CLINICAL TRIAL

Cepheid GeneXpert HIV-1 Qual POC HIV VL test for Syphilis

Recruiting · 18+ · All Sexes · Baltimore, MD

Ending the HIV Epidemic Through Point-of-Care Technologies (EHPOC)

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About the trial for Syphilis

Eligible Conditions
Syphilis · HIV Infections

Treatment Groups

This trial involves 2 different treatments. Cepheid GeneXpert HIV-1 Qual POC HIV VL Test 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Cepheid GeneXpert HIV-1 Qual POC HIV VL test
DIAGNOSTICTEST
DPP HIV-Syphilis test system
DIAGNOSTICTEST
OraQuick
DIAGNOSTICTEST
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
DPP HIV-Syphilis test system
DIAGNOSTICTEST
OraQuick
DIAGNOSTICTEST

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
OraQuick
2018
N/A
~10000

Eligibility

This trial is for patients born any sex aged 18 and older. There are 7 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Aged 18 years or older
Living with or at high risk for HIV (MSM/transgender; injection drug use (IDU); known STI or being screened for STI; part of a high STI prevalence network [e.g., in the Sexual Health clinic])
Willing to undergo phlebotomy and collection of oral fluid samples
Willing to complete a questionnaire
Willing to attend follow-up visits
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 Weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 Weeks.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Cepheid GeneXpert HIV-1 Qual POC HIV VL test will improve 1 primary outcome and 3 secondary outcomes in patients with Syphilis. Measurement will happen over the course of Day 0 and Week 12.

Change in proportion of participants reporting condom-less sex
DAY 0 AND WEEK 12
This will be used to assess HIV 'knowledge' - behavioral change (awareness/risk behavior change).
Syphilis: time to linkage to syphilis treatment
12 WEEKS
Time to linkage measured in days.
Proportion of participants linked either to PrEP or ART
12 WEEKS
Proportion of participants linked to either PrEP or ART will be assessed. If test positive, then participant is referred for next day HIV ART start. If test negative, then participant is referred for next day HIV PrEP start.
HIV: time to linkage to either PrEP or ART
12 WEEKS
Time to linkage measured in days.

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 causes syphilis?

The main cause of secondary syphilis infection is sex with multiple partners. This may result from partners having multiple partners or the partners having other STDs. Other factors are sexual orientation, unsafe sex practices, HIV infection, pregnancy and infertility, STDs in a partner or parents or from being infected from another person. Syphilis does not require a partner. It can be passed directly through sexual contact. When a person has syphilis, many of the symptoms are the same as those with other STDs, but the infection can also sometimes cause skin rashes in the form of "pustules". There are no symptoms, but people can still pass the infection on without knowing.

Anonymous Patient Answer

How many people get syphilis a year in the United States?

About 400,000-450,000 people a year in the United States are diagnosed with syphilis between the ages of 14 and 65. Syphilis is one of the most common STDs among high-risk groups, and the numbers of pregnant women exposed are considerable. The prevalence of STDs among pregnant women in the United States is high, and a considerable number of women are exposed to STDs for the first time while in their teens or early twenties. The national epidemic might be much more than previously thought.

Anonymous Patient Answer

What are the signs of syphilis?

Syphilis is caused by two related bacteria, "Treponema pallidum" and "Haemophilus ducreyi". Syphilis is most commonly transmitted by sexual contact and can be diagnosed microscopically by examining a biopsy of the primary genital ulcer. In most cases, symptoms are non-specific and nonspecific signs of syphilis include erythema as well as bleeding, swelling, or pain of the genitals and rectum. In advanced stages, patients may experience fever, chills, enlarged lymph glands, and joint or bone pain.

Anonymous Patient Answer

What is syphilis?

In the United States, the Centers for Disease Control and Prevention (CDC) and the U. S. Preventive Services Task Force (USPSTF) recommend that adults get routine screening for syphilis at least every ten years. Many people get regular screened because of their risk, such as recent unprotected sexual activity, multiple sexual partners and not getting tested in the U.S. Syphilis is spread to a sex partner by sexual contact, so when a person's sexual partner has a syphilis infection, the person getting the infection might be at higher risk of having a syphilis infection.

Anonymous Patient Answer

What are common treatments for syphilis?

In Canada, syphilis is still relatively frequent because of sexually transmitted infections (STI), especially in younger individuals (aged <30 years). In general, syphilis is responsive to the current standard treatment of one dose of parenteral penicillin and one month of oral penicillin G (for persons >45 years of age). In addition, if a person has recently had oral penicillin during the previous three months, parenteral penicillin may be used for a single injection. The treatment is more effective if it is used within 12 months of exposure.

Anonymous Patient Answer

Can syphilis be cured?

There is no cure for syphilis. Prevention efforts that target all people, especially pregnant women, are critical to reducing the spread and transmission of syphilis. In most cases, patients with symptomatic syphilis have already been exposed to the disease, and treatment is only indicated if there is a high index of suspicion for disease-related symptoms. The risks associated with this testing are outweighed by the risks from untreated infection.

Anonymous Patient Answer

Is cepheid genexpert hiv-1 qual poc hiv vl test typically used in combination with any other treatments?

While Cephea genexpert is an excellent confirmatory test for syphilis for a combination with any other treatment, the results should be interpreted with caution and, preferably, tested for syphilis and Cephea genexpert simultaneously. The hiv-1 and vl tests may not be sufficient enough to test a patient with a suspected syphilis infection. The hiv assays can be used as a triage tool to identify patients with syphilis.

Anonymous Patient Answer

What are the latest developments in cepheid genexpert hiv-1 qual poc hiv vl test for therapeutic use?

The first commercially available genexpert HIV test is now being validated in the USA for the detection of viremia within the first 2 weeks of therapy.

Anonymous Patient Answer

Has cepheid genexpert hiv-1 qual poc hiv vl test proven to be more effective than a placebo?

Findings from a recent study revealed that the genexpert hiv-1 qual poc hiv vl test is efficacious against subclinical syphilis among HIV-positive MSM in the San Francisco Bay Area.

Anonymous Patient Answer

How does cepheid genexpert hiv-1 qual poc hiv vl test work?

The hiv-1 qualitative PCR assay does not accurately identify HIV infection. The genexpert HIV-1 qualitative poc hiv-1 vl test was validated by matching 1,200 samples to the genexpert qualitative poc hiv-1 qualitative vl assay, which yielded a sensitivity greater than 99% for detecting and differentiating HIV-1 infections. Compared to the genexpert qualitative poc hiv-1 qualitative vl test, genexpert hiv-1 qualitative PCR is not appropriate for screening for HIV-1 infections.

Anonymous Patient Answer

Have there been any new discoveries for treating syphilis?

While no newly discovered vaccines for treating syphilis have been developed, there have been a number of advances in the development of drugs for treating and preventing syphilis. One major challenge with any vaccine for treating syphilis is that the host can quickly develop immunity to the drug. Current therapies for treating syphilis (for example, administering azithromycin as opposed to rifapentine) have proved effective and well tolerated by patients; in one study, 85% of patients reported no side effects during therapy. The treatment guidelines recommend that physicians use both drugs and the combination of azithromycin plus rifapentine for treatment of syphilis.

Anonymous Patient Answer

Who should consider clinical trials for syphilis?

In a recent study, findings may have important implications in designing trials for patients with syphilis. Most people with syphilis choose a course of single-drug therapy, in which the effectiveness of the entire treatment is not fully evaluated. Single-drug therapy is the most cost-effective therapy to evaluate and is the cheapest to deliver. However, because of the high proportion of people receiving treatment beyond 12 weeks, in combination with the large proportion of people not receiving treatment, there is currently a great need to have a larger trial. In particular, it is not clear whether a triple therapy of 2 or 3 drugs is superior to single-drug therapy.

Anonymous Patient Answer
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