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The world is not on track to reach the majority of the UNAIDS 2025 targets, and people who inject drugs (PWID) continue to be left behind, hindered by counterproductive law enforcement practices, punitive laws, economic distress, and social stigma and discrimination. Poor access to HIV pre-exposure prophylaxis (PrEP) among PWID is nested within the limited access to broader harm reduction services, including needle and syringe programs, opioid overdose management, opioid agonist therapy (also known as medication-assisted treatment), and condoms. Among PWID, women who inject drugs are disproportionately affected and face additional gender-based barriers. Intersections between PWID and other key and priority population groups also exist. Although the prioritization of PWID for new PrEP products like the dapivirine vaginal ring and injectable cabotegravir has lagged in research, studies have shown that PWID find injectable and long-acting options acceptable and preferrable, including among women who inject drugs. While new PrEP products introduce new opportunities, equity in access must be assured for optimized impact toward achieving epidemic control. Programming for services must engage and empower PWID community leadership to address the structural barriers to services, implement community-led, differentiated, and integrated service modalities, and offer the choice of all harm reduction options to close the equity gaps in health outcomes. While waiting for necessary evidence and approvals, programs should work together with the PWID community to prioritize, expand, and facilitate efforts and investments toward increased access to and integration of PrEP and all recommended harm reduction services for PWID., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Nishimoto, Olisa, Imohi, Chang, Obermeyer, Kabwali and Akolo.)

Purpose of Review: This review summarizes differentiated service delivery (DSD) models for HIV treatment and prevention that have been adapted for maintaining continuity of services during the COVID-19 pandemic and proposes strategies for sustaining their benefits now and during future disruptions., Recent Findings: The COVID-19 pandemic resulted in an overburdened and disrupted health system, forcing countries to adopt and/or scale up DSD models for HIV services. While initially implemented as emergency measures, these models evolved and were refined over time to fit recipient needs ensuring continued HIV treatment and prevention services with minimal health system impact. Successful models employed task shifting, community-based delivery models, multimonth scripting and dispensing, and telehealth for remote consultation. DSD models enabled HIV services globally to be maintained during the COVID-19 pandemic. Though these models and adaptations were critical in addressing health gaps and disruptions caused by the pandemic, they were beneficial in improving efficiency and access to client-centered services and should be sustained., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Hospitals within Nairobi County, Kenya, offer cervical cancer screening services. However, most female sex workers do not seek this service., Objective: To determine uptake of cervical cancer screening among female sex workers living with HIV in Nairobi, Kenya., Design: A descriptive cross-sectional study., Methods: Computerized simple random sampling was used to select 75 study participants who met the inclusion criteria; data were collected using a structured questionnaire. The study was carried out among female sex workers living with HIV in Nairobi, Kenya, attending the Sex Workers Outreach Program., Results: 40% ( n  = 30) of respondents were aged 18-25 years. Only 45.3% (34) had been screened for cervical cancer within the last 1 year. 65.3% ( n  = 49) of respondents knew that cervical cancer affects the cervix but were not aware of what caused the disease. 77.6% ( n  = 58) found the 8 am-5 pm health facility opening hours a hinderance to seeking services and 66.7% ( n  = 50) found the screening method uncomfortable. Cultural practices and beliefs fostered stigma in 39.2% ( n  = 29) of the sex workers; hence, they did not seek out services., Conclusion: Lack of information, cultural barriers, and facility operating hours prevent female sex workers living with HIV from getting tested for cervical cancer. These barriers once addressed could improve cervical cancer screening uptake among this high-risk population., (© The Author(s), 2024.)

Introduction: Children of key population individuals (CPK) often face the same stigma and discrimination as their parents, limiting their access to HIV services. The Meeting Targets and Maintaining Epidemic Control project analyzed pediatric HIV testing data from project-supported sites to better understand risk among CKP and improve comprehensive prevention, testing, and treatment for KP families., Methods: We conducted a retrospective analysis of routine program data collected October 1, 2021-September 30, 2022, in project-supported sites in Burundi, Côte d'Ivoire, Democratic Republic of Congo, Tanzania, and Togo. We compared HIV case finding (defined as the percentage of children diagnosed with HIV among those who were tested) and treatment initiation (defined as the percentage of children diagnosed with HIV who were initiated on antiretroviral therapy) data for children <15 years disaggregated by index versus non-index testing and CKP versus children of non-KP individuals (non-CKP)., Results: A total of 5,651 children were tested (n = 2,974 index testing; n = 2,677 non-index testing). Of those diagnosed with HIV, 33% (181/541) were CKP, with case finding 17% (181 positive/1,070 tested) among CKP and 8% among non-CKP (360 positive/4,581 tested). Almost half of CKP diagnosed were ages 1-4 years. Among the 2,974 (53%) reached through index testing, overall case finding was higher among CKP (17%; 178 positive/1,052 tested) than non-CKP (11%; 219 positive/1,922 tested). Treatment initiation was 97% among CKP and 94% among non-CKP., Discussion: CKP were identified primarily through index testing which, although considered a priority strategy to identify children at high risk, has not been widely used within KP family networks. Most CKP reached were children of female sex workers, but those of other KPs should also be prioritized., Conclusions: KP-focused programs have often excluded children, but the case-finding approaches in the project's KP programs were effective in reaching CKP. Comprehensive, family-centered KP programming is needed that includes family planning, prevention of vertical transmission, early infant diagnosis, and other maternal and child health services to reduce the impact of HIV on families and achieve an HIV-free generation., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background: According to UNAIDS, Togo halved AIDS-related deaths among children ages 0-14 from 2010 to 2020. However, available data show low dolutegravir (DTG)-containing antiretroviral therapy (ART) coverage and low viral load suppression (VLS) among children living with HIV (CLHIV). We analyzed routine facility data before and after implementation of root-cause-based solutions for improving DTG coverage, viral load (VL) testing coverage, and VLS among CLHIV., Description: We analyzed routine data for CLHIV ≤14 years from October 2019 through September 2022. We assessed proportion of CLHIV on ART receiving DTG, VL testing coverage (CLHIV on ART with documented VL test result), and VLS (CLHIV with documented VL test result of <1,000 copies among those with test result). From October 2019 to September 2020, 52% were on a DTG-containing regimen, 48% had documented VL test results, and 64% had VLS. Site-level teams conducted a root-cause analysis and designed corresponding solutions implemented beginning October 2020: line listing and contacting eligible CLHIV to start/transition to DTG-containing regimen and collect VL samples; ART adherence support; monthly DTG stock monitoring; tracking pending VL test results through laboratory focal persons; documenting VL test results; and informing caregivers within one week if CLHIV not virally suppressed. Granular data were used to prioritize technical assistance to sites with lowest DTG coverage, VL testing coverage, and VLS., Results: From baseline (October 2019-September 2020) to endline (October 2021-September 2022), increases were observed for DTG coverage (52% to 71%), VL testing coverage (48% to 90%), and VLS (64% to 82%). Age-disaggregated data showed positive trends., Conclusions: Root-cause-based solutions and granular data use increased DTG coverage, resulting in increased VL testing and VLS among CLHIV. These interventions should be scaled and become the national standard of care., Competing Interests: The authors have declared that no competing interests exist., (Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.)

Background : Restrictions on public gatherings and movement to mitigate the spread of COVID-19 may have disrupted access and availability of HIV services in Malawi. We quantified the impact of these restrictions on HIV testing services in Malawi. Methods : We conducted an interrupted time series analysis of routine aggregated programme data from 808 public and private, adult and paediatric health facilities across rural and urban communities in Malawi between January 2018 and March 2020 (pre-restrictions) and April to December 2020 (post restrictions), with April 2020 as the month restrictions took effect. Positivity rates were expressed as the proportion of new diagnoses per 100 persons tested. Data were summarised using counts and median monthly tests stratified by sex, age, type of health facility and service delivery points at health facilities. The immediate effect of restriction and post-lockdown outcomes trends were quantified using negative binomial segmented regression models adjusted for seasonality and autocorrelation. Results : The median monthly number of HIV tests and diagnosed people living with HIV (PLHIV) declined from 261 979 (interquartile range [IQR] 235 654-283 293) and 7 929 (IQR 6 590-9 316) before the restrictions, to 167 307 (IQR 161 122-185 094) and 4 658 (IQR 4 535-5 393) respectively, post restriction. Immediately after restriction, HIV tests declined by 31.9% (incidence rate ratio [IRR] 0.681; 95% CI 0.619-0.750), the number of PLHIV diagnosed declined by 22.8% (IRR 0.772; 95% CI 0.695-0.857), while positivity increased by 13.4% (IRR 1.134; 95% CI 1.031-1.247). As restrictions eased, total HIV testing outputs and the number of new diagnoses increased by an average of 2.3% each month (slope change: 1.023; 95% CI 1.010-1.037) and 2.5% (slope change:1.025; 95% CI 1.012-1.038) respectively. Positivity remained similar (slope change: 1.001; 95% CI 0.987-1.015). Unlike general trends noted, while HIV testing services among children aged <12 months declined 38.8% (IRR 0.351; 95% CI 0.351-1.006) with restrictions, recovery has been minimal (slope change: 1.008; 95% CI 0.946-1.073). Conclusion : COVID-19 restrictions were associated with significant but short-term declines in HIV testing services in Malawi, with differential recovery in these services among population subgroups, especially infants. While efforts to restore HIV testing services are commendable, more nuanced strategies that promote equitable recovery of HIV testing services can ensure no subpopulations are left behind.

Introduction: Multimonth dispensing (MMD) enables less frequent clinic visits and improved outcomes for people living with HIV, but few children and adolescents living with HIV (CALHIV) are on MMD. At the end of the October-December 2019 quarter, only 23% of CALHIV receiving antiretroviral therapy (ART) through SIDHAS project sites in Akwa Ibom and Cross River states, Nigeria, were receiving MMD. In March 2020, during COVID-19, the government expanded MMD eligibility to include children and recommended rapid implementation to minimize clinic visits. SIDHAS provided technical assistance to 36 "high-volume" facilities-≥5 CALHIV on treatment-in Akwa Ibom and Cross River to increase MMD and viral load suppression (VLS) among CALHIV, toward PEPFAR's 80% benchmark for people currently on ART. We present change in MMD, viral load (VL) testing coverage, VLS, optimized regimen coverage, and community-based ART group enrollment among CALHIV from the October-December 2019 quarter (baseline) to January-March 2021 (endline) based on retrospective analysis of routinely collected program data., Materials and Methods: We compared MMD coverage (primary objective), and optimized regimen coverage, community-based ART group enrollment, VL testing coverage, and VLS (secondary objectives), among CALHIV 18 years and younger pre-/post-intervention (baseline/endline) at the 36 facilities. We excluded children younger than two years, who are not recommended for or routinely offered MMD. The extracted data included age, sex, ART regimen, months of ART dispensed at last refill, most recent VL test results, and community ART group enrollment. Data on MMD-three or more months of ARVs dispensed at one time-were disaggregated into three to five months (3-5-MMD) vs. six or more months (6-MMD). VLS was defined as ≤1,000 copies. We documented MMD coverage by site, optimized regimen, and VL testing and suppression. Using descriptive statistics, we summarized the characteristics of CALHIV on MMD and non-MMD, number of CALHIV on optimized regimens, and proportion enrolled in differentiated service delivery models and community-based ART refill groups. For the intervention, SIDHAS technical assistance was data driven: weekly data analysis/review, site-prioritization scoring, provider mentoring, line listing eligible CALHIV, pediatric regimen calculator, child-optimized regimen transitioning, and community ART models., Results: The proportion of CALHIV ages 2-18 receiving MMD increased from 23% (620/2,647; baseline) to 88% (3,992/4,541; endline), while the proportion of sites reporting suboptimal MMD coverage among CALHIV (<80%) decreased (100% to 28%). In March 2021, 49% of CALHIV were receiving 3-5-MMD and 39% 6-MMD. In October-December 2019, 17%-28% of CALHIV were receiving MMD; by January-March 2021, 99% of those 15-18 years, 94% 10-14 years, 79% 5-9 years, and 71% 2-4 years were on MMD. VL testing coverage remained high (90%), while VLS increased (64% to 92%). The proportion on pediatric-optimized regimens increased (58% to 79%)., Conclusions: MMD was feasible among CALHIV without compromising VLS. Expanded eligibility criteria, line listing eligible children, monitoring pediatric antiretroviral stock, and data use contributed to positive results. Future efforts should address low 6-MMD uptake related to stock limitations and synchronize antiretroviral refill pickup with VL sample collection., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2023 Casalini et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Introduction: While oral preexposure prophylaxis (PrEP) is recommended for all individuals with substantial risk of acquiring HIV, people who inject drugs (PWID) have not been prioritized for oral PrEP services in most settings. The Meeting Targets and Maintaining Epidemic Control (EpiC) project implemented a comprehensive community-based program to increase access to and uptake of oral PrEP services among PWID in Bayelsa and Niger States, Nigeria., Program Description: EpiC established partnerships with community-based organizations working with the PWID community, identified hotspots (common locations for socialization and drug use), and engaged PWID in tailoring oral PrEP services. The HIV prevention package provided in hotspots and drop-in centers included HIV testing, oral PrEP, postexposure prophylaxis, sexually transmitted infection screening and management, condoms and lubricants, PWID-specific risk reduction counseling, and referrals to other support programs. At drop-in centers, paralegal and psychological services were also provided. Peer outreach workers led outreach efforts. All PWID who tested HIV negative were eligible for oral PrEP screening. National oral PrEP eligibility criteria included: no suspicion of acute HIV infection, absence of proteinuria, and willingness to use oral PrEP as prescribed. We used descriptive analysis of routine programmatic data to illustrate program outcomes., Results: From January 2020 to September 2021, 13,286 HIV tests were completed for PWID. Of these, 12,111 (91.16%) had negative results. Among those testing negative, 8,190 (67.62%) were screened for oral PrEP eligibility, and 2,661 (32.49%) were eligible. A total of 2,659 PWID (100% [312/312] among eligible females; 99.91% [2,347/2,349] among eligible males) initiated oral PrEP., Lessons Learned: Provision of oral PrEP services to PWID in Nigeria is feasible through a peer-led, differentiated, and holistic approach that addresses structural barriers among the PWID community. Greater efforts are needed to understand the needs and barriers to better tailor HIV services to reach females and other subpopulations in this community that are harder to reach., (© Nishimoto et al.)

Introduction: Globally, over half of the estimated new HIV infections now occur among key populations, including men who have sex with men, sex workers, people who inject drugs, transgender individuals, and people in prisons and other closed settings, and their sexual partners. Reaching epidemic control will, for many countries, increasingly require intensified programming and targeted resource allocation to meet the needs of key populations and their sexual partners. However, insufficient funding, both in terms of overall amounts and the way the funding is spent, contributes to the systematic marginalization of key populations from needed HIV services., Discussion: The Joint United Nations Programme on HIV/AIDS (UNAIDS) has recently highlighted the urgent need to take action to end inequalities, including those faced by key populations, which have only been exacerbated by the COVID-19 pandemic. To address these inequalities and improve health outcomes, key population programs must expand the use of a trusted access platform, scale up differentiated service delivery models tailored to the needs of key populations, rollout structural interventions and ensure service integration. These critical program elements are often considered "extras," not necessities, and consequently costing studies of key population programs systematically underestimate the total and unitary costs of services for key populations. Findings from a recent costing study from the LINKAGES project suggest that adequate funding for these four program elements can yield benefits in program performance. Despite this and other evidence, the lack of data on the true costs of these elements and the costs of failing to provide them prevents sufficient investment in these critical elements., Conclusions: As nations strive to reach the 2030 UNAIDS goals, donors, governments and implementers should reconsider the true, but often hidden costs in future healthcare dollars and in lives if they fail to invest in the community-based and community-driven key population programs that address structural inequities. Supporting these efforts contributes to closing the remaining gaps in the 95-95-95 goals. The financial and opportunity cost of perpetuating inequities and missing those who must be reached in the last mile of HIV epidemic control must be considered., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: Previous WHO guidance on tenofovir disoproxil fumarate-based oral pre-exposure prophylaxis (PrEP) suggests measuring creatinine levels at PrEP initiation and regularly afterwards, which might represent barriers to PrEP implementation and uptake. We aimed to systematically review published literature on kidney toxicity among tenofovir disoproxil fumarate-based oral PrEP users and conducted an individual participant data meta-analysis (IPDMA) on kidney function among PrEP users in a global implementation project dataset., Methods: In this systematic review and meta-analysis we searched PubMed up to June 30, 2021, for randomised controlled trials (RCTs) or cohort studies that reported on graded kidney-related adverse events among oral PrEP users (tenofovir disoproxil fumarate-based PrEP alone or in combination with emtricitabine or lamivudine). We extracted summary data and conducted meta-analyses with random-effects models to estimate relative risks of grade 1 and higher and grade 2 and higher kidney-related adverse events, measured by elevated serum creatinine or decline in estimated creatinine clearance or estimated glomerular filtration rate. The IPDMA included (largely unpublished) individual participant data from 17 PrEP implementation projects and two RCTs. Estimated baseline creatinine clearance and creatinine clearance change after initiation were described by age, gender, and comorbidities. We used random-effects regressions to estimate the risk in decline of creatinine clearance to less than 60 mL/min., Findings: We identified 62 unique records and included 17 articles reporting on 11 RCTs with 13 523 participants in meta-analyses. PrEP use was associated with increased risk of grade 1 and higher kidney adverse events (pooled odds ratio [OR] 1·49, 95% CI 1·22-1·81; I 2 =25%) and grade 2 and higher events (OR 1·75, 0·68-4·49; I 2 =0%), although the grade 2 and higher association was not statistically significant and events were rare (13 out of 6764 in the intervention group vs six out of 6782 in the control group). The IPDMA included 18 676 individuals from 15 countries (1453 [7·8%] from RCTs) and 79 (0·42%) had a baseline estimated creatinine clearance of less than 60 mL/min (increasing proportions with increasing age). Longitudinal analyses included 14 368 PrEP users and 349 (2·43%) individuals had a decline to less than 60 mL/min creatinine clearance, with higher risks associated with increasing age and baseline creatinine clearance of 60·00-89·99 mL/min (adjusted hazard ratio [aHR] 8·49, 95% CI 6·44-11·20) and less than 60 mL/min (aHR 20·83, 12·83-33·82)., Interpretation: RCTs suggest that risks of kidney-related adverse events among tenofovir disoproxil fumarate-based oral PrEP users are increased but generally mild and small. Our global PrEP user analysis found varying risks by age and baseline creatinine clearance. Kidney function screening and monitoring might focus on older individuals, those with baseline creatinine clearance of less than 90 mL/min, and those with kidney-related comorbidities. Less frequent or optional screening among younger individuals without kidney-related comorbidities may reduce barriers to PrEP implementation and use., Funding: Unitaid, Bill & Melinda Gates Foundation, WHO., Competing Interests: Declaration of interests J-MM declares that his institution has received grants from Gilead Sciences; receiving consulting fees from Gilead Sciences, Merck & Co, and ViiV Healthcare; and payments for expert testimony from Merck & Co, unrelated to the present work. KG declares receipt of travel grants by IAS and WHO to attend meetings unrelated to the present work. All other authors declare no competing interests., (© 2022 World Health Organization; licensee Elsevier. This is an Open Access article published under the CC BY 3.0 IGO license which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any use of this article, there should be no suggestion that WHO endorses any specific organisation, products, or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.)

Background: Despite progress in improving antiretroviral therapy (ART) for people with HIV in Malawi, the burden of HIV infections and HIV treatment outcomes among key populations is suboptimal. Client-centered differentiated service delivery approaches may facilitate addressing HIV prevention and treatment needs of key populations in Malawi., Methods: De-identified program data routinely collected as part of the LINKAGES project-Malawi were assembled from October 2017 to September 2019. HIV case finding was compared across different testing modalities for each population. Poisson regression was used to estimate the association between testing modalities and ART initiation., Results: Of the 18   397 people included in analyses, 10   627 (58%) were female sex workers (FSWs), 2219 (12%) were men who have sex with men (MSM), and 4970 (27%) were clients of FSWs. HIV case finding varied by modality and population, with index testing and enhanced peer outreach demonstrating high yield despite reaching relatively few individuals. FSWs who tested positive through risk network referral testing were more likely to initiate ART within 30 days compared with those who tested positive through clinic-based testing (adjusted risk ratio [aRR], 1.50; 95% CI, 1.23-1.82). For MSM, index testing (aRR, 1.45; 95% CI, 1.06-2.00) and testing through a drop-in center (aRR, 1.82; 95% CI, 1.19-2.78) were associated with 30-day ART initiation., Conclusions: These data suggest that differentiated HIV testing and outreach approaches tailored to the needs of different key populations may facilitate improved ART initiation in Malawi. Achieving 0 new infections by 2030 suggests the need to adapt treatment strategies given individual and structural barriers to treatment for key populations with HIV in high-prevalence settings., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)

Background: Men who have sex with men (MSM) are a key group for HIV interventions in Malawi considering their high HIV prevalence (17.5% compared to 8.4% among men in the general population). The use of oral preexposure prophylaxis (PrEP) presents a new opportunity for MSM to be protected. We present the findings from a qualitative assessment designed to assess awareness of and willingness and barriers to using PrEP among MSM in Malawi., Objective: The 3 main objectives of this assessment were to determine: (1) awareness of PrEP, (2) factors that influence willingness to use PrEP, and (3) potential barriers to PrEP use and adherence among MSM in order to guide the design and implementation of a PrEP program in Malawi., Methods: Ahead of the introduction of PrEP in Malawi, a qualitative study using in-depth interviews (IDIs) and focus group discussions (FGDs) was conducted in October 2018 in Blantyre, Lilongwe, and rural districts of Mzimba North and Mangochi. With support of members of the population, study participants were purposively recruited from 4 MSM-friendly drop-in centers where MSM receive a range of health services to ensure representativeness across sites and age. Participants were asked what they had heard about PrEP, their willingness to use PrEP, their barriers to PrEP use, and their preferences for service delivery. The data were analyzed using a thematic content analysis framework that was predetermined in line with objectives., Results: A total of 109 MSM were interviewed-13 through IDIs and 96 through FGDs. Most participants were aware of PrEP as a new HIV intervention but had limited knowledge related to its use. However, the majority were willing to use it and were looking forward to having access to it. IDI participants indicated that they will be more willing to take PrEP if the dosing frequency were appropriate and MSM were involved in information giving and distribution of the drug. FGD participants emphasized that places of distribution and characteristics of the service provider are the key factors that will affect use. Knowing the benefits of PrEP emerged as a key theme in both the IDIs and FGDs. Participants highlighted barriers that would hinder them from taking PrEP such as side effects which were cited in IDIs and FGDs. Key factors from FGDs include cost, fear of being outed, drug stockouts, fear of being known as MSMs by wives, and lack of relevant information. FGDs cited stigma from health care workers, forgetfulness, and community associated factors., Conclusions: Despite having inadequate knowledge about PrEP, study participants were largely willing to use PrEP if available. Programs should include an effective information, education, and communication component around their preferences and provide PrEP in MSM-friendly sites., (©Elizabeth Mpunga, Navindra Persaud, Christopher Akolo, Dorica Boyee, Gift Kamanga, Gift Trapence, David Chilongozi, Melchiade Ruberintwari, Louis Masankha Banda. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 27.10.2021.)

Background: Globally, drug resistant tuberculosis (DR-TB) continues to be a public health threat. Nigeria, which accounts for a significant proportion of the global burden of rifampicin/multi-drug resistant-TB (RR/MDR-TB) had a funding gap of $168 million dollars for TB treatment in 2018. Since 2010, Nigeria has utilized five different models of care for RR/MDR-TB (Models A-E); Models A, B and C based on a standardized WHO-approved treatment regimen of 20-24 months, were phased out between 2015 and 2019 and replaced by Models D and E. Model D is a fully ambulatory model of 9-12 months during which a shorter treatment regimen including a second-line injectable agent is utilized. Model E is identical to Model D but has patients hospitalized for the first four months of care while Model F which is to be introduced in 2020, is a fully ambulatory, oral bedaquiline-containing shorter treatment regimen of 9-12 months. Treatment models for RR/MDR-TB of 20-24 months duration have had treatment success rates of 52-66% while shorter treatment regimens have reported success rates of 85% and above. In addition, replacing the second-line injectable agent in a shorter treatment regimen with bedaquiline has been found to further improve treatment success in patients with fluoroquinolone-susceptible RR/MDR-TB. Reliable cost data for RR/MDR-TB care are limited, specifically costs of models that utilize shorter treatment regimens and which are vital to guide Nigeria through the provision of RR/MDR-TB care at scale. We therefore conducted a cost analysis of shorter treatment regimens in use and to be used in Nigeria (Models D, E and F) and compared them to three models of longer duration utilized previously in Nigeria (Models A, B and C) to identify any changes in cost from transitioning from Models A-C to Models D-F and opportunities for cost savings., Methods: We obtained costs for TB diagnostic and monitoring tests, in-patient and out-patient care from a previous study, inflated these costs to 2019 NGN and then converted to 2020 USD. We obtained other costs from the average of six health facilities and drug costs from the global drug facility. We modeled treatment on strict adherence to two Nigerian National guidelines for programmatic and clinical management of drug-resistant tuberculosis., Results: We estimated that the total costs of care from the health sector perspective for Models D, E and F were $4,334, $7,705 and $3,420 respectively. This is significantly lower than the costs of Models A, B and C which were $14,781, $12, 113, $7,572 respectively., Conclusion: Replacing Models A-C with Models D and E reduced the costs of RR/MDR-TB care in Nigeria by approximately $5,470 (48%) per patient treated and transitioning from Models D and E to Model F would result in further cost savings of $914 to $4,285 (21 to 56%) for every patient placed on Model F. If the improved outcomes of patients managed using bedaquiline-containing shorter treatment regimens in other countries can be attained in Nigeria, Model F would be the recommended model for the scale up of RR/MDR-TB care in Nigeria., Competing Interests: The authors have declared that no competing interests exist.

Background: Mononuclear cells play key roles in the pathogenesis of HIV-associated neurocognitive disorders (HAND). Limited studies have looked at the association of markers of monocyte activation with HAND in Africa. We examined this association among HIV-1-infected patients in Nigeria., Method: A total of 190 HIV-infected treatment-naive participants with immune marker data were included in this cross-sectional study. Plasma levels of soluble CD14 (sCD14), soluble CD163, monocyte chemoattractant protein-1 (MCP-1), tumor necrosis factor-alpha (TNF-α), and neopterin were measured. Demographically adjusted T scores obtained from a 7-domain neuropsychological test battery were generated, and functional status was assessed using activities of daily living questionnaire. Participants were classified as unimpaired, having asymptomatic neurocognitive impairment (ANI), mild neurocognitive disorder (MND), or HIV-associated dementia (HAD) in line with the "Frascati" criteria., Results: Thirty-two participants (16.8%) had ANI, 14 (7.4%) had MND, whereas none had HAD. In multivariable linear regression analyses, after adjusting for age, gender, education, CD4 count, and viral load, mean levels of sCD14 were higher among those with ANI and MND as compared with the unimpaired (P = 0.033 and 0.023, respectively). Similarly, the mean level of MCP-1 was greater among those with HAND as compared with the unimpaired (P = 0.047). There were also trends for higher levels of sCD163 and TNF-α among females with MND in univariable analyses., Conclusions: Levels of monocyte activation markers correlate with the severity of impairment among individuals with HAND. The mechanisms that underlie these effects and the potential role of gender require further study.

Recent studies of Indian men who have sex with men (MSM) have shown widespread use of social media for seeking sex partners. We piloted a peer mobilization approach to explore the feasibility of engaging previously unreached MSM online to link them to HIV testing services (HTS). MSM were encouraged to seek HTS through messages posted on a popular dating website. Those who visited the designated HTS site and tested for HIV were recruited as peer mobilizers and given coupons with unique identifying codes to distribute to other men in their virtual networks. If a network member presented at the site with a coupon and tested for HIV, the peer mobilizer was given a small monetary incentive. Network members presenting at the testing site were also recruited as peer mobilizers and given coupons. In a 6-month period, 247 MSM were recruited and tested for HIV and syphilis, of whom 244 (99%) were first-time testers. Two-thirds were less than 25 years old and about half reported inconsistent or no condom use during the last 10 anal sex acts. Eight individuals (3.2%) tested positive for HIV, and 22 (8.9%) had a high titer for syphilis; all were referred to tertiary hospitals for treatment. Our approach was modestly successful in reaching and providing HTS to previously unreached MSM, but challenges included lower-than-expected recruitment, individuals not returning for posttest counseling, and loss to follow-up of individuals with HIV. The next phase of peer mobilization will aim to scale up these services through government-supported targeted interventions for this subpopulation of primarily young, unreached MSM at high risk. The challenges will be addressed by targeting more dating sites, increasing access to testing using rapid HIV tests at several community-based facilities, and offering peer navigation support for people living with HIV., (© Das et al.)

Finding new HIV-positive cases remains a priority to achieve the UNAIDS goals. An enhanced peer outreach approach (EPOA) was implemented to expand the delivery of HIV services to female sex workers (FSWs) and men who have sex with men (MSM) in three countries in West and Central Africa. The aim of EPOA is to identify new HIV-positive cases. EPOA was implemented in Burundi among FSWs, and in Cote d'Ivoire and Democratic Republic of the Congo (DRC) among both FSWs and MSM. Implementation ranged from five to nine weeks and was nested within a three-month reporting period. Standard outreach was suspended for the duration of EPOA implementation but was resumed thereafter. Summary service statistics were used to compare HIV seropositivity during standard outreach and EPOA. Trends were analyzed during the quarter in which EPOA was implemented, and these were compared with the two preceding quarters. Differences in proportions of HIV seropositivity were tested using Pearson's chi-square test; p-values of less than 0.05 were considered statistically significant. Overall, EPOA resulted in a higher proportion of new HIV-positive cases being found, both within and between quarters. In Burundi, HIV seropositivity among FSWs was significantly higher during EPOA than during standard outreach (10.8% vs. 4.1%, p<0.001). In Cote d'Ivoire, HIV seropositivity was significantly higher during EPOA among both populations (FSWs: 5.6% vs. 1.81%, p<0.01; MSM: 15.4% vs. 5.9%; p<0.01). In DRC, HIV seropositivity was significantly higher during EPOA among MSM (6.9% vs. 1.6%; p<0.001), but not among FSWs (5.2% vs. 4.3%; p = 0.08). Trends in HIV seropositivity during routine outreach for both populations were constant during three successive quarters but increased with the introduction of EPOA. EPOA is a public health approach with great potential for reaching new populations and ensuring that they are aware of their HIV status., Competing Interests: The authors have declared that no competing interests exist.

The potential role of gender in the occurrence of HIV-related neurocognitive impairment (NCI) and associations with markers of HIV-related immune activity has not been previously examined. In this study 149 antiretroviral-naïve seropositive subjects in Nigeria (SP, 92 women and 57 men) and 58 seronegative (SN, 38 women and 20 men) were administered neuropsychological testing that assessed 7 ability domains. From the neuropsychological test scores was calculated a global deficit score (GDS), a measure of overall NCI. Percentages of circulating monocytes and plasma HIV RNA, soluble CD163 and soluble CD14 levels were also assessed. HIV SP women were found to be younger, more educated and had higher CD4+ T cell counts and borderline higher viral load measures than SP men. On the neuropsychological testing, SP women were more impaired in speed of information processing and verbal fluency and had a higher mean GDS than SN women. Compared to SP men, SP women were also more impaired in speed of information processing and verbal fluency as well as on tests of learning and memory. Numbers of circulating monocytes and plasma sCD14 and sCD163 levels were significantly higher for all SP versus all SN individuals and were also higher for SP women and for SP men versus their SN counterparts. Among SP women, soluble CD14 levels were slightly higher than for SP men, and SP women had higher viral load measurements and were more likely to have detectable virus than SP men. Higher sCD14 levels among SP women correlated with more severe global impairment, and higher viral load measurements correlated with higher monocyte numbers and sCD14 and sCD14 levels, associations that were not observed for SP men. These studies suggest that the risk of developing NCI differ for HIV infected women and men in Nigeria and, for women, may be linked to effects from higher plasma levels of HIV driving activation of circulating monocytes.

Background: In most resource constrained settings like Nigeria, breast self-examination self-breast examination (BSE) is culturally acceptable, religious friendly and attracts no cost. Women's knowledge and beliefs about breast cancer and its management may contribute significantly to medical help-seeking behaviours. This study aimed to assess knowledge and beliefs of BSE among market women., Methods: A descriptive cross-sectional study was conducted among 603 market women in Ibadan, Nigeria. Data was collected using semi-structured interviews and analyzed using descriptive and analytic statistical methods., Results: The mean age of the respondents was 34.6±9.3 years with 40% of the women aged between 30-39years. The proportion of married women was 339 (68.5%) with 425 (70.8%) respondents reporting that they do not know how to perform BSE. However, 372 (61.7%) women strongly agreed that BSE is a method of screening for breast cancer. Highest proportion 219 (36.3%) reported that the best time for a woman to perform BSE was 'anytime'. Most of the respondents believed breast cancer is a dangerous disease that kills fast and requires a lot of money for treatment., Conclusion: More efforts are needed in creating awareness and advocacy campaigns in the grassroots in order to detect early breast cancer and enhance prevention strategies that would reduce the burden of breast cancer in Nigeria.

Isoniazid preventive therapy (IPT) is the administration of isoniazid (INH) to people with latent tuberculosis (TB) infection (LTBI) to prevent progression to active TB disease. Despite being life-saving for human immunodeficiency virus (HIV)-infected persons who do not have active TB, IPT is poorly implemented globally due to misconceptions shared by healthcare providers and policy makers. However, amongst HIV-infected patients especially those living in resource-limited settings with a high burden of TB, available evidence speaks for IPT: Among HIV-infected persons, active TB- the major contraindication to IPT, can be excluded with symptom screening; chest X-ray and tuberculin skin testing are unreliable and often lead to logistic delays resulting in increased numbers of people with LTBI progressing to active TB; the use of IPT has not been found to increase the risk of the development of INH mono-resistance; IPT is cost-effective and cheaper than the cost of treating cases of active TB that would develop without IPT; ART and IPT have an additive effect on the prevention of TB, and both are safe and beneficial even in children. In order to sustain the recorded gains from ART scale-up and to further reduce TB-related morbidity and mortality, more efforts are needed to scale-up IPT implementation globally.

Objectives: The aim of the study was to describe the prevalence and correlates of chronic obstructive pulmonary disease (COPD) in a multicentre international cohort of persons living with HIV (PLWH)., Methods: We performed a cross-sectional analysis of adult PLWH, naïve to HIV treatment, with baseline CD4 cell count > 500 cells/μL enrolled in the Pulmonary Substudy of the Strategic Timing of AntiRetroviral Treatment (START) trial. We collected standardized, quality-controlled spirometry. COPD was defined as forced expiratory volume in 1 s:forced vital capacity (FEV1 :FVC) ratio less than the lower limit of normal., Results: Among 1026 participants from 80 sites and 20 countries, the median age was 36 [interquartile range (IQR) 30, 44] years, 29% were female, and the median time since HIV diagnosis was 1.2 (IQR 0.4, 3.5) years. Baseline median CD4 cell count was 648 (IQR 583, 767) cells/μL, median viral load was 4.2 (IQR 3.5, 4.7) log10 HIV-1 RNA copies/mL, and 10% had a viral load ≤ 400 copies/mL despite lack of HIV treatment. Current/former/never smokers comprised 28%/11%/61% of the cohort, respectively. COPD was present in 6.8% of participants, and varied by age, smoking status and region. Forty-eight per cent of those with COPD reported lifelong nonsmoking. In multivariable regression, age and pack-years of smoking had the strongest associations with FEV1 :FVC ratio (P < 0.0001). There was a significant effect of region on FEV1 :FVC ratio (P = 0.010)., Conclusions: Our data suggest that, among PLWH who were naïve to HIV treatment and had CD4 cell counts > 500 cells/μL, smoking and age were important factors related to COPD. Smoking cessation should remain a high global priority for clinical care and research in PLWH., (© 2015 British HIV Association.)

Background: Experimental evidence has shown that treatment of HIV infection with antiretroviral therapy (ART) prevents heterosexual transmission of HIV to an uninfected partner. However, the "real-world" application of this strategy to key populations such as men who have sex with men (MSM) has been limited. We report findings on acceptability of a treatment as prevention (TasP) strategy among HIV-infected MSM at a Trusted Community Center providing comprehensive HIV prevention and treatment services to MSM in Abuja, Nigeria., Methods: Using respondent-driven sampling (RDS), MSM who were 16 years and older and have engaged in either receptive or insertive anal intercourse within the previous 12 months were recruited into a prospective combination HIV prevention and treatment study (TRUST). Two weeks after enrollment, HIV testing and counseling was conducted. At each 3-month follow-up visits, HIV-infected individuals underwent clinical and laboratory evaluation, including CD4 count, plasma HIV viral load, immediate 3 weekly sessions of ART preparation, and then ART initiation per TasP strategy irrespective of CD4 count. Reasons for not engaging in pre-TasP preparation and TasP were documented. Characteristics associated with TasP engagement and loss to follow-up (LTFU) were determined using logistic and Cox regression, respectively., Results: Of 186 HIV-positive MSM enrolled, 58 (31.2%) were on ART at the time of recruitment, whereas 128 (68.8%) were ART-naive and provided opportunity for engaging TasP. Of these, 70 (54.7%) engaged in TasP. Compared with MSM who did not engage in TasP, those who engaged had significantly lower mean CD4 count (P = 0.001), were more likely to be Christian (P = 0.01), and had disclosed being MSM to family (P = 0.02) or health care providers (P = 0.02). In multivariate models, disclosure of being MSM to health care providers remained significantly associated with uptake of TasP. Among individuals engaged in TasP, 10% were LTFU in care at 18 months since enrollment. Being engaged in TasP (relative hazards = 0.08, P < 0.001) and on ART (relative hazards = 0.17, P < 0.001) were associated with decreased risk of LTFU., Conclusions: Although there was high acceptance of HIV testing and low LTFU among individuals who were already on ART or engaged in TasP, a higher than expected proportion did not engage in TasP, suggesting the need for customized treatment preparation and an increase in enabling environments to support HIV treatment access with this key population.

Detailed neuropsychological testing was performed on 133 human immunodeficiency virus (HIV) seropositive (SP) and 77 HIV seronegative (SN) individuals, 86 % with early stage HIV infection in Nigeria, to determine the frequency of HIV-related neurocognitive impairment among the HIV-infected group. The tests were administered to assess the following seven ability domains: speed of information processing, attention/working memory, executive functioning, learning, memory, verbal fluency, and motor function motor. Demographically corrected individual test scores and scores for each domain or reflecting a global deficit (a global deficit score, or GDS) were compared for the SP and SN groups. SP participants were older, had fewer years of education, were more likely to be married, differed in ethnicity, and had higher depression scores than SN individuals. Within the seven ability domains, SP performed worse than SN with respect to speed of information processing, executive function, learning, memory, and verbal fluency and also on the global measure. SP were also more frequently impaired on tests of SIP, and there was a borderline increase in the frequency of global impairment. On the individual tests, SP performed worse than SN on four tests that assessed learning, verbal fluency, memory, and motor function (the Timed Gait). SP subjects, however, performed better than SN on the Finger-tapping test, also a motor task. Performance by SP subjects was not associated on the timed gait which showed a borderline statistically significant correlation with CD4 counts. However, there were significant correlations between viral load measurements and individual tests of speed of information processing, executive function, learning, and verbal fluency and with overall executive function and a borderline correlation with the GDS. Depression scores for SP were associated with impairment on only a single test of executive function. These results demonstrate the ability of these assessments to identify areas of impairment that may be specifically linked to a history of HIV infection among individuals in Nigeria. Confirmation of these findings awaits analyses using data from a larger number of control subjects.

Background: In this era of highly active antiretroviral therapy (HAART), hepatitis B and C virus (HBV and HCV) co-infection have emerged as significant co-morbid conditions. Local reports indicate that co-infection is not uncommon in Nigeria as in other sub-Saharan African countries. Whether treatment outcomes of HIV mono-infected patients differ from those with co-infection remains largely unknown. We hypothesised that co-infected patients will have lower CD4+ count recovery and viralload reduction following HAART., Methods: A cohort study in antiretroviral therapy-naïve HIV-infected adults involving 150 cases (HIV and co-infection) and 150 controls (HIV infection only). Patients' care was according to the National guidelines and patients received first line therapy mostly comprising Lamivudine, Stavudine and Nevirapine. Medication adherence was monitored using pharmacy computerised system, and CD4+ cell counts and HIV viral load (VL) were compared at baseline, 3 and 6 months of therapy, Results: There were 98 (65.3%) and 96 (64%) female cases and controls (p = 0.79) respectively. The mean ages of cases and controls were 38 +/- 8.4 and 37 +/- 8.9 years (p = 0.20) respectively. Cases comprised 73 (48%) HBV, 70 (47%) HCV and 7 (5%) with both HBV and HCV infection. Medication adherence was > 95% in both arms. Attrition rate was 2.7% (8); seven of them were co-infected. Five cases (3.3%) compared to zero controls developed clinical hepatitis. The proportions of patients with CD4+ count < 200 cells/microl among cases and controls were 111 (74%) and 109 (72%), p = 0.36 at baseline; 66 (45.5%) and 64 (42.7%), p = 0.21 at 3 months; 60 (42%) and 56 (37.6%), p = 0.40 at 6 months respectively. Significantly more controls (60.7%) had CD4+ increases 50 cells/microl at 3 months compared to 37 (54.5%) HCV+ cases (p = 0.03). No significant difference in CD4+ counts between controls and cases at 6 months. The baseline median VL for cases and controls were log(10)4.95 and log(10)4.83 (p = 0.17) respectively. The proportions of cases and controls with undetectable VL at 3 and 6 months were 96 (66.2%) and 97 (65.5%); p = 0.74, and 116 (81.1%) and 97 (79.3%); p = 0.010 respectively., Conclusion: Co-infection has limited impact on immunologic and virologic outcomes, but may be an important cause of hepatotoxicity.

Human immunodeficiency virus (HIV) infection drives tuberculosis (TB) incidence, and in some African countries, 80% of persons with TB have HIV infection. By the end of 2008, an estimated 33.2 million persons were infected with HIV, and in 2007, there were 2.7 million new HIV infections and 2 million HIV infection-related deaths. During the same year, there were 1.37 million (15%) cases of TB and HIV coinfection, resulting in 456,000 deaths. Prevention of TB requires prevention interventions for both HIV infection and TB, including HIV counseling and testing, disclosure and partner testing, behavior modification, earlier antiretroviral therapy, and the "Three I's for HIV/TB": isoniazid preventive treatment, intensified case finding, and infection control for TB. Managers of HIV programs should work with their colleagues in the TB field and the community to ensure that persons infected with HIV have access to the "Three I's for HIV/TB" as part of universal access to high-quality comprehensive prevention, care, and treatment of HIV infection and TB.

Background: Individuals with human immunodeficiency virus (HIV) infection are at an increased risk of developing active tuberculosis (TB). It is known that treatment of latent TB infection (LTBI), also referred to as TB preventive therapy or chemoprophylaxis, helps to prevent progression to active disease in HIV negative populations. However, the extent and magnitude of protection (if any) associated with preventive therapy in those infected with HIV should be quantified. This present study is an update of the original review., Objectives: To determine the effectiveness of TB preventive therapy in reducing the risk of active tuberculosis and death in HIV-infected persons., Search Strategy: This review was updated using the Cochrane Controlled Trials Register (CCTR), MEDLINE, EMBASE, AIDSLINE, AIDSTRIALS, AIDSearch, NLM Gateway and AIDSDRUGS (publication date from 01 July 2002 to 04 April 2008). We also scanned reference lists of articles and contacted authors and other researchers in the field in an attempt to identify additional studies that may be eligible for inclusion in this review., Selection Criteria: We included randomized controlled trials in which HIV positive individuals were randomly allocated to TB preventive therapy or placebo, or to alternative TB preventive therapy regimens. Participants could be tuberculin skin test positive or negative, but without active tuberculosis., Data Collection and Analysis: Three reviewers independently applied the study selection criteria, assessed study quality and extracted data. Effects were assessed using relative risk for dichotomous data and mean differences for continuous data., Main Results: 12 trials were included with a total of 8578 randomized participants. TB preventive therapy (any anti-TB drug) versus placebo was associated with a lower incidence of active TB (RR 0.68, 95% CI 0.54 to 0.85). This benefit was more pronounced in individuals with a positive tuberculin skin test (RR 0.38, 95% CI 0.25 to 0.57) than in those who had a negative test (RR 0.89, 95% CI 0.64 to 1.24). Efficacy was similar for all regimens (regardless of drug type, frequency or duration of treatment). However, compared to INH monotherapy, short-course multi-drug regimens were much more likely to require discontinuation of treatment due to adverse effects. Although there was reduction in mortality with INH monotherapy versus placebo among individuals with a positive tuberculin skin test (RR 0.74, 95% CI 0.55 to 1.00) and with INH plus rifampicin versus placebo regardless of tuberculin skin test status (RR 0.69, 95% CI 0.50 to 0.95), overall, there was no evidence that TB preventive therapy versus placebo reduced all-cause mortality (RR 0.94, 95% CI 0.85 to 1.05)., Authors' Conclusions: Treatment of latent tuberculosis infection reduces the risk of active TB in HIV positive individuals especially in those with a positive tuberculin skin test. The choice of regimen will depend on factors such as availability, cost, adverse effects, adherence and drug resistance. Future studies should assess these aspects. In addition, trials evaluating the long-term effects of anti-tuberculosis chemoprophylaxis, the optimal duration of TB preventive therapy, the influence of level of immunocompromise on effectiveness and combination of anti-tuberculosis chemoprophylaxis with antiretroviral therapy are needed.

Background: The clinical characteristics and consequences of HIV-I infection observed in studies from developed countries cannot be generalized across the multiple virus subtypes that circulate in sub-Saharan Africa in general and Nigeria in particular. This study was therefore conducted to determine the commonest symptoms and signs at presentation in HIV-infected individuals at the Jos University Teaching Hospital., Method: This descriptive study was conducted at the antiretroviral clinic of the Jos University Teaching Hospital, Jos, between May and October 2004. Two hundred (200) newly diagnosed and laboratory confirmed adult cases of HIV infection without prior antiretroviral drug use were recruited after obtaining informed consent. Each qualified patient had a comprehensive history taken with emphasis on the clinical symptoms and detailed physical examination performed by the researchers. The data collected were analyzed using a multipurpose computer programme, Epi-info 2000 version 1.1.3 (Atlanta GA, USA)., Results: There were 86 (43.0%) males and 114 (57.0%) females whose mean ages were 39.0 +/- 7.8 and 32.0 +/- 8.1 years, respectively. The major symptoms in the study population were: weight loss (65.5%), fever (41.5%), chronic cough (38.5%), diarrhea (32.0%), pruritus (13.0%) and body rash (12.5%). The major signs were pallor (25.0%), oral thrush (20.5%), wasting (20.0%), lymphadenopathy (18.0%), dermatitis (16.0%), hyperpigmented nails (13.5%) and finger clubbing (8.5%)., Conclusion: The symptoms and signs of HIV/AIDS obtained were similar to those obtained by other workers from different parts of the world; however, the findings of hyperpigmented nails and finger clubbing have not been frequently reported for other populations.

This study examines the use of various direct observation therapy-HAART treatment support modalities in Jos, Nigeria. A 12-month observational study enrolling 175 antiretroviral naïve patients into four arms of direct observation therapy-HAART (highly active antiretroviral therapy); daily observed therapy (DOT), twice weekly observed therapy (TWOT), weekly observed therapy (WOT) and self-administered therapy (SAT), examined community treatment support using family and community members. Treatment outcomes were much better in the treatment-supported groups compared with the control self-therapy group. CD4 cell increases were 218/microL (DOT), 267/microL (TWOT), 205/microL (WOT) versus 224/microL (SAT), whereas plasma HIV-1 RNA reached undetectable levels (<400 copies/mL) in 91%, 88%, 84% versus 79% of patients in the DOT, TWOT, WOT versus SAT groups, respectively, at 48 weeks. We, therefore, strongly support the use of treatment support in our settings.