East Bay HIV/STI Case Management Manual

Author: Dr. Sami Lubega

Treatment for HIV is called antiretroviral therapy (ART). ART involves taking a combination of HIV medicines (called an HIV treatment regimen), either through daily pills, regular injections, or a combination of both. 

ART is recommended for everyone who has HIV. People with HIV get the most benefit from ART when they take it as soon as possible after they are diagnosed. ART can’t cure HIV, but HIV medicines help people with HIV live longer and healthier lives and prevent transmission to others. 

How meds work/HIV life cycle

HIV attacks and destroys the infection-fighting CD4 cells (CD4 T lymphocyte) of the immune system. Loss of CD4 cells makes it hard for the body to fight off infections and certain HIV-related cancers. 

HIV medicines prevent HIV from multiplying (making copies of itself), which reduces the amount of HIV in the body (called the viral load). Having less HIV in the body gives the immune system a chance to recover and produce more CD4 cells. Even though there is still some HIV in the body, the immune system is strong enough to fight off infections and certain HIV-related cancers.

By lowering the amount of HIV in the body, HIV medicines also reduce the risk of HIV transmission. A main goal of HIV treatment is to reduce a person’s viral load to an undetectable level. An undetectable viral load means that the level of HIV in the blood is too low to be detected by a viral load test. People with HIV who maintain an undetectable viral load have no risk of transmitting HIV to others through sex, and much lower risk of transmission during pregnancy or childbirth. This concept is known as undetectable equals untransmittable, or U=U.

HIV medications lower the amount of HIV in the body by working in combination to stop HIV from multiplying. Currently, a full regimen of ART needs at least two or more medications to be fully effective. These medications work at different parts of the HIV life cycle to stop the virus from multiplying in the body. When at least two parts of the HIV life cycle are effectively stopped by medications, the viral load in the body is suppressed and can reach undetectable levels in the blood. 

How soon should a person start treatment after testing positive for HIV?

As care teams, our goal is for a patient to start taking HIV medicines as soon as possible after being diagnosed with HIV, sometimes even before they see an HIV provider. 

Treatment with HIV medicines as soon as possible after diagnosis is known as rapid ART and is recommended for everyone with a new HIV diagnosis. This is because studies have found that people have fewer health complications when they start ART as soon as possible. Studies have also found that people prefer to be offered treatment right away, rather than waiting until after their first set of medical appointments with an HIV provider. 

Even if someone does not start ART immediately, getting on medications when they are ready (or getting back on medications after being off of them) helps people with HIV live longer, healthier lives. 

Medication classes

There are many HIV medicines available for ART regimens. The HIV medicines are grouped into seven drug classes according to which stage of the viral life cycle they interrupt.

The choice of an HIV treatment regimen depends on a person’s individual needs. When choosing an HIV treatment regimen, people with HIV and their healthcare providers consider many factors, including the individual’s preferences, other medical conditions, and potential drug interactions between HIV medications and their current medications.

For a detailed list of all FDA-approved medications with pictures, click here: https://www.hiv.uw.edu/page/treatment/drugs 

Medication Adherence

For people with HIV, treatment adherence means:

• Starting HIV treatment
• Taking HIV medicines as prescribed (also called medication adherence)
• Attending medical appointments

Adherence to treatment is a key part of staying healthy with HIV.

Why is medication adherence important?

Because HIV requires lifelong treatment, it is important for people with HIV to regularly take HIV medicines and get lab monitoring to make sure their treatment regimen is keeping the virus under control. During regular medical appointments, healthcare teams can also recommend resources to help people deal with any issues that may interfere with medication adherence. 

Taking HIV medicines every day prevents HIV from multiplying, which lowers the risk that the virus will mutate and produce drug-resistant HIV. Skipping HIV medicines allows HIV to multiply, which raises the risk of drug resistance and HIV treatment failure.

When a person is not taking any HIV treatment regimen, HIV can destroy the immune system. A damaged immune system makes it hard for the body to fight off infections and certain cancers.

Adapted from: https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-treatment-adherence 

Drug resistance and treatment failure

What is HIV drug resistance?

Once HIV enters the body, the virus begins to multiply. As HIV multiplies, it sometimes changes form (mutates). Some HIV mutations that develop while a person is taking HIV medicines can lead to drug-resistant HIV.

Once drug resistance develops, certain HIV medicines that previously controlled the person’s HIV are no longer effective. In other words, those HIV medicines cannot prevent the drug-resistant HIV from multiplying. Drug resistance can cause HIV treatment to fail.

Drug-resistant forms of HIV can also spread from person to person (called transmitted resistance). People with transmitted resistance have HIV that is resistant to one or more HIV medicines even before they start HIV treatment.

Even if someone has some HIV drug resistance, HIV providers can usually find a new regimen that can control their HIV, but it may involve more pills or injections than non-drug-resistant forms of HIV.

What is drug-resistance testing?

Drug-resistance testing identifies any HIV medicines that will not be effective against a person’s HIV. Drug-resistance testing is done using a sample of blood. Drug-resistance test results help determine which HIV medicines to include in a person’s HIV treatment regimen.

Someone newly diagnosed with HIV may start ART without drug-resistance testing. This is because newer HIV medications usually work well to reduce viral load to undetectable quickly. If the viral load doesn’t drop as quickly as expected, then the person may need drug-resistance testing. 

If someone has been on HIV medications in the past and is about to restart treatment, drug-resistance testing might be needed to select medications that will work well for them. This may mean that rapid ART restart is not an option, since the provider needs to wait for the drug resistance test results before prescribing an ART regimen.

Once treatment is started, a viral load test is used to monitor whether the ART regimen is controlling the person’s HIV. If viral load testing shows that their HIV treatment regimen is not effectively suppressing the viral load as expected, drug-resistance testing is repeated. The test results can identify whether drug resistance is the problem and, if so, can be used to select a new HIV treatment regimen.

Treatment failure is when an antiretroviral treatment that is being used is unable to suppress the individual’s viral load. Factors that can contribute to HIV treatment failure include drug resistance or low medication adherence.

Again, even if someone experiences a treatment failure, HIV providers can usually find a new regimen that can control their HIV.

How can a person taking HIV medicines reduce the risk of drug resistance?

Taking HIV medicines the way they are prescribed reduces the risk of drug resistance. Skipping HIV medicines allows HIV to multiply, which increases the risk that the virus will mutate and produce drug-resistant HIV, causing those medicines to no longer work for that person.

When starting HIV treatment, the healthcare team should talk to patients about any issues that can make medication adherence difficult. For example, a busy schedule, lack of a safe place to keep their medications, or fear that someone will see them taking medication can all make it hard to take HIV medicines consistently. 

Once someone starts treatment, they can work with their healthcare team to find strategies to help them take their pills daily (like a pill case, medication locker, unlabelled pill bottle, phone reminder, etc.). 

Adherence is also important with injectable medications: Getting HIV medication injections on time every time is critical for those medications continuing to work. If someone will be late to get their injection or misses their injection by more than a week or two, they may need to take a pill form of HIV treatment to protect them from developing drug resistance until they can get back to their regular injections. 

If someone does develop drug resistance to one or more of their injectable medications, they may not have as many medication options available in the future. This means they may not be able to stay on injectable HIV medications of any kind, they may not be able to go back to their previous medications, and they may not have a one-pill, once-a-day option that will work for their HIV. They may have to take more than one pill every day, take pills multiple times per day, or take a combination of pills and injections instead to overcome drug resistance. 

Adapted from: https://hivinfo.nih.gov/understanding-hiv/fact-sheets/drug-resistance 

Side effects

As with most medications, HIV medicines can sometimes cause side effects. Most side effects from HIV medicines are manageable and will not cause serious problems, but a few can be serious. Overall, the benefits of FDA-approved HIV medicines far outweigh the risk of side effects. In addition, HIV medicines have been improved over the years to cause fewer side effects, making people less likely to have side effects from HIV medicines.

If someone is starting HIV medicines or if they are starting a new HIV medicine, they should discuss the possible side effects of the medication with their healthcare provider. Healthcare providers can work with people to select an HIV treatment regimen based on their individual needs. 

If someone might be experiencing side effects from an HIV medicine, help them to consult with their healthcare provider to discuss this as soon as possible. People should always call their healthcare provider before they stop taking the medicine to make sure there is a plan to keep the virus suppressed by a treatment that will work for them.

Do all HIV medicines cause the same side effects?

Different HIV medicines can cause different side effects. Importantly, different people taking the same HIV medicine may have different side effects. This can be due to differences in people’s health, differences in how medications interact, or differences in how individual bodies respond to different types of medications. 

Some side effects from HIV medicines are very common and may last only a few days or weeks. For example, nausea, fatigue, and sleep problems are some short-term side effects of HIV medicines. Sometimes this is referred to as “start-up” syndrome, and can last for several weeks after starting a new medication.

HIV medicines can also cause other side effects that may not appear for months or years after starting a medicine. For example, high cholesterol—a major risk factor for heart disease—can be a side effect of some HIV medicines. 

Some HIV medications only have a risk of side effects if people develop certain health conditions. In these cases, a medication that had been safe for someone for many years may need to be changed because their health status or other health conditions have changed.

Having another medical condition or taking other medicines can increase the risk of side effects from HIV medicines. In addition, drug-drug interactions between HIV medicines and other medicines can also cause side effects. 

You can use the Clinicalinfo Drug Database to learn more about HIV medicines and their possible side effects. For help using the Drug Database, contact a Clinicalinfo health information specialist by phone (1-800-448-0440) or email (HIVinfo@NIH.gov).

What are some ways to manage side effects from HIV medicines?

Before starting HIV medicines, a person can talk to their healthcare provider about possible side effects. Depending on the HIV medicines in their HIV treatment regimen, their healthcare provider will:

• Tell them which specific side effects to look out for.
• Give them suggestions on how to deal with manageable side effects like nausea and vomiting.
• Tell them about the signs of life-threatening side effects that require immediate medical care, like swelling of the mouth and tongue.

Once someone starts taking HIV medicines, they should tell their healthcare provider about any side effects that they are having. Their healthcare provider can recommend ways to treat or manage side effects.

In some cases, it may be necessary to change HIV medicines to stop a side effect. However, they should NOT cut down on, skip, or stop taking their HIV medicines unless their healthcare provider tells them to. 

In some cases, possible side effects can be avoided by precautionary testing before starting the medication. For example, before starting treatment with the HIV drug abacavir (ABC), the FDA recommends taking a genetic test for hypersensitivity reactions.

Fortunately, there are many HIV medicines available as alternatives to include in an HIV treatment regimen. A person’s individual needs will determine the choice of HIV medicines to replace those causing side effects.

Adapted from: https://hivinfo.nih.gov/understanding-hiv/fact-sheets/hiv-medicines-and-side-effects 

Building adherence

When someone starts HIV medications, talk with them about medication adherence. Talking with your client and their healthcare provider will help your client understand why they are starting HIV treatment and why medication adherence is important.

You can normalize ART by reminding them that: 

• treatment with HIV medicines is recommended for everyone with HIV;
• HIV medicines help people with HIV live longer, healthier lives; and
• Adherence to an HIV treatment regimen reduces the risk of HIV transmission (U=U) and drug resistance. 

How can I support a client starting a new HIV treatment regimen?

If you aren’t already a part of their healthcare provider’s team, consider asking your client to sign a release of information that will allow you to coordinate their care directly with their provider on their behalf when needed. This will allow you to talk directly with the medical team to help with any issues that are coming up. 

Encourage your client to tell their healthcare provider about other prescription and nonprescription medicines, vitamins, nutritional supplements, and herbal products they are taking, plan to take, or hope to take in the future (for example, gender-affirming hormones). Consider making the list together with the patient and providing it to the healthcare provider before or at the medical visit. 

Other medicines or products they take may interact with HIV medicines, so the healthcare provider will need that information to make the safest recommendations to avoid drug interactions. 

Encourage your client to tell their healthcare provider about any issues that might make adherence difficult. For example, people who have difficulty swallowing pills can work with their provider to avoid pills, use the smallest pills possible, or use liquid formulations for certain medications. People who do not have a safe place to keep their medications or a regular place to live can work with their case manager or provider to store medications at the clinic or in medication lockers, or get medications delivered from the pharmacy to their clinic.

Have your client describe their daily schedule to you and their healthcare provider. You and your client can work together to design a plan that fits in with their day-to-day routine, including using phone reminders, getting regular text reminders, using pill cases, and incorporating daily medication doses into other parts of their daily routines. 

Encourage your client to ask their healthcare provider for written instructions on how to follow their HIV treatment regimen. The instructions should include the following details:

• How much of each medicine to take
• When to take each medicine
• How to take each medicine (for example, with or without food)

What strategies can I suggest to help my client to stick to an HIV treatment regimen?

To help your client maintain adherence, work together to try out some of the following strategies:

• Use a 7-day pill box. Once a week, fill the pill box with HIV medicines for the entire week. Have the client bring in medications and demonstrate to the care team how they fill the pill box. 
• Consider asking the pharmacy about an option for bubble-packing medications to better keep track of daily doses.
• Make a plan to take HIV medicines at the same time every day.
• Help them set an alarm on their cell phone to remind them to take their medicines.
• Have them consider asking a family member or friend to remind them to take their medicines.
• Plan and prepare for changes in their daily routine, including weekends and holidays. If they are going away, pack enough medicine to last the entire trip or ask the medical team to help them get an early refill before their trip.
• Use an app or an online or paper medicine diary to record each dose as they take it. Reviewing the diary together will help identify the times that they are most likely to forget to take their medicines.
• Help to provide reminders and set up transportation for all medical appointments and lab appointments, if you are able. 

What should someone do if they forget to take their HIV medicines?

Generally, unless their healthcare provider tells them otherwise, they should take the medicine they missed as soon as they realize they missed it. But if it is almost time for the next dose, they should not take the missed dose; just take their next dose at the usual time. They should not take a double dose of a medicine to make up for a missed dose. Help them to reach out to a member of the medical team if there are any questions about missed doses to confirm a plan. 

Discuss medication adherence at each appointment and check in with your client to ask if they are having difficulty with their treatment regimen. Normalize issues such as forgetting doses, being confused about instructions, or concerns about the number of pills they are prescribed or their side effects by reminding them that these are common issues that case managers can help with. 

Remind them to mention any side effects they are having to their provider, and offer to share a message with their provider about any issues they bring up. Side effects from HIV medicines (or from other medicines that someone is taking) can interfere with medication adherence. 

Let their healthcare provider know if you have concerns about their treatment regimen based on what they share, what you observe, or information that you learn about their life circumstances (for example, losing housing, losing a source of income, experiencing depression, substance use, or any personal life stressors) so that you can work together as a team to explore how it might affect their ability to stay adherent to their HIV medicines. 

People often feel more comfortable sharing these details with their case managers rather than with their healthcare providers directly, or they forget to mention things to their provider because they didn’t have enough time in their medical visit. Case managers can be the critical factor in communicating important information and creating a successful medication plan with a client and their provider. 

Adapted from: https://hivinfo.nih.gov/understanding-hiv/fact-sheets/following-hiv-treatment-regimen-steps-take-and-after-starting-hiv

Takeaways & tips for case managers

To support people who are recently diagnosed in preparing for a first medical visit: https://hivinfo.nih.gov/understanding-hiv/fact-sheets/just-diagnosed-next-steps-after-testing-positive-hiv 

Important links/resources 

For the most up-to-date version of the East Bay Rapid ART protocols, visit this page: https://www.ebgtz.org/rapid/ 

References: 

• https://hivinfo.nih.gov/understanding-hiv/fact-sheets
• https://www.hiv.uw.edu/page/treatment/drugs
• https://targethiv.org/topics