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Abstract Background World Health Organization recommended community-based ART (CBART) approaches to improve access to antiretroviral treatment (ART) and treatment outcomes among key populations living with (KPLHIV). Key populations (KP) are female sex workers, men who have sex with men, persons who inject drugs, and transgender people. How CBART for KP (KP-CBART) worked and why, for whom and in what circumstances it worked within KP communities or at community sites, are yet to be described. The aim of this study is to describe the different KP-CBART approaches or models in Nigeria, identifying the context conditions and mechanisms that are likely to produce the desired outcomes. Method Building on our previous study eliciting an initial programme theory for KP-CBART, we used a multiple case design and cross-case analysis to evaluate 3 KP-CBART approaches, namely: One Stop Shop clinic; community drop-in centre; and outreach venue. Between 2021 and 2023, we conducted a retrospective cohort study, 99 indepth interviews and 5 focused group discussions with various actors. Using realist evaluation, we synthesised context-mechanism-outcome configurations (CMOCs) and developed programme theory for each of the cases and an overall theory. Result The analysis showed the central importance of decentralizing ART service delivery to a safe place within the community for KPLHIV. The provision of ART in a KP friendly environment triggered a feeling of safety and trust in the healthcare workers among KPLHIV, resulting in KP-CBART acceptance and improved ART uptake, medication adherence and retention on ART. KP community engagement in ART delivery, peer support through support group meetings, and linkages with KP-led organizations improved self-efficacy, fostered solidarity and a sense of belonging among KP. These resources encouraged and motivated clients to engage with the KP-CBART model. However, fear of disclosure of HIV and KP status, and lack of trust between KP groups, demotivated and discouraged KPLHIV from initiating ART and continuing their treatment in KP-CBART. Conclusion To optimise access to ART and treatment outcomes for KPLHIV, policy makers and health practitioners should ensure the provision of a safe place for ART service delivery that can be trusted by the clients and the KP communities.

Background: The combined effect of the aging human immunodeficiency virus (HIV) population, HIV’s natural progression, and HIV drugs have great implications for comorbidity burden and hypertension control among people living with HIV (PLHIV). Objectives: This study assessed hypertension burden, treatment outcomes, and treatment outcome predictors among PLHIV in Nigeria. Design: Cross-sectional design. Methods: A cross-sectional study of 2613 adult PLHIV who initiated antiretroviral therapy (ART) between 2004 and 2020 in two HIV clinics in Northern and Southern Nigeria. Study outcomes were: (1) controlled blood pressure defined as two consecutive blood pressure (BP) measurements of

Background: Understanding the time to hypertension occurrence after antiretroviral treatment (ART) initiation in people living with HIV (PLHIV) and its determinants is important for designing interventions for control. Objective: This study sought to estimate the median time of ART use to hypertension onset and its predictors in Nigerian PLHIV. Design: A retrospective longitudinal study. Methods: This retrospective review of 2503 normotensive adult PLHIV (⩾18 years) from 2004 to 2020 in two HIV clinics in Nigeria. Incident hypertension was based on clinical diagnosis or two consecutive blood pressure readings ⩾140/90 mmHg, taken during the 8 months of data collection. Survival event was defined as incident hypertension during follow-up or interview day for observed patients unless they were right censored. The Kaplan-Meier survival curve was used to estimate the survival probabilities of hypertension. The Cox proportional hazard model was fitted to identify predictors of hypertension at p

Abstract 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.

Abstract 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.

Abstract 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

Abstract 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.

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 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.

Objective: High-risk behaviors among MSM have continually made this group susceptible to HIV and other STIs. Therefore, the study seeks to assess the prevalence of high-risk behaviors among MSM in Nigeria. Methodology: This quantitative descriptive cross-sectional survey examined the high-risk behaviors among MSM. The study was conducted in the state's three local government areas using a multistage cluster sampling technique. Data collection was done using an interviewer-administered structured questionnaire, and analysis was performed with IBM-SPSS version 25.0. Result: A significant number, 91.2% (114) of MSM in Benue State, had anal sex but mostly without protection, 75.2% (94). However, 108 (94.7%) used lubricants during anal sex, particularly those with multiple sexual partners (79, 63.2%). Also, 66 (52.8%) used/inject drugs. Sexual health was also challenging as 110 (88.0%) had been diagnosed with STIs. Most participants with STIs (118, 94.3%) said their sexual partner infected them. A substantial proportion, 16 (76.2%) of MSM aged 18-20 years, were using or injecting drugs, likewise those aged 21-25 years (14, 63.6%) (p

Abstract 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.

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.

Abstract 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 – 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

Abstract Background In Nigeria, there is an estimated 1.9 million people living with HIV (PLHIV), 53% of whom utilize HIV care and services. With decreasing HIV-related deaths and increasing new infections, HIV with its associated comorbidities continue to be a key public health challenge in Nigeria. Untreated, comorbid mental disorders are a critical but potentially modifiable determinant of optimal HIV treatment outcomes. This study aimed to identify the challenges and opportunities related to integrating mental health care into existing HIV programs in Nigeria. Method Attendees at the Nigeria Implementation Science Alliance (NISA)‘s 2019 conference participated in nominal group technique (NGT) exercise informed by the “Exploration, Preparation, Implementation, and Sustainment (EPIS)” framework. The NGT process was conducted among the nominal groups in two major sessions of 30-min phases followed by a 30-min plenary session. Data analysis proceeded in four steps: transcription, collation, theming and content analysis. Results The two major theoretical themes from the study were – opportunities and challenges of integrating mental health treatment into HIV services. Three sub-themes emerged on opportunities: building on health care facilities for HIV services (screening, counseling, task-sharing monitoring and evaluation frameworks), utilizing existing human resources or workforce in HIV programs (in-service training and including mental health in education curriculum) and the role of social and cultural structures (leveraging existing community, traditional and faith-based infrastructures). Four sub-themes emerged for challenges: double burden of stigma and the problems of early detection (HIV and mental health stigma, lack of awareness), existing policy gaps and structural challenges (fragmented health system), limited human resources for mental health care in Nigeria (knowledge gap and burnout) and dearth of data/evidence for planning and action (research gaps). Conclusions Potential for integrating treatments for mental disorders into HIV programs and services exist in Nigeria. These include opportunities for clinicians’ training and capacity building as well as community partnerships. Multiple barriers and challenges such as stigma, policy and research gaps would need to be addressed to leverage these opportunities. Our findings serve as a useful guide for government agencies, policy makers and research organizations to address co-morbid mental disorders among PLHIV in Nigeria.

Abstract Background Expanded access to combination antiretroviral therapy (cART) throughout sub-Saharan Africa over the last decade has remarkably improved the prognosis of persons living with HIV (PLWH). However, some PLWH experience virologic rebound after a period of viral suppression, usually followed by selection of drug resistant virus. Determining factors associated with drug resistance can inform patient management and healthcare policies, particularly in resource-limited settings where drug resistance testing is not routine. Methods A case–control study was conducted using data captured from an electronic medical record in a large treatment program in Nigeria. Cases PLWH receiving cART who developed acquired drug resistance (ADR) and controls were those without ADR between 2004 and 2011. Each case was matched to up to 2 controls by sex, age, and education. Logistic regression was used estimate odds ratios (ORs) and 95% confidence intervals (CIs) for factors associated with ADR. Results We evaluated 159 cases with ADR and 299 controls without ADR. In a multivariate model, factors associated with ADR included older age (OR = 2.35 [age 30–40 years 95% CI 1.29, 4.27], age 41 + years OR = 2.31 [95% CI 1.11, 4.84], compared to age 17–30), higher education level (secondary OR 2.14 [95% CI 1.1.11–4.13]), compared to primary and tertiary), non-adherence to care (OR = 2.48 [95% CI 1.50–4.00]), longer treatment duration (OR = 1.80 [95% CI 1.37–2.35]), lower CD4 count((OR = 0.95 [95% CI 0.95–0.97]) and higher viral load (OR = 1.97 [95% CI 1.44–2.54]). Conclusions Understanding these predictors may guide programs in developing interventions to identify patients at risk of developing ADR and implementing prevention strategies.

Abstract Background We identified a HIV-positive cohort in virologic failure (VF) who re-suppressed without drug switch. We characterized their drug resistance mutations (DRM) and adherence profiles to learn how to better manage HIV drug resistance. A retrospective cohort study utilizing clinical data and stored samples. Patients received ART at three Nigerian treatment centres. Plasma samples stored when they were in VF were genotyped. Result Of 126 patients with samples available, 57 were successfully genotyped. From ART initiation, the proportion of patients with adherence ≥90% increased steadily from 54% at first high viral load (VL) to 67% at confirmed VF, and 81% at time of re-suppressed VL. Sixteen (28%) patients had at least one DRM. Forty-six (81%) patients had full susceptibility to the three drugs in their first-line (1 L) regimen. Thirteen (23%) were resistant to at least one antiretroviral drug but three were resistant to drugs not used in Nigeria. Ten patients had resistance to their 1 L drug(s) and six were fully susceptible to the three drugs in the recommended second-line regimen. Conclusion This cohort had little drug resistance mutations. We conclude that if adherence is not assured, patients could exhibit virologic failure without having developed mutations associated with drug resistance.

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.

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.

BackgroundIneffective 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.MethodsThe 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.ResultsOf 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.ConclusionsActive 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.

BackgroundKey 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.MethodThis 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.ResultOf 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.ConclusionAlthough 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.

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.

BackgroundGlobal HIV funding cutbacks have been accompanied by the adoption of user fees to address funding gaps in treatment programs. Our objective was to assess the impact of user fees on HIV care utilization and medication adherence in Nigeria.MethodsWe conducted a retrospective analysis of patients enrolled in care before (October 2012-September 2013) and after (October 2014-September 2015) the introduction of user fees in a Nigerian clinic. We assessed pre- vs. post-user fee patient characteristics and enrollment trends, and determined risk of care interruption, loss to follow-up, and optimal medication adherence.ResultsAfter fees were instituted, there was a 66% decline in patient enrollment and 75% decline in number of ART doses dispensed. There was no difference in the proportion of female clients (64% vs 63%, p = 0.46), average age (36 vs. 37 years, p = 0.15), or median baseline CD4 (220/ul vs. 222/uL, p = 0.24) in pre- and post-fee cohorts. There was an increase in clients employed and/or had tertiary education (24% vs. 32%, pConclusionsPatients enrolled in care after introduction of user fees in Nigeria were more likely to be educated or employed, and effectively retained in care after starting ART. However, fees were accompanied by a drastic reduction in new patient enrollment, suggesting that many patients may have been marginalized from HIV care.

IntroductionHIV is a highly diverse virus with significant genetic variability which may confer biologic differences that could impact on treatment outcomes.Materials and methodsWe studied the association between HIV subtypes and immunologic and virologic outcomes in a longitudinal cohort of 169 patients on combination antiretroviral therapy. Participants were followed up for 5 years. Demographic data, CD4 cell count and viral loads (VL) were extracted from medical records. Whole protease gene and codon 1-300 of the reverse transcriptase gene were sequenced and analysed.ResultsSixty-four percent of participants were females with a median age of 35 years. Twelve different subtypes were observed, the commonest being CRF 02_AG (55.0%) and subtypes G (23.1%). All subtypes showed steady rise in CD4 count and there was no difference in proportion who achieved CD4+ cell count rise of ≥100 cells/μL from baseline within 12 months' post-initiation of ART, or ≥350 cells/μL at 60 months' post-initiation. Median time to attaining a rise of ≥350 cells/μL was 24 months (6-48 months). The proportion that achieved undetectable VL at month 6 and 12 post-initiation of ART were comparable across subtypes. At end of 5th year, there was no statistical difference in proportion with virologic failure.ConclusionNo association between HIV subtypes and immunologic or virologic response to therapy was observed, suggesting that current first-line ART may have similar efficacy across subtype predominating in South-West Nigeria.

IntroductionAdherence to antiretroviral therapy (ART) and retention in treatment programs are required for successful virologic suppression and treatment outcomes. As the number of adolescents living with HIV continues to increase globally, more information about adherence and retention patterns during and through transition from child- to adult-centered care is needed to ensure provision of a high level of care and inform development of targeted interventions to improve patient outcomes in this vulnerable population. In this analysis, we sought to describe long-term trends in adherence, retention, and virologic suppression in adolescents receiving ART at a pediatric HIV clinic in Nigeria through transition to the adult clinic.SettingThe Jos University Teaching Hospital, United States President's Emergency Plan for AIDS Relief (PEPFAR)-funded HIV clinic in Jos, Plateau State, Nigeria.MethodsWe conducted a retrospective observational longitudinal evaluation of data that had been collected during the course of care in a large pediatric ART program in Nigeria. We used descriptive statistics to define our patient population and quantify retention from ART initiation through adolescence and transition to adult-centered care. Logistic regression was used to evaluate predictors of loss to follow-up. We used medication possession ratio (MPR) to quantify adherence for each year a patient was on ART. To evaluate adherence and virologic suppression, we measured the proportion of patients with ≥95% MPR and the proportion with virologic suppression (viral load ≤400 copies/mL) within each age cohort, and used bivariate analyses to examine any association between MPR and VL suppression for all person-years observed.ResultsA total of 476 patients received at least one dose of ART as an adolescent (ages 10-19 years). The proportions of patients lost to follow-up were: 11.9% (71/597) prior to adolescence, 19.1% (31/162) during adolescence, and 13.7% (10/73) during transition to adult-centered care. While over 80% of patients had ≥95% medication adherence in all age groups, their viral load suppression rates through adolescence and post-transition were only 55.6%-64.0%. For patients that successfully transitioned to adult-centered care, we observed 87.7% (50/57) retention at month 12 post-transition, but only 34.6% (9/26) viral load suppression.ConclusionsOur evaluation found considerable proportions of adolescents lost to follow-up throughout the ART program cascade. We also found discrepancies between the proportions of patients with ≥95% MPR and the proportions with VL suppression, suggesting that true medication adherence in this population may be poor. Significant attention and targeted interventions to improve retention and adherence focused on adolescents are needed in order for global programs to achieve 90-90-90 goals.

Abstract Background Despite being disproportionately burdened by preventable diseases than more advanced countries, low- and middle-income countries (LMICs) continue to trail behind other parts of the world in the number, quality and impact of scholarly activities by their health researchers. Our strategy at the Nigerian Implementation Science Alliance (NISA) is to utilise innovative platforms that catalyse collaboration, enhance communication between different stakeholders, and promote the uptake of evidence-based interventions in improving healthcare delivery. This article reports on findings from a structured group exercise conducted at the 2016 NISA Conference to identify (1) gaps in developing research capacity and (2) potential strategies to address these gaps. Methods A 1-hour structured group exercise was conducted with 15 groups of 2–9 individuals (n = 94) to brainstorm gaps for implementation, strategies to address gaps and to rank their top 3 in each category. Qualitative thematic analysis was used. First, duplicate responses were merged and analyses identified emerging themes. Each of the gaps and strategies identified were categorised as falling into the purview of policy-makers, researchers, implementing partners or multiple groups. Results Participating stakeholders identified 98 gaps and 91 strategies related to increasing research capacity in Nigeria. A total of 45 gaps and an equal number of strategies were ranked; 39 gaps and 43 strategies were then analysed, from which 8 recurring themes emerged for gaps (lack of sufficient funding, poor research focus in education, inadequate mentorship and training, inadequate research infrastructure, lack of collaboration between researchers, research-policy dissonance, lack of motivation for research, lack of leadership buy-in for research) and 7 themes emerged for strategies (increased funding for research, improved research education, improved mentorship and training, improved infrastructure for research, increased collaboration between academic/research institutions, greater engagement between researchers and policy-makers, greater leadership buy-in for research). Conclusions The gaps and strategies identified in this study represent pathways judged to be important in increasing research and implementation science capacity in Nigeria. The inclusion of perspectives and involvement of stakeholders who play different roles in policy, research and implementation activities makes these findings comprehensive, relevant and actionable, not only in Nigeria but in other similar LMICs.

Abstract Background Adolescents living with HIV (ALHIV) have worse health outcomes than other populations of people living with HIV. Contributing factors include lack of standard and comprehensive procedures for ALHIV transitioning from pediatric to adult care. This has contributed to poor retention at, and following transition, which is problematic especially in high ALHIV-burden, resource-limited settings like Nigeria. Methods Using a two-arm cluster randomized control design, the Adolescent Coordinated Transition (ACT) trial will measure the comparative effectiveness of a graduated transition and organized support group intervention against the usual practice of abrupt transfer of Nigerian ALHIV from pediatric to adult care. This study will be conducted at 12 secondary and tertiary healthcare facilities (six intervention, six control) across all six of Nigeria’s geopolitical zones. The study population is 13- to 17-year-old ALHIV (N = 216, n = 108 per study arm) on antiretroviral therapy. Study participants will be followed through a 12-month pre-transfer/transition period and for an additional 24 months post transfer/transition. The primary outcome measure is the proportion of ALHIV retained in care at 12 and 24 months post transfer. Secondary outcome measures are proportions of ALHIV achieving viral suppression and demonstrating increased psychosocial wellbeing and self-efficacy measured by psychometric tests including health locus of control, functional social support, perceived mental health, and sexual risk and behavior. Discussion We hypothesize that the ACT intervention will significantly increase psychosocial wellbeing, retention in care and ultimately viral suppression among ALHIV. ACT’s findings have the potential to facilitate the development of standard guidelines for transitioning ALHIV and improving health outcomes in this population. The engagement of a consortium of local implementing partners under the Nigeria Implementation Science Alliance allows for nationwide study implementation and expedient results dissemination to program managers and policy-makers. Ultimately, ACT may also provide evidence to inform transitioning guidelines not only for ALHIV but for adolescents living with other chronic diseases in resource-limited settings. Trial registration ClinicalTrials.gov, ID: NCT03152006. Registered on May 12, 2017.

Abstract Background For patients on antiretroviral therapy (ART), treatment interruptions can impact patient outcomes and result in the accumulation of drug resistance mutations leading to virologic failure. There are minimal published data on the impact of an ART stock shortage on development of drug resistance mutations (DRMs). In this report, we evaluate data from patients enrolled in the Government of Nigeria National ART Program that were receiving treatment at the time of a national drug shortage in late 2003. Methods We conducted a cross-sectional evaluation of samples collected between December 2004 and August 2005 from ART patients in virologic failure that either had a treatment interruption or did not during the late 2003 drug shortage period at the Jos University Teaching Hospital (JUTH). Plasma virus was genotyped, sequence data were edited and analyzed, and mutation profiles were categorized to evaluate predicted drug susceptibility. Data were analyzed to examine factors associated with development of resistance mutations. A genotypic sensitivity score to the alternate recommended regimen was computed to assess drug susceptibility if regimens were changed. Results A total of 56 patients were included in this evaluation (28 interrupted, 28 uninterrupted). Patients in the interrupted group had more DRMs than those in the uninterrupted group (p

Background: Contextual research evidence is needed to reduce morbidity and mortality due to chronic but preventable diseases in low- and middle-income countries. Nigeria, Africa’s most populous country, is particularly burdened by these diseases despite its academic and research infrastructure. A major impediment to developing robust evidence on sustainable disease prevention and treatment strategies is the lack of skilled research personnel. Objective: This study aimed to identify (1) training barriers for research assistants and coordinators and (2) potential strategies to counter these barriers using a Nominal Group Technique (NGT) exercise conducted at the 2017 conference of the Nigeria Implementation Science Alliance (NISA). Method: A one-hour NGT exercise was conducted with 26 groups of 2–9 persons each (N = 134) drawn from conference attendees. Group members were presented with questions related to the two objectives. Each member was asked to generate, list, discuss and vote on ideas that were eventually ranked by the group. Qualitative Thematic Analysis (QTA) was conducted for the collated responses. Findings: The QTA identified 166 training gaps and 147 potential solutions, out of which 104 were ranked. Themes that emerged for gaps included: 1) inadequate mentorship; 2) inadequate training/ lack of organized curriculum; 3) limited access to opportunities for training and employment; 4) lack of government funding; 5) lack of interest, motivation; and 6) lack of research culture. Themes for potential strategies to address the gaps were: 1) trainings/curriculum development; 2) research modules implemented in secondary and tertiary institutions; 3) creating a sustainable forum for research-related questions and answers; and 4) advocating for and accessing more government funding for research training. Conclusion: This study identified actionable strategies that reflect practical realities in implementation research in Nigeria, which can guide government agencies, policy makers, research organizations, and local foundations as they work together to increase research capacity in Nigeria.

The transition to PEPFAR 2.0 with its focus on country ownership was accompanied by substantial funding cuts. We describe the impact of this transition on HIV care in a large network of HIV clinics in Nigeria. We surveyed 30 comprehensive HIV treatment clinics to assess services supported before (October 2013-September 2014) and after (October 2014-September 2015) the PEPFAR funding policy change, the impact of these policy changes on service delivery areas, and response of clinics to the change. We compared differences in support for staffing, laboratory services, and clinical operations pre- and post-policy change using paired t-tests. We used framework analysis to assess answers to open ended questions describing responses to the policy change. Most sites (83%, n = 25) completed the survey. The majority were public (60%, n = 15) and secondary (68%, n = 17) facilities. Clinics had a median of 989 patients in care (IQR: 543-3326). All clinics continued to receive support for first and second line antiretrovirals and CD4 testing after the policy change, while no clinics received support for other routine drug monitoring labs. We found statistically significant reductions in support for viral load testing, staff employment, defaulter tracking, and prevention services (92% vs. 64%, p = 0.02; 80% vs. 20%, 100% vs. 44%, 84% vs. 16%, respectively, p

Objectives and Method: There are growing concerns of tenofovir disoproxil fumarate (TDF)–associated renal toxicity. We evaluated the effect of long-term TDF exposure on renal function in a cohort of HIV-1-infected Nigerians between 2006 and 2015. Multivariate logistic regression was used to identify predictors of renal impairment at different time over 144 weeks of antiretroviral therapy (ART). Results: Data of 4897 patients, median age 42 years (interquartile range: 36-49), and 61% females were analyzed. The prevalence of renal impairment increased from 10% at week 24 to 45% at 144 weeks in TDF-exposed participants compared to an increase from 8% at 24 weeks to 14% at 144 weeks in TDF-unexposed participants. Tenofovir disoproxil fumarate exposure predicted the risk of renal impairment at 144 weeks of ART (odds ratio: 2.36; 95% confidence interval: 1.28-4.34). Conclusion: Long-term exposure to TDF-based ART significantly increases the likelihood of renal impairment. The continued use of TDF-based regimen in our setting should be reviewed. We recommend the urgent introduction of tenofovir alafenamide–based regimen in the HIV treatment guidelines of Nigeria and other resource-limited countries.

The authors conducted a retrospective cohort study of unplanned care interruption (UCI) among adults initiating antiretroviral therapy (ART) from 2009 to 2011 in a Nigerian clinic. The authors used repeated measures regression to model the impact of UCI on CD4 count upon return to care and rate of CD4 change on ART. Among 2496 patients, 83% had 0, 15% had 1, and 2% had ≥2 UCIs. Mean baseline CD4 for those with 0, 1, or ≥2 UCIs was 228/cells/mm 3 , 355/cells/mm 3 , and 392/cells/mm 3 ( P < .0001), respectively. The UCI was associated with a 62 CD4 cells/mm 3 decrease (95% confidence interval [CI]: −78 to −45) at next measurement. In months 1 to 6 on ART, patients with 0 UCI gained 10 cells/µL/mo (95% CI: 7-4). Those with 1 and ≥2 UCIs lost 2 and 5 cells/µL/mo (95% CI: −18 to 13 and −26 to 16). Patients with UCI did not recover from early CD4 losses associated with UCI. Preventing UCI is critical to maximize benefits of ART.

Background. Decentralization of care and treatment for HIV infection in Africa makes services available in local health facilities. Decentralization has been associated with improved retention and comparable or superior treatment outcomes, but patient experiences are not well understood. Methods. We conducted a qualitative study of patient experiences in decentralized HIV care in Plateau State, north central Nigeria. Five decentralized care sites in the Plateau State Decentralization Initiative were purposefully selected. Ninety-three patients and 16 providers at these sites participated in individual interviews and focus groups. Data collection activities were audio-recorded and transcribed. Transcripts were inductively content analyzed to derive descriptive categories representing patient experiences of decentralized care. Results. Patient participants in this study experienced the transition to decentralized care as a series of “trade-offs.” Advantages cited included saving time and money on travel to clinic visits, avoiding dangers on the road, and the “family-like atmosphere” found in some decentralized clinics. Disadvantages were loss of access to ancillary services, reduced opportunities for interaction with providers, and increased risk of disclosure. Participants preferred decentralized services overall. Conclusion. Difficulty and cost of travel remain a fundamental barrier to accessing HIV care outside urban centers, suggesting increased availability of community-based services will be enthusiastically received.

Correction In the original publication [1] the figure captions of Figs. 2 and 3 were reversed. The correct version can be found in this Erratum.

Objectives: We examined the association between adherence to drug-refill visits and virologic outcomes in a cohort of HIV-infected adults on combination antiretroviral therapy (cART) in North Central Nigeria. Methods: Retrospectively, 588 HIV-infected, cART-naive adults (aged ≥15 years), initiated on first-line ART between 2009 and 2010 at the Jos University Teaching Hospital, were evaluated. Association between adherence to drug-refill visits, virologic (viral load > 1000 copies/mL), and immunologic failure was assessed using multivariable logistic regression. Results: After a median of 12 months on cART, 16% (n = 94) and 10% (n = 59) of patients had virologic and immunologic failures, respectively. In the final multivariable model, suboptimal adherence to drug-refill visits was a significant predictor of both virologic (adjusted odds ratio [AOR] 1.6; 95% confidence interval [CI]:1.2–2.3) and immunologic (AOR 1.92; 95% CI:1.06–3.49) failures. Conclusion: Adherence to drug refill is a useful predictor of successful virologic control and could be utilized for routine monitoring of adherence to cART in our clinical setting.

Introduction: From 2004–2012, the Harvard/AIDS Prevention Initiative in Nigeria, funded through the US President’s Emergency Plan for AIDS Relief programme, scaled up HIV care and treatment services in Nigeria. We describe the methodologies and collaborative processes developed to improve laboratory capacity significantly in a resource-limited setting. These methods were implemented at 35 clinic and laboratory locations. Methods: Systems were established and modified to optimise numerous laboratory processes. These included strategies for clinic selection and management, equipment and reagent procurement, supply chains, laboratory renovations, equipment maintenance, electronic data management, quality development programmes and trainings. Results: Over the eight-year programme, laboratories supported 160 000 patients receiving HIV care in Nigeria, delivering over 2.5 million test results, including regular viral load quantitation. External quality assurance systems were established for CD4+ cell count enumeration, blood chemistries and viral load monitoring. Laboratory equipment platforms were improved and standardised and use of point-of-care analysers was expanded. Laboratory training workshops supported laboratories toward increasing staff skills and improving overall quality. Participation in a World Health Organisation-led African laboratory quality improvement system resulted in significant gains in quality measures at five laboratories. Conclusions: Targeted implementation of laboratory development processes, during simultaneous scale-up of HIV treatment programmes in a resource-limited setting, can elicit meaningful gains in laboratory quality and capacity. Systems to improve the physical laboratory environment, develop laboratory staff, create improvements to reduce costs and increase quality are available for future health and laboratory strengthening programmes. We hope that the strategies employed may inform and encourage the development of other laboratories in resource-limited settings.

There is an understanding that greater availability of HIV treatment for the 40.3 million people currently infected with HIV is a humanitarian imperative that could prolong the lives of millions, restore economic productivity, and stabilise societies in some of the world's hardest-hit regions. The Nigerian government recognises that the country has the third highest burden of infection, with people living with HIV estimated to total 4.0 million, and so in 2002 commenced the implementation of one of Africa's largest antiretroviral (ARV) treatment programmes. A successful ARV programme requires that all components of a functional management system be put in place for effective and efficient functioning. This would include logistics, human resources, financial planning, and monitoring and evaluation systems, as well as sustainable institutional capacities. The Nigerian national ARV treatment training programme was conceived to meet the human resource needs in hospitals providing ARV therapy. This paper reports on the evaluation of the training programme. It examines knowledge and skills gained, and utilisation thereof. Recommendations are made for improved training effectiveness and for specific national policy on training, to meet the demand for scaling up therapy to the thousands who need ARV.

Background. Decentralization of antiretroviral therapy (ART) services is a key strategy to achieving universal access to treatment for people living with HIV/AIDS. Our objective was to assess clinical and laboratory outcomes within a decentralized program in Nigeria. Methods. Using a tiered hub-and-spoke model to decentralize services, a tertiary hospital scaled down services to 13 secondary-level hospitals using national and program guidelines. We obtained sociodemographic, clinical, and immunovirologic data on previously antiretroviral drug naïve patients aged ≥15 years that received HAART for at least 6 months and compared treatment outcomes between the prime and satellite sites. Results. Out of 7,747 patients, 3729 (48.1%) were enrolled at the satellites while on HAART, prime site patients achieved better immune reconstitution based on CD4+ cell counts at 12 (P

BackgroundTo date, antiretroviral therapy (ART) guidelines and programs in resource-limited settings (RLS) have focused on 1(st)- and 2(nd)-line (2 L) therapy. As programs approach a decade of implementation, policy regarding access to 3(rd)-line (3 L) ART is needed. We aimed to examine the impact of maintaining patients on failing 2 L ART on the accumulation of protease (PR) mutations.Methods and findingsFrom 2004-2011, the Harvard/APIN PEPFAR Program provided ART to >100,000 people in Nigeria. Genotypic resistance testing was performed on a subset of patients experiencing 2 L failure, defined as 2 consecutive viral loads (VL)>1000 copies/mL after ≥6 months on 2 L. Of 6714 patients who received protease inhibitor (PI)-based ART, 673 (10.0%) met virologic failure criteria. Genotypes were performed on 61 samples. Patients on non-suppressive 2 L therapy for 24 months. Patients developed a median of 0.6 (IQR: 0-1.4) IAS PR mutations per 6 months on failing 2 L therapy. In 38% of failing patients no PR mutations were present. For patients failing >24 months, high- or intermediate-level resistance to lopinavir and atazanavir was present in 63%, with 5% to darunavir.ConclusionsThis is the first report assessing the impact of duration of non-suppressive 2 L therapy on the accumulation of PR resistance in a RLS. This information provides insight into the resistance cost of failing to switch non-suppressive 2 L regimens and highlights the issue of 3 L access.