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Fewer adolescents achieve viral suppression compared to adults. One impediment may be a history of adverse childhood experiences (ACEs). To better develop targets and timeframes for intervention, this study created more robust estimates of the impact of cumulative adversity on viral suppression, tested whether the association is sensitive to the timing of adversity, and simultaneously tested several potential mechanisms. We focus on males, who have lower viral suppression than females and who may contribute to disproportionate incidence among young women. We recruited 251 male perinatally HIV-infected adolescents aged 15–19 from HIV clinics in Soweto, South Africa. Adversity was captured using the Adverse Childhood Experience – International Questionnaire (ACE-IQ). Viral load was measured using blood samples; viral suppression was defined as <20 copies/mL. Indicators of medication adherence, depression, post-traumatic stress disorder (, and substance misuse were captured. A series of pathway analysis were performed. Our sample experienced a median of 7 lifetime and 4 past-year adversities. Less than half (44%) exhibited viral suppression. Adversity demonstrated a significant association with suppression; depression mediated the association. Primary prevention of adversity among children living with HIV is paramount, as is addressing the subsequent mental and behavioral health challenges that impede viral suppression among adolescents. [ABSTRACT FROM AUTHOR]

South Africa has the largest share of people living with HIV in the world and this population is ageing. The social context in which people seek HIV care is often ignored. Apart from clinical interventions, socio-behavioural factors impact successful HIV care outcomes for older adults living with HIV. We use cross-sectional data linked with demographic household surveillance data, consisting of HIV positive adults aged above 40, to identify socio-behavioural predictors of a detectable viral load. Older adults were more likely to have a detectable viral load if they did not disclose their HIV positive status to close family members (aOR 2.56, 95% CI 1.89-3.46), resided in the poorest households (aOR 1.98, 95% CI 1.23-3.18), or were not taking medications other than ART (aOR 1.83, 95% CI 1.02-1.99) likely to have a detectable. Clinical interventions in HIV care must be supported by understanding the socio-behavioural barriers that occur outside the health facility. The importance of community health care workers in bridging this gap may offer more optimum outcomes for older adults ageing with HIV. [ABSTRACT FROM AUTHOR]

Background We aimed to compare clinical outcomes after viremia between dolutegravir vs efavirenz-based first-line antiretroviral therapy (ART) as evidence is lacking outside clinical trials in resource-limited settings. Methods We conducted a retrospective cohort analysis with routine data from 59 South African clinics. We included people with HIV aged ≥15 years receiving first-line tenofovir disoproxil fumarate, lamivudine, dolutegravir (TLD) or tenofovir disoproxil fumarate, emtricitabine, efavirenz (TEE) and with first viremia (≥50 copies/mL) between June and November 2020. We used multivariable modified Poisson regression models to compare retention in care and viral suppression (<50 copies/mL) after 12 months between participants on TLD vs TEE. Results At first viremia, among 9657 participants, 6457 (66.9%) were female, and the median age (interquartile range [IQR]) was 37 (31–44) years; 7598 (78.7%) were receiving TEE and 2059 (21.3%) TLD. Retention in care was slightly higher in the TLD group (84.9%) than TEE (80.8%; adjusted risk ratio [aRR], 1.03; 95% CI, 1.00–1.06). Of 6569 participants retained in care with a 12-month viral load, viral suppression was similar between the TLD (78.9%) and TEE (78.8%) groups (aRR, 1.02; 95% CI, 0.98–1.05). However, 3368 participants changed ART during follow-up: the majority from TEE to first-line TLD (89.1%) or second-line (TLD 3.4%, zidovudine/emtricitabine/lopinavir-ritonavir 2.1%). In a sensitivity analysis among the remaining 3980 participants who did not change ART during follow-up and had a 12-month viral load, viral suppression was higher in the TLD (78.9%) than TEE (74.9%) group (aRR, 1.07; 95% CI, 1.03–1.12). Conclusions Among people with viremia on first-line ART, dolutegravir was associated with slightly better retention in care and similar or better viral suppression than efavirenz. [ABSTRACT FROM AUTHOR]

Introduction: There is an urgent need for more efficient models of differentiated antiretroviral therapy (ART) delivery for people living with HIV (PLHIV), with the World Health Organization calling for evidence to guide whether annual ART prescriptions and consultations (12M scripts) should be recommended in global guidelines. We assessed the association between 12M scripts (allowed temporarily during the COVID‐19 pandemic) versus standard 6‐month prescriptions and consultations (6M scripts) and clinical outcomes. Methods: We performed a retrospective cohort study using routine, de‐identified data from 59 public clinics in KwaZulu‐Natal, South Africa. We included PLHIV aged ≥18 years with a recent suppressed viral load (VL) who had been referred for community ART delivery with 6M or 12M scripts. We used modified Poisson regression to compare 12‐month retention‐in‐care (≤90 days late for all visits) and viral suppression (<50 copies/ml) between prescription groups. Results: Among 27,148 PLHIV referred for community ART during Jun–Dec 2020, 57.4% received 12M scripts. The median age was 39 years and 69.4% were women. Age, sex, prior community ART use and time on ART were similar across groups. However, more of the 12M script group had dolutegravir‐based regimens (60.0% vs. 46.3%). The median (interquartile range) number of clinic visits in the year of follow‐up was 1(1‐1) in the 12M group and 2(2‐3) in the 6M group. Retention was 94.6% (95% confidence interval [CI]: 94.2%–94.9%) among those receiving 12M scripts and 91.8% (95% CI: 91.3%–92.3%) among those with 6M scripts. 17.1% and 16.9% of clients in the 12M and 6M groups were missing follow‐up VL data, respectively. Among those with VLs, 92.4% (95% CI: 92.0%–92.9%) in the 12M group and 91.4% (95% CI: 90.8%–92.0%) in the 6M group were suppressed. After adjusting for age, sex, ART regimen, time on ART, prior community ART use and calendar month, retention (adjusted risk ratio [aRR]: 1.03, 95% CI: 1.01–1.05) and suppression (aRR: 1.00, 95% CI: 0.99–1.01) were similar across groups. Conclusions: Among PLHIV referred for community ART with a recent suppressed VL, the use of 12M scripts reduced clinic visits without impacting short‐term clinical outcomes. 12M scripts should be considered for differentiated service delivery programmes. [ABSTRACT FROM AUTHOR]

Introduction: There is little data on long‐term implementation and outcomes for people living with HIV (PLHIV) in differentiated antiretroviral therapy (ART) delivery programmes. We aimed to analyse usage patterns of and associated treatment outcomes in a community ART programme, within the Centralized Chronic Medicines Dispensing and Distribution programme, in South Africa over 3.5 years. Methods: We performed a retrospective cohort study among PLHIV on first‐line ART who were eligible for community ART delivery between October 2016 and March 2019, from 56 urban clinics in KwaZulu‐Natal, South Africa. Follow‐up ended in March 2020. We measured referral rates and, among those referred, we characterized patterns of community ART usage using group‐based trajectory modelling following referral. We used survival analysis to measure the association between community ART usage and loss‐to‐care (no visit for ≥365 days) and logistic regression to measure the association between community ART usage and viraemia (≥50 copies/ml). Results: Among the 80,801 patients eligible for community ART, the median age was 36 years, 69.8% were female and the median (interquartile range [IQR]) follow‐up time was 22 (13–31) months. In total, 49,961 (61.8%) were referred after a median of 6 (IQR 2–13) months from first eligibility. After referral, time spent in community ART varied; 42% remained consistently in community ART, 15% returned to consistent clinic‐based care and the remaining 43% oscillated between community ART and clinic‐based care. Following referral, the incidence of loss‐to‐care was 3.93 (95% confidence interval [CI]: 3.71–4.15) per 100 person‐years during periods of community ART usage compared to 5.75 (95% CI: 5.28–6.25) during clinic‐based care. In multivariable models, community ART usage was associated with a 36% reduction in the hazards of loss‐to‐care (adjusted hazard ratio: 0.64 [95% CI: 0.57–0.72]). The proportion of patients who became viraemic after first community ART referral was 5.2% and a 10% increase in time in community ART was associated with a 3% reduction in odds of viraemia (adjusted odds ratio: 0.97 [95% CI: 0.95–0.99]). Conclusions: Community ART usage patterns vary considerably, while clinical outcomes were good. Promoting consistent community ART usage may reduce clinic burden and the likelihood of patients being lost to care, while sustaining viral suppression. [ABSTRACT FROM AUTHOR]

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Research suggests that women's experience of intimate partner violence (IPV) is associated with poor engagement in HIV care and treatment. However, most studies have been cross-sectional and conducted in North America. We examined the association between physical IPV and HIV care outcomes in a prospective cohort study of women living with HIV (WLHIV) in Malawi, South Africa, Uganda, and Zimbabwe. At enrollment, 15% of the 351 participants self-reported physical IPV. IPV experience was not associated with time to first engagement in HIV care or the proportion virally suppressed after 6 months on ART. Women reporting physical IPV were less likely to initiate ART within 6 months of becoming eligible (adjusted RR 0.74, 95% CI 0.53–1.03). IPV screening is critical to identify survivors and link them to appropriate services. However, addressing IPV may not increase engagement in HIV care or viral load suppression among WLHIV in sub-Saharan Africa. [ABSTRACT FROM AUTHOR]

HIV has globally infected over 37.9 million people, of which 28.2 million (73%) are on antiretroviral treatment, and 66% of those on treatment are virally suppressed. In South Africa, however, low rate of viral suppression (47%) among people living with HIV is a major health problem that has continued to fuel HIV prevalence. A cross-sectional quantitative research design was used to investigate the relationship between treatment comorbidities and viral suppression among HIV-infected adults aged 18–49 who were diabetic, had cancer, or tuberculosis in Johannesburg. HIV Care Continuum formed the theoretical framework for this research. An existing HIV-infected patient de-identifiable dataset (n = 602) was used for the descriptive and logistic regression analysis. Results revealed a statistically significant association between tuberculosis treatment and viral suppression—adjusted OR = 1.534, (1.053, 2.234), and p = 0.02—indicating that treatment of comorbidities, such as tuberculosis, has positive impact on viral suppression outcomes. Results, however, revealed that the model for diabetes treatment and viral suppression—OR = 0.993, (0.658, 1.498), and p = 0.97—and the model for cancer treatment and viral suppression—OR= 1.234, (0.844, 1.805), and p = 0.27—were not statistically significant. Treatment of comorbidities, such as TB and HIV, positively impacts viral suppression outcomes. These findings suggested that concurrent, simultaneous, or integrated treatment models for comorbidities can help to achieve HIV viral suppression. This study contributes to positive social change by highlighting the effect of treatment comorbidities on viral suppression in people living with HIV (PLWHIV) in an under-resourced setting, which could inform policy and influence decisions on HIV care and management. [ABSTRACT FROM AUTHOR]

Background: South Africa has made significant progress in scaling up antiretroviral therapy (ART) to achieve the aspirational goal of HIV epidemic control. The aim of this study was to determine the prevalence of HIV, assess progress towards each of the Joint United Nations Programme on HIV/AIDS (UNAIDS) indicators and determine factors associated with achieving viral suppression among pregnant adolescents and women living with HIV in rural KwaZulu-Natal, South Africa. Methods: Pregnant adolescents and women, 12 years and older seeking antenatal care at six primary health care clinics were enrolled in a cross-sectional study. Following written informed consent, structured questionnaires were administered, and finger-prick blood samples were collected for HIV antibody testing and viral load measurement. Viral suppression was defined as HIV viral load of < 400 copies per mL. Results: Between Dec 2016 and March 2017, among the 546 enrolled participants, data for 545 were analysed. The overall HIV prevalence was 40.2% [95% Confidence Interval (CI) 36.1–44.3]. Age-stratified prevalence increased from 22.1% (95% CI, 15.9–30.0) in the 14–19 year age group to 63.9% (95% CI, 55.1–71.9) among women ≥ 30 years (Χ2 trend P < 0.0001). Of the HIV positive participants, 84.5% (95% CI, 79.0–88.8) knew their HIV positive status, 98.3% (95% CI 95.1–99.4) who knew their status were on ART, and of those on ART, 95.9% (95% CI 91.8–98.0) were virally suppressed. Among all HIV-positives 90.8% (95% CI, 86.3–94.0) had achieved viral suppression, whilst those in the 14–19 year age group were least likely to be virally suppressed at 82.8% (95% CI 65.5–92.4) compared to those in the older age groups. Married women compared to those unmarried were more likely to have achieved viral suppression (PRR) of 1.11 (95% CI 1.05–1.18), P < 0.001. Conclusions: The proportion of HIV positive pregnant women achieving viral suppression was encouraging though far short of the target towards achieving epidemic control. Importantly, adolescent pregnant women were less likely to know their HIV status and to achieve viral suppression, underscoring the public health implications of sustained risk of HIV transmission. Thus, greater effort and strong social support are essential to improve HIV knowledge of status and care continuum towards the goal to achieving HIV epidemic control. Plain language summary: To "fast-track" the response to achieve HIV epidemic control and end the AIDS epidemic, the Joint United Nations Programme on HIV/AIDS (UNAIDS) set ambitious HIV testing and treatment targets for people living with HIV. Meeting these targets through scaling up testing for HIV, initiating and sustaining antiretroviral therapy (ART) to maintain viral suppression provides both therapeutic and preventive benefits with the potential to reduce HIV transmission. Viral suppression among pregnant adolescents and women living with HIV is crucial for the prevention of mother-to-child transmission of HIV including onward transmission to sexual partners. As a public health approach, in South Africa all pregnant women are offered routine HIV testing and immediate initiation of lifelong ART irrespective of CD4 cell count. It is, therefore, important to ascertain progress towards reaching the targets. The proportion of HIV positive pregnant adolescents and women achieving viral suppression was encouraging though far short of the target towards achieving epidemic control. Importantly, pregnant adolescents were less likely to know their HIV status and to achieve viral suppression, underscoring the public health implications of sustained risk of HIV transmission. Thus, greater effort and strong social support are essential to improve HIV knowledge of status and care continuum towards the goal to achieving HIV epidemic control. [ABSTRACT FROM AUTHOR]

Background: In 2019, about 1.7 million adolescents between the ages of 10 and 19 years were living with HIV worldwide, of which 170 000 were newly infected with HIV in 2019. South Africa has the highest number of persons living with HIV. Although there has been major improvement in access to antiretroviral therapy (ART), it is still unclear what proportion of adolescents (aged 10–19 years) are virally suppressed in the provinces of South Africa. Objectives: To determine the prevalence of and the factors associated with viral suppression among adolescents (10–19 years) on ART in the Thabo Mofutsanyane District Municipality of the Free State province of South Africa. Method: A retrospective cross-sectional analysis of demographic, clinical and treatmentrelated information that were extracted from an electronic database was conducted using Statistical Package for the Social Sciences version 26. Results: The median duration on ART was 6.58 years. Although 78% (n = 4520) of adolescents living with HIV who were on ART achieved viral suppression (< 1000 copies/mL), only 9.5% (n = 430) were fully suppressed at < 50 copies/mL. In multivariate analysis, the odds of being virally suppressed reduced with increasing age at ART initiation. Adolescents with CD4 counts greater than 500 cells/mm3 at baseline had a higher odds ratio of viral suppression (adjusted odds ratio [AOR]: 1.77; confidence interval [CI]: 1.28–2.47). The odds of viral suppression were significantly lower among those not retained in care (AOR: 0.45; CI: 0.35–0.58). Conclusion: Tailored interventions should be developed to improve viral suppression among adolescents on ART. [ABSTRACT FROM AUTHOR]

Introduction: Same‐day initiation (SDI) of antiretroviral therapy (ART) for HIV consistently increases ART uptake, but concerns remain about higher attrition from care after initiation. We analysed 12‐month retention in the SLATE SDI trials. Methods: SLATE I (Simplified Algorithms for Treatment Eligibility I, enrolment 06 March–28 July 2017) and SLATE II (enrolment 14 March–18 September 2018) were individually randomized trials at public outpatient clinics in Johannesburg that enrolled patients not yet on ART and administered the SLATE I or II algorithm. This included a symptom self‐report, medical history, brief physical examination and readiness questionnaire to assess the eligibility for SDI. The studies compared the offer of SDI using the SLATE algorithms to standard of care initiation procedures. ART uptake and early retention were previously reported. Using routine clinic records, we conducted a pooled analysis of retention in care and HIV viral suppression 14 months after study enrolment, a time point equivalent to 12 months potential on ART, with an additional month allowed on either end to initiate ART and to return for the 12‐month visit. Results and discussion: We enrolled 1193 study participants (standard arms, n = 599, 50%; intervention arms, n = 594, 50%) and analysed by originally assigned groups. By 14 months after enrolment, 50% of intervention arm patients and 46% of standard arm patients remained in care at the initiating site (crude risk difference 4% (95% confidence interval −1%‐10%); crude relative risk 1.10 (0.97–1.23), with similar viral suppression between arms. Observed attrition from care at site by 14 months was high in both study arms, but we found no evidence that the offer of SDI led to greater overall attrition or lower rates of viral suppression 1 year after starting ART and may have generated small improvements. SDI may have shifted some attrition from before to after dispensing of the first dose of medication. Conclusions: An offer of SDI of ART, following a carefully designed protocol to identify patients who are eligible and ready to start treatment, is not inherently associated with an overall increase in patient attrition from care and leads to similar rates of viral suppression. Trial registration: Clinicaltrials.gov NCT02891135, registered 01 September 2016. First participant enrolled 06 March 2017 in South Africa. Clinicaltrials.gov NCT03315013, registered 19 October 2017. First participant enrolled 14 March 2018. [ABSTRACT FROM AUTHOR]

Introduction: Antiretroviral treatment (ART) adherence rates are lower among adolescents living with HIV (ALHIV) than among adults and children, but more evidence is needed on long‐term sustained ART adherence among ALHIV. This study assesses rates of sustained ART adherence in a cohort of adolescents in South Africa. Methods: A prospective cohort of adolescents (10‐19 years) living with HIV (baseline sample N = 1 046, 55% female, mean age 13.6) in the Eastern Cape Province in South Africa were interviewed at baseline (2014‐15) and followed‐up twice (2015‐16, 2017–18). All adolescents ever initiated on treatment in 52 government health facilities were traced (with 90% uptake, 94% retention at Wave 2, and 97% retention at Wave 3, 3.4% mortality) and their clinic records were extracted where available. We investigate sustained ART adherence among adolescents interviewed at all three waves of data collection (N = 933). To quantify adherence at each study wave, we used self‐reported past‐week adherence (including weekdays and weekends). Self‐reported adherence was validated using HIV‐1 RNA viral load (>50 copies/mL cut‐off) reported in clinic records, in a random‐intercept logistic regression. Results and discussion: At baseline, approximately 66% (N = 615) of adolescents reported past‐week ART adherence, and of these 45.3% reported adherence at both baseline and follow‐up. Only 37.1% of the sample reported sustained past‐week ART adherence over the three waves of the study. Most adolescents (N = 587, 62.9%) report inconsistent adherence across time (including 6.4% disengaged from care). Older (P = 0.007) and adolescents with horizontally acquired HIV (P = 0.002) were more likely to report inconsistent adherence across time. Controlling for socio‐demographic characteristics, past‐week adherence was associated with non‐detectable viral load (aOR 1.72, 95%CI 1.14‐2.59, P = 0.009). Overall, of the adolescents with viral load measurements at study Wave 1 and Wave 2, 50.6% maintained undetectable viral load for the preceding year. Conclusions: Adolescents living with HIV reported very low rates of sustained ART adherence. Adherence reported at a single time may mask high rates of variability in adherence over time. These findings highlight the urgent need for enhanced and effective interventions to assist ALHIV with ART adherence through the challenging years of adolescence. [ABSTRACT FROM AUTHOR]

Objectives: South Africa has made remarkable progress in increasing the coverage of antiretroviral therapy (ART) among pregnant women; however, viral suppression among pregnant women receiving ART is reported to be low. Access to routine viral load testing is crucial to identify women with unsuppressed viral load early in pregnancy and to provide timely intervention to improve viral suppression. This study aimed to determine the coverage of maternal viral load monitoring nationally, focusing on viral load testing, documentation of viral load test results, and viral suppression (viral load < 50 copies/mL). At the time of this study, the first‐line regimen for women initiating ART during pregnancy was non‐nucleoside reverse transcriptase (NNRTI)‐based regimen. Methods: Between 1 October and 15 November 2019, a cross‐sectional survey was conducted among 15‐ to 49‐year‐old pregnant women attending antenatal care in 1589 nationally representative public health facilities. Data on ART status, viral load testing and viral load test results were extracted from medical records. Logistic regression was used to examine factors associated with coverage of viral load testing. Results: Of 8112 participants eligible for viral load testing, 81.7% received viral load testing, and 94.1% of the viral load test results were documented in the medical records. Of those who had viral load test results documented, 74.1% were virally suppressed. Women initiated on ART during pregnancy and who received ART for three months had lower coverage of viral load testing (73%) and viral suppression (56.8%) compared with women initiated on ART before pregnancy (82.8% and 76.1%, respectively). Initiating ART during pregnancy rather than before pregnancy was associated with a lower likelihood of receiving a viral load test during pregnancy (adjusted odds ratio = 1.6, 95% confidence interval: 1.4–1.8). Conclusions: Viral load result documentation was high; viral load testing could be improved especially among women initiating ART during pregnancy. The low viral suppression among women who initiated ART during pregnancy despite receiving ART for three months highlights the importance of enhanced adherence counselling during pregnancy. Our finding supports the WHO recommendation that a Dolutegravir‐containing regimen be the preferred regimen for women who are newly initiating ART during pregnancy for more rapid viral suppression. [ABSTRACT FROM AUTHOR]

Despite improvements in access to antiretroviral treatment over the past decade, sub-optimal HIV care outcomes persist among youth with HIV (YWH) in rural South Africa. Psychosocial stressors could impede improved HIV treatment outcomes within this population. We linked self-reported psychosocial health and demographic data from a cross-sectional survey conducted among YWH aged 12–24 in rural South Africa to individual medical record data, including facility visit history and viral load measurements. Poisson regression with robust standard errors was used to estimate the associations between five psychosocial stressors- heightened depressive symptoms (Center for Epidemiological Studies-Depression scale scores ≥ 16), lower social support (Medical Outcomes Social Support Scale scores ≤ 38), lower resilience (Conner-Davidson Resilience Scale scores ≤ 73), lower self-esteem (Rosenberg Self-Esteem Scale scores ≤ 21), and higher perceived stress (Sheldon Cohen Perceived Stress Scale scores ≥ 10)- and viral non-suppression (viral load ≥ 400 copies/mL) and loss to care (no documented clinic visits within the 90 days prior to survey), separately. A total of 359 YWH were included in this analysis. The median age of study participants was 21 (interquartile range: 16–23), and most were female (70.2%), single (82.4%), and attending school (54.7%). Over a quarter of participants (28.1%) had heightened depressive symptoms. Just 16.2% of all participants (n = 58) were lost to care at the time of survey, while 32.4% (n = 73) of the 225 participants with viral load data were non-suppressed. The prevalence of non-suppression in individuals with lower self-esteem was 1.71 (95% confidence interval: 1.12, 2.61) times the prevalence of non-suppression in those with higher self-esteem after adjustment. No meaningful association was observed between heightened depressive symptoms, lower social support, lower resilience, and higher perceived stress and viral non-suppression or loss to care in adjusted analyses. Retention in care and viral suppression among YWH in rural South Africa are below global targets. Interventions aimed at improving viral suppression among YWH should incorporate modules to improve participant's self-esteem as low self-esteem is associated with viral non-suppression in this setting. Future studies should longitudinally explore the joint effects of co-occurring psychosocial stressors on HIV care outcomes in YWH and assess meaningful differences in these effects by age, gender, and route of transmission. [ABSTRACT FROM AUTHOR]

Background: South Africa, with one of the highest HIV prevalences in the world, introduced the universal test and treat (UTT) programme in September 2016. Barriers to sustained viral suppression may include drug resistance in the pre-treated population, non-adherence, acquired resistance; pharmacokinetics and pharmacodynamics, and concurrent use of alternative treatments. Objective: The purpose of this review is to highlight potential challenges to achieving sustained viral load suppression in South Africa (SA), a major expectation of the UTT initiative. Methodology: Through the PRISMA approach, published articles from South Africa on transmitted drug resistance; adherence to ARV; host genetic factors in drug pharmacokinetics and pharmacodynamics, and interactions between ARV and herbal medicine were searched and reviewed. Results: The level of drug resistance in the pre-treated population in South Africa has increased over the years, although it is heterogeneous across and within Provinces. At least one study has documented a pre-treated population with moderate (> 5%) or high (> 15%) levels of drug resistance in eight of the nine Provinces. The concurrent use of ARV and medicinal herbal preparation is fairly common in SA, and may be impacting negatively on adherence to ARV. Only few studies have investigated the association between the genetically diverse South African population and pharmacokinetics and pharmacodynamics of ARVs. Conclusion: The increasing levels of drug resistant viruses in the pre-treated population poses a threat to viral load suppression and the sustainability of first line regimens. Drug resistance surveillance systems to track the emergence of resistant viruses, study the burden of prior exposure to ARV and the parallel use of alternative medicines, with the goal of minimizing resistance development and virologic failure are proposed for all the Provinces of South Africa. Optimal management of the different drivers of drug resistance in the pre-treated population, non-adherence, and acquired drug resistance will be beneficial in ensuring sustained viral suppression in at least 90% of those on treatment, a key component of the 90-90-90 strategy. [ABSTRACT FROM AUTHOR]

Introduction: virological non-suppression is not only associated with increased risk of transmission of the Human Immunodeficiency virus (HIV) to others; perinatally and sexually, but it also decreases the life expectancy among the individuals who are on antiretroviral therapy (ART). This study sought to determine the level of virological non-suppression among ART patients from selected health facilities of a sub-district in uMgungundlovu district. This sub-district has high HIV transmission rates in KwaZulu Natal (KZN) and had one of the highest HIV prevalence in the district in 2018; population weighted HIV prevalence of 36.3% among men and women aged 15-49 years old, which was twice the average national prevalence of 18.8%., Methods: this descriptive, cross-sectional, and quantitative study was conducted among participants who were HIV-positive, 18 years old and above, and initiated on ART between January 2017 and January 2019 at selected PHC facilities of Vulindlela sub district. Health facility treatment registers, patient medical files and face-to-face interviews were used to collect the data and these were captured onto an Excel spreadsheet, cleaned, coded before importation into Epiinfo 17 for statistical analyses. Logistic regression analyses were conducted to investigate the factors associated with virological non-suppression., Results: the study found a majority of participants were females (240/401 (60%)). The mean age of the participants was 38.1 (SD=11.2), with most participants who were between the ages of 29 and 39 years old (167 (41.7%)). Virological non-suppression was observed among 10% (40/401) of participants. The odds of virological non-suppression were higher among participants who were married (aOR 4.76, 95% CI 1.49-15.19; p=0.008)., Conclusion: a virological non-suppression of 10% translates to viral suppression of 90%, which is below the target of UNAIDS 95-95-95 strategy. Hiding and skipping medication indicate how non-disclosure continues to hinder HIV treatment adherence. High odds of virological non-suppression among married participants indicate non-disclosure of the positive HIV status, or lack in spousal support., Competing Interests: The authors declare no competing interests., (Copyright: Slindile Zondi et al.)

Introduction: Mental health problems are prevalent in adolescents living with HIV (ALHIV), often remain untreated, and may negatively affect antiretroviral therapy (ART) adherence and viral suppression. We implemented routine mental health screening at a paediatric ART clinic to improve the identification and management of mental health problems in ALHIV. In this report, we examine screening outcomes, associated patient characteristics and the odds of unsuppressed viral load in ALHIV screening positive for mental disorders. Methods: Adolescents aged 10 to 19 years attending Rahima Moosa Hospital in Johannesburg, South Africa between February 1, 2018, and January 1, 2020, were offered mental health screening at each routine HIV care visit. The screening included four pre‐screening questions followed by full screening (conditional on positive pre‐screening) for depression (Patient Health Questionnaire‐9 [PHQ‐9]), suicide (Adolescent Innovations Project [AIP]‐handbook), anxiety (Generalized Anxiety Disorder‐7 [GAD‐7]), post‐traumatic stress disorder (PTSD) (Primary Care PTSD Screen [PC‐PTSD‐5]) and substance use (CAGE Adapted to Include Drugs [CAGE‐AID]). We assessed screening outcomes and calculated adjusted odds ratios for associations between positive screening tests at the first screen and unsuppressed viral load (>400 copies/mL) at the measurement taken closest to the date of screening, within hundred days before and one day after screening. Results: Out of 1203 adolescents who attended the clinic, 1088 (90.4%) were pre‐screened of whom 381 (35.0%) underwent full screening, 48 (4.4%) screened positive for depression (PHQ‐9 ≥10), 29 (2.8%) for suicidal concern, 24 (2.2%) for anxiety (GAD‐7 ≥10), 38 (3.2%) for PTSD (PC‐PTSD‐5 ≥3), 18 (1.7%) for substance use (CAGE‐AID ≥2) and 97 (8.9%) for any of these conditions. Positive screening for depression (aOR 2.39, 95% CI 1.02 to 5.62), PTSD (aOR 3.18, 95% CI 1.11 to 9.07), substance use (aOR 7.13, 95% CI 1.60 to 31.86), or any condition (aOR 2.17, 95% CI 1.17 to 4.02) were strongly associated with unsuppressed viral load. Conclusions: ALHIV affected by mental health problems have increased rates of unsuppressed viral load and need specific clinical attention. The integration of routine mental health screening in paediatric ART programmes is a feasible approach for identifying and referring adolescents with mental health and adherence problems to counselling and psychosocial support services and if needed to psychiatric care. [ABSTRACT FROM AUTHOR]

Background: A strategy implemented by the South African Department of Health to manage the high burden of human immunodeficiency virus (HIV) has been to task-shift services to primary health care clinics. Outcomes of paediatric patients with HIV are poorer than those of adults, particularly in rural areas. Viral suppression in paediatric patients at the feeder clinics of a rural South African hospital was anecdotally far below the aim of the Joint United Nations Programme on HIV/AIDS (UNAIDS) of 90%. Methods: A quality improvement approach was used to conduct a baseline assessment of HIV viral suppression in paediatric patients and other process measures, implement a clinical mentorship intervention and evaluate its effectiveness. Results: An initial audit of 235 clinical folders of paediatric patients with HIV revealed a viral suppression of 55.3%. Other poor measures included prescription accuracy, viral loads performed within schedule and response to successive high viral loads. A clinical mentorship intervention using dedicated doctor outreach was implemented and the audit repeated after 12 months (263 folders). Viral suppression improved to 67.4%, as did most other process measures. Conclusion: The quality improvement approach regarding the aim to significantly improve viral suppression in paediatric patients through the implementation of clinical mentorship was successful. [ABSTRACT FROM AUTHOR]

Introduction: In South Africa, HIV patients with an elevated viral load (VL) should receive repeat VL testing after adherence counselling. We set out to use a national HIV Cohort to describe time to repeat viral load testing across South Africa and identify predictors of time to repeat testing. Methods: We conducted a cohort study of prospectively collected laboratory data. HIV treatment guidelines have changed over time in South Africa, but call for repeat VL testing within six months if 400 to 1000 copies/mL and two to three months if >1000 copies/mL. We included patients with suppressed viral loads (indicating they are on ART) and a first elevated VL (>400 copies/mL) between April 2004 and December 2014. Follow‐up began at first elevated VL and continued until repeat testing, loss to follow‐up or December 2016. We calculated adjusted hazard ratios (aHR) using Cox proportional hazard models. Results: Of 371,648 patients with a VL > 400, 83.9% (311,790) had a repeat VL, in a median (IQR) of 7.0 (4.1 to 12.2) months. Of those with a first viral load 400 to 1000 copies/mL, 56.4% had a repeat VL within guideline recommended six months (defined as up to nine months), whereas among those >1000 copies/mL only 47.7% had a repeat viral load within guideline recommended two to three months (defined as up to six months). We found a small increase in repeat testing associated with higher VL value (aHR 1.11; 95% CI: 1.10 to 1.12 comparing >1000 vs 400 to 1000 copies/mL) and very low CD4 counts at first elevated VL (aHR 1.16; 95% CI: 1.13 to 1.19 comparing CD4 < 50 vs <500 cells/mm3). We also found strong variation in time to repeat VL testing by province. Conclusions: Median time to repeat viral load testing for those with an elevated viral load was longer than guidelines recommend. Future work should identify whether delays are due to patient or provider factors. [ABSTRACT FROM AUTHOR]

Introduction: Despite improved treatment and access to care, adolescent AIDS deaths are decreasing more slowly than in any other age group. There is lack of longitudinal data around adolescent adherence and the dynamics of viraemia over time. We aimed to describe patterns of detectable viral load (VL) in a cohort of adolescents attending an ARV clinic in Cape Town, South Africa. Methods: We conducted a retrospective cohort study of all patients on antiretroviral therapy aged 10 to 19 years. Participants were included if they underwent at least two VL measurements and remained in care at the Groote Schuur Hospital HIV Clinic for at least 24 months between 2002 and 2016. The primary outcome was two consecutive HIV VL >100 copies/mL, in line with the lower limit of detection of assays in use over the follow‐up period. Results and discussion: Of the 482 screened participants, 327 met inclusion criteria. Most participants had perinatally acquired HIV (n = 314; 96%), and 170 (52%) were males. Overall, there were 203 episodes of confirmed detectable VL involving 159 (49% (95% CI 43% to 54%)) participants during the follow‐up period. Six participants had genotyped resistance to protease inhibitors. Four of these never suppressed, while two suppressed on salvage regimens. Total follow‐up time was 1723 person years (PY), of which 880 (51%) were contributed by the 159 participants who experienced detectable VL. Overall time with detectable VL was 370 PY. This comprised 22% of total follow‐up time, and 42% of the follow‐up time contributed by those who experienced detectable VL. The rate of detectable VL was 11.8 (95% CI 10.3 to 13.5) episodes per 100 PY. The risk increased by 24% for each year of increasing age (Relative Risk 1.24 (95% CI 1.17 to 1.31); p < 0.0001). There was no sex difference with respect to duration (p = 0.4), prevalence (p = 0.46) and rate (p = 0.608) of detectable VL. Conclusions: Clinicians need to be alert to the high prevalence of detectable VL during adolescence so as to pre‐empt it and act swiftly once it is diagnosed. This study helps to highlight the risk of detectable VL that is associated with increase in age as well the high proportion of time that poorly adherent adolescents spend in this state. [ABSTRACT FROM AUTHOR]

The delivery of high-quality HIV care in rural settings is a global challenge. Despite the successful expansion of antiretroviral therapy (ART) in Africa, viral load (VL) monitoring and ART adherence are poor, especially in rural communities. This article describes a case study of an ART program in the deeply rural Eastern Cape of South Africa. The Zithulele ART Program initiated five innovations over time: (1) establishing district hospital as the logistical hub for all ART care in a rural district, (2) primary care clinic delivery of prepackaged ART and chronic medications for people living with HIV (PLH), (3) establishing central record keeping, (4) incentivizing VL monitoring, and (5) providing hospital-based outpatient care for complex cases. Using a pharmacy database, on-time VL monitoring and viral suppression were evaluated for 882 PLH initiating ART in the Zithulele catchment area in 2013. Among PLH initiating ART, 12.5% (n = 110) were lost to follow-up, 7.7% (n = 68) transferred out of the region, 10.2% (n = 90) left the program and came back at a later date, and 4.0% (n = 35) died. Of the on-treatment population, 82.9% (n = 480/579) had VL testing within 7 months and 92.6% (n = 536/579) by 1 year. Viral suppression was achieved in 85.2% of those tested (n = 457/536), or 78.9% (n = 457/579) overall. The program's VL testing and suppression rates appear about twice as high as national data and data from other rural centers in South Africa, despite fewer resources than other programs. Simple system innovations can ensure high rates of VL testing and suppression, even in rural health facilities. [ABSTRACT FROM AUTHOR]

Background: Eligibility for differentiated antiretroviral therapy (ART) delivery models has to date been limited to low-risk stable patients. Objectives: We examined the outcomes of patients who accessed their care and treatment through an ART adherence club (AC), a differentiated ART delivery model, immediately following receiving support to achieve viral suppression after experiencing elevated viral loads (VLs) at a high-burden ART clinic in Khayelitsha, South Africa. Methods: Beginning in February 2012, patients with VLs above 400 copies/mL either on first- or second-line regimens received a structured intervention developed for patients at risk of treatment failure. Patients who successfully suppressed either on the same regimen or after regimen switch were offered immediate enrolment in an AC facilitated by a lay community health worker. We conducted a retrospective cohort analysis of patients who enrolled in an AC directly after receiving suppression support. We analysed outcomes (retention in care, retention in AC care and viral rebound) using Kaplan–Meier methods with follow-up from October 2012 to June 2015. Results: A total of 165 patients were enrolled in an AC following suppression (81.8% female, median age 36.2 years). At the closure of the study, 119 patients (72.0%) were virally suppressed and 148 patients (89.0%) were retained in care. Six, 12 and 18 months after AC enrolment, retention in care was estimated at 98.0%, 95.0% and 89.0%, respectively. Viral suppression was estimated to be maintained by 90.0%, 84.0% and 75.0% of patients at 6, 12 and 18 months after AC enrolment, respectively. Conclusion: Our findings suggest that patients who struggled to achieve or maintain viral suppression in routine clinic care can have good retention and viral suppression outcomes in ACs, a differentiated ART delivery model, following suppression support. [ABSTRACT FROM AUTHOR]

Background: South Africa has a high HIV burden. Despite increased uptake of persons living with HIV into the South African national antiretroviral therapy programme, the incidence of HIV increased between 2013 and 2016. Studies suggest that increased community viral suppression results in reduced HIV incidence in that community 'independent of unsafe sexual behaviours and sharing used syringes'. Objective: The aim of this study was to investigate the viral and immunologic responses of patients, in a rural community health centre in South Africa, to combination antiretroviral therapy (cART) between January 2004 and July 2016. Methods: This was a retrospective medical record review conducted in Thohoyandou Community Health Centre. Data analysis was done using SPSS 24.0 and Microsoft Excel. The estimates used were 95% confidence intervals, and a p -value < 0.05 was considered to be statistically significant. Results: Analysis was done using 1247 individuals, with 76% of the cohort being female and 98% first-line cART. The proportion of patients with a suppressed viral load (VL) at 6 months post-treatment was 64%, and 72% at 60 months. Fifty-nine per cent had consistent viral suppression over a 6-month period and 14% over at least 54 months. The mean CD4+ cell count at baseline was 227 cells/µL, and 538 cells/µL at 60 months. Multivariate regression analysis revealed that males had poorer immunologic and virologic responses. Conclusions: Viral suppression in the study population was inferior to the UNAIDS target of 90%. The sustainability of viral suppression, once attained, was also low. These may have a negative impact on HIV transmission. [ABSTRACT FROM AUTHOR]

Introduction: Little is known about the effects of universal test and treat (UTT) policies on HIV care outcomes among youth living with HIV (YLHIV). Moreover, there is a paucity of information regarding when YLHIV are most susceptible to disengagement from care under the newest treatment guidelines. The longitudinal HIV care continuum is an underutilized tool that can provide a holistic understanding of population-level HIV care trajectories and be used to compare treatment outcomes across groups. We aimed to explore effects of the UTT policy on longitudinal outcomes among South African YLHIV and identify temporally precise opportunities for re-engaging this priority population in the UTT era., Methods: Using medical record data, we conducted a retrospective cohort study among youth aged 18-24 diagnosed with HIV from August 2015-December 2018 in nine health care facilities in South Africa. We used Fine and Gray sub-distribution proportional hazards models to characterize longitudinal care continuum outcomes in the population overall and stratified by treatment era of diagnosis. We estimated the proportion of individuals in each stage of the continuum over time and the restricted mean time spent in each stage in the first year following diagnosis. Sub-group estimates were compared using differences., Results: A total of 420 YLHIV were included. By day 365 following diagnosis, just 23% of individuals had no 90-or-more-day lapse in care and were virally suppressed. Those diagnosed in the UTT era spent less time as ART-naïve (mean difference=-19.3 days; 95% CI: -27.7, -10.9) and more time virally suppressed (mean difference = 17.7; 95% CI: 1.0, 34.4) compared to those diagnosed pre-UTT. Most individuals who were diagnosed in the UTT era and experienced a 90-or-more-day lapse in care disengaged between diagnosis and linkage to care or ART initiation and viral suppression., Conclusions: Implementation of UTT yielded modest improvements in time spent on ART and virally suppressed among South African YLHIV- however, meeting UNAIDS' 95-95-95 targets remains a challenge. Retention in care and re-engagement interventions that can be implemented between diagnosis and linkage to care and between ART initiation and viral suppression (e.g., longitudinal counseling) may be particularly important to improving care outcomes among South African YLHIV in the UTT era., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Poor adherence is a main challenge to successful second-line ART in South Africa. Studies have shown that patients can re-suppress their viral load following intensive adherence counselling. We identify factors associated with failure to re-suppress on second-line ART. The study was a retrospective cohort study which included HIV-positive adults who experienced an elevated viral load ≥400 copies/ml on second-line ART between January 2013-July 2014, had completed an adherence counselling questionnaire and had a repeat viral load result recorded within 6 months of intensive adherence counselling. Log-binomial regression was used to evaluate the association between patient characteristics and social, behavioral or occupational factors and failure to suppress viral load (≥400 copies/ml). A total of 128 patients were included in the analysis, and of these 39% (n = 50) failed to re-suppress their viral load. Compared to those who suppressed, far more patients who failed to suppress reported living with family (44.2% vs. 23.7%), missing a dose in the past week (53.3% vs. 30.0%), using traditional/herbal medications (63.2% vs. 34.3%) or had symptoms suggestive of depression (57.7% vs. 34.3%). These patient-related factors could be targeted for interventions to reduce the risk for treatment failure and prevent switching to expensive third-line ART. [ABSTRACT FROM AUTHOR]

Background: Accurately identifying individuals who are on antiretroviral therapy (ART) is important to determine ART coverage and proportion on ART who are virally suppressed. ART is also included in recent infection testing algorithms used to estimate incidence. We compared estimates of ART coverage, viral load suppression rates and HIV incidence using ART self-report and detection of antiretroviral (ARV) drugs and we identified factors associated with discordance between the methods.Methods: Cross-sectional population-based survey in KwaZulu-Natal, South Africa. Individuals 15-59 years were eligible. Interviews included questions about ARV use. Rapid HIV testing was performed at the participants' home. Blood specimens were collected for ARV detection, LAg-Avidity HIV incidence testing and viral load quantification in HIV-positive individuals. Multivariate logistic regression models were used to identify socio-demographic covariates associated with discordance between self-reported ART and ARV detection.Results: Of the 5649 individuals surveyed, 1423 were HIV-positive. Median age was 34 years and 76.3% were women. ART coverage was estimated at 51.4% (95%CI:48.5-54.3), 53.1% (95%CI:50.2-55.9) and 56.1% (95%CI:53.5-58.8) using self-reported ART, ARV detection and both methods combined (classified as ART exposed if ARV detected and/or ART reported) respectively. ART coverage estimates using the 3 methods were fairly similar within sex and age categories except in individuals aged 15-19 years: 33.3% (95%CI:23.3-45.2), 33.8% (95%CI:23.9-45.4%) and 44.3% (95%CI:39.3-46.7) using self-reported ART, ARV detection and both methods combined. Viral suppression below 1000cp/mL in individuals on ART was estimated at 89.8% (95%CI:87.3-91.9), 93.1% (95%CI:91.0-94.8) and 88.7% (95%CI:86.2-90.7) using self-reported ART, ARV detection and both methods combined respectively. HIV incidence was estimated at 1.4 (95%CI:0.8-2.0) new cases/100 person-years when employing no measure of ARV use, 1.1/100PY (95%CI:0.6-1.7) using self-reported ART, and 1.2/100PY (95%CI:0.7-1.7) using ARV detection. In multivariate analyses, individuals aged 15-19 years had a higher risk of discordance on measures of ARV exposure (aOR:9.4; 95%CI:3.9-22.8), while migrants had a lower risk (aOR:0.3; 95%CI:0.1-0.6).Conclusions: In KwaZulu-Natal, the method of identifying ARV use had little impact on estimates of ART coverage, viral suppression rate and HIV incidence. However, discordant results were more common in younger individuals. This may skew estimates of ART coverage and viral suppression, particularly in adolescent surveys. [ABSTRACT FROM AUTHOR]

Introduction: South Africa has the largest number of individuals living with HIV and the largest antiretroviral therapy (ART) programme worldwide. In September 2016, ART eligibility was extended to all 7.1 million HIV-positive South Africans. To ensure that further expansion of services does not compromise quality of care, long-term outcomes must be monitored. Few studies have reported long-term mortality in resource-constrained settings, where mortality ascertainment is challenging. Combining site records with data linked to the national vital registration system, sites in the International Epidemiology Databases to Evaluate AIDS Southern Africa collaboration can identify >95% of deaths in patients with civil identification numbers (IDs). This study used linked data to explore long-term mortality and viral suppression among adults starting ART in South Africa. Methods: The study was a cohort analysis of routine data on adults with IDs starting ART 2004-2015 in five large ART cohorts. Mortality was estimated overall and by gender using the Kaplan-Meier estimator and Cox's proportional hazards regression. Standardized mortality ratios (SMRs) were calculated by dividing observed numbers of deaths by numbers expected if patients had been HIV-negative. Viral suppression in patients with viral loads (VLs) in their last year of follow-up was the secondary outcome. Results: Among 72,812 adults followed for 350,376 person years (pyrs), the crude mortality rate was 3.08 (95% CI 3.02-3.14)/100 pyrs. Patients were predominantly female (67%) and the percentage of men initiating ART did not increase. Cumulative mortality 12 years after ART initiation was 23.9% (33.4% male and 19.4% female). Mortality peaked in patients enrolling in 2007-2009 and was higher in men than women at all durations. Observed mortality rates were higher than HIV-negative mortality, decreasing with duration. By 48 months, observed mortality was close to that in the HIV-negative population, and SMRs were similar for all baseline CD4 strata. Three-quarters of patients had VLs in their last year, and 86% of these were virally suppressed. Conclusions: The South African ART \programme has shown a remarkable ability to initiate and manage patients successfully over 12 years, despite rapid expansion. With further scale-up, testing and initiating men on ART must be a national priority. [ABSTRACT FROM AUTHOR]

High levels of adherence are required to achieve the full benefit of ART. We assess the effectiveness of electronic adherence monitoring devices among patients failing second-line ART, as measured by viral load suppression. Cohort study of Wisepill™ real-time adherence monitoring in addition to intensified adherence counselling over 3 months in adults with a viral load ≥400 copies/ml on second-line ART in Johannesburg, South Africa between August 2013 and January 2014. Patients were sent SMS reminders upon missing a scheduled dose. We compared outcomes to earlier historical cohorts receiving either intensified adherence counselling or adherence counselling alone. Overall, 63 % of the participants (31/49) took >80 % of their prescribed medication; this dropped from 76 to 53 and 49 % at 1, 2 and 3 months post-enrolment respectively. Compared to those with good adherence (>80 %), participants with poor adherence (≤80 %) had a higher risk for a subsequently elevated viral load ≥400 copies/ml (relative risk (RR) 1.47 95 % CI 0.97-2.23). Participants found the intervention 'acceptable and useful' but by 6 months after eligibility they were only slightly more likely to be alive, in care and virally suppressed compared to those who received intensified adherence counselling (44.9 vs. 38.5 %; RR 1.19; 95 % CI 0.85-1.67) or adherence counselling alone (44.9 vs. 40.9 %; RR 1.12; 95 % CI 0.81-1.56). In patients with an elevated viral load on second-line ART electronic adherence monitoring was associated with a modest, but not significant, improvement in viral suppression. [ABSTRACT FROM AUTHOR]

Objectives: As the scale of the South African HIV epidemic calls for innovative models of care that improve accessibility for patients while overcoming chronic human resource shortages, we (i) assess the cost-effectiveness of lay health worker-led group adherence clubs, in comparison with a nurse-driven 'standard of care' and (ii) describe and evaluate the associated patient cost and accessibility differences.Methods: Our cost-effectiveness analysis compares an 'adherence club' innovation to conventional nurse-driven care within a busy primary healthcare setting in Khayelitsha, South Africa. In each alternative, we calculate provider costs and estimate rates of retention in care and viral suppression as key measures of programme effectiveness. All results are presented on an annual or per patient-year basis. In the same setting, a smaller sample of patients was interviewed to understand the direct and indirect non-healthcare cost and access implications of the alternatives. Access was measured using McIntyre and colleagues' 2009 framework.Results: Adherence clubs were the more cost-effective model of care, with a cost per patient-year of $300 vs. $374 and retention in care at 1 year of 98.03% (95% CI 97.67-98.33) for clubs vs. 95.49% (95% CI 95.01-95.94) for standard of care. Viral suppression in clubs was 99.06% (95% CI 98.82-99.27) for clubs vs. 97.20% (95% CI 96.81-97.56) for standard of care. When interviewed, club patients reported fewer missed visits, shorter waiting times and higher acceptability of services compared to standard of care.Conclusions: Adherence clubs offer the potential to enhance healthcare efficiency and patient accessibility. Their scale-up should be supported. [ABSTRACT FROM AUTHOR]

Background:  Progress has been made to increase access to antiretroviral therapy (ART) for adolescents living with HIV (ALHIV) to improve their survival, but ALHIV still have worse treatment adherence and viral suppression compared to adults and children., Objective:  To determine the prevalence of viral suppression and the associated factors among adolescents aged 10-19 years on ART at an urban public primary healthcare facility in the Sedibeng district, Gauteng., Method:  A cross-sectional survey was conducted among 192 adolescents who were on ART for at least six months between 2015 and 2018. A self-developed data extraction tool was used to collect data from the Tier.Net electronic database and clinical folders. Data were captured on Microsoft Excel, and descriptive and inferential analyses were performed using SPSS 27 statistical software., Results:  The median age at ART initiation of adolescents was 9.0 years (interquartile range [IQR]: 5.0-12.0), and the median duration on ART was 70.5 (IQR: 30.25-105.5) months. The prevalence of viral suppression ( 1000 copies/mL) among adolescents on ART was 74%, with 41% achieving full suppression ( 50 copies/mL). Those adolescents who reported optimal ART adherence were more likely to be virally suppressed compared to those who reported poor adherence (98.1% vs 25.0%; p ≤ 0.001)., Conclusion:  Adolescent viral suppression of 74% is higher than in comparable sites, but still way too short of the UNAIDS target of 90%. We recommend adherence support for adolescents to achieve viral suppression.Contribution: The study highlights the urgent need for targeted adherence support interventions for adolescents living with HIV on antiretroviral therapy to improve rates of viral suppression to meet UNAIDS target of 95%.

Background: Lower antiretroviral therapy (ART) adherence is associated with higher systemic inflammation in virally suppressed people with HIV (PWH); however, previous studies have mostly relied on subjective adherence measures and have not assessed this association by disease stage upon ART initiation., Methods: In the Monitoring Early Treatment Adherence study, adherence was monitored electronically in real time among adult, treatment-naïve PWH in Uganda and South Africa who initiated tenofovir disoproxil fumarate/emtricitabine/efavirenz during early-stage (CD4 > 350 cells/µL) or late-stage (CD4 < 200 cells/µL) disease. Participants who achieved viral suppression (< 400 copies/mL) at 6 months and remained suppressed after 12 months were analysed. The association between average ART adherence and plasma concentrations of interleukin 6 (IL-6), soluble CD14 (sCD14) and D-dimer was evaluated using adjusted multivariable linear regression, stratified by disease stage., Results: In all, 488 PWH (61% women, mean age 35 years) were included in the analysis. Median ART adherence overall was 87%. In adjusted models, every 10% increase in average adherence was associated with a 3.0% decrease in IL-6 [95% confidence interval (CI): -5.9 to -0.01, p = 0.05] at 12 months. This relationship was observed in PWH with both early-stage (5.9%, 95% CI: -10.1 to -1.6, p = 0.009) and late-stage disease (3.7%, 95% CI: -7.2 to -0.2, p = 0.039). No significant associations were found with sCD14 or D-dimer., Conclusions: Objective ART adherence measurement was inversely associated with systemic inflammation in PWH who achieved viral suppression after ART initiation in sub-Saharan Africa, with a greater association in those with early-stage HIV. This finding underscores the importance of ART adherence beyond establishing viral suppression., (© 2021 British HIV Association.)

Introduction: The World Health Organization recommends full disclosure of HIV-positive status to adolescents who acquired HIV perinatally (APHIV) by age 12. However, even among adolescents (aged 10-19) already on antiretroviral therapy (ART), disclosure rates are low. Caregivers often report the child being too young and fear of disclosure worsening adolescents' mental health as reasons for non-disclosure. We aimed to identify the predictors of disclosure and the association of disclosure with adherence, viral suppression and mental health outcomes among adolescents in sub-Saharan Africa., Methods: Analyses included three rounds (2014-2018) of data collected among a closed cohort of adolescents living with HIV in Eastern Cape, South Africa. We used logistic regression with respondent random-effects to identify factors associated with disclosure, and assess differences in ART adherence, viral suppression and mental health symptoms between adolescents by disclosure status. We also explored differences in the change in mental health symptoms and adherence between study rounds and disclosure groups with logistic regression., Results: Eight hundred and thirteen APHIV were interviewed at baseline, of whom 769 (94.6%) and 729 (89.7%) were interviewed at the second and third rounds, respectively. The proportion aware of their HIV-positive status increased from 63.1% at the first round to 85.5% by the third round. Older age (adjusted odds ratio [aOR]: 1.27; 1.08-1.48) and living in an urban location (aOR: 2.85; 1.72-4.73) were associated with disclosure between interviews. There was no association between awareness of HIV-positive status and ART adherence, viral suppression or mental health symptoms among all APHIV interviewed. However, among APHIV not aware of their status at baseline, adherence decreased at the second round among those who were disclosed to (N = 131) and increased among those not disclosed to (N = 151) (interaction aOR: 0.39; 0.19-0.80). There was no significant difference in the change in mental health symptoms between study rounds and disclosure groups., Conclusions: Awareness of HIV-positive status was not associated with higher rates of mental health symptoms, or lower rates of viral suppression among adolescents. Disclosure was not associated with worse mental health. These findings support the recommendation for timely disclosure to APHIV; however, adherence support post-disclosure is important., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: Achieving undetectable viral load is crucial for the reduction of HIV transmissions, AIDS-related illnesses and death. Adolescents (10 to19 years) living with HIV (ALHIV) on antiretroviral treatment (ART) have worse treatment adherence and lower viral suppression rates compared to adults. We report on the clinical factors associated with viral suppression among ALHIV in the Ehlanzeni district, Mpumalanga in South Africa., Methods: A cross-sectional analysis was conducted with 9386 ALHIV, aged 10 to 19 years, who were enrolled in 136 ART clinics in the Ehlanzeni district. Clinical and immunological data were obtained from electronic medical records (Tier.net). ALHIV were categorised as having achieved viral suppression if their latest viral load count was < 1000 ribonucleic acid (RNA) copies/mL. Using a backward stepwise approach, a multivariate logistic regression analysis was performed to identify factors independently associated with viral suppression., Results: The mean age of the participants was 14.75 years (SD = 2.9), and 55.43% were female. Mean duration on ART was 72.26 (SD = 42.3) months. Of the 9386 adolescents with viral load results recorded, 74% had achieved viral suppression. After adjusting for other covariates, the likelihood of achieving viral suppression remained significantly higher among ALHIV who were: female (AOR = 1.21, 95% CI 1.05-1.39), and had most recent CD4 count > 200 (AOR = 2.53, 95% CI 2.06-3.11). Furthermore, the likelihood of having viral suppression was lower among adolescents with CD4 count > 200 at baseline (AOR = 0.73, 95% CI 0.61-0.87), and who were switched to second line regimen (AOR = 0.41, 95% CI 0.34-0.49)., Conclusions: Viral suppression amongst ALHIV at 74% is considerably lower than the WHO target of 95%. Of particular concern for intervention is the lower rates of viral suppression amongst male ALHIV. Greater emphasis should be placed to early enrolment of ALHIV on ART and keeping them engaged in care (beyond 6 months). Furthermore, improved and regular viral load monitoring will help to adequately identify and manage ALHIV with unsuppressed viral load and subsequently switching to second line treatment., (© 2021. The Author(s).)

Factors that influence viral response when antiretroviral therapy (ART) is initiated in neonates are not well characterized. We assessed if there is consistency in predictive factors when operationalizing viral response using different methods. Data were collected from a clinical study in South Africa that started ART in neonates within 14 days of birth (2013–2018). Among 61 infants followed for ≥48 weeks after ART initiation, viral response through 72 weeks was defined by three methods: (1) clinical endpoints (virologic success, rebound, and failure); (2) time to viral suppression, i.e., any viral load (VL: copies/mL) <400, <50, or target not detected (TND) using time-to-event methods; and (3) latent class growth analysis (LCGA) to empirically estimate discrete groups with shared patterns of VL trajectories over time. We investigated the following factors: age at ART initiation, sex, birthweight, preterm birth, mode of delivery, breastfeeding, pre-treatment VL and CD4, maternal ART during pregnancy, and maternal VL and CD4 count. ART was initiated 0–48 h of birth among 57.4% of the infants, 48 h–7 days in 29.5% and 8–14 days in 13.1%. By Method 1, infants were categorized into 'success' (54.1%), 'rebound' (21.3%), and 'failure' (24.6%) for viral response. For Method 2, median time to achieving a VL <400, <50, or TND was 58, 123, and 331 days, respectively. For Method 3, infants were categorized into three trajectories: 'rapid decline' (29.5%), 'slow decline' (47.5%), and 'persistently high' (23.0%). All methods found that higher pre-treatment VL, particularly >100,000, was associated with less favorable viral outcomes. No exposure to maternal ART was associated with a better viral response, while a higher maternal VL was associated with less favorable viral response and higher maternal CD4 was associated with better viral response across all three methods. The LCGA method found that infants who initiated ART 8–14 days had less favorable viral response than those who initiated ART earlier. The other two methods trended in a similar direction. Across three methods to operationalize viral response in the context of early infant treatment, findings of factors associated with viral response were largely consistent, including infant pre-treatment VL, maternal VL, and maternal CD4 count. [ABSTRACT FROM AUTHOR]

Introduction: Adolescents and young people comprise a growing proportion of new HIV infections globally, yet current approaches do not effectively engage this group, and adolescent HIV-related outcomes are the poorest among all age groups. Providing psychosocial interventions incorporating psychological, social, and/or behavioural approaches offer a potential pathway to improve engagement in care and health and behavioural outcomes among adolescents and young people living with HIV (AYPLHIV)., Methods: A systematic search of all peer-reviewed papers published between January 2000 and July 2020 was conducted through four electronic databases (Cochrane Library, PsycINFO, PubMed and Scopus). We included randomized controlled trials evaluating psychosocial interventions aimed at improving engagement in care and health and behavioural outcomes of AYPLHIV aged 10 to 24 years., Results and Discussion: Thirty relevant studies were identified. Studies took place in the United States (n = 18, 60%), sub-Saharan Africa (Nigeria, South Africa, Uganda, Zambia, Zimbabwe) and Southeast Asia (Thailand). Outcomes of interest included adherence to antiretroviral therapy (ART), ART knowledge, viral load data, sexual risk behaviours, sexual risk knowledge, retention in care and linkage to care. Overall, psychosocial interventions for AYPLHIV showed important, small-to-moderate effects on adherence to ART (SMD = 0.3907, 95% CI: 0.1059 to 0.6754, 21 studies, n = 2647) and viral load (SMD = -0.2607, 95% CI -04518 to -0.0696, 12 studies, n = 1566). The psychosocial interventions reviewed did not demonstrate significant impacts on retention in care (n = 8), sexual risk behaviours and knowledge (n = 13), viral suppression (n = 4), undetectable viral load (n = 5) or linkage to care (n = 1) among AYPLHIV. No studies measured transition to adult services. Effective interventions employed various approaches, including digital and lay health worker delivery, which hold promise for scaling interventions in the context of COVID-19., Conclusions: This review highlights the potential of psychosocial interventions in improving health outcomes in AYPLHIV. However, more research needs to be conducted on interventions that can effectively reduce sexual risk behaviours of AYPLHIV, as well as those that can strengthen engagement in care. Further investment is needed to ensure that these interventions are cost-effective, sustainable and resilient in the face of resource constraints and global challenges such as the COVID-19 pandemic., (© 2021 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: Measuring progress towards the Joint United Nations Programme on HIV/AIDS (UNAIDS) 90-90-90 treatment targets is key to assessing progress towards turning the HIV epidemic tide. In 2017, the UNAIDS model estimated that 75% of people living with HIV (PLHIV) globally knew their HIV positive status, 79% of those who knew their status were on antiretroviral therapy (ART), and 81% of those who knew their HIV status and were on ART had a suppressed viral load. The fifth South African national HIV sero-behavioural survey collected nationally representative data that enabled the empirical estimation of these 90-90-90 targets for the country stratified by a variety of key factors., Methods: To evaluate progress towards achievement of the 90-90-90 targets for South Africa, data obtained from a national, representative, cross-sectional population-based multi-stage stratified cluster random survey conducted in 2017 were analysed. The Fifth South African National HIV Prevalence, Incidence, Behaviour and Communication Survey (SABSSM V), collected behavioural and biomarker data from individuals residing in households from 1000 randomly selected Small Area Layers (SALs), across all nine provinces of the country. Structured questionnaires were used to collect socio-demographic data, knowledge and perceptions about HIV, and related risk behaviours. Blood samples were collected to test for HIV infection, antiretroviral use, and viral suppression (defined as < 1000 copies/ml). Weighted proportions of study participants aged 15 years and older who tested HIV positive were computed for those who reported awareness of their status (1st 90), and among these, those who were currently on ART (2nd 90) and of these, those who were virally suppressed (3rd 90)., Results: Among persons 15 years and older who were HIV positive, 84.8% were aware of their HIV positive status, of whom 70.7% were currently on ART, with 87.4% of these estimated to have suppressed viral load at the time of the survey. These estimates varied by sex, age, and geo-location type. Relatively higher percentages across all three indicators for women compared to men were observed: 88.7% versus 78.2% for those aware of their status, 72.3% versus 67.7% for on ART, and 89.8% versus 82.3% for viral suppression. Knowing one's positive HIV status increased with age: 74.0, 85.8, and 88.1% for age groups 15-24 years old, 25-49 years old and 50-64 years old, although for those 65 years and older, 78.7% knew their HIV positive status. A similar pattern was observed for the 2nd 90, among those who knew their HIV positive status, 51.7% of 15 to 24 year olds, 70.5% of those aged 25-49 years old, 82.9% of those aged 50-64 years old and 82.4% of those aged 65 years or older were currently on ART. Viral suppression for the above mentioned aged groups, among those who were on ART was 85.2, 87.2, 89.5, and 84.6% respectively. The 90-90-90 indicators for urban areas were 87.7, 66.5, and 87.2%, for rural settings was 85.8, 79.8, and 88.4%, while in commercial farming communities it was 56.2, 67.6 and 81.4%., Conclusions: South Africa appears to be on track to achieve the first 90 indicator by 2020. However, it is behind on the second 90 indicator with ART coverage that was ~ 20-percentage points below the target among people who knew their HIV status, this indicates deficiencies around linkage to and retention on ART. Overall viral suppression among those on ART is approaching the target at 87.4%, but this must be interpreted in the context of low reported ART coverage as well as with variation by age and sex. Targeted diagnosis, awareness, and treatment programs for men, young people aged 15-24 years old, people who reside in farming communities, and in specific provinces are needed. More nuanced 90-90-90 estimates within provinces, specifically looking at more granular sub-national level (e.g. districts), are needed to identify gaps in specific regions and to inform provincial interventions.

Introduction: Maternal viral load monitoring (mVL) and early infant diagnosis (EID) are necessary to achieve elimination of mother-to-child transmission of HIV. Point-of-care testing can achieve better outcomes compared to centralized laboratory testing (CLT). We describe the first implementation of point-of-care (POC) mVL and EID testing around delivery at four high volume tertiary obstetric units (TOUs) in Gauteng, South Africa., Methods: Prospective study of pregnant women living with HIV (WLHIV) and their infants. During the period 1 June 2018 to 31 March 2019, routine staff collected blood specimens from women and their infants around delivery. Specimen collection occurred throughout the week while dedicated POC operators, conducted testing during working hours on weekdays. Descriptive statistics and multivariable Poisson regression with robust error variance were used to describe outcomes and associated factors. Outcomes determined were (i) coverage of mVL and EID testing defined as a proportion of live births to WLHIV admitted at each facility (ii) results returned prior to discharge (iii) turn-around time (TAT) and iv) performance of POC testing compared to CLT., Results: In total, 8147 live births to pregnant WLHIV were recorded in the implementation period. Of these, 2912 mVL and 5074 EID specimens were included in the analysis, with 131 (4.5%) mVL and 715 (14.1%) EID specimens having initial invalid/error results. Overall coverage of POC mVL and EID testing was 35.6% (range 20.9% to 60.1%) and 61.9% (range 47.0% to 88.0%) respectively. Proportions of POC tested mothers and infants with results returned prior to discharge were 74.3% (range 39.0% to 95.7%) and 73.0% (range 50.0 to 97.9%). Return of results was independently associated with TOU, after-hours specimen collection, having an initial invalid or error result and period of implementation. Overall TAT for specimens collected from mother-infant pairs where both had POC testing, during weekdays was longer for EID compared to mVL testing (median 3.3 hours vs. 2.9 hours, p-value sign test <0.001). POC results were comparable to those from laboratory testing., Conclusion: Accurate and timely POC mVL and EID testing around delivery was implemented with variable success across TOUs. Further scale up would need to address health system factors at facility level and high analytical error rates., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Introduction: To achieve epidemic control of HIV by 2030, countries aim to meet 90‐90‐90 targets to increase knowledge of HIV‐positive status, initiation of antiretroviral therapy (ART) and viral suppression by 2020. We assessed the progress towards these targets from 2014 to 2016 in South Africa as expanded treatment policies were introduced using population‐representative surveys. Methods: Data were collected in January to March 2014 and August to November 2016 in Dr. Ruth Segomotsi Mompati District, North West Province. Each multi‐stage cluster sample included 46 enumeration areas (EA), a target of 36 dwelling units (DU) per EA, and a single resident aged 18 to 49 per DU. Data collection included behavioural surveys, rapid HIV antibody testing and dried blood spot collection. We used weighted general linear regression to evaluate differences in the HIV care continuum over time. Results: Overall, 1044 and 971 participants enrolled in 2014 and 2016 respectively with approximately 77% undergoing HIV testing. Despite increases in reported testing, known status among people living with HIV (PLHIV) remained similar at 68.7% (95% Confidence Interval (CI) = 60.9–75.6) in 2014 and 72.8% (95% CI = 63.6–80.4) in 2016. Men were consistently less likely than women to know their status. Among those with known status, PLHIV on ART increased significantly from 80.9% (95% CI = 71.9–87.4) to 91.5% (95% CI = 84.4–95.5). Viral suppression (<5000 copies/mL using DBS) among those on ART increased significantly from 55.0% (95% CI = 39.6–70.4) in 2014 to 81.4% (95% CI = 72.0–90.8) in 2016. Among all PLHIV an estimated 72.0% (95% CI = 63.8–80.1) of women and 45.8% (95% CI = 27.0–64.7) of men achieved viral suppression by 2016. Conclusions: Over a period during which fixed‐dose combination was introduced, ART eligibility expanded, and efforts to streamline treatment were implemented, major improvements in the second and third 90‐90‐90 targets were achieved. Achieving the first 90 target will require targeted and improved testing models for men. [ABSTRACT FROM AUTHOR]

Introduction: Linkage to care and mobility postpartum present challenges to long-term retention after initiating antiretroviral therapy (ART) in pregnancy, but there are few insights from sub-Saharan Africa. We aimed to describe postpartum linkage to care, mobility, retention and viral suppression after ART initiation in pregnancy., Methods: Using routine electronic data we assessed HIV-specific health contacts and clinic movements among women initiating ART in an integrated antenatal care (ANC) and ART clinic in Cape Town, South Africa. The local care model includes mandatory transfer to general ART clinics postpartum. We investigated linkage to care after leaving the integrated clinic and mobility to new clinics until 30 months on ART. We used Poisson regression to explore predictors of linkage, retention (accessing care at least once at both 12 [6 to <18] and 24 [18 to <30] months on ART), and viral suppression (HIV viral load [VL] ≤50 and ≤1000 copies/mL after 12 months on ART)., Results: Among 617 women, 23% never linked to care; 71% and 65% were retained at 12 and 24 months on ART respectively, with 59% retained in care at both times. Those who linked (n = 485) accessed HIV care at 98 different clinics and 21% attended ≥2 clinics. Women >25 years, married/cohabiting or presenting early for ANC were more likely to link. Younger and unemployed women were more likely to attend ≥2 clinics (adjusted risk ratio [aRR] 1.10 95% confidence interval [CI] 1.02 to 1.18 and aRR 1.06 95% CI 0.99 to 1.12 respectively). Age >25 years (aRR 1.17 95% CI 1.02 to 1.33) and planned pregnancy (aRR 1.20 95% CI 1.09 to 1.33) were associated with being retained. Among 338 retained women with VL available, attending ≥2 clinics reduced the likelihood of viral suppression when defined as ≤50 copies/mL (aRR 0.81 95% CI 0.69 to 0.95). Distance moved was not associated with VL., Conclusions: These data show that a substantial proportion of women do not link to postpartum ART care in this setting and, among those that do, long-term retention remains a challenge. Women move to a variety of clinics and young women appear particularly vulnerable to attrition. Interventions promoting linkage and continued retention for women initiating ART during pregnancy warrant urgent consideration., (© 2018 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.)

Introduction: Previous research has raised concerns that patients given nevirapine (NVP)-based regimens experience more virologic failure than patients given efavirenz (EFV)-based regimens. We investigated this hypothesis in a cohort of HIV-positive patients at a large HIV treatment clinic in South Africa., Methods: All antiretroviral therapy (ART)-naïve non-pregnant patients, ≥ 18 years old, without tuberculosis, who initiated treatment with either NVP or EFV from April 2004 to August 2011 at the Themba Lethu Clinic in Johannesburg, South Africa, were included. Log-binomial regression and modified Poisson regression were used to estimate risk ratios (RR) with 95% confidence intervals (CI) for predictors of virologic failure, virologic suppression, and loss to follow-up (LTF), whereas a Cox proportional hazards model was used to estimate the risk of death, all within one year., Results: Of 12,840 included patients, 62.0% were female and the median baseline CD4 count was 98 cells/mm(3) (36-169). Of these patients, 93.2% initiated an EFV-based regimen. After adjusting for baseline characteristics, no difference in death (adjusted Hazards Ratio (aHR): 0.92; 95% CI: 0.68-1.25), LTF (adjusted Risk Ratio (aRR): 1.00; 95% CI: 0.79-1.25), nor suppression (aRR: 0.98; 95% CI: 0.95-1.00) at one year was found between regimens. Among patients with ≥ 1 viral load ≥ 4 months after ART initiation, 4% (n=350) experienced virologic failure within 12 months of initiation. Patients initiating NVP-based regimens were 60% more likely to fail than patients initiating EFV-based regimens (aRR: 1.58; 95% CI: 1.13-2.22)., Conclusions: In this cohort, patients initiating NVP-based regimens experienced more virologic failure than patients initiating EFV-based regimens. Future guidelines should consider the implications of different efficacy profiles when making recommendations for which drugs to prioritize.

Introduction: The prognostic role of CD4 response in the first six months of treatment in patients achieving early viral suppression during HIV treatment is unclear., Methods: This was a cohort study of HIV-positive adults initiating antiretroviral therapy (ART) between April 2004 and August 2007 who achieved viral suppression (<400 copies/ml) by six months on treatment in South Africa. Immunological response at six months was defined as: (1) absolute CD4 reached (<200 vs. ≥ 200 cells/ml); (2) absolute CD4 reached (0-49, 50-200 and ≥ 200 cells/ml); and (3) CD4 increase from ART initiation (<0, 0-49, 50-199 and ≥ 200 cells/ml). We used Cox regression models to determine the relationship between each definition and both new AIDS-defining condition and death., Results: A total of 4129 patients were eligible for analysis; 212 (5.1%) of those patients experienced a new AIDS-defining condition and 154 (3.7%) died. Smaller CD4 gains by six months were associated with higher hazards of progression to AIDS (CD4<50 vs. ≥ 200 cells/ml; adjusted hazard ratio (aHR): 2.6; 95% CI: 1.2-2.1) and death (aHR: 2.8; 95% CI: 1.4-5.7). A decrease in CD4 count since ART initiation through six months (aHR: 2.4; 95% CI: 1.2-4.9) and smaller CD4 count gains (0-49 cells/ml; aHR: 2.0; 95% CI: 1.2-3.4 and 50-199 cells/ml; aHR: 1.5; 95% CI: 0.9-2.2) were also associated with greater risk of progression to AIDS compared to an increase of ≥ 200 cells/ml. When we examined mortality differences by gender among this virally suppressed cohort, a higher proportion of males died compared to females, 4.7% versus 3.2%, p=0.01. However, in multivariable analysis, we did not observe any significant differences: aHR: 1.39; 95% CI: 0.98-1.95., Conclusions: Patients on ART with poor CD4 recovery early in treatment are at greater risk of progression to new AIDS diagnosis or death despite viral suppression. Approaches to managing this sub-group of patients need further investigation.