EVALUATING STABILIZATION TUBES FOR STORAGE OF CD4 HIV POSITIVE SAMPLES AT KILIFI DISTRICT HOSPITAL, KENYA Nella Raphael Kalama

Introduction HIV/AIDS is a major health concern in many parts of Africa (UNAIDS 2014). 37 million people living with HIV worldwide 2.1 million people have become infected with HIV and 39 million people have died of AIDS-related illnesses. Over 78 million people have been infected with HIV since the start of the epidemic HIV prevalence in Kenya (6%), Coast (7.4%) and Kilifi 4.4%).

Problem statement and justification Monitoring ART in HIV + patients requires assessment of CD4+ T cell count. 2 studies (CD4+ T cell tubes performance) done in the field in Uganda (2006) and Zimbabwe (2014) respectively. The study field condition there was different from those of Kilifi County. VL is the test used for the eligibility of HIV + clients to ART while CD4 is the alternative. Not all facilities have access to VL and VL TAT is longer than CD4 TAT.

Objectives Evaluating CD4 blood samples in stabilization tubes from HIV positive persons at Kilifi District Hospital Kenya 1.To assess the suitability and accuracy of CD4+ T cell samples collected in ST stored at ambient temperature for varying periods of time. 2. To compare CD4+ T cell counts and viral load for HIV positive on ART monitoring. 3.To document the process involved and any challenges in collection, handling, transporting and reporting the CD4+ results.

Null hypothesis CD4+ T cell sample test results are neither stable nor accurate when collected in BD ST before processing and analysis There are no factors affecting collection, storage and transportation of CD4+ T cell blood samples in BD ST

Methodology Study area; KDH and the RHF in Kilifi County Coast region. Study design; sectional, descriptive . Study population; HIV + people on HAART attending RHF in Kilifi Sampling technique; HIV + clients on HAART from respective RHF register. Lab procedure; Venous blood samples from HIV + persons were collected in ST and EDTA tubes. Sample size; determined using the formula of Fisher et al., 2008

Methodology cont’d Data analysis Distribution; ST CD4 counts is similar to EDTA Counts (mean ST 532.47/ EDTA 513.36) respectively. ( no significant difference) Distribution; ST/EDTA CD4 counts verses ST /EDTA VL copies are similar (mean ST 1809/1317 and 1796/1298). No significant difference.

To assess the suitability and accuracy of CD4+ T cell samples collected in ST stored at ambient temperature for varying periods of time at Mtwapa HC Figure; 1. % change in CD4 counts at day 3,5,7 and 8 compared with day 0 P< 0.05, df 198

To assess the suitability and accuracy of CD4+ T cell samples collected in ST stored at ambient temperature for varying periods of time at Vipingo HC Figure.: 2. % change in CD4 counts at day 3,5,7 and 8 compared with day 0 P< 0.05, df 198

To assess the suitability and accuracy of CD4+ T cell samples collected in ST stored at ambient temperature for varying periods of time at Chasimba HC Figure: 3. % change in CD4 counts at day 3,5,7 and 8 compared with day 0 P< 0.05, df 198

To assess the suitability and accuracy of CD4+ T cell samples collected in ST stored at ambient temperature for varying periods of time at Matsangoni HC Figure: 4: % change in CD4 counts at day 3,5,7 and 8 compared with day 0 P< 0.05, df 198

To assess the suitability and accuracy of CD4+ T cell samples collected in ST stored at ambient temperature for varying periods of time at Vitengeni H C Figure: 5. % change in CD4 counts at day 3,5,7 and 8 compared with day 0 P< 0.05, df 198

Summary of 5 facilities Figure: 6. % change in CD4 counts at day 3,5,7 and 8 compared with day 0 P< 0.05, df 198

Results To compare CD4+ T cell counts and viral load for HIV positive on ART monitoring. Mean Std. Deviation CD4 T cells ST mean 532.47 SD 329.468 EDTA 513.36 349.358 VL copies 1809 1317 1796 1298 To compare CD4+ T cell counts and viral load for HIV positive on ART monitoring. Table 1. Mean CD4 count for ST stored samples at ambient temp over time P< 0.05, df 198

Results cont’d To document the process involved and any challenges in collection, handling, transporting and reporting the CD4+ results HIV clients are tested for CD4 count before ART admission and or monitored 6 months. Vacutainer systems used in safe venous collection of blood. Some tubes vacuum is not consumerate with the sample volume. Some samples were degraded and could not read on day zero. Hand mixing was used to mix samples

Conclusions No statistical significance of values in individual facilities noted from day 0, 3 5 7 and 8. Success rate is 96% of the samples analyzed. There was inter facility statistical significance of values due to non uniformity of sample population

Conclusions The sample variations within the days and between facilities is accounts for 10%. 90% of the variation is being caused by other factors 4% was noted as sample degradation No statistical difference on CD4 count and VL copies of ST and EDTA samples

Recommendation Confounding factors should be controlled to maximize use of stabilization tubes. An alternative equipment should be used for comparison A semi automated mixer should be used for proper sample mixing

Acknowledgement RHF staff KDH staff Statistician Family

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