Patient and health facility attributes associated with retention and virologic suppression in private for-profit health facilities in Nigeria.

BACKGROUND: In Nigeria, private for-profit health facilities present an opportunity to achieve the UNAIDS 95-95-95 HIV targets because of their reach and patronage. However, little is known about determinants of outcomes in these facilities. This study describes patient outcomes and the patient and health facility characteristics associated with these outcomes in adults receiving HIV treatment in private facilities in the Federal Capital Territory (FCT), Benue and Nasarawa states in north-central Nigeria. METHODS: A retrospective longitudinal analysis of program data collected between 2013 and 2019 was done. Patient attributes and outcomes were compared across the two states and FCT. Incidence rates were determined for all cause exit, mortality and loss to follow up (LTFU). Cox proportional hazard models were used to identify associations between patient and facility attributes and these outcomes. Bivariate and multivariate logistic regression models were used to determine the factors associated with viral suppression among the study participants. RESULTS: Of the 22,010 study subjects, 42.7%, 22.2% and 35.1%, respectively, were in Benue, FCT and Nasarawa. Almost a third (31.8%) had received antiretroviral treatment (ART) for less than a year at censoring. Incidence rates for all-cause exit, mortality and loss to follow up (LTFU) were 17.2 (95% CI 16.8, 17.5), 2.1 (95% CI 2.0, 2.2), and 11.2 (95% CI 10.8, 11.8) per 100 person years respectively. Males had higher risks of death (HR = 1.47, 95% CI 1.25-1.73), and LTFU (HR = 1.08, 95% CI 1.00-1.16). Age at ART start showed a dose-response association with both mortality and LTFU. Care at model facilities (OR = 2.16, p < 0.001), Zidovudine (AZT)-based regimens (OR = 2.00, p < 0.001), and lowest quartile baseline CD4 + count (OR = 2.40, p < 0.001) were associated with regimen switch. 75.6% of subjects were viral suppressed. Male gender (OR = 0.84, p = 0.025); AZT-based regimen (OR = 0.72, p < 0.001), age in the bottom quartile (OR = 0.71, p = 0.002) were associated with virally suppression. CONCLUSION: Private for-profit facilities are a major provider of HIV and other health services in Nigeria. With appropriate technical support and engagement, they can help accelerate efforts to achieve epidemic control of HIV in Nigeria, and contribute to achievement of UNAIDS 95-95-95 target by 2030.

Expanding access to HIV services during the COVID-19 pandemic-Nigeria, 2020.

BACKGROUND: To accelerate progress toward the UNAIDS 90-90-90 targets, US Centers for Disease Control and Prevention Nigeria country office (CDC Nigeria) initiated an Antiretroviral Treatment (ART) Surge in 2019 to identify and link 340,000 people living with HIV/AIDS (PLHIV) to ART. Coronavirus disease 2019 (COVID-19) threatened to interrupt ART Surge progress following the detection of the first case in Nigeria in February 2020. To overcome this disruption, CDC Nigeria designed and implemented adapted ART Surge strategies during February-September 2020. METHODS: Adapted ART Surge strategies focused on continuing expansion of HIV services while mitigating COVID-19 transmission. Key strategies included an intensified focus on community-based, rather than facility-based, HIV case-finding; immediate initiation of newly-diagnosed PLHIV on 3-month ART starter packs (first ART dispense of 3 months of ART); expansion of ART distribution through community refill sites; and broadened access to multi-month dispensing (MMD) (3-6 months ART) among PLHIV established in care. State-level weekly data reporting through an Excel-based dashboard and individual PLHIV-level data from the Nigeria National Data Repository facilitated program monitoring. RESULTS: During February-September 2020, the reported number of PLHIV initiating ART per month increased from 11,407 to 25,560, with the proportion found in the community increasing from 59 to 75%. The percentage of newly-identified PLHIV initiating ART with a 3-month ART starter pack increased from 60 to 98%. The percentage of on-time ART refill pick-ups increased from 89 to 100%. The percentage of PLHIV established in care receiving at least 3-month MMD increased from 77 to 93%. Among PLHIV initiating ART, 6-month retention increased from 74 to 92%. CONCLUSIONS: A rapid and flexible HIV program response, focused on reducing facility-based interactions while ensuring delivery of lifesaving ART, was critical in overcoming COVID-19-related service disruptions to expand access to HIV services in Nigeria during the first eight months of the pandemic. High retention on ART among PLHIV initiating treatment indicates immediate MMD in this population may be a sustainable practice. HIV program infrastructure can be leveraged and adapted to respond to the COVID-19 pandemic.

Optimizing community linkage to care and antiretroviral therapy Initiation: Lessons from the Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS) and their adaptation in Nigeria ART Surge.

BACKGROUND: Ineffective linkage to care (LTC) is a known challenge for community HIV testing. To overcome this challenge, a robust linkage to care strategy was adopted by the 2018 Nigeria HIV/AIDS Indicator and Impact Survey (NAIIS). The NAIIS linkage to care strategy was further adapted to improve Nigeria's programmatic efforts to achieve the 1st 90 as part of the Nigeria Antiretroviral Therapy (ART) Surge initiative, which also included targeted community testing. In this paper we provide an overview of the NAIIS LTC strategy and describe the impact of this strategy on both the NAIIS and the Surge initiatives. METHODS: The NAIIS collaborated with community-based organizations (CBOs) and deployed mobile health (mHealth) technology with real-time dashboards to manage and optimize community LTC for people living with HIV (PLHIV) diagnosed during the survey. In NAIIS, CBOs' role was to facilitate linkage of identified PLHIV in community to facility of their choice. For the ART Surge, we modified the NAIIS LTC strategy by empowering both CBOs and mobile community teams as responsible for not only active LTC but also for community testing, ART initiation, and retention in care. RESULTS: Of the 2,739 PLHIV 15 years and above identified in NAIIS, 1,975 (72.1%) were either unaware of their HIV-positive status (N = 1890) or were aware of their HIV-positive status but not receiving treatment (N = 85). Of these, 1,342 (67.9%) were linked to care, of which 952 (70.9%) were initiated on ART. Among 1,890 newly diagnosed PLHIV, 1,278 (67.6%) were linked to care, 33.7% self-linked and 66.3% were linked by CBOs. Among 85 known PLHIV not on treatment, 64 (75.3%) were linked; 32.8% self-linked and 67.2% were linked by a CBO. In the ART Surge, LTC and treatment initiation rates were 98% and 100%, respectively. Three-month retention for monthly treatment initiation cohorts improved from 76% to 90% over 6 months. CONCLUSIONS: Active LTC strategies by local CBOs and mobile community teams improved LTC and ART initiation in the ART Surge initiative. The use of mHealth technology resulted in timely and accurate documentation of results in NAIIS. By deploying mHealth in addition to active LTC, CBOs and mobile community teams could effectively scale up ART with real-time documentation of client-level outcomes.

Scale-up of antiretroviral treatment access among people living with HIV in Rivers State, Nigeria, 2019--2020.

OBJECTIVE: The aim of this study was to describe and evaluate the impact of the programme intervention of the Rivers State Antiretroviral Treatment (ART) Surge, a collaboration between the US President's Emergency Plan for AIDS Relief (PEPFAR) and the State Ministry of Health, to increase HIV case-finding and ART access in Rivers State, the state with the largest ART gap among people living with HIV (PWH) in Nigeria. DESIGN: During April 2019-September 2020, the intervention included six specific strategies: using local government area-level ART gap analysis to guide case-finding; expanding targeted community testing; tailoring comprehensive key population HIV services; engaging HIV treatment programme stakeholders; synchronizing team efforts; and using near real-time data for programme action. METHODS: Weekly reported facility and community data on tests conducted, PWH diagnosed, and PWH initiated on ART were aggregated. The total number of PWH maintained on ART was reported quarterly. RESULTS: During May 2019-September 2020, the weekly number of newly diagnosed PWH initiated on ART supported by PEPFAR in Rivers State increased from 82 to 1723. During October 2019-September 2020, the monthly number of people screened for HIV testing eligibility in the community increased from 44 000 to 360 000. During April 2019-September 2020, the total number of PWH on ART supported by PEPFAR statewide increased by 3.8 times, from 26 041 to 99 733. CONCLUSION: The strategies applied by HIV program stakeholders contributed to scale-up of PWH identification and ART linkage within the Rivers State ART Surge. Continued gains through time indicate the importance of the application of a quality improvement approach to maintain programme flexibility and effectiveness.

Effect of community antiretroviral therapy on treatment outcomes among stable antiretroviral therapy patients in Nigeria: A quasi experimental study.

OBJECTIVES: This study evaluates the effect of Community Anti-retroviral Groups on Immunologic, Virologic and clinical outcomes of stable Antiretroviral Therapy patients in Nigeria. METHOD: A cohort of 251 eligible adults (≥18 years) on first-line ART for at least 6 months with CD4 counts >200 cells/mm3 and viral load <1000 c/ml were devolved from 10 healthcare facilities to 51 community antiretroviral therapy groups. Baseline immunologic, virologic and clinical parameters were collected and community antiretroviral therapy group patients were followed up for a year after which Human Immunodeficiency Virus treatment outcomes at the baseline and a year after follow-up were compared using paired sample t-test. All the analyses were performed in STATA version 14. RESULT: Out of the 251 stable antiretroviral therapy adults enrolled, 186 (75.3%) were female, 52 (22.7%) had attained post-secondary education and the mean age of participants was 38 years (SD: 9.5). Also, 66 (27.9%) were employed while 125 (52.7%) were self-employed and 46(19.41%) unemployed. 246 (98.0%) of the participants were retained in care. While there was no statistically significant change in the CD4 counts (456cells/mm3 vs 481cells/mm3 P-0.489) and Log10 viral load (3.54c/ml vs 3.69c/ml P-0.359) after one year of devolvement into the community, we observed a significant increase in body weight (60.8 vs 65, P-0.01). CONCLUSION: This study demonstrates that community antiretroviral therapy has a potential of maintaining optimum treatment outcomes while improving adherence and retention, and reducing the burden of HIV treatment on the health facility. This study provides baseline information for further research and vital information for HIV program implementers planning to decentralize the management of stable antiretroviral therapy clients.

Prevalence and risk factors for obesity among elderly patients living with HIV/AIDS in a low-resource setting.

ABSTRACT: Obesity is associated with detrimental changes in cardiovascular and metabolic parameters, including blood pressure, dyslipidemia, markers of systemic inflammation, and insulin resistance. In the elderly living with the human immunodeficiency virus (EPLHIV), and being treated with antiretroviral medications, the obesity complications escalate and expose the elderly to the risk of noncommunicable diseases. Given that over 3 million EPLHIV in sub-Sahara Africa, we assessed the prevalence of obesity and its associated factors among EPLHIV in a low-resource setting.This was a cross sectional study of EPLHIV aged 50 years and older, being treated with antiretroviral medications from 2004 to 2018. HIV treatment data collected from multiple treatment sites were analyzed. Baseline characteristics of the participants were described, and multivariable relative risk model was applied to assess the associations between obesity (body mass index [BMI] ≥30 kg/m2) and the prespecified potential risk factors.Of the 134,652 in HIV cohort, 19,566 (14.5%) were EPLHIV: 12,967 (66.3%) were normal weight (18.5 ≤ BMI < 25), 4548 (23.2%) were overweight (25 ≤ BMI < 30), while 2,051 (10.5%) were obese (BMI ≥30). The average age the normal weight (57.1; standard deviation 6.6) and the obese (56.5; standard deviation 5.5) was similar. We observed that being an employed (relative risk [RR] 1.71; 95% confidence interval [CI] 1.48-2.00; P < .001), educated (RR 1.93; 95% CI 1.54-2.41; P < .001), and presence of hypertension (RR 1.78; 95% CI 1.44-2.20; P < .001), increased the risk of obesity. Also, being male (RR 0.38; 95% CI 0.33-0.44; P < .001), stages III/IV of the World Health Organization clinical stages of HIV (RR 0.58; 95% CI 0.50-0.68; P < .001), tenofovir-based regimen (RR 0.84; 95% CI 0.73-0.96, P < .001), and low CD4 count (RR 0.56; 95% CI 0.44-0.71; P < .001) were inversely associated with obesity.This study demonstrates that multiple factors are driving obesity prevalence in EPLHIV. The study provides vital information for policy-makers and HIV program implementers in implementing targeted-interventions to address obesity in EPLHIV. Its findings would assist in the implementation of a one-stop-shop model for the management of HIV and other comorbid medical conditions in EPLHIV.

Predictors of first-line antiretroviral therapy failure among adults and adolescents living with HIV/AIDS in a large prevention and treatment program in Nigeria.

BACKGROUND: A substantial number of persons living with HIV (PLWH) in Nigeria do not experience durable viral suppression on first-line antiretroviral therapy (ART). Understanding risk factors for first-line treatment failure informs patient monitoring practices and distribution of limited resources for second-line regimens. We determined predictors of immunologic and virologic failures in a large ART delivery program in Abuja, Nigeria. METHODS: A retrospective cohort study was conducted at the University of Abuja Teaching Hospital, a tertiary health care facility, using data from February 2005 to December 2014 in Abuja, Nigeria. All PLWH aged ≥ 15 years who initiated ART with at least 6-month follow-up and one CD4 measurement were included. Immunologic failure was defined as a CD4 decrease to or below pre-ART level or persistent CD4 < 100 cells per mm3 after 6 months on ART. Virologic failure (VF) was defined as two consecutive HIV-1 RNA levels > 1000 copies/mL after at least 6 months of ART and enhanced adherence counselling. HIV drug resistance (Sanger sequences) was analyzed using the Stanford HIV database algorithm and scored for resistance to common nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs). Univariate and multivariate log binomial regression models were used to estimate relative risks (RRs) and 95% confidence intervals (CIs). RESULTS: Of 12,452 patients followed, a total of 5928 initiated ART with at least 6 months of follow-up and one CD4 measurement. The entry point for 3924 (66.2%) was through the program's own voluntary counseling and testing (VCT) center, while 1310 (22.1%) were referred from an outside clinic/program, 332 (5.6%) in-patients, and 373 (6.3%) through other entry points including prevention of mother to child transmission (PMTCT) and transferred from other programs. The mean CD4 at enrollment in care was 268 ± 23.7 cells per mm3, and the mean HIV-1 RNA was 3.3 ± 1.3.log10 copies/mL. A total of 3468 (80.5%) received nevirapine (NVP) and 2260 (19.5%) received efavirenz (EFV)-based regimens. A total of 2140 (36.1%) received tenofovir (TDF); 2662 (44.9%) zidovudine (AZT); and 1126 (19.0%) stavudine (d4T). Among those receiving TDF, 45.0% also received emtricitabine (FTC). In a multivariate model, immunologic failure was more common among PLWH with female gender as compared to male [RR (95% CI) 1.22 (1.07-1.40)] and less common among those who entered care at the program's VCT center as compared to other entry points [0.79 (0.64-0.91)], WHO stage 3/4 as compared to 1/2 [0.19 (0.16-0.22)], or CD4 200 + cells per mm3 as compared to lower [0.19 (0.16-0.22)]. Virologic failure was more common among PLWH who entered care at the program's VCT center as compared to other entry points [RR (95% CI) 1.45 (1.11-1.91) and those with CD4 < 200 cells per mm3 at entry into care as compared to higher [1.71 (1.36-2.16)]. Of 198 patient-derived samples sequenced during virologic failure, 42 (21%) were wild-type; 145 (73%) carried NNRTI drug resistance mutations; 151 (76.3%) M184I/V; 29 (14.6%) had ≥ 3 TAMs, and 37 (18.7%) had K65R, of whom all were on TDF-containing first-line regimens. CONCLUSIONS: In this cohort of Nigerian PLWH followed for a period of 9 years, immunologic criteria poorly predicted virologic failure. Furthermore, a subset of samples showed that patients failing ART for extended periods of time had HIV-1 strains harboring drug resistance mutations.

Cohort profile: the Nigerian HIV geriatric cohort study.

BACKGROUND: The Nigerian HIV Geriatric Cohort (NHGC) is a longitudinal cohort setup to learn how elderly people living with HIV (EPLHIV) in Nigeria fare, despite not being prioritized by the national treatment program, and to deepen knowledge for their differentiated care and achieve better outcomes. In this paper, we describe data collected on sociodemographic and clinical data from EPLHIV from the inception of Nigeria's national HIV program to 2018. METHODS: Patient-level data spanning the period 2004 to 2018, obtained from comprehensive HIV treatment hospitals, that are supported by four major PEPFAR-implementing partners in Nigeria were used. These 4 entities collaborated as member organizations of the Nigeria Implementation Science Alliance. We defined elderly as those aged 50 years and above. From deidentified treatment records, demographic and clinical data of EPLHIV ≥50-year-old at ART initiation during the review period was extracted, merged into a single REDcap® database, and described using STATA 13. RESULTS: A total of 101,652 EPLHIV were analysed. Women accounted for 53,608 (53%), 51,037 (71%) of EPLHIV identified as married and 33,446 (51%) unemployed. Median age was 57.1 years (IQR 52-60 years) with a median duration on ART treatment of 4.1 years (IQR 1.7-7.1 years). ART profile showed that 97,586 (96%) were on 1st-line and 66,125 (65%) were on TDF-based regimens. Median body mass index (BMI) was 22.2 kg/m2 (IQR 19.5-25.4 kg/m2) with 43,012 (55%), 15,081 (19%) and 6803 (9%) showing normal (BMI 18.5 - < 25 kg/m2), overweight (BMI 25 - < 30 kg/m2) and obese (BMI ≥30 kg/m2) ranges respectively. Prevalence of hypertension (systolic-BP > 140 mmHg or diastolic-BP > 90 mmHg) was 16,201 (21%). EPLHIV median CD4 count was 381 cells/µL (IQR 212-577 cells/µL) and 26,687 (82%) had a viral load result showing < 1000copies/ml within one year of their last visit. As for outcomes at their last visit, 62,821 (62%) were on active-in-treatment, 28,463 (28%) were lost-to-follow-up, 6912 (7%) died and 2456 (3%) had stopped or transferred out. Poor population death records and aversion to autopsies makes it almost impossible to estimate AIDS-related deaths. CONCLUSIONS: This cohort describes the clinical and non-clinical profile of EPLHIV in Nigeria. We are following up the cohort to design and implement intervention programs, develop prognostic models to achieve better care outcomes for EPLHIV. This cohort would provide vital information for stakeholders in HIV prevention, care and treatment to understand the characteristics of EPLHIV.

Predictors of loss to follow-up in art experienced patients in Nigeria: a 13 year review (2004-2017).

BACKGROUND: Expanded access to antiretroviral therapy (ART) leads to improved HIV/AIDS treatment outcomes in Nigeria, however, increasing rates of loss to follow-up among those on ART is threatening optimal standard achievement. Therefore, this retrospective cross-sectional study is aimed at identifying correlates and predictors of loss to follow-up in patients commencing ART in a large HIV program in Nigeria. METHODS: Records of all patients from 432 US CDC Presidents Emergency Plan for AIDS Relief (PEPFAR) supported facilities across 10 States and FCT who started ART from 2004 to 2017 were used for this study. Bivariate and multivariate analysis of the demographic and clinical parameters of all patients was conducted using STATA version 14 to determine correlates and predictors of loss to follow-up. RESULTS: Within the review period, 245,257 patients were ever enrolled on anti-retroviral therapy. 150,191 (61.2%) remained on treatment, 10,960 (4.5%) were transferred out to other facilities, 6926 (2.8%) died, 2139 (0.9%) self-terminated treatment and 75,041 (30.6%) had a loss to follow-up event captured. Males (OR: 1.16), Non-pregnant female (OR: 4.55), Patients on ≥ 3-monthly ARV refills (OR: 1.32), Patients with un-suppressed viral loads on ART (OR: 4.52), patients on adult 2nd line regimen (OR: 1.23) or pediatric on 1st line regimen (OR: 1.70) were significantly more likely to be lost to follow-up. CONCLUSION: Despite increasing access to anti-retroviral therapy, loss to follow-up is still a challenge in the HIV program in Nigeria. Differentiated care approaches that will focus on males, non-pregnant females and paediatrics is encouraged. Reducing months of Anti-retroviral drug refill to less than 3 months is advocated for increased patient adherence.

Social barriers in accessing care by clients who returned to HIV care after transient loss to follow-up.

BACKGROUND: People living with HIV (PLHIV) constantly need to address social issues such as the cost of accessing care, stigma, and lack of social support which impacts on their level of adherence to clinic visits or antiretroviral treatment leading to adverse health outcomes. This study examined the social barriers in accessing care by clients who returned to care after transient loss to follow-up. METHODS: This study was a cross-sectional survey of PLHIV from 99 US CDC PEPFAR-supported HIV clinics located in 10 of Nigeria's 36 states and Federal Capital Territory, who were momentarily lost to follow-up but returned to care after tracking. Demographic and social factors at bivariate and multivariate level were analyzed to determine the predictors of difficulty in accessing HIV clinics. RESULTS: Of the 7483 clients tracked, 1386 (18.5%) were confirmed to be in care, 2846 (38.2%) were lost to follow-up (LTFU), 562 (7.5%) returned to care, 843 (11.2%) discontinued care, 827 (11.1%) transferred out to other facilities for care, 514 (6.8%) had died while 505 (6.7%) could not be reached by phone or located at their addresses. 438 out of the 562 (78%) returnee PLHIV gave consent and participated in the study. 216 out of the 438 (50%) clients who returned to care were transiently lost to follow-up because they had difficulty accessing their HIV clinic. Also, 126/438 (29%) of returnee PLHIV were previously lost to follow-up. Difficult access to a HIV clinic was significantly influenced by prior LTFU (OR 2.5 [95% CI 1.3-4.8], p = 0.008), history of being stigmatized (OR 2.1 [95% CI 1.1-3.8], p = 0.02), lack of social or financial support (OR 2.8 [95% CI 1.3-6.0], p = 0.01) and perceived in-adequate healthcare workers support (OR 3.8 [95% CI 1.2-11.2], p = 0.02). Age (p = 0.218) and gender (p = 0.771) were not significant determinants of difficult access to an HIV clinic. CONCLUSION: Stigma, lack of support and prior loss to follow-up event are essential factors affecting retention in care. Social constructs such as home-based visits, community-based care services, transportation subsidies, and robust strong social systems should be built into HIV service delivery models to improve retention in care of people on HIV treatment. The authors advocate for further studies on how differentiated care models impact on retention of patients in care.

Effect of community treatment initiative on antiretroviral therapy uptake among linkage-resistant people living with HIV in Northern Nigeria.

BACKGROUND: Community Treatment Initiative (CTI) was developed in northern Nigeria as an intervention to link a cohort of people living with HIV (PLHIV) who refused antiretroviral treatment through a conventional linkage method to care and treatment. The CTI attempted to take treatment to PLHIV in the community. METHODS: This was a non-control interventional study that evaluated the proportion of linkage-resistant PLHIV linked to treatment through the CTI in nine geographical areas. Data were collected between October and December 2015. Linkage-resistant PLHIV were identified and linked to treatment using the CTI. Data were analyzed using Excel and IBM SPSS version 20.0. The simple proportion was used to estimate the linkage-resistant PLHIV who were eventually linked and retained in care and who ultimately achieved virological suppression (viral load <1000 copies/ml). The Chi-square test was used and the level of significance set at a p-value of <0.05. RESULTS: An estimated 541 (20%) PLHIV (239 (44.2%) male, 302 (55.8%) female) seen from October to December 2015 refused linkage to treatment. This was statistically significant at a p-value of <0.0001. Three hundred and seventy-seven (69.7%) of the PLHIV who refused linkage to treatment eventually accepted treatment using an alternative community treatment method; this was significant (p<0.0001). The 6-month retention rate for PLHIV who accepted the alternative treatment method was 88.1% (n=332); this was significant (p<0.0001). Seventy-eight percent of those retained in care attained virological suppression. CONCLUSIONS: The CTI improved linkage to care and treatment for a cohort of linkage-resistant PLHIV. Focus on this cohort of linkage-resistant positive clients is required to achieve HIV epidemic control.

Addressing the under-reporting of adverse drug reactions in public health programs controlling HIV/AIDS, Tuberculosis and Malaria: A prospective cohort study.

BACKGROUND: Adverse Drug Reactions (ADRs) are a major clinical and public health problem world-wide. The prompt reporting of suspected ADRs to regulatory authorities to activate drug safety surveillance and regulation appears to be the most pragmatic measure for addressing the problem. This paper evaluated a pharmacovigilance (PV) training model that was designed to improve the reporting of ADRs in public health programs treating the Human Immunodeficiency Virus (HIV), Tuberculosis (TB) and Malaria. METHODS: A Structured Pharmacovigilance and Training Initiative (SPHAR-TI) model based on the World Health Organization accredited Structured Operational Research and Training Initiative (SOR-IT) model was designed and implemented over a period of 12 months. A prospective cohort design was deployed to evaluate the outcomes of the model. The primary outcomes were knowledge gained and Individual Case Safety Reports (ICSR) (completed adverse drug reactions monitoring forms) submitted, while the secondary outcomes were facility based Pharmacovigilance Committees activated and health facility healthcare workers trained by the participants. RESULTS: Fifty-five (98%) participants were trained and followed up for 12 months. More than three quarter of the participants have never received training on pharmacovigilance prior to the course. Yet, a significant gain in knowledge was observed after the participants completed a comprehensive training for six days. In only seven months, 3000 ICSRs (with 100% completeness) were submitted, 2,937 facility based healthcare workers trained and 46 Pharmacovigilance Committees activated by the participants. Overall, a 273% increase in ICSRs submission to the National Agency for Food and Drug Administration and Control (NAFDAC) was observed. CONCLUSION: Participants gained knowledge, which tended to increase the reporting of ADRs. The SPHAR-TI model could be an option for strengthening the continuous reporting of ADRs in public health programs in resource limited settings.

Active tracking of rejected dried blood samples in a large program in Nigeria.

AIM: To study the impact of rejection at different levels of health care by retrospectively reviewing records of dried blood spot samples received at the molecular laboratory for human immunodeficiency virus (HIV) early infant diagnosis (EID) between January 2008 and December 2012. METHODS: The specimen rejection rate, reasons for rejection and the impact of rejection at different levels of health care was examined. The extracted data were cleaned and checked for consistency and then de-duplicated using the unique patient and clinic identifiers. The cleaned data were ciphered and exported to SPSS version 19 (SPSS 2010 IBM Corp, New York, United States) for statistical analyses. RESULTS: Sample rejection rate of 2.4% (n = 786/32552) and repeat rate of 8.8% (n = 69/786) were established. The mean age of infants presenting for first HIV molecular test among accepted valid samples was 17.83 wk (95%CI: 17.65-18.01) vs 20.30 wk (95%CI: 16.53-24.06) for repeated samples. HIV infection rate was 9.8% vs 15.9% for accepted and repeated samples. Compared to tertiary healthcare clinics, secondary and primary clinics had two-fold and three-fold higher likelihood of sample rejection, respectively (P < 0.05). We observed a significant increase in sample rejection rate with increasing number of EID clinics (r = 0.893, P = 0.041). The major reasons for rejection were improper sample collection (26.3%), improper labeling (16.4%) and insufficient blood (14.8%). CONCLUSION: Programs should monitor pre-analytical variables and incorporate continuous quality improvement interventions to reduce errors associated with sample rejection and improve patient retention.

Performance of Genotype MTBDRplus in the Detection of Resistance to Rifampicin and Isoniazid Among Clinical Mycobacteria Isolates in Ilorin, Nigeria.

BACKGROUND: Performance of Genotype MTBDRplus assay against Lowenstein Jensen (LJ) proportion method of Drug Susceptibility Testing (DST) in detection of resistance among clinical mycobacteria isolates to rifampicin (RMP) and isoniazid (INH) was evaluated in Ilorin, Nigeria. METHODS: This retrospective study characterized one hundred mycobacteria isolates from pulmonary TB patients, stored on LJ medium and subcultured unto fresh LJ slants before being genotyped using MTBDRplus assay. DST was performed on the isolates against RMP, INH, Ethambutol and Streptomycin. RESULTS: Genotype MTBDRplus identified 97% and 3% of the 100 isolates as Mycobacterium tuberculosis Complex (MTBC) and Non-Tuberculous Mycobacteria (NTM) respectively. Fourteen of the isolates, (14%) were resistant to RMP while 86% were sensitive by the genotypic method. Three of these 14 RMP-resistant isolates were NTMs while 11 were MTBC. Twelve (12%) of the 100 isolates were resistant to INH. Three INH-resistant isolates were NTMs, and 9 were MTBC. Phenotypically and genotypically, the 3 NTMs were resistant to RMP and INH and ten of the 97 MTBC strains were RMP-resistant. One RMP-phenotypically-sensitive strain was genotypically resistant to RMP. Six of the MTBC isolates were resistant to both RMP and INH by both methods. Most mutations occurred in the S-531L and S315T1 codons of rpoB and KatG genes of RMP and INH, respectively. CONCLUSION: The high specificity and positive predictive values recorded by MTBDRplus in our study make it suitable for use in the programmatic management of drug-resistant TB in resource-limited settings.

Doing no harm? Adverse events in a nation-wide cohort of patients with multidrug-resistant tuberculosis in Nigeria.

BACKGROUND: Adverse events (AEs) of second line anti-tuberculosis drugs (SLDs) are relatively well documented. However, the actual burden has rarely been described in detail in programmatic settings. We investigated the occurrence of these events in the national cohort of multidrug-resistant tuberculosis (MDR-TB) patients in Nigeria. METHOD: This was a retrospective, observational cohort study, using pharmacovigilance data systematically collected at all MDR-TB treatment centers in Nigeria. Characteristics of AEs during the intensive phase treatment were documented, and risk factors for development of AEs were assessed. RESULTS: Four hundred and sixty patients were included in the analysis: 62% were male; median age was 33 years [Interquartile Range (IQR):28-42] and median weight was 51 kg (IQR: 45-59). Two hundred and three (44%) patients experienced AEs; four died of conditions associated with SLD AEs. Gastro-intestinal (n = 100), neurological (n = 75), ototoxic (n = 72) and psychiatric (n = 60) AEs were the most commonly reported, whereas ototoxic and psychiatric AEs were the most debilitating. Majority of AEs developed after 1-2 months of therapy, and resolved in less than a month after treatment. Some treatment centers were twice as likely to report AEs compared with others, highlighting significant inconsistencies in reporting at different treatment centers. Patients with a higher body weight had an increased risk of experiencing AEs. No differences were observed in risk of AEs between HIV-infected and uninfected patients. Similarly, age was not significantly associated with AEs. CONCLUSION: Patients in the Nigerian MDR-TB cohort experienced a wide range of AEs, some of which were disabling and fatal. Early identification and prompt management as well as standardized reporting of AEs at all levels of healthcare, including the community is urgently needed. Safer regimens for drug-resistant TB with the shortest duration are advocated.