HIV Viral Load Monitoring Among Patients Receiving Antiretroviral Therapy - Eight Sub-Saharan Africa Countries, 2013-2018.

One component of the Joint United Nations Programme on HIV/AIDS (UNAIDS) goal to end the HIV/AIDS epidemic by 2030, is that 95% of all persons receiving antiretroviral therapy (ART) achieve viral suppression.† Thus, testing all HIV-positive persons for viral load (number of copies of viral RNA per mL) is a global health priority (1). CDC and other U.S. government agencies, as part of the U.S. President's Emergency Plan for AIDS Relief (PEPFAR), together with other stakeholders, have provided technical assistance and supported the cost for multiple countries in sub-Saharan Africa to expand viral load testing as the preferred monitoring strategy for clinical response to ART. The individual and population-level benefits of ART are well understood (2). Persons receiving ART who achieve and sustain an undetectable viral load do not transmit HIV to their sex partners, thereby disrupting onward transmission (2,3). Viral load testing is a cost-effective and sustainable programmatic approach for monitoring treatment success, allowing reduced frequency of health care visits for patients who are virally suppressed (4). Viral load monitoring enables early and accurate detection of treatment failure before immunologic decline. This report describes progress on the scale-up of viral load testing in eight sub-Saharan African countries from 2013 to 2018 and examines the trajectory of improvement with viral load testing scale-up that has paralleled government commitments, sustained technical assistance, and financial resources from international donors. Viral load testing in low- and middle-income countries enables monitoring of viral load suppression at the individual and population level, which is necessary to achieve global epidemic control. Although there has been substantial achievement in improving viral load coverage for all patients receiving ART, continued engagement is needed to reach global targets.

Malaria Parasite Density as a Predictor of Hematological Parameter Changes among HIV Infected Adults Attending Two Antiretroviral Treatment Clinics in Kano, Northwest Nigeria.

BACKGROUND: Despite public health significance of dual infections of human immunodeficiency virus (HIV) and malaria in developing countries like Nigeria, information on the association between malaria parasite density count (MPDC) and hematological parameter changes among HIV-infected individuals is rarely available. OBJECTIVES: To evaluate burden of HIV and malaria dual infections and assess the predictive association of MPDC with hematological parameter changes among HIV infected adults attending two antiretroviral treatment clinics in Kano, Nigeria. Methodology. This was a cross-sectional study consisting of 1521 consented participants randomly selected between June 2015 and May 2016. Participants' basic characteristics and clinical details were collected using a pretested and validated standardized questionnaire. Collected venous blood was analyzed for malaria by rapid testing and microscopy including malaria parasite density; hematological parameters were estimated using a Sysmex XP-300 autoanalyzer. Data was reviewed, cleaned, and analyzed using SPSS software version 23.0. Mean hematological parameters and HIV/malaria status were compared using the independent t-test; hematological parameters and MPDC relationship was tested by simple linear regression analysis. Statistically significant difference at probability of <0.05 was considered for all variables. RESULTS: The majority (70.6%) of the participants were females. Mean (SD) age was 37.30 ± (10.41) years and ranged from 18 to 78 years. 25.4% of participants had dual infection, 99% due to Plasmodium falciparum species. Mean MPDC was 265 ± 31.8 (SD) cells/µl and ranged from 20 to 2500 cells/µl. Dual infection was highest (37.5%) among respondents in the age group ≥60 years. Prevalence was similar among other age groups (p = 0.165) and gender (p = 0.942). Of the 16 hematological parameters evaluated, 11 showed significant difference between HIV mono-infected and dual infected participants. Of the 11 parameters, only 7 (Hb, MCHC, red cells count, neutrophil and lymphocyte percentage, absolute lymphocyte count, and red cell distribution width) were significantly predictive of changes with respect to MPDC. CONCLUSIONS: MPDC was significantly predictive of changes in 7 hematological parameters among dual infected participants in these settings. In routine malaria diagnosis, MPDC determination with respect to changes in some hematological parameters should be considered in ART programs for improved patient management.

Evaluation of standard diagnostic rapid test kits for malaria diagnosis among HIV patients in Kano, Nigeria.

BACKGROUND: Malaria diagnosis among HIV-positive patients is uncommon in Nigeria despite the high burden of both diseases. OBJECTIVES: We evaluated the performance of a malaria rapid diagnostic test (MRDT) against blood smear microscopy (BSM) among HIV-positive patients in relation to anti-retroviral treatment (ART) status, CD4+ count, fever, cotrimoxazole prophylaxis and malaria density count. METHOD: A cross-sectional study involving 1521 consenting randomly selected HIV-positive adults attending two ART clinics in Kano, Nigeria, between June 2015 and May 2016. Venous blood samples were collected for testing with MRDT, BSM, and CD4+ T cells count by cytometry. Biodata and other clinical details were extracted from patient folders into an Excel file, cleaned, validated, and exported for analysis into SPSS version 23.0. Sensitivity, specificity, predictive values of MRDT were compared with BSM with a 95% confidence interval. RESULTS: Malaria parasites were detected in 25.4% of enrollees by BSM and 16.4% by MRDT. Overall sensitivity of MRDT was 58% and specificity was 97%. Cotrimoxazole prophylaxis and fever status did not affect MRDT sensitivity and specificity. Unexpectedly, the sensitivity was highest at parasite density count of less than 500 cells/µL. At CD4+ T cells count over 500 cells/µL the sensitivity was higher (62.4%) compared to 56% at less than 500 cells/µL. In the non-ART group sensitivity was higher (65%) compared to those on ART (56%) but the specificity was similar. All differences were significant for all variables (p < 0.05). CONCLUSION: Although the MRDT specificity was good, the sensitivity was poor, requiring further evaluation for use in malaria diagnosis among HIV-malaria co-infected persons in these settings.

Effect of HIV and malaria parasites co-infection on immune-hematological profiles among patients attending anti-retroviral treatment (ART) clinic in Infectious Disease Hospital Kano, Nigeria.

BACKGROUND: Human immunodeficiency virus (HIV) and malaria co-infection may present worse health outcomes in the tropics. Information on HIV/malaria co-infection effect on immune-hematological profiles is critical for patient care and there is a paucity of such data in Nigeria. OBJECTIVE: To evaluate immune-hematological profiles among HIV infected patients compared to HIV/malaria co-infected for ART management improvement. METHODS: This was a cross sectional study conducted at Infectious Disease Hospital, Kano. A total of 761 consenting adults attending ART clinic were randomly selected and recruited between June and December 2015. Participants' characteristics and clinical details including two previous CD4 counts were collected. Venous blood sample (4ml) was collected in EDTA tube for malaria parasite diagnosis by rapid test and confirmed with microscopy. Hematological profiles were analyzed by Sysmex XP-300 and CD4 count by Cyflow cytometry. Data was analyzed with SPSS 22.0 using Chi-Square test for association between HIV/malaria parasites co-infection with age groups, gender, ART, cotrimoxazole and usage of treated bed nets. Mean hematological profiles by HIV/malaria co-infection and HIV only were compared using independent t-test and mean CD4 count tested by mixed design repeated measures ANOVA. Statistical significant difference at probability of <0.05 was considered for all variables. RESULTS: Of the 761 HIV infected, 64% were females, with a mean age of ± (SD) 37.30 (10.4) years. Prevalence of HIV/malaria co-infection was 27.7% with Plasmodium falciparum specie accounting for 99.1%. No statistical significant difference was observed between HIV/malaria co-infection in association to age (p = 0.498) and gender (p = 0.789). A significantly (p = 0.026) higher prevalence (35.2%) of co-infection was observed among non-ART patients compared to (26%) ART patients. Prevalence of co-infection was significantly lower (20.0%) among cotrimoxazole users compared to those not on cotrimoxazole (37%). The same significantly lower co-infection prevalence (22.5%) was observed among treated bed net users compared to those not using treated bed nets (42.9%) (p = 0.001). Out of 16 hematology profiles evaluated, six showed significant difference between the two groups (i) packed cell volume (p = <0.001), (ii) mean cell volume (p = 0.005), (iii) mean cell hemoglobin concentration (p = 0.011), (iv) absolute lymphocyte count (p = 0.022), (v) neutrophil percentage count (p = 0.020) and (vi) platelets distribution width (p = <0.001). Current mean CD4 count cell/µl (349±12) was significantly higher in HIV infected only compared to co-infected (306±17), (p = 0.035). A significantly lower mean CD4 count (234.6 ± 6.9) was observed among respondents on ART compared to non-ART (372.5 ± 13.2), p<0.001, mean difference = -137.9). CONCLUSION: The study revealed a high burden of HIV and malaria co-infection among the studied population. Co-infection was significantly lower among patients who use treated bed nets as well as cotrimoxazole chemotherapy and ART. Six hematological indices differed significantly between the two groups. Malaria and HIV co-infection significantly reduces CD4 count. In general, to achieve better management of all HIV patients in this setting, diagnosing malaria, prompt antiretroviral therapy, monitoring CD4 and some hematology indices on regular basis is critical.

Evaluating laboratory request forms submitted to haematology and blood transfusion departments at a hospital in Northwest Nigeria.

BACKGROUND: The laboratory request form (LRF) is a communication link between laboratories, requesting physicians and users of laboratory services. Inadequate information or errors arising from the process of filling out LRFs can significantly impact the quality of laboratory results and, ultimately, patient outcomes. OBJECTIVE: We assessed routinely-submitted LRFs to determine the degree of correctness, completeness and consistency. METHODS: LRFs submitted to the Department of Haematology (DH) and Blood Transfusion Services (BTS) of Aminu Kano Teaching Hospital in Kano, Nigeria, between October 2014 and December 2014, were evaluated for completion of all items on the forms. Performance in four quality indicator domains, including patient identifiers, test request details, laboratory details and physician details, was derived as a composite percentage. RESULTS: Of the 2084 LRFs evaluated, 999 were from DH and 1085 from BTS. Overall, LRF completeness was 89.5% for DH and 81.2% for BTS. Information on patient name, patient location and laboratory number were 100% complete for DH, whereas only patient name was 100% complete for BTS. Incomplete information was mostly encountered on BTS forms for physician's signature (60.8%) and signature of laboratory receiver (63.5%). None of the DH and only 9.4% of BTS LRFs met all quality indicator indices. CONCLUSION: The level of completion of LRFs from these two departments was suboptimal. This underscores the need to review and redesign the LRF, improve on training and communication between laboratory and clinical staff and review specimen rejection practices.

Piloting laboratory quality system management in six health facilities in Nigeria.

BACKGROUND: Achieving accreditation in laboratories is a challenge in Nigeria like in most African countries. Nigeria adopted the World Health Organization Regional Office for Africa Stepwise Laboratory (Quality) Improvement Process Towards Accreditation (WHO/AFRO- SLIPTA) in 2010. We report on FHI360 effort and progress in piloting WHO-AFRO recognition and accreditation preparedness in six health facility laboratories in five different states of Nigeria. METHOD: Laboratory assessments were conducted at baseline, follow up and exit using the WHO/AFRO- SLIPTA checklist. From the total percentage score obtained, the quality status of laboratories were classified using a zero to five star rating, based on the WHO/AFRO quality improvement stepwise approach. Major interventions include advocacy, capacity building, mentorship and quality improvement projects. RESULTS: At baseline audit, two of the laboratories attained 1- star while the remaining four were at 0- star. At follow up audit one lab was at 1- star, two at 3-star and three at 4-star. At exit audit, four labs were at 4- star, one at 3-star and one at 2-star rating. One laboratory dropped a 'star' at exit audit, while others consistently improved. The two weakest elements at baseline; internal audit (4%) and occurrence/incidence management (15%) improved significantly, with an exit score of 76% and 81% respectively. The elements facility and safety was the major strength across board throughout the audit exercise. CONCLUSION: This effort resulted in measurable and positive impact on the laboratories. We recommend further improvement towards a formal international accreditation status and scale up of WHO/AFRO- SLIPTA implementation in Nigeria.

Prevalence of intestinal parasites among HIV/AIDS patients attending Infectious Disease Hospital Kano, Nigeria.

INTRODUCTION: Intestinal parasitic infection has been a major source of morbidity in tropical countries especially among HIV patients. The aim of this study was to determine prevalence of intestinal parasites and its association with immunological status and risk factors among HIV infected patients in Kano, Nigeria. METHODS: 105 HIV+ subjects and 50 HIV- controls were recruited into the studies from June to December 2010. Clinical information was collected using a questionnaire. Single stool and venous blood samples were collected from each subject. Stool examination and CD4+ count were performed. RESULTS: Prevalence of intestinal parasites was 11.4% and 6% among the HIV+ and control subjects respectively with no statistically significant difference (p = 0.389). Specifically, the following intestinal parasites were isolated from HIV+ subjects: Entamoebahistolytica (5.7%), hookworm (3.8%), Entamoeba coli (1%), Blastocystishominis (1%). Only Entamoebahistolytica was isolated among the control subjects. The mean CD4+ count of HIV+ and control subjects was 287 cells/ul and 691 cells/µl respectively while the median was 279(Q1-120, Q3-384) cell/µl and 691(Q1-466, Q3-852) cell/µl respectively with statistically significant difference (P= 0.021). Diarrhea and the absence of anti-parasitic therapy seem to be important risk factors associated with the occurrence of intestinal parasites among HIV+ subjects. A higher prevalence (14.5%) of intestinal parasites was observed in subject with CD4+ count 350 cell/µl. CONCLUSION: Routine examination for intestinal parasites should be carried out for better management of HIV/AIDS patients.

Implementing and measuring the level of laboratory service integration in a program setting in Nigeria.

BACKGROUND: The surge of donor funds to fight HIV&AIDS epidemic inadvertently resulted in the setup of laboratories as parallel structures to rapidly respond to the identified need. However these parallel structures are a threat to the existing fragile laboratory systems. Laboratory service integration is critical to remedy this situation. This paper describes an approach to quantitatively measure and track integration of HIV-related laboratory services into the mainstream laboratory services and highlight some key intervention steps taken, to enhance service integration. METHOD: A quantitative before-and-after study conducted in 122 Family Health International (FHI360) supported health facilities across Nigeria. A minimum service package was identified including management structure; trainings; equipment utilization and maintenance; information, commodity and quality management for laboratory integration. A check list was used to assess facilities at baseline and 3 months follow-up. Level of integration was assessed on an ordinal scale (0 = no integration, 1 = partial integration, 2 = full integration) for each service package. A composite score grading expressed as a percentage of total obtainable score of 14 was defined and used to classify facilities (≤ 80% FULL, 25% to 79% PARTIAL and <25% NO integration). Weaknesses were noted and addressed. RESULTS: We analyzed 9 (7.4%) primary, 104 (85.2%) secondary and 9 (7.4%) tertiary level facilities. There were statistically significant differences in integration levels between baseline and 3 months follow-up period (p<0.01). Baseline median total integration score was 4 (IQR 3 to 5) compared to 7 (IQR 4 to 9) at 3 months follow-up (p = 0.000). Partial and fully integrated laboratory systems were 64 (52.5%) and 0 (0.0%) at baseline, compared to 100 (82.0%) and 3 (2.4%) respectively at 3 months follow-up (p = 0.000). DISCUSSION: This project showcases our novel approach to measure the status of each laboratory on the integration continuum.

Phlebotomy and quality in the African laboratory.

Phlebotomy, the act of drawing blood through venepuncture, is one of the most common medical procedures in healthcare, as well as being a basis for diagnosis and treatment. A review of the available research has highlighted the dearth of information on the phlebotomy practice in Africa. Several studies elsewhere have shown that the pre-analytical phase (patient preparation, specimen collection and identification, transportation, preparation for analysis and storage) is the most error-prone process in laboratory medicine. The validity of any laboratory test result hinges on specimen quality; thus, as the push for laboratory quality improvement in Africa gathers momentum, the practice of phlebotomy should be subjected to critical appraisal. This article offers several suggestions for the improvement of phlebotomy in Africa.

HIV infection in rural villages of Cameroon.

OBJECTIVE: To evaluate HIV-1 antibody seroprevalence and risk factors for HIV seropositivity in rural areas of Cameroon. METHOD: The prevalences of HIV antibodies in 53 villages in rural Cameroon visited during May-October 2000 were determined with an HIV1/2 rapid assay, standard ELISA, and western blot. Demographic data and risk factors were elicited via face-to-face interviews with a structured questionnaire. RESULTS: HIV seroprevalence was 5.8% (243/4156, 95% confidence interval [CI] = 5.1-6.6) overall, 6.3% (151/2394, 95% CI = 5.4-7.4) among females and 5.2% (92/1762, 95% CI = 4.3-6.4) among males. HIV seroprevalence among persons aged 15 - 70 years did not differ significantly by province (5.6% in Center, 4.5% in East, 6.9% in South, and 5.8% in South-West) ( =.10). Analysis of age- and gender-standardized prevalence by village across provinces indicated a near-significant difference (nonparametric Wilcoxon signed rank test, =.06), with highest prevalence in South-West, followed by South, Center, and East. Multivariate analysis revealed that single women were significantly more likely to be HIV seropositive than were married or widowed women. Women with a history of sexual relations while traveling were at significantly increased risk of HIV seropositivity (OR adjusted for age and marital status = 2.4, 95% CI = 1.4-9.7). Among men, those who reported ever having a sexually transmitted disease were at significantly increased risk of HIV-seropositivity (OR adjusted for age = 1.8, 95% CI = 1.1-2.8). CONCLUSION: We have documented a wide range of HIV prevalences among rural villages of Cameroon. Age, marital status (in women) and sexual risk factors appear to be associated with HIV infection in this setting.