual practices can be of value." - 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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