Clinical Outcomes in a Randomized Controlled Trial Comparing Point-of-Care With Standard Human Immunodeficiency Virus (HIV) Viral Load Monitoring in Nigeria.

BACKGROUND: Point-of-care (POC) viral load (VL) tests provide results within hours, enabling same-day treatment interventions. We assessed treatment outcomes with POC vs standard-of-care (SOC) VL monitoring. METHODS: We implemented a randomized controlled trial at an urban and rural hospital in Nigeria. Participants initiating antiretroviral therapy (ART) were randomized 1:1 for monitoring via the POC Cepheid Xpert or SOC Roche COBAS (v2.0) HIV-1 VL assays. Viral suppression (VS) and retention in care at 12 months were compared via intention-to-treat (ITT) and per-protocol (PP) analyses. Post-trial surveys for POC patients and healthcare workers (HCWs) evaluated acceptability. RESULTS: During April 2018-October 2019, 268 SOC and 273 POC patients enrolled in the trial. Viral suppression at <1000 copies/mL at 12 months was 59.3% (162/273) for POC and 52.2% (140/268) for SOC (P = .096) in ITT analysis and 77.1% (158/205) for POC and 65.9% (137/208) for SOC (P = .012) in PP analysis. Retention was not significantly different in ITT analysis but was 85.9% for POC and 76.9% for SOC (P = .02) in PP analysis. The increased VS in the POC arm was attributable to improved retention and documentation of VL results. POC monitoring was preferred over SOC by 90.2% (147/163) of patients and 100% (15/15) of HCWs thought it facilitated patient care. CONCLUSIONS: POC VL monitoring did not improve 12-month VS among those with results but did improve retention and VS documentation and was preferred by most patients and HCWs. Further research can inform best POC implementation conditions and approaches to optimize patient care. CLINICAL TRIALS REGISTRATION: NCT03533868.

Timeliness of Point-of-Care Viral Load Results Improves Human Immunodeficiency Virus Monitoring in Nigeria.

BACKGROUND: Human immunodeficiency virus (HIV) viral load (VL) monitoring is critical for antiretroviral therapy (ART) management. Point-of-care (POC) VL testing has been reported to be feasible and preferred over standard-of-care (SOC) testing in many low- and middle-income country settings where rapid results could improve patient outcomes. METHODS: The timeliness of receipt of VL results was evaluated in an open-label, randomized, controlled trial among patients newly initiating ART. Clinical outcomes with POC VL monitoring using Cepheid Xpert vs SOC VL at Jos University Teaching Hospital and Comprehensive Health Centre Zamko in Nigeria were assessed. We determined time between specimen collection and recording of VL in patient charts, receipt of results, and ART switch for those who met virologic failure criteria. RESULTS: Between April 2018 and October 2019, we screened 696 ART-naive individuals; 273 were randomized to POC and 268 to SOC HIV-1 VL testing. Participants in the POC arm received VL results significantly faster than those in the SOC arm (0.1 median days, interquartile range [IQR], 0.1-0.2 vs 143.1 days, IQR, 56.0-177.1, respectively; P < .0001). Participants in the POC arm with confirmed virologic failure vs those in the SOC arm were switched more rapidly to a second-line regimen (0 median days, IQR, 0-28 vs 66 days, IQR, 63-123, respectively; P = .03). CONCLUSIONS: POC VL testing resulted in significant improvement in the timeliness of VL result receipt by patients and use for effective HIV clinical management. In patients experiencing VL failure, POC monitoring enabled prompt switching to second-line ART regimens. CLINICAL TRIALS REGISTRATION: NCT03533868.

Effect of Baseline Symptom Manifestations on Retention in Care and Treatment among HIV-Infected Patients in Nigeria.

BACKGROUND: Symptom management is an important component of HIV care. But symptom patterns and how they affect engagement with HIV care and treatment services have not been adequately explored in the era of increased HIV treatment scale-up. We investigated the relationship between symptom patterns among people living with HIV (PLHIV) and 12 months retention in care, within the context of other clinical and demographic characteristics. METHODS: Retrospective cohort analysis of 5114 PLHIV receiving care within a large HIV treatment program in Nigeria. We assessed the prevalence and burden of baseline symptoms reported during routine clinic visits from January 2015 to December 2017. Multivariable regression was used to identify relationships between 12-month retention and symptom dimensions (prevalence and burden) while controlling for demographic and other clinical variables. RESULTS: Increasing symptom burden was associated with higher likelihood of retention at 12 months (adjusted odds ratio [aOR] = 1.19 [95% confidence interval, CI: 1.09-1.29]; P < .001) as was the reporting of skin rashes/itching symptom (aOR = 2.59 [95% CI: 1.65-4.09]; P < .001). Likelihood of retention reduced with increasing World Health Organization (WHO) Clinical staging, with CD4 ≥500 cells/mL and self-reported heterosexual mode of HIV transmission. Conclusions: Symptom dimensions and standardized clinical/immunological measures both predicted retention in care, but effects differed in magnitude and direction. Standardized clinical/immunological measures in HIV care (eg, WHO clinical staging and CD4 count categories) can mask important differences in how PLHIVs experience symptoms and, therefore, their engagement with HIV care and treatment. Symptom management strategies are required alongside antiretroviral treatment to improve outcomes among PLHIV, including retention in care.

First report of camel contagious ecthyma in Nigeria.

Camel contagious ecthyma (CCE) is a viral disease of camelids that is caused by a Parapoxvirus (PPV) which is a DNA virus of the viral family: Poxviridae. Diseases affecting camels in Nigeria are scarcely reported. CCE or the laboratory detection of camel PPV (CPPV) has not been reported in Nigeria. This study investigated and described the clinical presentation of CCE and molecular detection of CPPV in Nigeria. Suspected cases of CCE were reported in a farm, live animal market and abattoir, in three different states (Bauchi, Plateau and Zamfara) in Northern Nigeria. Skin scabs, lungs, liver and intestine samples were collected. Polymerase chain reaction (PCR) was carried out using the primers which targets the RPO30 gene fragment of the genus PPV. The clinical signs observed from the suspected cases of CCE were proliferative skin lesions, papules, scabs on the lips and nares. CPPV was detected in 80.0% (4/5) of the samples collected by PCR. CCE was diagnosed based on clinical signs and PCR results. This is the first report of CCE in Nigeria. Further studies should be carried out to genetically characterize the CPPV circulating in Nigeria.

Loss to Follow-Up within the Prevention of Mother-to-Child Transmission Care Cascade in a Large ART Program in Nigeria.

BACKGROUND: The 2013 WHO guidelines incorporated simplified and more effective antiretroviral regimens for the purposes of preventing mother-to-child transmission of HIV. With ideal implementation of these recommendations, perinatal HIV transmission could be reduced to less than 2%. However, loss to follow-up (LTFU) has the potential to erode the success of programs and a number of studies report high rates of LTFU within the prevention of mother-to-child transmission (PMTCT) care cascade. We evaluated the timing and magnitude of LTFU in a large programmatic PMTCT cohort in Nigeria in order to focus future efforts to reduce loss in this high burden setting. METHODS: From 2004-2014, the APIN/Harvard PEPFAR program supported antenatal HIV screening for nearly one million pregnant women and provided PMTCT care to over 30,000 women. The care cascade for women enrolling in the PMTCT program includes antenatal, delivery, and infant follow-up services through 12-18 months of life. In this retrospective cohort analysis, we examined data collected between 2004-2014 from 31 clinical sites in Nigeria and assessed the numbers of mothers and infants enrolled and LTFU at various points along the care cascade. RESULTS: Among 31,504 women (median age 30, IQR: 27-34) entering PMTCT care during the antenatal period, 20,679 (66%) completed the entire cascade of services including antenatal, delivery, and at least one infant follow-up visit. The median gestational age at presentation for antenatal care services was 23 weeks (IQR: 17-29). The median infant age at last follow-up visit was 12 months (IQR: 5-18). The greatest loss in the PMTCT care cascade occurred prior to delivery care (21%), with a further 16% lost prior to first infant visit. Of the 38,223 women who entered at any point along the PMTCT cascade, an HIV DNA PCR was available for 20,202 (53%) of their infants. Among infants for whom DNA PCR results were available, the rate of HIV transmission for infants whose mothers received any antenatal and/or delivery care was 2.8% versus 20.0% if their mother received none. CONCLUSION: In this large cohort analysis, the proportion of women LTFU in the PMTCT care cascade was lower than that reported in previous cohort analyses. Nevertheless, this proportion remains unacceptably high and inhibits the program from maximally achieving the goals of PMTCT care. We also provide the largest analysis to date on rates of perinatal HIV transmission, with low rates among women receiving NNRTI- or PI-based regimens, approaching that reported in clinical trials. However, among mothers who received any antenatal care, infant outcomes were unknown for 48%, and women presented later in pregnancy than that recommended by current guidelines. Implementation research to evaluate ways to improve integration of services, particularly transitions from antenatal to delivery and pediatric care, are critically needed to reduce LTFU within PMTCT programs and achieve the ultimate goal of eliminating pediatric HIV infection.