HIV-related stigma and psychological distress in a cohort of patients receiving antiretroviral therapy in Nigeria.

Psychological distress is increasingly recognized as a barrier to engagement in HIV care, resulting in poor HIV outcomes. HIV-related stigma is a potential driver of distress in people living with HIV (PLWH). We conducted a prospective cohort study in 288 PLWH who newly initiated ART in a Nigeria. We assessed overall stigma (range 40-160) and four stigma subtypes (personalized, disclosure, negative self-image, and public stigma) at enrollment, and assessed psychological distress at enrollment, 6, and 12-months after ART initiation. We used logistic regression to assess the relationship between stigma and 12-month psychological distress. Overall stigma was high (102.34 ± 5.65) and was higher in both unmarried patients (p < 0.01) and those who had not disclosed their HIV status to anyone at enrollment (p < 0.01). Higher overall stigma (OR: 1.05, 95% CI 1.00-1.09) and personalized stigma (OR:1.08, 95% CI 1.00-1.16) were associated with higher odds of psychological distress at 12-months. Conclusions: Overall stigma levels were high in a cohort of PLWH initiating care in Nigeria. Higher stigma was associated with psychological distress. These data support the need for integration of measures to reduce stigma and psychological distress in the care of PLWH.

PEERNaija-a mobile health platform incentivizing medication adherence among youth living with HIV in Nigeria: study protocol for a randomized controlled trial.

BACKGROUND: Poor medication adherence is a major barrier to HIV control among youth living with HIV (Y-PLWH). The PEERNaija application (app) is an adapted smartphone app grounded in social cognitive and contigency management theories and designed to harness peer-based social incentives and conditional financial incentives to promote medication adherence. The app delivers a multifaceted medication adherence intervention including (1) peer-based social incentives, (2) financial incentives, (3) virtual peer social support, and (4) early clinic-based outreach for non-adherent Y-PLWH. A pilot trial of the app will be conducted in Nigeria, Africa's most populous country with the 4th largest HIV epidemic, and home to 10% of the world's four million Y-PLWH. METHODS: In this randomized controlled trial, we will compare implementation outcomes (feasibility, acceptability, appropriateness measured via validated scales, enrollment and application installation rates, feedback surveys and focus group discussions with participants, and back-end application data), and preliminary efficacy (in improving medication adherence and viral suppression) of the PEERNaija app at 6 months. Participants in Arm 1 (PEERNaija) will receive daily medication reminders, peer-based social incentives, and virtual peer social support. Participants in Arm 2 (PEERNaija +) will additionally receive a conditional financial incentive based on their adherence performance. Eligibility for Y-PLWH includes (1) being aged 14-29 years, (2) being on ART, (3) owning a smartphone, (4) being willing to download an app, and (5) being able to read simple text in English. DISCUSSION: This study will serve as the basis for a larger intervention trial evaluating the PEERNaija app (and the integration of mHealth, incentive, and peer-support-based strategies) to improve HIV outcomes in a critically important region of the world for Y-PLWH. TRIAL REGISTRATION: ClinicalTrials.gov. NCT04930198. First submitted date: May 25, 2021. Study start: August 1, 2021, https://clinicaltrials.gov/ . PROTOCOL VERSION: January 21, 2022.

Understanding why and how youth-friendly health services improve viral load suppression among adolescents and young people living with HIV in Nigeria: realist evaluation with qualitative comparative analysis.

INTRODUCTION: Youth-friendly health service (YFHS) approaches are essential to better outcomes for young people. We evaluated attainment of viral load suppression among young people living with HIV (YPLHIV) enrolled in an HIV treatment programme implementing YFHS models in Nigeria. METHODS: A realist evaluation using qualitative and quantitative programme data from 10 implementing health facilities. We used qualitative information to explore how and why viral load suppression was attained across different settings and quantitative data to describe patterns and associations between youth-friendly structures and processes of care, care retention and viral load suppression. To consolidate the theories, we used qualitative comparative analysis to identify the necessary and sufficient conditions for attaining viral load suppression, using 30 YPLHIV as cases. RESULTS: Between baseline (2018) and study-end (May 2022), viral load suppression coverage increased in 8 of the 10 study facilities. The number of facilities with viral load suppression coverage ≥90% rose from two to seven, while one facility remained unchanged, and another had a decline in coverage. Among the 30 selected YPLHIV cases, 18 had viral load suppression during the first test and 24 at the second test. However, viral load suppression attainment varied in different contexts. We identified the different YFHS interventions and key mechanisms that influenced viral load suppression in different contexts. CONCLUSION: YFHS interventions can improve young people's engagement with HIV services, but their effectiveness depends on specific mechanisms and contextual factors influencing their response to interventions. By exploring how and why viral load suppression was attained in different contexts, the findings will improve the design and implementation of strategies to improve outcomes in young people, which will be relevant for achievement of global goals to eliminate HIV by 2030.

Cervical cancer screening and treatment for PLWHIV: experiences from an innovative program in Nigeria.

BACKGROUND: We evaluated cervical cancer program for women living with HIV (WLHIV) to determine program screening rate, primary case finder screening accuracy and treatment and post-treatment screening rate among screen-positive patients. METHODS: A ten-month review of cervical cancer program data among WLHIV aged 15-49 years on HIV care across forty-one comprehensive ART sites, supported by APIN (a PEPFAR implementing partner) for cervical cancer screening and treatment in Nigeria, was conducted from October 2020 to July 2021. Initial screening was done using visual inspection with acetic acid (VIA) followed by a gynaecologist expert review through a program-designed software named AVIVA, as a confirmatory test. Associations were measured between the primary case finder screening accuracy and study covariates at p-value of 0.05. RESULTS: About 10,289 asymptomatic women aged 15-49 years living with HIV were screened for cervical cancer by primary case finders using VIA-based screening test. About 732 (7.1%) had a positive screening test suggestive of precancerous lesions or cervical cancer. Three hundred and fifteen (43.0%) of VIA positive women had treatment using thermal ablation and less than one-third (21.6%) of those treated came back for post-treatment screening test. Primary case finder screening sensitivity, specificity, positive predictive and negative predictive accuracy using gynaecologist review as confirmatory test were 60.8%, 71.5%, 41.7% and 84.5% respectively. Overall screening accuracy was 68.8%. CONCLUSION AND RECOMMENDATIONS: This innovative approach to cervical cancer screening among WLHIV yielded modest results in preventing program error and wastages. Wider deployment of expert-based reviews of VIA though AVIVA software might be a veritable approach to improve screening accuracy in low resource settings.

AVIVA: a telehealth tool to improve cervical cancer screening in resource-constrained settings.

Cervical cancer accounts for 21.7% of all cancer deaths in the sub-Saharan Africa with a case fatality rate of 68%. Nigeria's Federal Ministry of Health has adopted cervical cancer screening (CCS) using visual inspection with acetic acid or Lugol's iodine (VIA/VILI) and cryotherapy treatment for precancerous lesions as the preferred screening and treatment strategy. Using the Exploration, Preparation, Implementation and Sustainment Framework, our study documents our experience during the development, piloting and roll-out of the APIN Public Health Initiatives (APIN)-developed VIA Visual Application (AVIVA) for CCS using the VIA method in 86 APIN-supported health facilities across 7 states in Nigeria. Between December 2019 and June 2022, with the aid of 9 gynaecologists and 133 case finders, a total of 29 262 women living with HIV received VIA-based CCS and 1609 of them were VIA-positive, corresponding to VIA positivity rate of 5.5%. Over the 30 months duration and the 5 phases of CCS scale-up, AVIVA development and expansion, a total of 1247 cases were shared via the AVIVA App (3741 pictures), with 1058 of such cases undergoing expert review, corresponding to a reviewer rate of 84.8%. Overall, the use of the AVIVA App improved both the VIA-positive and VIA-negative concordance rates by 16 percentage points each (26%-42% and 80%-96%, respectively) from baseline to the end of the study. We concluded that the AVIVA App is an innovative tool to improve CCS rates and diagnostic precision by connecting health facility staff and expert reviewers in resource-limited settings.

Achieving a robust mentoring and research capacity program in a LMIC - the BRAINS faculty development model.

BACKGROUND: A research and training program (RTP) was carried out to build the capacity of faculty and improve the culture of research in the College of Medicine, University of Lagos (CMUL), Nigeria. METHODS: Realist-guided mixed methods evaluation of the BRAINS project was carried out using secondary data generated during the 5-years (2015 - 2020) of project implementation. Capacity building workshops and mentored research activities targeted at faculty in the CMUL were conducted. Overall, 1,418 participants attended the workshops in batches. Among the participants, forty-five faculty received grants and were mentored by senior professionals (local & international) to conduct research. Data were extracted from all project-related documents including coursework biodata, workshop evaluation forms, quarterly project reports, and end- of-project reports, submitted by the mentees, minutes of meetings, and the proposal submitted for funding. It was in the form of continuous variables and prose (sentences & stories). Quantitative data were analysed with IBM SPSS statistics version 20. Mean knowledge score and mean difference was calculated, paired t-test was carried out using p < 0.05 to determine statistical significance. The prose was thematically analysed to generate themes and narratives. Both were subsequently combined for interpretation and used to refine the initial programme theory into an evidence-informed theory. RESULTS: Twelve courses were deployed, and 1,418 participants (47.8% males and 52.2% females) from medical, nursing, and allied medical departments were trained. Eighty participants were trained in Responsible Conduct of Research and eighty-one on Manuscript Writing over three years. A comparison of the pre/post-test knowledge scores showed a positive mean difference. Thematic analysis of workshop data produced three thematic domains representing effectiveness and gains namely: cognitive, reward, and behavioural. 45 trainees were awarded grants and mentored, and analysis of mentee's data generated 4 themes: Achieving a robust mentoring program; Benefits of the mentoring program; Resilience in research; Improving the mentoring program. CONCLUSION: By contributing to the body of knowledge available on RTPs, this evaluation identified key components that contributed to the success of the project and developed a model for achieving a robust training and mentoring program which can be replicated in other LMICs.

Initial programme theory for community-based ART delivery for key populations in Benue State, Nigeria: a realist evaluation study.

BACKGROUND: The community-based antiretroviral therapy delivery (CBART) model was implemented in Benue State in Nigeria to increase access of key populations living with HIV (KPLHIV) to antiretroviral treatment. Key populations (KP) are female sex workers, men who have sex with men, persons who inject drugs, and transgender people. Evidence shows that the CBART model for KP (KP-CBART) can improve HIV outcomes along the cascade of HIV care and treatment in sub-Saharan Africa. However, how KP-CBART works, for whom, why, and under what circumstances it generates specific outcomes are not yet clear. Therefore, the aim of this study is to identify the initial programme theory (IPT) of the KP-CBART in Benue State using a realist approach. METHOD: The study design is exploratory and qualitative, exploring the implementation of KP-CBART. We reviewed the intervention logic framework & guidelines for the KP-CBART in Nigeria, conducted a desk review of KP-CBART in Sub-Saharan Africa (SSA) and interviewed programme managers in the Benue HIV programme between November 2021 and April 2022. Findings were synthesized using the Context-Mechanism-Outcome (CMO) heuristic tool to explain the relationship between the different types of CBART models, contextual factors, actors, mechanisms and outcomes. Using a generative causality logic (retroduction and abduction), we developed, following a realist approach, CMO configurations (CMOc), summarized as an empirically testable IPT. RESULT: We developed 7 CMOc and an IPT of the KP-CBART. Where KPLHIV receive ART in a safe place while living in a setting of punitive laws, harassment, stigma and discrimination, KP will adhere to treatment and be retained in care because they feel safe and trust the healthcare providers. Where KPLHIV are involved in the design, planning and implementation of HIV services; medication adherence and retention in care will improve because KP clients perceive HIV services to be KP-friendly and participate in KP-CBART. CONCLUSION: Implementation of CBART model where KPLHIV feel safe, trust healthcare providers, and participate in HIV service delivery can improve medication adherence and retention in care. This programme hypothesis will be tested and refined in the next phase of the realist evaluation of KP-CBART.

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.

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.

Psychological Distress Increases 30-Fold Among People with HIV in the First Year on ART in Nigeria-a Call for Integrated Mental Health Services.

BACKGROUND: Few studies have longitudinally assessed psychological distress among people with HIV (PWH) initiating ART in resource-limited settings. METHOD: Baseline, 6-month, and 12-month psychological distress were measured in a Nigerian cohort newly initiating therapy; the relationship between baseline factors and psychological distress at 12 months was assessed; and the association between psychological distress at 12 months and care retention or immunologic failure was determined. RESULTS: Among 563 patients, median age was 38 years (IQR: 33-46 years), 62% were female, and 51% were married. Psychological distress increased from 3% at baseline to 34% at 12 months. Age (aOR 1.28, 95% CI 1.06-1.56), female sex (aOR 2.89, 95% CI 1.93-4.33), lack of disclosure (aOR 4.32, 95% CI 2.48-7.51), and time on ART (6 months [aOR 6.91, 95% CI 3.14-15.18] and 12 months [aOR 32.63, 95% CI 16.54-64.36]) were associated with psychological distress while being married (OR 0.42, 95% CI 0.30-0.61) was associated with reduced odds. Tweve-month psychological distress was associated with increased risk of immunologic failure (aOR 2.22, 95% CI 1.31-3.82). CONCLUSION: The risk of psychological distress increased 30-fold in the first year on therapy in PWH in Nigeria.

Outcomes of a community-based antiretroviral therapy programme for key populations living with HIV in Benue State, Nigeria: protocol for a realist evaluation.

INTRODUCTION: Key populations (KP) living with HIV are underserved and often face social and health system barriers to HIV care. To optimise access to quality HIV services among KP, the WHO recommended community-based approaches to HIV service delivery for KP. However, to inform the successful rollout and scale-up of community-based antiretroviral therapy service delivery models for KP (KP-CBART), there is a need to study the programme implementation. This study aims to evaluate the outcomes of KP-CBART in Benue State Nigeria using a realist impact evaluation approach. Our evaluation question is: what are the mechanisms and context conditions that drive successful community-based implementation and how do these lead to better retention in care, treatment adherence and viral suppression among which categories of KP? METHODS AND ANALYSIS: This study will be conducted in three phases, relying on a mixed-method design and following the realist evaluation cycle. The first phase is the development of the initial programme theory grounded in a scoping review, programme and policy document review and in-depth interviews with key stakeholders. In phase 2, findings from case studies of KP-CBART programme implementation in one Nigerian state are used to test the initial programme theory and to refine it. The quantitative part is a retrospective cohort study. All HIV-positive KP clients enrolled into the KP-CBART between 2016 and 2020 will be included in the study. While maximum variation and data saturation will inform sample size for the qualitative part, an estimated 90 purposively selected study participants will be interviewed. In phase 3, findings will be synthesised into a middle-range theory through cross-case analysis. The heuristic intervention, context, agents, mechanisms and outcomes (ICAMO) tool will be used to refine the initial programme theory. ETHICS AND DISSEMINATION: The study protocol was approved by the Institutional Review Boards of APIN Public Health Initiatives (IRB022-FR), Institute of Tropical Medicine Antwerp (1503/21), and the Benue State Ministry of Health and Human Services (MOH/STA/204/VOL1/154). Written informed consent will be obtained from all study participants. Study results will be disseminated through stakeholders meeting, peer-reviewed journals and conferences.

Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance.

There is limited capacity and infrastructure in sub-Saharan Africa to conduct clinical trials for the identification of efficient and effective new prevention, diagnostic and treatment modalities to address the disproportionate burden of disease. This paper reports on the process to establish locally driven infrastructure for multicentre research and trials in Nigeria known as the Nigeria Implementation Science Alliance Model Innovation and Research Centres (NISA-MIRCs). We used a participatory approach to establish a research network of 21 high-volume health facilities selected from all 6 geopolitical zones in Nigeria capable of conducting clinical trials, implementation research using effectiveness-implementation hybrid designs and health system research. The NISA-MIRCs have a cumulative potential to recruit 60 000 women living with HIV and an age-matched cohort of HIV-uninfected women. We conducted a needs assessment, convened several stakeholder outreaches and engagement sessions, and established a governance structure. Additionally, we selected and trained a core research team, developed criteria for site selection, assessed site readiness for research and obtained ethical approval from a single national institutional review board. We used the Exploration, Preparation, Implementation, Sustainment framework to guide our reporting of the process in the development of this network. The NISA-MIRCs will provide a nationally representative infrastructure to initiate new studies, support collaborative research, inform policy decisions and thereby fill a significant research infrastructure gap in Africa's most populous country.

Long-term retention and predictors of attrition for key populations receiving antiretroviral treatment through community-based ART in Benue State Nigeria: A retrospective cohort study.

BACKGROUND: Key populations (KP) are disproportionately infected with HIV and experience barriers to HIV care. KP include men who have sex with men (MSM), female sex workers (FSW), persons who inject drugs (PWID) and transgender people (TG). We implemented three different approaches to the delivery of community-based antiretroviral therapy for KP (KP-CBART) in Benue State Nigeria, including One Stop Shop clinics (OSS), community drop-in-centres (DIC), and outreach venues. OSS are community-based health facilities serving KP only. DIC are small facilities led by lay healthcare providers and supported by an outreach team. Outreach venues are places in the community served by the outreach team. We studied long-term attrition of KP and virological non-suppression. METHOD: This is a retrospective cohort study of KP living with HIV (KPLHIV) starting ART between 2016 and 2019 in 3 0SS, 2 DIC and 8 outreach venues. Attrition included lost to follow-up (LTFU) and death. A viral load >1000 copies/mL showed viral non-suppression. Survival analysis was used to assess retention on ART. Cox regression and Firth logistic regression were used to assess risk factors for attrition and virological non-suppression respectively. RESULT: Of 3495 KPLHIV initiated on ART in KP-CBART, 51.8% (n = 1812) were enrolled in OSS, 28.1% (n = 982) in DIC, and 20.1% (n = 701) through outreach venues. The majority of participants were FSW-54.2% (n = 1896), while 29.8% (n = 1040), 15.8% (n = 551) and 0.2% (n = 8) were MSM, PWID, and TG respectively. The overall retention in the programme was 63.5%, 55.4%, 51.2%, and 46.7% at 1 year, 2 years, 3 years, and 4 years on ART. Of 1650 with attrition, 2.5% (n = 41) died and others were LTFU. Once adjusted for other factors (age, sex, place of residence, year of ART enrollment, WHO clinical stage, type of KP group, and KP-CBART approach), KP-CBART approach did not predict attrition. MSM were at a higher risk of attrition (vs FSW; adjusted hazard ratio (aHR) 1.27; 95%CI: 1.14-1.42). Of 3495 patients, 48.4% (n = 1691) had a viral load test. Of those, 97.8% (n = 1654) were virally suppressed. CONCLUSION: Although long-term retention in care is low, the virological suppression was optimal for KP on ART and retained in community-based ART care. However, viral load testing coverage was sub-optimal. Future research should explore the perspectives of clients on reasons for LTFU and how to adapt approach to CBART to meet individual client needs.

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.

Derangement of protein S and C4b-binding protein levels as acquired thrombophilia in HIV-infected adult Nigerians.

BACKGROUND: HIV is a chronic inflammatory state with the production of many acute-phase-reactant proteins. Some of these proteins have procoagulant activities that predispose HIV-infected patients to thrombosis. OBJECTIVES: The aim of the study was to evaluate the effects of HIV infection on the serum levels of C4b-binding protein (C4BP) and protein S as markers of predisposition to thrombosis in HIV-infected adults. METHODS: The study population comprised of 61 HIV-infected adults on antiretroviral treatment (ART) who had achieved virological suppression, 58 HIV-infected adults not yet on ART and 59 HIV-negative healthy controls. The serum levels of free protein S, C4BP and the euglobulin clot lysis time (ECLT) were determined. RESULTS: The mean plasma-free protein S level of HIV-infected patients on ART (86.9% ± 25.8%) was significantly higher than that of treatment-naïve HIV-infected patients (75.7% ± 27.3%) (p = 0.005). Conversely, there was no statistically significant difference between the protein S levels of the HIV-infected subjects on ART (86.9% ± 25.8%) and those of the controls (94.9% ± 7.9%) (p = 0.119). The mean C4BP was significantly higher in the treatment-naïve HIV-infected subjects (36.7 ± 1.7 ng/dL) than that in those on ART (30.7 ± 2.6 ng/dL) and that in the controls (22.4 ± 2.4 ng/dL) (p < 0.0001). Protein S deficiency was more prevalent among the subjects with elevated C4BP (p = 0.023). The mean ECLT was significantly more prolonged in the treatment-naïve HIV-infected subjects (241.9 ± 34.7 s) than controls (189.5 ± 40.7 s) (p < 0.0001). CONCLUSION: HIV infection causes elevated levels of C4BP and diminishes the serum levels of free protein S. We infer that the risk of thrombosis (as measured by these biomarkers) decreases with the use of antiretroviral drugs.

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.

Early detection of Pre-XDR TB with line probe assay in a high TB burden country.

BACKGROUND: Worldwide, tuberculosis (TB) is one of the top 10 causes of death. Drug resistant tuberculosis has lately become a major public health problem that threatens progress made in Tuberculosis (TB) care and control worldwide. The aim of this study was to determine the prevalence of Pre-extensive drug resistant TB among MDR TB in North Central of Nigeria. METHODS: This study was conducted from October, 2018 to August, 2019 with 150 samples. In Nigeria, guidelines for DR-TB as recommended by WHO is followed. All the samples from the patients who gave their consent were transported to a zonal reference TB laboratory (ZRL). RESULTS: Mean age was 38.6 ± 13.4 years with peak age at 35-44. Out of these 103 samples processed with LPA, 101(98%) were rifampicin resistant and 2 were rifampicin sensitive, 99(96%) were INH resistant and 4 (4%) were INH sensitive, 5(5%) were fluoroquinolone resistant, 98(95%) were fluoroquinolone sensitive, 12 (12%) were Aminoglycoside + Capreomycin resistant, 91(83%) were Aminoglycoside + Capreomycin sensitive. CONCLUSION: Multidrug resistant TB and its severe forms (Pre-extensive & extensively drug resistant TB) can be detected early with rapid tool- Line Probe Assay rapid and prevented timely by early initiation on treatment.

PEERNaija: A Gamified mHealth Behavioral Intervention to Improve Adherence to Antiretroviral Treatment Among Adolescents and Young Adults in Nigeria.

BACKGROUND: HIV is the leading cause of death for youth in Sub-Saharan Africa (SSA). The rapid proliferation of smart phones in SSA provides an opportunity to leverage novel approaches to promote adherence to life-saving antiretroviral therapy (ART) for adolescents and young adults living with HIV (AYA-HIV) that go beyond simple medication reminders. METHODS: Guided by the Integrate, Design, Assess and Share (IDEAS) framework, our multidisciplinary team developed a peer-based mHealth ART adherence intervention-PEERNaija. Grounded in Social Cognitive Theory, and principles of contingency management and supportive accountability, PEERNaija delivers a multi-faceted behavioral intervention within a smartphone application to address important obstacles to adherence. RESULTS: PEERNaija was developed as a gamified Android-based mHealth application to support the behavioral change goal of improving ART adherence among AYA-HIV within Nigeria, a low- and middle- income country (LMIC). Identified via foundational interviews with the target population and review of the literature, key individual (forgetfulness and poor executive functioning), environmental (poor social support) and structural (indirect cost of clinic-based interventions) barriers to ART adherence for AYA-HIV informed application features. Further informed by established behavioral theories and principles, the intervention aimed to improve self-efficacy and self-regulation of AYA-HIV, leverage peer relationships among AYA to incentivize medication adherence (via contingency management, social accountability), provide peer social support through an app-based chat group, and allow for outreach of the provider team through the incorporation of a provider application. Gamification mechanics incorporated within PEERNaija include: points, progress bar, leaderboard with levels, achievements, badges, avatars and targeted behavior change messages. PEERNaija was designed as a tethered mobile personal health record application, sharing data to the widely deployed OpenMRS electronic health record application. It also uses the secure opensource Nakama gamification platform, in line with Principles of Digital Development that emphasize use of opensource systems within LMICs. CONCLUSIONS: Theory-based gamified mHealth applications that incorporate social incentives have the potential to improve adherence to AYA-HIV. Ongoing evaluations of PEERNaija will provide important data for the potential role for a gamified, smartphones application to deliver multifaceted adherence interventions for vulnerable AYA-HIV in SSA.

Rifabutin pharmacokinetics and safety among TB/HIV-coinfected children receiving lopinavir/ritonavir-containing second-line ART.

BACKGROUND: Treatment options are limited for TB/HIV-coinfected children who require PI-based ART. Rifabutin is the preferred rifamycin for adults on PIs, but the one study evaluating rifabutin with PIs among children was stopped early due to severe neutropenia. METHODS: We evaluated rifabutin safety and plasma pharmacokinetics among coinfected children 3-15 years of age receiving rifabutin 2.5 mg/kg daily with standard doses of lopinavir/ritonavir. The AUC0-24 at 2, 4 and 8 weeks after rifabutin initiation was described using intensive sampling and non-compartmental analysis. Clinical and laboratory toxicities were intensively monitored at 12 visits throughout the study. RESULTS: Among 15 children with median (IQR) age 13.1 (10.9-14.0) years and weight 25.5 (22.3-30.5) kg, the median (IQR) rifabutin AUC0-24 was 5.21 (4.38-6.60) µg·h/mL. Four participants had AUC0-24 below 3.8 µg·h/mL (a target for the population average exposure) at week 2 and all had AUC0-24 higher than 3.8 µg·h/mL at the 4 and 8 week visits. Of 506 laboratory evaluations during rifabutin, grade 3 and grade 4 abnormalities occurred in 16 (3%) and 2 (0.4%) instances, respectively, involving 9 (60%) children. Specifically, grade 3 (n = 4) and grade 4 (n = 1) neutropenia resolved without treatment interruption or clinical sequelae in all patients. One child died at week 4 of HIV-related complications. CONCLUSIONS: In children, rifabutin 2.5 mg/kg daily achieved AUC0-24 comparable to adults and favourable HIV and TB treatment outcomes were observed. Severe neutropenia was relatively uncommon and improved with ongoing rifabutin therapy. These data support the use of rifabutin for TB/HIV-coinfected children who require lopinavir/ritonavir.