Antiretroviral Therapy (ART): ART Monitoring of Treatment Failure

Learning Objective:

  • Assess monitoring for treatment success according to clinical and immunological criteria

  • Discussion questions/quiz

    Tell your mentee you would like to assess his or her knowledge related to ART monitoring with the following questions. The text in italics are answers and notes for the mentor.

    • An HIV-positive client, Kuda, has been taking ART and coming to your clinic for a couple of years. According to the Zimbabwe guidelines, what type of monitoring should you be doing to assess whether or not his ART is working and how often is this monitoring done?

      If the mentee describes any of these options, you could ask him/her the broader term for each area.
      1. Clinical monitoring (clinical improvement)
        Clinical monitoring is done at every visit. If he is maintaining > 95% adherence his visits can be every 3 months.
      2. Immunological monitoring (CD4 count)
        CD4 count should be done at six-monthly intervals.
      3. Virological monitoring (HIV viral load)
        Due to limited resources, Zimbabwe conducts targeted viral load testing for suspected clinical or immunological failure. This is primarily done by the medical officers.

    • What specifically would you look at when doing clinical monitoring for Kuda?

      [note text]
      Ask whether he:
      • Feels better.
      • Is gaining weight.
      • Is seeing an improvement in symptoms and signs of the original presenting illness.
      Check for infections or symptoms, such as oral thrush, hairy leukoplakia, genital herpes, skin rash, diarrhoea and molluscum contagiosum.
      When the number of CD4s increases, the body's defence will improve. If the body's defence works better, fewer OIs should occur. That is why looking at the clinical status of the client (evaluating the occurrence of OIs) is a good way of evaluating if the therapy is effective.

    • How often do you monitor Kuda’s CD4 count?

      [note text]

      Every 6 months

    • Kuda is frustrated that his CD4 count is improving so slowly. What would you tell him?

      [note text]

      The time it takes to see the number of CD4 cells increase varies from person to person. The number of CD4 may rise by between 100 and 200 in the first year if you have never taken ART before and are taking the drugs with an adherence rate of 95% or more. It depends a lot on where you start: sometimes a lower CD4 when you start ART means it will take longer before the CD4 rises substantially.

    • What would you do if Kuda’s CD4 count persistently declines?

      [note text]

      Persistently declining CD4 counts, as measured on two occasions, at least three to six months apart and a clinical deterioration indicate that he may be experiencing treatment failure. Consult with your clinical mentor or HO or refer to a higher-level facility.

    • What are some ways you can monitor a client’s antiretroviral intake?

      [note text]
      • Pill count
      • Pharmacy refill tracking
      • Client self-reporting although the client may not admit to missed doses

    • Kuda wonders what successful treatment looks like. What do you say in response?

      [note text]

      If therapy reaches its goal (success), the client’s weight should increase and no new OIs would occur. We say a client has treatment failure when a new opportunistic infection develops, or prior opportunistic infections relapse, or symptoms do not disappear over time. Successful treatment is also when the CD4 count rises from baseline and either continues to rise or maintains a consistent level.

    • [activity type]

      Explain to the mentee that you are going to engage in a role play to help him or her conduct clinical monitoring. He or she will play the role of health care provider, and you will be the client.

      Show the mentee the instructions below for the health worker. Then, tap on the box for the client instructions. Do not show this to the mentee.


      The client is a 47-year-old female who started on ART 6 months ago. Her WHO clinical stage was 3 at initiation due to a history of pulmonary TB the year before she tested HIV positive. Her baseline laboratory tests were normal; CD4 count was 170 cells/mm³. Along with cotrimoxazole, she started EFV/3TC/TDF – FDC once daily at bedtime. She had a difficult time with fatigue and dizziness for the first 2 weeks but reported that those side effects slowly went away. Her adherence by self-report has been “good.” However, she has not been bringing back her empty bottles since she reports that she must hide her medication from her husband. She throws out the bottle before she gets home and keeps the pills in a small box in her drawer. She reports not missing any doses of her medication and has come to her appointments on time. Today is her 6-month follow-up appointment and you will be taking blood for a CD4 count as indicated by the Zimbabwe ART guidelines.

      • You are a 47-year-old HIV + woman who has been on ART (TDF-3TC-EFV) for 6 months. You have been feeling good after initially experiencing some dizziness and fatigue. You have not disclosed your HIV status to your husband since he works far away and has not been home in a very long time. You have been seen by several providers the past six months and have mentioned to each of them that you do not want to have more bloodwork done due to the terrible experience you had when you were first diagnosed. Your veins are small and have always been difficult to get a specimen. In fact, the nurse had such a hard time when you first came to clinic that you passed out! You are determined not to have that happen again. You were told that the laboratory test was necessary every 6 months to see if the medication was working but you know it is working! You have talked to other HIV + women and they told you that as long as you take your medication every day, there is no need for all of the blood they take out of you. There is a feeling in the community that the blood is being tested for “other diseases” and used for research. You feel good, you have not missed any doses and you are sure the laboratory test is not needed.

        Check the boxes below to indicate whether the mentee asked the appropriate questions. At the end of the role play, review any problem areas with the mentee.

        Did the mentee

    • [activity type]

      Instructions: Tell your mentee that you will review a case study and ask some questions to help him or her improve skills in immunological monitoring.

      You have been assigned to the HIV clinic covering for the regular nurse who is on annual leave. You review the clinic record for Rejoice, who is a 20-year-old female first seen in the HIV clinic when she was 18 years old. She was clinically well at the time with WHO stage 1 disease, but her CD4 count was 160 cells/mL (13%). You note that her parents have both died (mother in 2009, father in 2010) and shortly after these deaths, she and her 3 younger siblings were moved to their grandmother’s.

      Rejoice presents to the clinic today as a quiet, withdrawn young woman, although she seems to be managing working part-time and attending classes at a local college. She reports that her grandmother frequently shouts at her for staying out late in the evenings, especially when she is out with her much older male “friend.” He has attended clinic with her on the last 2 occasions and waits in the waiting room. Today he appears intoxicated.

      She was started on lamivudine (3TC), tenofovir (TDF), and efavirenz (EFV) = FDC and cotrimoxazole 2 years ago. According to Rejoice, she “takes her medicines without any problems” and adherence was documented as “good” in her record. There were pill counts done intermittently but many times she forgot to bring her bottles. You also note that she has missed appointments in the past but always reports that she “had enough medication.” She has remained clinically well and her weight today is 58kg, height 167cm. Her blood monitoring results are tabulated below:

      July 2013 Dec 2013 June 2014 Dec 2014 June 2015
      CD4 # 160 ND 210 ND 170
      CD4 % 13 - 16 - 13

      She tells you today that she is tired of taking medicine and asks you about stopping the tablet for pneumonia.

      1. Are there any challenges in the management of this case and what interventions can the provider use to address the challenges? Be specific.

      Answers:
      Poor assessment & documentation of adherence
      “Good” does not tell you exactly what her adherence has been. It is subjective (client self-report) vs. objective (pill count) data. Pill counts at each visit would be a more accurate way to assess adherence, and documentation of the percentage of adherence will give the provider a better indicator of poor vs. excellent adherence.

      Missed appointments
      Poor adherence to clinic appointments can be a strong indicator of poor medication adherence. If clients are given a month’s supply of medication, are late for their appointment, and tell the provider that they had “enough medication,” the provider needs to explore this further using open-ended questions and address the barriers clients are experiencing.

      Immunological monitoring
      Rejoice not only missed her clinic appointment but important laboratory monitoring on 2 occasions. The Zimbabwe ART guidelines specifically state clients taking antiretroviral medication should have their CD4 count done at 6 month intervals, especially during the first 2 years after initiation. With successful ART, the CD4 count increases. With this case, the provider should be concerned that the client’s CD4 count and CD4 percentage has not increased as expected. “Stepped-up” adherence counselling and consultation with your clinical mentor or HO is indicated.

      Psychosocial issues

      • Rejoice has experienced loss of her parents and a diagnosis of HIV at a young age. She is also experiencing challenges with living with her grandmother.
      • Her “friend” has come to clinic intoxicated and we are not sure about his HIV status. HIV testing and safer sex counselling is needed.
      • Referral to a counsellor is recommended if available as well as HIV support groups. Risk reduction counselling is also needed for her “friend” to address his alcohol use.

    • [activity type]

      Instructions: Tell your mentee that you will do a pill counting exercise. The mentee should write down on a piece of paper the information necessary to conduct a pill count to calculate adherence.

      A year ago, Kuda started taking ARVs. He is taking:

      • Zidovudine 300mg twice daily
      • Lamivudine 150mg twice daily
      • Efavirenz 600mg daily

      You last saw Kuday a month ago. Today, Kuda has brought all his pill bottles with him. Counting his pills you find:

      • Zidovudine: 10 pills
      • Lamivudine: 5 pills
      • Efavirenz: 0 pills

      What is Kuda’s adherence rate?

      [note text]
      Zidovudine (2 x 30) + Lamivudine (2 x 30) + Efavirenz (1 x 30) = 150 pills
      150-15= 135
      135/150 * 100 = 90 (so 90%)

      if the mentee doesn’t know the calculation, you can show him/her this:

      (Total # of pills provided at previous visit) - (# pills remaining) / (# pills instructed to take daily) x (# days since last visit)
      X 100

      Is Kuda at risk for treatment failure?

      [note text]
      Yes

    • [activity type]

      Discuss the following questions with your mentee.

      Activity

      1. How do you monitor a client’s drug intake? Pill counts? Other?
      2. What are some challenges you’ve experienced with the method you use?
      3. Let’s brainstorm some ways to overcome these challenges.

      Possible answers:
      Pill Count – Forgetting to bring back bottles

      • Write a reminder on their appointment card or on the bottle
      • Suggest that they put the empty bottle in the bag they carry
      • Ask the treatment supporter to remind the client to bring back the bottles
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