Los instrumentos de gestión educativa en donde se evidencia la gestión en

The Instrument: A structured questionnaire was developed by the researcher based on literature from other studies and on certain socio -cultural factors peculiar to the study area.

19,60,61,64 (See appendix 2) It was an interviewer administered questionnaire with four (4) sections.

Section A-Socio-demographic Characteristics of patients

This section contained the socio-demographic and socio-economic characteristics of the respondents which were age, sex, marital status, income level and occupation and educational level completed.

Section B- Clinical Determinations.

Information contained in this section was partly determined by the researcher and research assistants and some were obtained from patients’ case notes. They were clinical ( biochemical, haematological and anthropometric) variables namely baseline CD4 count determined using the flow cytometer with heparinised sample ¹⁶⁶, baseline packed cell volume (PCV) determined using centrifugal method with heparinized saline ¹⁶⁷ ,baseline urea determined using the Berthelot method¹⁶⁸ ,baseline creatinine values determined by the kinetic Jafase method ¹⁶⁹, baseline total lymphocyte counts(TLC) with EDTA sample determined with the haematological analyser ¹⁷⁰, baseline hepatitis B and C status determined using chromatographic strip method ¹⁷¹ , baseline tuberculosis status determined

32 using the sputum Acid Fast Bacilli test x3 and clinical assessment, types of first-line anti-retroviral regimen and the initial WHO clinical staging at commencement of HAART.

The pre-treatment weight, height, body mass index (baseline anthropometric variables) were determined by the researcher and assistants.

Section C: HIV Care and Support Variables

The third part of the questionnaire, section C, contained information on HIV Care and Support activities which the patient benefitted from namely: availability of free condom distribution services by the treatment partners to the clients and the use of the condoms by the clients, availability of free insecticide treated bed nets to clients and use of the nets by clients, availability of free water treatment chemical and water storage cans to the clients and the regular use of these to treat and store their drinking water, availability of free health education/counselling activities to clients, availability of home based care services in the centres, visit by members of the home based health team to clients, phone calls by members of the home based health team to clients, availability of support groups in the centres and attendance of client of support group activities, adherence of clients to medications and provision of free foods/supplements to patients.

Section D. Determinations of Variables at 6 months

The fourth part section D, contained information on CD4 cell count and weight measured by the researcher and research assistants at 6 months (end of study). Weight was also measured at each monthly visit. Care and support variables initiated at baseline were equally assessed at 6 months. The different respondents were identified using their unique clinic numbers.

33 3.7a Definition and Measurement of Key Variables

Socio-economic Data: Income Level- Estimated monthly income was calculated by adding the respondent's income from all declared sources ranging from no income to<10,000,

>10,000-40,000, >40,000-70,000,>70,000-100,000, and above >100,000 naira ¹⁷²

Occupation-There has not been a consensus on various socio-economic classifications in Nigeria because of the unstructured nature of the society. Therefore, for the purpose of this study, a modified classification from Oyedeji et al to reflect the local scenario was used and patients were classified into the following groups: Professionals/Civil servants, traders, artisans, chief executive/political office holder, Students and apprentices, farmers, and unemployed.¹⁷²

Anthropometric characteristics: These were determined by the researcher at enrolment.

Weight: A digital (electronic) weighing scale validated with a known standard weight was used to measure the weight to the nearest 0.5 kg. The weight was measured with the subject wearing light clothes, barefooted, and looking straight ahead. The subjects stood without any support, with the weight distributed evenly over the centre of the weighing scale.¹⁷³ Baseline weight was the average of two weight measurements taken before the commencement of HAART. Thereafter, weights were monitored during each monthly visit for drug pick up and at 6 month visit. The difference between baseline weight and 6 month weight was determined.

Height: The height of clients at baseline was measured to the nearest 0.1cm using a

stadiometer by the researcher and the trained research assistants. Standard procedures were observed during height measurements.¹⁷³

34 Body Mass Index: The body mass index (BMI) was calculated as the weight in kilograms divided by the squared height in metres (kg/m²) .¹⁷³ The nutritional status was defined as severe malnutrition if BMI <15.9kg/m ², moderate malnutrition if BMI lies between 16-16.9kg/m², mild malnutrition (BMI between 17-18.4kg/m ²),normal (BMI 18.5-24.9) and overweight (BMI >30Kg/ m²) ¹⁷⁴

Anthropometric measurements was used as a proxy for nutritional assessments and was obtained for each study subject following WHO guidelines.¹⁷⁴

Biochemical parameters:

CD4 cell count: The baseline CD4 cell count in the study is defined as the pre-HAART CD4 cell count. CD4 cell count measurement was repeated 6 months after HAART initiation and was regarded as the end point CD4 cell count in the study. The CD4 cell count was determined using a flow cytometer. Standard precautions was observed while taking the measurements.¹⁶⁶ Early immunological response was defined as Patients who achieve a gain in CD4 cell count of > 50 cells at 6 months on HAART. Immune non- response were patients who did not achieve up to 50 cells of CD4 cell count at 6months on HAART. The mean increase in CD4 cell count and the rate of immunological success (an increase in CD4 cell count of > 50 cells /ul over the baseline value) after commencing HAART was measured.

Care and Support Variables: These were obtained from patients at enrolment

HAART was defined according to the 1997 Department of Health and Human Services guidelines¹.Patients were initiated on first line regimen according to the treatment guidelines All patients were followed up for 6 months. This included monthly visit for clinical observation, treatment of minor illnesses, adherence evaluation, health education and drug pick up by the researcher and trained research assistants which included the patients’

35 physicians. Patients were allowed to return to see the researcher and their physicians without prior appointment for any problem occurring between scheduled visits.

The response to therapy was assessed by changes in CD4 cell counts and weight from baseline. The baseline socio-demographic, clinical and Care and support factors that predicted achievement of early immune response were determined.

Blood collection, Storage and processing: Venous blood was collected by the researcher and trained research assistants in vacutainer tubes and divided in two parts: one part into EDTA tubes for haematological and immunological investigations, and the other into plain tubes to separate serum for urea and creatinine¹⁷⁵. The different tests were done in each of the standard laboratories in the treatment centres. In some facilities where some of the investigations could not be done, patients were referred to the next treatment centre with facilities to perform the test and results were obtained. Biochemical determinations were done by the researcher with the guidance of Chief laboratory scientists at each of the centres.

Storage of samples was done according to recommended laboratory guidelines for each of the test.¹⁶⁶ Standard precautions were observed while taking the measurements involving any body fluids.

Pre testing and Validation of Instruments

The questionnaires were pre-tested at the ART clinic at the General Hospital, Calabar, Cross River State to ensure the validity and reliability of the instrument.

Training of Research Assistants

Eleven research assistants (one from each treatment centre) were recruited. They were rigorously trained at the public health laboratory, Community Health Department of the University of Uyo Teaching Hospital Uyo for one day by the researcher on the sampling

36 method, the administration of the questionnaires, taking anthropometric measurements and collection and storage of blood samples. They were graduate students in health related fields (nurses, laboratory scientist including the patient’s physicians).

Statistical Analysis

The data collected was cleaned and entered into the computer for analysis using the Stata 10 statistical software.

Step 1: Descriptive analysis was done on Socio-demographic and clinical characteristics of patients. Categorical variables were reported as percentages and proportions. For biological variables which were normally distributed continuous data, mean and standard deviation was calculated. For continuous data were not normally distributed, median and inter-quartile range was reported. Chi square test was used to test for associations between categorical variables at baseline and student’s t test was used to test for the difference between two mean values.

Step 2: A binary variable was created to show the early immunological response of patients