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Abstract Background The rapid start of antiretroviral therapy (RSA) model initiates antiretroviral therapy (ART) as soon as possible after a new or preliminary diagnosis of HIV, in advance of HIV-1 RNA and other baseline laboratory testing. This observational study aims to determine if RSA with a single tablet regimen of bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) is an effective regimen for achieving viral suppression and accepted by patients at the time of diagnosis. Methods Adults newly or preliminarily diagnosed with HIV were enrolled from October 2018 through September 2021. Real world advantage, measured in days between clinical milestones and time to virologic suppression, associated with B/F/TAF RSA was compared to historical controls. Results All Study RSA participants (n = 45) accepted treatment at their first visit and 43(95.6%) achieved virologic suppression by week 48. Study RSA participants had a significantly shorter time (median 32 days) from diagnosis to ART initiation and virologic suppression, in comparison to historical controls (median 181 days) (n = 42). Qualitative feedback from study RSA participants showed high acceptance positive response to RSA. Conclusions RSA is feasible and well accepted by patients in a real-world community-based clinic setting. Promoting RSA in community-based clinics is an important tool in ending the HIV epidemic.

Background: The rapid start of antiretroviral therapy (RSA) model initiates antiretroviral therapy (ART) as soon as possible after a new or preliminary diagnosis of HIV, in advance of HIV-1 RNA and other baseline laboratory testing. This observational study aims to determine if RSA with a single tablet regimen of bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) is an effective regimen for achieving viral suppression and accepted by patients at the time of diagnosis. Methods: Adults newly or preliminarily diagnosed with HIV were enrolled from October 2018 through September 2021. Real world advantage, measured in days between clinical milestones and time to virologic suppression, associated with B/F/TAF RSA was compared to historical controls. Results: All Study RSA participants (n = 45) accepted treatment at their first visit and 43(95.6%) achieved virologic suppression by week 48. Study RSA participants had a significantly shorter time (median 32 days) from diagnosis to ART initiation and virologic suppression, in comparison to historical controls (median 181 days) (n = 42). Qualitative feedback from study RSA participants showed high acceptance positive response to RSA. Conclusions: RSA is feasible and well accepted by patients in a real-world community-based clinic setting. Promoting RSA in community-based clinics is an important tool in ending the HIV epidemic. [ABSTRACT FROM AUTHOR]

BackgroundPeople who inject drugs living with HIV (PWIDLH) suffer the lowest rates of HIV viral suppression due to episodic injection drug use and poor mental health coupled with poor retention in HIV care. Approximately 44% of PWIDLH along the US-Mexico border are retained in care and only 24% are virally suppressed. This underserved region faces a potential explosion of transmission of HIV due to highly prevalent injection drug use. This protocol describes an optimization trial to promote sustained viral suppression among Spanish-speaking Latinx PWIDLH.MethodsThe multiphase optimization strategy (MOST) is an engineering-inspired framework for designing and building optimized interventions and guides this intervention. The primary aim is to conduct a 24 factorial experiment in which participants are randomized to one of 16 intervention conditions, with each condition comprising a different combination of four behavioral intervention components. The components are peer support for methadone uptake and persistence; behavioral activation therapy for depression; Life-Steps medication adherence counseling; and patient navigation for HIV care. Participants will complete a baseline survey, undergo intervention, and then return for 3-,6-,9-, and 12-month follow-up assessments. The primary outcome is sustained viral suppression, defined as viral loads of

Background: Low viral load suppression rates among older adolescents and young adults with HIV are a global challenge, including in Namibia. Healthcare providers struggle with managing these age groups due to their unique demographic characteristics. Monitoring viral load suppression is vital for evaluating antiretroviral treatment effectiveness, making it essential to identify and address existing gaps. Objectives: This study aimed to explore and describe healthcare practitioners’ understanding and experiences in managing older adolescents and younger adults living with HIV in seven high-burden districts of Namibia. Method: Qualitative descriptive phenomenological research was followed in this study. Healthcare practitioners directly managing older adolescents and younger adults living with HIV were purposively recruited. Telephonic individual interviews were conducted, and data saturation was achieved with the 29th participant. Colaizzi’s seven-step analysis was used to analyse the data. Results: Two themes emerged from the study: (1) healthcare practitioners’ knowledge of viral load management and (2) the strategies employed to manage high viral load in these age groups. These strategies included implementing differentiated service delivery, adopting interprofessional and Ubuntu approaches, psychosocial support, community engagement, enhancing adherence counselling, and support from implementing partners. Conclusion: The findings revealed inadequate knowledge among healthcare practitioners regarding viral load management, which negatively impacts the provision of quality care and an effective HIV response within the spirit of Ubuntu. Contribution: This study enhances healthcare practitioners’ capacity in viral load management and guides policy makers in supporting this unique population, thus improving their health outcomes.

Abstract Background People who inject drugs living with HIV (PWIDLH) suffer the lowest rates of HIV viral suppression due to episodic injection drug use and poor mental health coupled with poor retention in HIV care. Approximately 44% of PWIDLH along the US-Mexico border are retained in care and only 24% are virally suppressed. This underserved region faces a potential explosion of transmission of HIV due to highly prevalent injection drug use. This protocol describes an optimization trial to promote sustained viral suppression among Spanish-speaking Latinx PWIDLH. Methods The multiphase optimization strategy (MOST) is an engineering-inspired framework for designing and building optimized interventions and guides this intervention. The primary aim is to conduct a 24 factorial experiment in which participants are randomized to one of 16 intervention conditions, with each condition comprising a different combination of four behavioral intervention components. The components are peer support for methadone uptake and persistence; behavioral activation therapy for depression; Life-Steps medication adherence counseling; and patient navigation for HIV care. Participants will complete a baseline survey, undergo intervention, and then return for 3-,6-,9-, and 12-month follow-up assessments. The primary outcome is sustained viral suppression, defined as viral loads of

Background:  Low viral load suppression rates among older adolescents and young adults with HIV are a global challenge, including in Namibia. Healthcare providers struggle with managing these age groups due to their unique demographic characteristics. Monitoring viral load suppression is vital for evaluating antiretroviral treatment effectiveness, making it essential to identify and address existing gaps., Objectives:  This study aimed to explore and describe healthcare practitioners' understanding and experiences in managing older adolescents and younger adults living with HIV in seven high-burden districts of Namibia., Method:  Qualitative descriptive phenomenological research was followed in this study. Healthcare practitioners directly managing older adolescents and younger adults living with HIV were purposively recruited. Telephonic individual interviews were conducted, and data saturation was achieved with the 29th participant. Colaizzi's seven-step analysis was used to analyse the data., Results:  Two themes emerged from the study: (1) healthcare practitioners' knowledge of viral load management and (2) the strategies employed to manage high viral load in these age groups. These strategies included implementing differentiated service delivery, adopting interprofessional and Ubuntu approaches, psychosocial support, community engagement, enhancing adherence counselling, and support from implementing partners., Conclusion:  The findings revealed inadequate knowledge among healthcare practitioners regarding viral load management, which negatively impacts the provision of quality care and an effective HIV response within the spirit of Ubuntu.Contribution: This study enhances healthcare practitioners' capacity in viral load management and guides policy makers in supporting this unique population, thus improving their health outcomes.

Background: The population-based HIV impact assessment (population-based HIV impact assessments) surveys are among the first to estimate national adult HIV incidence, subnational prevalence of viral load suppression, and pediatric HIV prevalence. We summarize the survey methods implemented in Zimbabwe, Malawi, and Zambia, as well as response rates and quality metrics. Methods: Each cross-sectional, household-based survey used a 2-stage cluster design. Survey preparations included sample design, questionnaire development, tablet programming for informed consent and data collection, community mobilization, establishing a network of satellite laboratories, and fieldworker training. Interviewers collected demographic, behavioral, and clinical information using tablets. Blood was collected for home-based HIV testing and counseling (HBTC) and point-of-care CD4+ T-cell enumeration with results immediately returned. HIV-positive blood samples underwent laboratory-based confirmatory testing, HIV incidence testing, RNA polymerase chain reaction (viral load), DNA polymerase chain reaction (early infant diagnosis), and serum antiretroviral drug detection. Data were weighted for survey design, and chi square automatic interaction detection-based methods were used to adjust for nonresponse. Results: Each survey recruited a nationally representative, household-based sample of children and adults over a 6-10-month period in 2015 and 2016. Most (84%-90%) of the 12,000-14,000 eligible households in each country participated in the survey, with 77%-81% of eligible adults completing an interview and providing blood for HIV testing. Among eligible children, 59%-73% completed HIV testing. Across the 3 surveys, 97.8% of interview data were complete and had no errors. Conclusion: Conducting a national population-based HIV impact assessment with immediate return of HIV and other point-of-care test results was feasible, and data quality was high. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus (HIV) infections and less-than-optimal care of people living with HIV (PLHIV) continue to challenge public health and clinical care organizations in the communities that are most impacted by HIV. In the era of evidence-based public health, it is imperative to monitor viral load (VL) in PLHIV according to global and national guidelines and assess the factors associated with variation in VL levels. Purpose: This study had two objectives—(a) to describe the levels of HIV VL in persons on antiretroviral therapy (ART), and (b) to analyze the significance of variation in VL by patients’ demographic and clinical characteristics, outcomes of HIV care, and geographic characteristics of HIV care facilities. Methods: The study population for this quantitative study was 49,460 PLHIV in the Democratic Republic of Congo (DRC) receiving ART from 241 CDC-funded HIV/AIDS clinics in the Haut-Katanga and Kinshasa provinces of the DRC. Analysis of variance (ANOVA) was performed, including Tamhane’s T2 test for pairwise comparisons using de-identified data on all patients enrolled in the system by the time the data were extracted for this study by the HIV programs in May 2019. Results: The VL was undetectable (p < 0.001) higher for males than for females (32,446 copies/mL vs. 20,786, respectively), persons p ≤ 0.05 in this cohort. Conclusions: The VL was >1000 copies/mL for 19% of PLHIV receiving ART, indicating that these CDC-funded clinics and programs in the Haut-Katanga and Kinshasa provinces of DRC have more work to do. Strategically designed innovations in services are desirable, with customized approaches targeting PLHIV who are younger, male, those LTFU, with HIV/TB co-infection, and those receiving care from urban clinics.

Background: We describe the timing of human immunodeficiency virus (HIV) diagnosis and antiretroviral treatment (ART) initiation after implementation of universal testing and treatment policies in New York City (NYC).Methods: Using NYC population-based HIV registry data for persons with HIV diagnosed from 2012 through 2015 and followed up through June 2017, we examined trends in the proportion with diagnosis soon after HIV infection (ie, with CD4 cell count ≥500/μL or with acute HIV infection) and used Kaplan-Meier plots and proportional hazards regression to examine the timing of ART initiation after diagnosis.Results: Among 9987 NYC residents with HIV diagnosed from 2012 to 2015, diagnosis was early in 35%, and 87% started ART by June 2017. The annual proportion of persons with early diagnosis did not increase appreciably (35% in 2012 vs 37% in 2015; P = .08). By 6 months after diagnosis, 62%, 67%, 72% and 77% of persons with HIV diagnosed in 2012, 2013, 2014, or 2015, respectively, had started ART, with median (interquartile range) times to ART initiation of 3.34 (1.34-12.75), 2.62 (1.28-10.13), 2.16 (1.15-7.11), and 2.03 (1.11-5.61) months, respectively.Conclusions: Although recommendations for ART initiation on diagnosis are increasingly being implemented, the findings of the current study suggest that immediate treatment initiation is not universal. Continued efforts are needed to expand and better target HIV testing to promote earlier diagnosis. [ABSTRACT FROM AUTHOR]

Background: Limited data are available on HIV viral suppression rates among men and women on antiretroviral therapy (ART) and factors associated with HIV RNA viral load (VL) suppression in Vietnam. Methods: We conducted a cross-sectional survey of 1255 adult patients on ART for at least 1 year across four provinces in Vietnam. Data collection included a standardised questionnaire, routine laboratory testing, and an HIV VL assay. Bivariate and logistic multivariate analyses were conducted to assess viral suppression rates and factors associated with unsuppressed HIV VL. Results: The median age was 34.5 years and the median time on ART was 46 months. Gender was 66% male (n=828) and 34% female (n=427). HIV viral suppression below 1000 copies/mL was 93%. Viral suppression among woman was not significantly different than among men (93.7% vs92.9%; P=0.59). On multivariate analysis, unsuppressed HIV VL was independently associated with lower CD4 cell count, social isolation, high stigma, not receiving a single-tablet daily regimen, multiple late appointments in past year, and immunological failure. Conclusion: On-treatment viral load suppression rates in Vietnam are high and already exceed the UNAIDS 90% target for viral suppression on ART. Gender does not impact viral suppression rates of patients on ART in Vietnam. Access to routine viral load testing should be improved, adherence monitoring and counselling streamlined, and ART regimens simplified to maintain viral suppression rates, as more people start ART. Psychological and social factors are also associated with unsuppressed HIV VL, necessitating treatment support interventions to address social isolation and stigma among people living with HIV in Vietnam.

To evaluate whether elevated CD8 counts are associated with increased risk of virologic treatment failure in HIV-infected individuals.Retrospective cohort study.US Military HIV Natural History Study participants who initiated highly active antiretroviral therapy (HAART) in 1996-2008 had 6- and 12-month post-HAART HIV RNA <400 copies per milliliter, ≥2 subsequent HIV viral loads and a baseline CD8 count were eligible (n = 817). Baseline was 12 months after the start of HAART, virologic failure (VF) was defined as confirmed HIV RNA ≥400 copies per milliliter, and CD8 counts ≥1200 cells per cubic millimeter were considered elevated. Cox models were used to examine the effect of baseline and time-updated CD8 counts on VF.There were 216 failures for a rate of 5.6 per 100 person-years [95% confidence interval (CI): 4.9 to 6.4]. Among those initiating HAART in 2000-2008, the participants with elevated baseline CD8 counts had significantly greater risk of VF compared with those with baseline CD8 counts ≤600 cells per cubic millimeter [hazard ratio (HR) = 2.68, 95% CI: 1.13 to 6.35]. The participants with elevated CD8 counts at >20% of previous 6-month follow-up visits had a greater risk of failure at the current visit than those who did not (HR = 1.53, 95% CI: 1.14 to 2.06). Those with CD8 counts that increased after the start of HAART had a greater risk of failure than those with CD8 counts that decreased or remained the same (HR = 1.59, 95% CI: 1.19 to 2.13).Initial or serial elevated CD8 counts while on HAART or an increase in CD8 counts from HAART initiation may be early warnings for future treatment failure. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus (HIV) infections and less-than-optimal care of people living with HIV (PLHIV) continue to challenge public health and clinical care organizations in the communities that are most impacted by HIV. In the era of evidence-based public health, it is imperative to monitor viral load (VL) in PLHIV according to global and national guidelines and assess the factors associated with variation in VL levels. Purpose: This study had two objectives—(a) to describe the levels of HIV VL in persons on antiretroviral therapy (ART), and (b) to analyze the significance of variation in VL by patients' demographic and clinical characteristics, outcomes of HIV care, and geographic characteristics of HIV care facilities. Methods: The study population for this quantitative study was 49,460 PLHIV in the Democratic Republic of Congo (DRC) receiving ART from 241 CDC-funded HIV/AIDS clinics in the Haut-Katanga and Kinshasa provinces of the DRC. Analysis of variance (ANOVA) was performed, including Tamhane's T2 test for pairwise comparisons using de-identified data on all patients enrolled in the system by the time the data were extracted for this study by the HIV programs in May 2019. Results: The VL was undetectable (<40 copies/mL) for 56.4% of the patients and 24.7% had VL between 40 copies/mL and less than 1000 copies per mL, indicating that overall, 81% had VL < 1000 and were virologically suppressed. The remaining 19% had a VL of 1000 copies/mL or higher. The mean VL was significantly (p < 0.001) higher for males than for females (32,446 copies/mL vs. 20,786, respectively), persons <15 years of age compared to persons of ages ≥ 15 years at the time of starting ART (45,753 vs. 21,457, respectively), patients who died (125,086 vs. 22,090), those who were lost to follow-up (LTFU) (69,882 vs. 20,018), those with tuberculosis (TB) co-infection (64,383 vs. 24,090), and those who received care from urban clinics (mean VL = 25,236) compared to rural (mean VL = 3291) or semi-rural (mean VL = 26,180) clinics compared to urban. WHO clinical stages and duration on ART were not statistically significant at p ≤ 0.05 in this cohort. Conclusions: The VL was >1000 copies/mL for 19% of PLHIV receiving ART, indicating that these CDC-funded clinics and programs in the Haut-Katanga and Kinshasa provinces of DRC have more work to do. Strategically designed innovations in services are desirable, with customized approaches targeting PLHIV who are younger, male, those LTFU, with HIV/TB co-infection, and those receiving care from urban clinics. [ABSTRACT FROM AUTHOR]

Background and Objectives: There is growing international concern that food insecurity may negatively impact antiretroviral (ARV) treatment outcomes, but no studies have directly evaluated the effect of food insecurity on viral load suppression and antiretroviral adherence. We hypothesized that food insecurity would be associated with poor virologic response among homeless and marginally housed HIV-positive ARV-treated patients.Design: This is a cross-sectional study.Participants and Setting: Participants were ARV-treated homeless and marginally housed persons receiving adherence monitoring with unannounced pill counts in the Research on Access to Care in the Homeless (REACH) Cohort.Measurements: Food insecurity was measured by the Household Food Insecurity Access Scale (HFIAS). The primary outcome was suppression of HIV viral RNA to <50 copies/ml. We used multivariate logistic regression to assess whether food insecurity was associated with viral suppression.Results: Among 104 participants, 51% were food secure, 24% were mildly or moderately food insecure and 25% were severely food insecure. Severely food insecure participants were less likely to have adherence > or =80%. In adjusted analyses, severe food insecurity was associated with a 77% lower odds of viral suppression (95% CI = 0.06-0.82) when controlling for all covariates. In analyses stratified by adherence level, severe food insecurity was associated with an 85% lower odds of viral suppression (95% CI = 0.02-0.99) among those with < or =80% adherence and a 66% lower odds among those with >80% adherence (95% CI = 0.06-1.81).Conclusions: Food insecurity is present in half of the HIV-positive urban poor in San Francisco, one of the best resourced settings for HIV-positive individuals in the United States, and is associated with incomplete viral suppression. These findings suggest that ensuring access to food should be an integral component of public health HIV programs serving impoverished populations. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus (HIV) infections and less-than-optimal care of people living with HIV (PLHIV) continue to challenge public health and clinical care organizations in the communities that are most impacted by HIV. In the era of evidence-based public health, it is imperative to monitor viral load (VL) in PLHIV according to global and national guidelines and assess the factors associated with variation in VL levels., Purpose: This study had two objectives-(a) to describe the levels of HIV VL in persons on antiretroviral therapy (ART), and (b) to analyze the significance of variation in VL by patients' demographic and clinical characteristics, outcomes of HIV care, and geographic characteristics of HIV care facilities., Methods: The study population for this quantitative study was 49,460 PLHIV in the Democratic Republic of Congo (DRC) receiving ART from 241 CDC-funded HIV/AIDS clinics in the Haut-Katanga and Kinshasa provinces of the DRC. Analysis of variance (ANOVA) was performed, including Tamhane's T2 test for pairwise comparisons using de-identified data on all patients enrolled in the system by the time the data were extracted for this study by the HIV programs in May 2019., Results: The VL was undetectable (<40 copies/mL) for 56.4% of the patients and 24.7% had VL between 40 copies/mL and less than 1000 copies per mL, indicating that overall, 81% had VL < 1000 and were virologically suppressed. The remaining 19% had a VL of 1000 copies/mL or higher. The mean VL was significantly ( p < 0.001) higher for males than for females (32,446 copies/mL vs. 20,786, respectively), persons <15 years of age compared to persons of ages ≥ 15 years at the time of starting ART (45,753 vs. 21,457, respectively), patients who died (125,086 vs. 22,090), those who were lost to follow-up (LTFU) (69,882 vs. 20,018), those with tuberculosis (TB) co-infection (64,383 vs. 24,090), and those who received care from urban clinics (mean VL = 25,236) compared to rural (mean VL = 3291) or semi-rural (mean VL = 26,180) clinics compared to urban. WHO clinical stages and duration on ART were not statistically significant at p ≤ 0.05 in this cohort., Conclusions: The VL was >1000 copies/mL for 19% of PLHIV receiving ART, indicating that these CDC-funded clinics and programs in the Haut-Katanga and Kinshasa provinces of DRC have more work to do. Strategically designed innovations in services are desirable, with customized approaches targeting PLHIV who are younger, male, those LTFU, with HIV/TB co-infection, and those receiving care from urban clinics.

Background: Limited data are available on HIV viral suppression rates among men and women on antiretroviral therapy (ART) and factors associated with HIV RNA viral load (VL) suppression in Vietnam., Methods: We conducted a cross-sectional survey of 1255 adult patients on ART for at least 1 year across four provinces in Vietnam. Data collection included a standardised questionnaire, routine laboratory testing, and an HIV VL assay. Bivariate and logistic multivariate analyses were conducted to assess viral suppression rates and factors associated with unsuppressed HIV VL., Results: The median age was 34.5 years and the median time on ART was 46 months. Gender was 66% male (n=828) and 34% female (n=427). HIV viral suppression below 1000 copies/mL was 93%. Viral suppression among woman was not significantly different than among men (93.7% vs 92.9%; P=0.59). On multivariate analysis, unsuppressed HIV VL was independently associated with lower CD4 cell count, social isolation, high stigma, not receiving a single-tablet daily regimen, multiple late appointments in past year, and immunological failure., Conclusion: On-treatment viral load suppression rates in Vietnam are high and already exceed the UNAIDS 90% target for viral suppression on ART. Gender does not impact viral suppression rates of patients on ART in Vietnam. Access to routine viral load testing should be improved, adherence monitoring and counselling streamlined, and ART regimens simplified to maintain viral suppression rates, as more people start ART. Psychological and social factors are also associated with unsuppressed HIV VL, necessitating treatment support interventions to address social isolation and stigma among people living with HIV in Vietnam.