Participants workbook

Republic of Kenya Ministry of Health

Antiretroviral Drug Therapy in Kenya

The ART/HMIS

Training Materials (Participant’s Workbook)

National AIDS and STI Control Programme (NASCOP)

August 2006

ART/HMIS Materials - Participant=s Workbook i

Table of Contents Table of Contents............................................................................................................i Module VI: Data Collection...........................................................................................1

Part 1: Completing the Comprehensive Care Clinic Patient Card.............................1 Instructions: Exercise 6-1 ................................................................................1

Module VI: Data Collection.........................................................................................10 Part 2: Completing the Pre-ART Register ...............................................................10 Instructions: Exercise 6-2 ............................................................10

Module VI: Data Collection.........................................................................................13 Part 3: Completing the ART Register......................................................................13 Instructions: Exercise 6-3 ...............................................................................13

Module VII: Aggregation and Reporting.....................................................................17 Part 1: Completing the Comprehensive Care Clinic Monthly Summary Sheet.......17 Instructions: Exercise 7-1 .........................................................................17

Module VII: Aggregation and Reporting.....................................................................25 Part 2: Completing the Comprehensive Care Clinic Cohort Summary Sheet .........25 Instructions: Exercise 7-2 ............................................................25

Module VIII: ART Programme Measures ...................................................................29 Calculating ART Indicators/Measures.....................................................................29 Understanding HIV/Care and ART Indicators ........................................................29 Instructions: Exercise 8-1 ......................................................................29

ART/HMIS Materials - Participant=s Workbook 1

Module VI: Data Collection Part 1: Completing the Comprehensive Care Clinic Patient Card Instructions:

Exercise 6-1 1. Read carefully, the two case studies provided below. Case No. 1: Clara Twaha Nzomo

On 22/09/2005, a patient by the name of Clara Nzomo, reports to Kenyatta National Hospital Comprehensive Care Clinic (CCC). She provided the following particulars to clinic staff: Date of birth: 16/09/1970, Address: Plot 142 Market Road, Nairobi, Near the Catholic Church. Her telephone number is +254000000000. She reported that she was a business woman and had no husband. She was divorced the previous year. She came coming walking by herself and was in the company of Mrs. P. Njuguma, her sister who is also her treatment supporter (they live together). The patient had undergone VCT at Kenyatta National Hospital VCT Centre, on 14/09/2005 and her HIV test was reactive.

The VCT counsellor then referred her to the CCC for further services. At the CCC; she was attended to by Dr. K. Otieno. The following clinical presentations were recorded: Weight: 58 kg, Temp: 36.9 oC, BP: 130/60. The patient presented a history of Bacterial Pneumonia and Oral Thrush. She had also experienced fatigue, fever, weakness, weight loss, productive cough, nausea/vomiting, headache, abdominal pain and thrush in the last month.

She had never taken ARVs before for either HIV/AIDS or PMTCT, nor was she on any other medication. She was ignorant of having any allergies.

Because she had severe bacterial infections, candidiasis and had lost more than 10% weight, she was classified under WHO stage 3. On the same day (22/09/2005) the doctor ordered the following investigations: Hemoglobin, Full Blood Count, RPR, Liver Function Test, Creatinine, Pregnancy Test, RBS, Chest X-ray and CD4 count.


The patient’s CD4 count was 170 and was declared medically eligible for ART on 22/09/2005. She was ready to commence ART on 23/09/2005 and was put on the 1st line (AZT-3TC-NVP) on the same day. Her Unique Patient Number was 10100100001 and was put on CTX prophylaxis for two weeks.

The following is a summary of the patient’s subsequent visits:

Date Weight (kg) WHO stage 23/10/2005 59 3 She indicated she was not on any FP method. Her Hb was 10 and she was given an appointment on the 22nd of November, 2005. Date Weight (kg) WHO stage 22/11/2005 61 3

On this date she reported that she had diarhhoea in the last week before coming to the clinic. Her Hb had risen to 11 and her CD4 was now 198. She was still on the same drug regimen.

Case No. 2: Brenda Wekesa Kamau

Brenda Kamau works as a nurse at one of the health centres in town and is married with 4 children. She was born on 4/05/1964. Besides Brenda Kamau, her husband, John M. Kamau, has two other wives. Her address is Flat 555.10B, Maseno University Road, Kisumu. On 12/09/2005 she reported to the CCC at Kisumu District Hospital.

Earlier before coming to the CCC she had been attending a TB clinic within the same hospital and it was from here that she was referred to the CCC. She has the following medical history on her Out-patient file/referral documents: • She was confirmed HIV positive on 10/11/2004

at Kibera Community Health Clinic. • Diagnosed with TB in January 2005; Herpes

Zoster in 2004, On this visit, she recorded the following parameters: weight: 47kg; Pulse 75/m; BP 130/72 She reported the following problems in the previous month: fever, fatigue, weakness and weight loss, non-productive


cough, nausea, headache, numbness and pain in the legs and feet,

She had never taken ARVs before and was not on any medication. She also reported that she was not aware of having any known allergies. Upon assessment, it was discovered that she has severe bacterial infections, candidiasis, and so her WHO clinical stage is 3. She completed her TB Rx on 12/9/05 and was cured. The clinician (Dr. C. Kiprop) ordered the following tests: Hemoglobin, FBC, RPR, Liver Function Test, Creatinine, Sputum, Pregnancy Test, Chest X-ray and CD4 count.

Her second visit to the CCC was on 19/09/2005, she got her CD4 count result of 84 and was declared medically eligible for ART, She weighed 47kg at this visit. She was started on ART on the same day. Her original 1st line was d4t(40)-3TC-NVP. She was allocated the unique patient number as 60200200003. Her treatment supporter was her husband, who was also in care.

On her next visit, Brenda missed her appointment by two days. She came to the clinic on 5/10/2005. She reported having developed a cough and fever in the last 2 weeks and had night sweats and poor appetite but upon weighing her, the weight had increased to 54 kg and her Hb was 9.4.The client showed good adherence to treatment and had no signs of TB. She continues on her original 1st line combination.

2. Locate the blank Comprehensive Care Clinic Patient Cards, provided on pages

4-9 of this workbook 3. Fill out the information about all the visits made to the clinic so far. 4. Is there missing information in the cases that you needed to have to complete

the Care Cards 5. Did you remain with some redundant information from the cases that you

could not find a place for on the card Note: For additional details on completing the Care Card, you may refer to section 2.2.1 of the ART/HMIS Procedures Manual.


Module VI: Data Collection Part 2: Completing the Pre-ART Register Instructions: Exercise 6-2 1. Locate the two Comprehensive Care Clinic Patient Card(s), completed in Part 1 of this

module and a blank Pre-ART Register located on pages 11 and 12 of this Workbook. 2. You may read again the two cases in Part 1 to clarify those issues you may not be sure of. 3. Transfer all necessary information to the appropriate columns in the Pre-ART Register 4. Prepare to discuss the following questions during plenary Note: For additional details on completing the Pre ART Register, you may refer to section 2.2.2 of the ART/HMIS Procedures Manual. • Is there missing information on the cards that you needed to have to complete the Pre

ART Register • Did you remain with some data from the cases that you could not find a place for on

the card?


Module VI: Data Collection Part 3: Completing the ART Register Instructions: Exercise 6-3 1. Locate the following documents:

a. The two Comprehensive Care Clinic Patient Card(s), completed in Part 1 of this

module b. The Pre-ART Register completed in Part 2 of this module and; c. A blank ART Register on pages 14-16 of this workbook.

2. Update the ART register using data from the Care Cards. Tip: Patient records are only transferable to the ART register upon commencement of

ART. There after, each patient record in the ART register is updated monthly.

3. Prepare to discuss the following questions during plenary Note: For additional details on completing the ART Register, you may refer to section 2.2.3 of the ART/HMIS Procedures Manual. Use the space provided below each question to write the answer. Use pencil as you may need to alter your answers during plenary. • When did the patients start ART? • What were the clinic stages of the patient on those dates? • What does the month/year mean at the top of each page of the ART register? • What missing information do you need to know? • Did you remain with some data from the cases that you could not find a place for on

the card?


Module VII: Aggregation and Reporting Part 1: Completing the Comprehensive Care Clinic Monthly Summary Sheet Instructions: Exercise 7-1 1. Locate the pre-populated pre-ART and ART register pages on pages 20-21 and 22-23,

respectively. You will also find the blank Comprehensive Care Clinic Monthly Summary Sheet on page 24 of this workbook.

2. To complete the blank Comprehensive Care Clinic Monthly Summary Sheet, you are

going to use the pre-populated pre-ART and ART register inserts on pages 20-23 of this workbook.

3. Assume that you are a staff member of Port Reitz District Hospital (Code 304-002) in

Mombasa of Coast Province owned by the GOK, and from the your previous month’s report, you have the following details:-

a. The cumulative numbers of persons ever enrolled in HIV care at this facility were:

Males (0-14 years): 23

Females (0-14 years): 15 Males (> 14 years): 42 Females (> 14 years): 63 b. The cumulative numbers of persons ever started on ART at this facility were: Males (0-14 years): 17 Females (0-14 years): 13 Males (> 14 years): 33 Females (> 14 years): 45 c. The cumulative numbers of persons currently on PEP Prophylaxis at this facility,

from the previous month were: Sexual assault Males (0-14 years): 1 Females (0-14 years): 12 Males (> 14 years): 0 Females (> 14 years): 23 Occupational exposure Males (> 14 years): 18 Females (> 14 years): 24


Others Males (0-14 years): 0 Females (0-14 years): 0 Males (> 14 years): 4 Females (> 14 years): 5 d. The cumulative numbers of persons currently on Cotrimoxazole and Fluconazole

Prophylaxis at this facility, from the previous month were: Cotrimoxazole: Males (0-14 years): 8 Females (0-14 years): 11 Males (> 14 years): 10 Females (> 14 years): 34 Fluconazole Males (0-14 years): 0 Females (0-14 years): 0 Males (> 14 years): 24 Females (> 14 years): 25

4. Using the pre-populated Pre-ART Register, complete the following measures on the Monthly Summary Sheet:

a. No of new patients enrolled within the month for HIV care by entry point. b. Cumulative no. of persons ever enrolled in HIV care at this facility by end of this

month c. No. of persons enrolled and eligible for ART but not yet started on ART (assume

all patients who became eligible before April 2006 have been commenced on ART).

d. Total no. of patients enrolled on post exposure prophylaxis(PEP) this month 5. Using the pre-populated ART Register, complete the following measures on the

Monthly Summary Sheet:

a. Number of patients Starting ART within the month by WHO Stage b. Cumulative number of persons ever started on ART at this facility at the end of

the month c. Assuming that all the patients ever started on ART were still active as at end of

March, find the total number of patients currently on ARVs by the end of April. 6. Using both registers complete the number of persons started currently on prophylaxis this

month.


7. Prepare to discuss the following questions during plenary Use the spaces provided below each question to write the answer. Use pencil as you may need to alter your answers during plenary. • How do you find the number of patients who are enrolled and eligible for ART but

have not been started on ART? • How do you find the number of patients who are currently on ARVs? • How do you find the number of patients who are currently on post exposure

prophylaxis (PEP)? • How do you find the number of patients on Cotrimoxaxole or Fluconazole?


Module VII: Aggregation and Reporting Part 2: Completing the Comprehensive Care Clinic Cohort Summary Sheet Instructions: Exercise 7-2 1. Locate the pre-populated ART register insert on pages 22-23 and the blank

Comprehensive Care Clinic Cohort Summary Sheets on pages 27-28. 2. Using the ART register provided on pages 22-23, fill in the following parts of the register

before moving on to completing the Cohort Summary Sheet.

a. In the top left corner of the third page fill in the Cohort ID, Month and Year b. Using the answer in (a), above the label “month 0” in column (x), write the

calendar month in which this cohort is in month 0. Similarly, do so for columns (y) through (ap) for months 1 through month 12 respectively.

3. Before proceeding to answering questions 4 onwards, through the facilitator, ensure that

you have reached consensus with your fellow participants. Resolve the questions in box below:

• What cohort is this? • What month is “month 0”? • In what month will these patients be 6 months old? • In what month will these patients be 12 months old?

4. Turn to the blank Cohort Summary Sheet located on pages 27-28. Assume that you are a

staff member of Port Reitz District Hospital (Code 304-002) in Mombasa of Coast Province owned by the GOK.

5. Using the answer to the question “What cohort is this?” in 3 above, examine the grey

shaded columns on the cohort Summary Sheet. To the right of the cohort you will have picked, you will notice the corresponding cohort months for 6 months, 12 months and 24 months.

Note: This exercise does not cover 24 months; the column for 24 months will

therefore not be used.


6. Against the cohort selected in 5 above, starting with month 0 (grey shading), count from

the sample register provided to complete each respective time block for (G, TI, TO, N, H, I, J, Stopped, Died and Drop) on the monthly cohort summary sheet provided on pages 27-28.

7. Using the formula provided ((H + I + J)/N * 100), calculate the Percentage of Cohort

Alive and on ART :

a. At 6 months b. At 12 months

8. What proportion of the patients has CD4 median or fraction ≥ 200 [of those with available CD4]?

9. What is the number of persons who picked up ARVs each month for 6, 12 months?

• Demonstrate step by step how you calculated the median • Explain how you were able to pick the number of patients who consistently

picked drugs for 6 and 12 months?


Module VIII: ART Programme Measures The main goal for the ART programme is to increase accessibility to antiretroviral therapy with a view of prolonging the lives of the patients infected with HIV. This is measured through the data that is collected in the registers and reports encountered earlier. These measures provide important information on what is going on at the facility, the district and the national level. Calculating ART Indicators/Measures Understanding HIV/Care and ART Indicators Instructions: Exercise 8-1 1. Indicators are expressed in many formats. They can be absolute numbers, rates, ratios or

proportions. Both the Monthly and Cohort Summary Sheets contain some important indicators. Using the box below, from each form identify what you may call important indicators?

• From the Monthly Summary Sheet?

• From the Cohort Summary Sheet?

• Are there any measures or counts that you have removed from the “indicators” family by not including them in answers above.

In discussing question 1 above, you may have noticed that certain data elements only qualify to be called indicators if used in combination with other data elements. Indicators to measure an ART programme, include those that target individual patients and those the focus on the programme as whole. Below is a short description of these categories and the indicators that may fall under each of them.


Access to HIV Care or ART The following indicators relate to patients accessing HIV care or ART.

a. Number enrolled in HIV care b. Number started on ART c. Number currently on ART d. Number, Proportion of persons who are enrolled and eligible for ART but have

not been started on ART. e. Number, proportion of patients on both TB treatment and ART. f. Percentage of those eligible for ART in the clinic who has been started on ART.

ART Programme Success The following indicators measure ART Programme Success.

a. Survival at 6, 12, 24, 36 months etc after initiation of ART. b. Continuation on first-line ARV regimen at 12 and 24 months after initiating

treatment. c. Proportion of CD4 counts done which are ≥ 200 at 6 and at 12 months on ART.

HIV Drug Resistance Early Warning The following indicators may provide a flag for potential or apparent resistance towards a specific line of drugs (mostly first line) or towards a given combination in given family of drugs. It is desired that as long as it takes, patients should remain on the original 1st line drug. Below are some indicators that may point to drug resistance.

a. Percentage of patients who started ART 6 or 12 months ago who picked up ARV medications 6/6 or 12/12 months.

b. Percentage of patients whose adherence to ART is satisfactory.


Calculating HIV Care/ART Indicators Instructions: Exercise 9-2 1. Locate the completed monthly summary sheet on pages 31 of this workbook. 2. Calculate the following indicators using the information provided item 1 above. At

the end of each calculation, explain the meaning the indicator.

a. Percentage contribution of patients registered at Pre-ART through VCT Numerator: Total number entering through VCT Denominator: Total enrolled

Meaning:

b. Number of patients enrolled in the Pre-ART during this period who were

medically eligible for ART but not commenced on ART

Numerator: Total enrolled in care this month and were eligible before the end of the month but could not be commenced on ART

Meaning:

c. Percentage of expected patients ever enrolled onto the ART programme.

Note: Assume that the target for this facility is 500 patients on ART by end the year.

.


Meaning:

d. Number of patients enrolled on 1st line drug regimens by age and sex

Numerator: Number of patients commenced on the first line drug regimens

in this facility, distributed by age and sex.

Meaning: 3. Locate the completed cohort summary sheet on page 32 of this workbook. Assume

that the reporting facility was opened as CCC in January 2005 and you are provided with the CC summary sheet completed at the end of January 2006. Calculate the following:

a. Percentage of patients ALIVE and on ART after 6 months on therapy (January2005 cohort only)

Numerator: The number of patients on ART (6mths) Denominators: The number of patients who started ART 6 months ago

Meaning:

b. Proportion of patients still prescribed a 1st Line Regimen, 12 months after initiating ART

Numerator: Number of people still on 1st line drugs 12 months after starting Denominator: Number of people alive and on ART at 12 months

Meaning:


c. Proportion of patients still on ORIGINAL 1st Line Regimen, 12 months after initiating ART.

Numerator: Number of patients still on original regimen Denominator: Number of patients on ART

Meaning:

d. Proportion of patients who have SUBSTITUTED to an alternative 1st Line

Regimen after 12 months of initiating therapy.

Numerator: Patients who SUBSTITUTED to alternative 1st line ARV. Denominator: Number of patients on ART

Meaning:

e. Proportion of patients who SWITCHED to a 2nd Line (or higher) Regimen after 12 months of initiating therapy.

Numerator: Patients who switched to 2nd line ARV during quarter Denominator: Number of patients on ART

Meaning:

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Participants workbook