Real Time Electronic Monitoring Is Improving Anti-Retroviral Therapy Adherence

Treatment compliance is a real problem all over the world. Managing bacterial infections from sinusitis up to tuberculosis, and viral infections such as HIV, needs to be done with oral medication and when patients are not compliant by taking the correct medication at the correct times for the prescribed duration, then this can result in treatment failure. Treatment failure can lead to medication resistance (where patients can end up transferring resistant organisms to others) and complications from the infections.

Electronic adherence monitoring (EAM) is used in many places to check up on treatment adherence.The problem is that the data that's gathered using EAM is only downloaded when patients visit the clinics, so sustained therapy interruptions and/or ongoing intermittent adherence can only be checked retrospectively. This means that rebound of HIV may already have occurred by the time the data is reviewed and compliance issues are noticed.

Real-time EAM was developed to detect treatment interruptions and missed doses immediately, which means that reminders can be sent electronically to patients instantly and/or more intensive compliance support is initiated faster.

Researchers in Uganda therefore wanted to investigate whether there was an association between changing over from standard to real-time EAM and increased compliance to HIV treatment, and if there was a sustained increase over six months and if real-time EAM decreased the number of home visits to check for sustained, 48 hour or more treatment interruptions.

The study

An analysis was conducted by researchers on 112 cohort participants, and was an observational design, that involved standard electronic adherence monitoring (EAM), where information regarding the date and time pill containers were opened was stored for later download to a computer. This was then followed by real-time EAM, where information regarding the opening of medicine containers was transmitted instantly via wireless networks, and home visits. These were done on patients who had sustained adherence interruptions of at least 48 hours.

The test subjects' average age was 36 years, of which 82% were literate and nearly 70% were female. The average CD4 count of the patients, before starting HIV treatment, was just over 140 cells/mm3.

The findings

The analysis of the data yielded the following findings:

• Immediately after switching from standard to real-time EAM, the treatment adherence of the participants increased from 84% to 93%, and remained this way for 6 months.
• Real-time EAM plus home visits for sustained interruptions, as compared to the standard EAM, was not only linked to an increase in therapy adherence but also a decrease in therapy interruptions from 2,2 to 0,7.

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• Increased therapy adherence and decreased interruptions in treatment are both associated with viral suppression and decreased immune system activation, but real-time EAM didn't increase the rate of suppressing the virus. This was thought to be because the overall high therapy compliance decreased the ability to demonstrate a difference in suppressing the virus between these monitoring periods.
• In another 255 patients who were reviewed and only had real-time EAM, the compliance level was nearly the same to those patients who changed from standard to real-time EAM (92% and 93%, respectively). However, the incidence of 48-hour or more interruptions in treatment was higher for patients with real-time EAM than those who had switched.

The clinical significance

The review of the data demonstrated that real-time EAM is a promising approach for improving therapy compliance in patients using ART for HIV infections. 

Human Immunodeficiency Virus 

Human Immunodeficiency Virus, or HIV, is a Retrovirus that damages patients' immune systems and, therefore, interferes with the body's ability to fight microorganisms that cause other infections and diseases.

HIV is a sexually transmitted infection, but can also be transmitted from mother to child or by contact with infected blood. It can take a long time, up to years, before HIV weakens the immune system to a level where the affected person develops AIDS (Acquired Immunodeficiency Syndrome), which is defined as a CD4 count of below 200 or being diagnosed with an AIDS-defining condition.

Symptoms

HIV develops flu-like symptoms within a month or two after the virus enters the body of the affected individual. Known as acute or primary HIV infection, this condition may persist with symptoms for a few weeks. These possible symptoms and signs include:

• Fever.
• Muscle and joint aches and pains.
• Headache.
• Sore throat.
• Swollen lymph glands that mainly affect the neck.
• Rash.

Symptoms of primary HIV infection can be mild enough to go unnoticed, but the amount of virus in the bloodstream (known as the viral load) is actually high at this time. Due to this, HIV infection can end up spreading more efficiently during the primary infection than during the chronic phase.

As the virus continues to spread and destroy the immune cells (called CD4), the patient can begin to develop mild infections or chronic signs and symptoms that may include:

• Fatigue.
• Generalized swelling of the lymph nodes.
• Weight loss.
• Diarrhoea.
• Herpes-zoster infection (shingles).
• Oral thrush (fungal infection).

Complications

Patients who don't receive treatment, or who are not compliant with their therapies, for HIV infection may end up developing AIDS at around 10 or so years after the initial infection. By this time, the patient's immune system has been damaged to the point where they are prone to developing opportunistic infections, which are illnesses that don't usually cause issues in people with normal functioning and healthy immune systems.

The symptoms and signs of some of these infections may include:

• Persistently recurring fevers.
• Chronic, excessive and soaking night sweats.
• Unexplained and persistent fatigue.
• Chronic diarrhoea.
• Major weight loss.
• Persistent lesions or white spots on the tongue or in the mouth.
• Skin bumps or rashes.

AIDS-defining conditions, as mentioned above, include the following:

• Candidiasis of the trachea, bronchi or lungs.
• Oesophageal candidiasis.
• Extrapulmonary cryptococcosis.
• Coccidioidomycosis.
• Cytomegalovirus retinitis causing loss of vision.
• Cytomegalovirus disease (other than in the lymph nodes, spleen or liver).
• HIV related encephalopathy.
• Chronic intestinal cryptosporidiosis.
• Histoplasmosis.
• Herpes simplex associated chronic ulcers or causing bronchitis, pneumonitis or oesophagitis.
• Kaposi's sarcoma.
• Chronic intestinal isosporiasis.
• Immunoblastic lymphoma. 
• Burkitt's lymphoma.
• Primary lymphoma of the brain.
• Mycobacterium kansasii or Mycobacterium avium complex.
• Pneumocystis jirovecii pneumonia (formerly Pneumocystis carinii).
• Disseminated or extrapulmonary tuberculosis.
• Progressive multifocal leukoencephalopathy.
• Toxoplasmosis of the brain.
• Recurrent Salmonella septicaemia.
• Wasting syndrome due to HIV.

Conditions that were included in 1993

• Recurrent episodes of pneumonia.
• Invasive cervical cancer.
• Tuberculosis in any areas of the lungs.

In children under 13 years

The following are also included in these patients.

• Multiple or recurrent bacterial infections.
• Pulmonary lymphoid hyperplasia complex or lymphoid interstitial pneumonia.