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INTRODUCTION: Perspectives on long-acting injectable cabotegravir/rilpivirine (CAB/RPV-LA) from HIV health disparity populations are under-represented in current literature yet crucial to optimize delivery. METHODS: Between August 2022 and May 2023, we conducted in-depth interviews with people with HIV (PWH) at four HIV clinics in Atlanta, Chicago and San Francisco. Eligibility criteria were current CAB/RPV-LA use with receipt of ≥3 injections or CAB/RPV-LA discontinuation. We purposefully sampled for PWH who initiated with viraemia (plasma HIV RNA >50 copies/ml) due to adherence challenges, discontinuers, and cis and trans women. Interviews were coded and analysed using thematic methods grounded in descriptive phenomenology. Clinical data were abstracted from the medical record. RESULTS: The sample (San Francisco n = 25, Atlanta n = 20, Chicago n = 14 for total n = 59, median number of injections = 6) consisted of 48 PWH using CAB/RPV-LA and 11 who had discontinued. The median age was 50 (range 25-73) and 40 (68%) identified as racial/ethnic minorities, 19 (32%) cis or trans women, 16 (29%) were experiencing homelessness/unstable housing, 12 (20%) had recently used methamphetamine or opioids and 11 (19%) initiated with viraemia. All participants except one (who discontinued) had evidence of viral suppression at interview. Typical benefits of CAB/RPV-LA included increased convenience, privacy and freedom from being reminded of HIV and reduced anxiety about forgetting pills. However, PWH who became virally suppressed through CAB/RPV-LA use also experienced an amelioration of feelings of shame and negative self-worth related to oral adherence challenges. Regardless of baseline viral suppression status, successful use of CAB/RPV-LA amplified positive provider/clinic relationships, and CAB/RPV-LA was often viewed as less work than oral antiretroviral therapy, which created space to attend to other aspects of health and wellness. For some participants, CAB/RPV-LA remained work, particularly with regard to injection site pain and visit frequency. At times, these burdens outweighed the aforementioned benefits, resulting in discontinuation. CONCLUSIONS: CAB/RPV-LA offers a range of logistical, psychosocial and care engagement benefits, which are experienced maximally by PWH initiating with viraemia due to adherence challenges; however, benefits do not always outweigh treatment burdens and can result in discontinuation. Our findings on rationales for persistence versus discontinuation can inform both initial and follow-up patient counselling.

Background: Adolescents and young adults (AYAs) (age 13–24 years) accounted for 20% of HIV diagnoses in the United States and 6 dependent areas in 2020. Optimal treatment adherence during adolescence and young adulthood decreases the pool of infectious individuals during the risky sexual activity commonly reported among AYAs living with HIV. Methods: Adolescents and young adults newly recommended to start antiretroviral therapy (ART) were recruited, nationally, from 7 clinical sites. At each clinical site, participants were randomized to receive a 2-session (baseline and 1 month) online intervention. For the Motivational Enhancement System for Health (MESA) intervention condition, based on the principles of motivational interviewing, participants received ART information and personalized feedback + ART standard of care (n = 86), while for the System for Health (SH) control condition, participants received information on healthy eating and physical activity + ART standard of care (n = 66). Results: Adherence was 21% greater in the MESA intervention group compared with the SH control group at 6 months. In addition, the MESA intervention group was significantly more adherent during the postintervention, and was more likely to maintain viral suppression up to 12 months after initiating ART if both doses of the intervention were received compared with the SH control group. Conclusions: A brief, scalable online computer-delivered intervention shows promise for achieving long-term health outcomes because of improved adherence when intervention occurs early in the course of treatment. Trial Registration: NCT02761746. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is Available in the Text. Background: Sustained viral suppression in patients with multidrug-resistant (MDR) HIV infection remains difficult; accordingly, agents targeting different steps in the HIV life cycle are needed. Ibalizumab, a humanized immunoglobulin G4 monoclonal antibody, is a cluster of differentiation (CD4)-directed postattachment inhibitor. Methods: In this phase 2b study, 113 patients with MDR HIV-1 and limited treatment options were assigned an optimized background regimen (OBR) and randomized to either 800 mg ibalizumab every 2 weeks (q2wk; n = 59) or 2000 mg ibalizumab every 4 weeks (q4wk; n = 54) up to week 24. Results: Viral loads (VL) below the detection limit were achieved in 44% and 28% of patients in the 800 mg q2wk and 2000 mg q4wk groups, respectively, at week 24. Mean (SD) VL (log10 copies/mL) decreased from Baseline [4.6 (0.8), 800 mg q2wk; 4.7 (0.7), 2000 mg q4wk] to week 2, with the reduction maintained through week 24 [2.9 (1.5), 800 mg q2wk; 3.2 (1.4), 2000 mg q4wk]. Baseline CD4+ counts were 80.5 and 54.0 cells/μL in the 800 mg q2wk and 2000 mg q4wk groups, respectively. Mean CD4+ T-cell count was increased at week 24 in both groups. No serious adverse events were related to ibalizumab. Conclusions: In heavily treatment-experienced patients with HIV (PWH) at a more advanced baseline disease severity, clinically significant response rates at week 24 were achieved with ibalizumab plus OBR. Ibalizumab's unique mechanism of action and lack of cross-resistance to other antiretroviral agents make it an important component of combination treatment regimens for PWH with limited treatment options. [ABSTRACT FROM AUTHOR]

Cytomegaloviruses, species-specific members of the betaherpesviruses, encode an impressive array of immune evasion strategies committed to the manipulation of the host immune system enabling these viruses to remain for life in a stand-off with host innate and adaptive immune mechanisms. Even though they are species-restricted, cytomegaloviruses are distributed across a wide range of different mammalian species in which they cause systemic infection involving many different cell types. Regulated, or programmed cell death has a recognized potential to eliminate infected cells prior to completion of viral replication and release of progeny. Cell death also naturally terminates replication during the final stages of replication. Over the past two decades, the host defense potential of known programmed cell death pathways (apoptosis, necroptosis, and pyroptosis), as well as a novel mitochondrial serine protease pathway have been defined through studies of cytomegalovirus-encoded cell death suppressors. Such virus-encoded inhibitors prevent virus-induced, cytokine-induced, and stress-induced death of infected cells while also moderating inflammation. By evading cell death and consequent inflammation as well as innate and adaptive immune clearance, cytomegaloviruses represent successful pathogens that become a critical disease threat when the host immune system is compromised. This review will discuss cell death programs acquired for mammalian host defense against cytomegaloviruses and enumerate the range of modulatory strategies this type of virus employs to balance host defense in favor of lifelong persistence. [ABSTRACT FROM AUTHOR]

Introduction: Modern antiretroviral therapy is associated with reduced rates of HIV-related morbidity and mortality. HIV viral suppression and retention in care are critically important outcomes requiring successful continuous patient engagement. However, barriers to such engagement are complex and require innovative solutions. Areas covered: A multistakeholder group of experts comprising clinicians and service delivery researchers assembled to clarify what constitutes engagement in HIV care and identify overarching themes that inform strategies in this field. This article captures this expert opinion and adds relevant literature on selected current best practices. Expert opinion: The multistakeholder group felt strongly that a better understanding of the facilitators of continuous care engagement was critical. Unlike 'retention in care,' 'engagement in care' for an individual is nuanced, flexible, evolves and requires ongoing communication between patients, providers, and other key stakeholders. The following approaches highlight care engagement strategies at different stakeholder levels: 1) patient-level: personalized care and incentivization; 2) clinic-level: wraparound, co-localized, patient-centered low-barrier care, a diverse multidisciplinary team, patient support networks, and expanded use of telemedicine; 3) healthcare system-level: utilization of external partnerships. We propose a series of diverse and complementary approaches based on a more nuanced understanding of the qualitative aspects of engagement in care. [ABSTRACT FROM AUTHOR]

Background: Globally, Human Immune-deficiency Virus (HIV) continues to be one of the world's most significant public health issues. At the end of 2022, 39.0 million people were living with HIV (PLHIV) worldwide with 9% resident in Nigeria. Viral suppression is associated with a reduction in HIV disease progression. However, Nigeria is yet to achieve the UNAIDS 2020 third 95, community wide viral suppression for elimination of global HIV epidemic. This study assessed the clinical predictors and correlates of viral suppression among adults accessing care at HIV clinic in Federal Medical Center, Abeokuta, Ogun State, Nigeria. Methods: The study design was a facility-based retrospective cohort study that was conducted among adults on antiretroviral therapy (ART) at HIV clinic from May 2016 to October 22, 2021, Federal Medical Center of Abeokuta (FMCA), Ogun State Nigeria. Two thousand one hundred and seventy-six (2176) case records were explored within the study period, but only one thousand five hundred and twenty (1520) met the inclusion criteria. Variables in the participants' hospital record (secondary data) were extracted into Microsoft Excel which were exported into Stata MP 17 for data cleaning and recoding, and analysis. Stepwise model selection was done for factors associated with viral suppression and binary logistic regression was used to investigate the predictors of viral suppression among participants at p-value < 0.05. Results: One thousand five hundred and twenty (1520) were included in the study. Majority (1116 − 73.4%) of the study participants were females and 241(15.9%) were aged 25–34 years. One thousand three hundred and eighty-six (1386- 90%) of the clients achieved viral suppression. Predictors of viral suppression were older age group of 25–34 years (OR: 2.62, 95% CI: 1.19–5.78, p < 0.017) and > 45 years (OR: 2.42, 95% CI: 1.11–5.28, p < 0.026), and active on ART (OR: 6.05, 95% CI: 4.10–8.91, p < 0.000). Conclusion: This study showed a significant viral suppression among the study participants. Being active on ART and age 25 years and above were the only significant clinical predictor and correlate of viral suppression respectively. Improving viral suppression should be a focus among adults HIV under age 25 years and loss to follow-up (LTFU) category. [ABSTRACT FROM AUTHOR]

Introduction: Viral suppression is a critical component for preventing mother-to-child transmission of HIV(MTCT). Mothers' perceptions of viral load suppression is crucial in the attainment of successful outcomes in preventing mother to child transmission of HIV. We therefore aimed to explore the experiences and perceptions of women on viral suppression. Methods: This was a qualitative sub-study embedded in a cluster-randomized trial (NCT04122144) designed to improve viral load outcomes among pregnant and breastfeeding mothers living with HIV in four level III/IV health facilities in South-western Uganda. Thirty-two in-depth interviews were conducted with pregnant and breastfeeding women with HIV from 1st March 2020 to 30th September 2020 to explore their understanding and interpretation of viral suppression. Interviews were audio-recorded, transcribed, and coded in Dedoose software for analysis. Results: A total of 32 Women living with HIV were enrolled in this qualitative study. WLHIV explained viral suppression in the context of attaining good health and having HIV-free babies. Adherence to ART was presented as a key avenue to viral suppression. The level of engagement with providers was presented as a key attribute of attaining viral suppression. The participants narrated their experiences with viral load testing within the routine services. However, they revealed experiencing some proximate barriers to suppression including anticipated stigma, challenges with non-disclosure of HIV status, pregnancy distress, and distance to the health facility. Conclusion: The understanding and interpretation of viral suppression among pregnant and breastfeeding mothers living with HIV provides a basis for adopting behaviors leading to prevention of vertical transmission of HIV. Health care workers can support women by providing clear and culturally appropriate education about viral suppression, adherence strategies and creating a supportive and non-judgmental environment. [ABSTRACT FROM AUTHOR]

Background: Many prevention of vertical transmission (PVT) studies assess outcomes within 12 months postpartum and exclude those lost to follow-up (LTFU), potentially biasing outcomes toward those retained in care. Setting: Five public facilities in western Kenya. Methods: We recruited women living with HIV (WLH) ≥18 years enrolled in antenatal clinic (ANC). WLH retained in care (RW) were recruited during pregnancy and followed with their children through 6 months postpartum; WLH LTFU (LW, last visit >90 days) after ANC enrollment and ≤6 months postpartum were recruited through community tracing. Recontact at 3 years was attempted for all participants. Primary outcomes were retention and child HIV-free survival. Generalized linear regression was used to estimated risk ratios (RRs) for associations with becoming LTFU by 6 months postpartum, adjusting for age, education, facility, travel time to facility, gravidity, income, and new vs. known HIV positive at ANC enrollment. Results: Three hundred thirty-three WLH (222 RW, 111 LW) were recruited from 2018 to 2019. More LW versus RW were newly diagnosed with HIV at ANC enrollment (49.6% vs. 23.9%) and not virally suppressed at study enrollment (40.9% vs. 7.7%). 6-month HIV-free survival was lower for children of LW (87.9%) versus RW (98.7%). At 3 years, 230 WLH were retained in care (including 51 previously LTFU before 6 months), 30 transferred, 70 LTFU, and 3 deceased. 3-year child HIV-free survival was 81.9% (92.0% for children of RW, 58.6% for LW), 3.7% were living with HIV, 3.7% deceased, and 10.8% had unknown HIV/vital status. Being newly diagnosed with HIV at ANC enrollment was the only factor associated with becoming LTFU (aRR 1.21, 95% CI: 1.11 to 1.31). Conclusions: Outcomes among those LTFU were worse than those retained in care, underscoring the importance of retention in PVT services. Some, but not all, LW re-engaged in care by 3 years, suggesting the need for PVT services must better address the barriers and transitions women experience during pregnancy and postpartum. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to compare viral load suppression levels among men who have sex with men (MSM) living with HIV who were put on risk reduction interventions versus a control group in Mvita sub-county, Mombasa County, Kenya between December 2020 and June 2021. Methodology: A quasi-experimental study design using quantitative methods was conducted among MSM living with HIV from December 2020 to June 2021. The study involved a questionnaire and various laboratory investigations. The respondent-driven sampling (RDS) was used to obtain the sample of respondents. A total of 114 HIV positive MSM completed the study and were all subjected to a battery of tests. Blood was drawn for alcohol, syphilis, hepatitis B, and viral load tests, while urine was used to screen for drugs and gonorrhoea. Half (57) of the HIV positive MSM were actively followed and risk reduction interventions such as adherence to ARVs, general counselling, and HIV prevention measures such as prompt treatment of STI/OI and condom use were offered after every 2 months. The control group (57) received no risk reduction interventions. Thereafter, both groups were asked to respond to a questionnaire. Since the study was carried out during COVID-19, the risk reduction interventions were conducted over the phone to minimize transmission. Log-binomial univariate and the multivariate regression analysis model was used to identify the variables which were associated with undetectable viral load. Undetectable viral load was defined as having an HIV viral load of less than 50 copies/ml. Data generated from the questionnaires were collected, cleaned, coded and analysed using STATA software, Version 17. Level of significance was fixed at 5% (95% confidence interval). Findings: Majority of MSM living with HIV were between 19-20 years and 49% were actively followed by the researcher and received risk reduction interventions while 54% were in the control group. However, the baseline demographic characteristics were not significantly different (all p>0.05). MSM in the control group who were neither Christian nor Muslim (11%) and had a lower income (35%), were likely to have detectable viral load. However, MSM who had a higher income in both groups (1.8%), were likely to have undetectable viral load. MSM in the control group, who reported ever use of PEP/PrEP (44%), were likely to have detectable viral load while MSM who received interventions, who reported condom break more than once during anal sex (61%), who had more than one regular anal sex partner (61% both groups), and those who drunk more than 2 bottles of beer (33% both groups) were likely to have undetectable viral load. However, MSM who received interventions but used nonprescribed injectables drugs 1 to 2 times in a week (15%), were likely to have detectable viral load. MSM in the control group who reported being always high on alcohol during anal sex (19%), were likely to have detectable viral load but those chewing muguka (type of khat) (79%) were likely to have undetectable viral load. MSM who received interventions who reported feeling uneasy while seeking health services (75%), had detectable viral load while those in the control group who attended private clinics (42%), had undetectable viral load. Overall, after six months, the proportion of MSM achieving viral load suppression was significantly higher in the intervention group as compared to control group by 60% (95% CI 49-70)), p-value < 0.001. Unique contribution to theory, practice, and policy: The study found out that majority of HIV positive MSM who received risk reduction intervention, had undetectable viral load as compared to those in the control group. HIV viral suppression is the desirable outcome for MSM on ART, since once achieved, MSM cannot transmit the virus to their sex partners. The Government/NGO should encourage peer-led HIV services to run the HIV programmes involving MSM with other stakeholders. Thus, many MSM will be able to access the HIV services where their needs will be addressed and supported in a non-judgemental environment. [ABSTRACT FROM AUTHOR]

People with HIV face challenges securing housing and employment. Patient navigation is an effective intervention that can improve the receipt of these services, which have been linked to better health outcomes. The purpose of this study was to assess implementation of patient navigation in diverse delivery settings. We also evaluated the relationship between these services and health outcomes among participants. Twelve sites in the United States (N = 1,082) implemented navigation using single or multiple navigator interventions to improve housing, employment, viral suppression, and retention in care. Sites included health departments, health centers, and AIDS service organizations (ASO). Client-level data were used to model relationships of interest. Across the 12 sites, regardless of model, housing (odds ratio (OR) = 1.18, p <.001), employment (OR = 1.09, p <.001) and retention in care (OR 1.11, p =.007) improved significantly over time; however, viral suppression did not (OR = 1.04, p =.120). Regardless of model of care, patient navigation improved housing, employment, and retention in care. This study demonstrated that while navigation supports people with HIV in securing housing and employment, models using a more intensive format worked best in specific settings. While most studies focus on unimodal strategies, this study builds on the evidence by examining how navigation models can be delivered to reduce barriers to care. [ABSTRACT FROM AUTHOR]

We assessed whether symptomatic neurocognitive impairment (NCI) and asymptomatic NCI -of which the clinical relevance is debated- affect HIV control and the role of ART adherence in this relationship. Observational study on the relationship between NCI and viral control during the 2 years before and the 2 after the neurocognitive evaluation (NCE) of 322 PLWH on ART. Viral load (VL) was defined as undetectable, very low-level (VLLV), low-level (LLV), or high-level viremia (HLV), and classified overtime as persistent (p; ≥2 consecutive values in the same worst category), viral failure (VF; ≥1 HLV requiring ART changes), or optimal control. Adherence was the proportion of days covered by ART. Frascati criteria were used. Adjusted models were performed for factors associated with viral control. Mediation analyses informed causality in the path from NCI to viral control through adherence. Sensitivity analyses were focused on the year following NCE for only participants with optimal viral control before. Among the participants (53 ± 10 years, CD4 + T-cells 630/µL), 41.6% and 10.8% presented asymptomatic and symptomatic NCI. Over 3,304 VLs, 8.4% and 22.1% of participants had VF and pLLV/pVLLV. Both symptomatic and asymptomatic NCI were independently associated with VF (aRRR = 8.5; aRRR = 4.3) and pVLLV/pLLV (aRRR = 4.3; aRRR = 2.1). Specific cognitive domains showed independent associations with VL categories (models' P < 0.001). Adherence partially mediated these relationships (models' P < 0.001). Sensitivity analysis confirmed these findings. Prevalence and severity of poor viral control increased as the severity of NCI increased, with ART adherence mediating this relationship. The current "asymptomatic" attribution used by Frascati's criteria could overlook clinical risks. [ABSTRACT FROM AUTHOR]

Abstract Background Globally, Human Immune-deficiency Virus (HIV) continues to be one of the world’s most significant public health issues. At the end of 2022, 39.0 million people were living with HIV (PLHIV) worldwide with 9% resident in Nigeria. Viral suppression is associated with a reduction in HIV disease progression. However, Nigeria is yet to achieve the UNAIDS 2020 third 95, community wide viral suppression for elimination of global HIV epidemic. This study assessed the clinical predictors and correlates of viral suppression among adults accessing care at HIV clinic in Federal Medical Center, Abeokuta, Ogun State, Nigeria. Methods The study design was a facility-based retrospective cohort study that was conducted among adults on antiretroviral therapy (ART) at HIV clinic from May 2016 to October 22, 2021, Federal Medical Center of Abeokuta (FMCA), Ogun State Nigeria. Two thousand one hundred and seventy-six (2176) case records were explored within the study period, but only one thousand five hundred and twenty (1520) met the inclusion criteria. Variables in the participants’ hospital record (secondary data) were extracted into Microsoft Excel which were exported into Stata MP 17 for data cleaning and recoding, and analysis. Stepwise model selection was done for factors associated with viral suppression and binary logistic regression was used to investigate the predictors of viral suppression among participants at p-value 45 years (OR: 2.42, 95% CI: 1.11–5.28, p

Abstract Introduction Viral suppression is a critical component for preventing mother-to-child transmission of HIV(MTCT). Mothers’ perceptions of viral load suppression is crucial in the attainment of successful outcomes in preventing mother to child transmission of HIV. We therefore aimed to explore the experiences and perceptions of women on viral suppression. Methods This was a qualitative sub-study embedded in a cluster-randomized trial (NCT04122144) designed to improve viral load outcomes among pregnant and breastfeeding mothers living with HIV in four level III/IV health facilities in South-western Uganda. Thirty-two in-depth interviews were conducted with pregnant and breastfeeding women with HIV from 1st March 2020 to 30th September 2020 to explore their understanding and interpretation of viral suppression. Interviews were audio-recorded, transcribed, and coded in Dedoose software for analysis. Results A total of 32 Women living with HIV were enrolled in this qualitative study. WLHIV explained viral suppression in the context of attaining good health and having HIV-free babies. Adherence to ART was presented as a key avenue to viral suppression. The level of engagement with providers was presented as a key attribute of attaining viral suppression. The participants narrated their experiences with viral load testing within the routine services. However, they revealed experiencing some proximate barriers to suppression including anticipated stigma, challenges with non-disclosure of HIV status, pregnancy distress, and distance to the health facility. Conclusion The understanding and interpretation of viral suppression among pregnant and breastfeeding mothers living with HIV provides a basis for adopting behaviors leading to prevention of vertical transmission of HIV. Health care workers can support women by providing clear and culturally appropriate education about viral suppression, adherence strategies and creating a supportive and non-judgmental environment.

BackgroundPersons with HIV (PWH) with high mobility face obstacles to HIV care engagement and viral suppression. We sought to understand whether a patient-centered intervention for mobile PWH would improve viral suppression and retention in care, and if so, which subgroups would benefit most.MethodsIn a randomized trial, we evaluated the effect of an intervention designed to address barriers to care among mobile (≥2 weeks out of community in previous year) PWH with viral nonsuppression or recent missed visits in Kenya and Uganda (NCT04810650). The intervention included dynamic choice of a "travel pack" (emergency antiretroviral therapy [ART] supply, discrete ART packaging, and travel checklist), multimonth and offsite refills, facilitated transfer to out-of-community clinics, and hotline access to a mobility coordinator. The primary outcome was viral suppression (

IntroductionUnhealthy alcohol use significantly contributes to viral non-suppression among persons with HIV (PWH). It is unknown whether brief behavioural interventions to reduce alcohol use can improve viral suppression among PWH with unhealthy alcohol use in sub-Saharan Africa (SSA).MethodsAs part of the SEARCH study (NCT04810650), we conducted an individually randomized trial in Kenya and Uganda of a brief, skills-based alcohol intervention among PWH with self-reported unhealthy alcohol use (Alcohol Use Disorders Identification Test-Consumption [AUDIT-C], prior 3 months, ≥3/female; ≥4/male) and at risk of viral non-suppression, defined as either recent HIV viral non-suppression (≥400 copies/ml), missed visits, out of care or new diagnosis. The intervention included baseline and 3-month in-person counselling sessions with interim booster phone calls every 3 weeks. The primary outcome was HIV viral suppression (200 ng/ml (RR 0.97, 95% CI: 0.92-1.02).ConclusionsIn a randomized trial of 401 PWH with unhealthy alcohol use and risk for viral non-suppression, a brief alcohol intervention reduced unhealthy alcohol use but did not affect viral suppression at 24 weeks. Brief alcohol interventions have the potential to improve the health of PWH in SSA by reducing alcohol use, a significant driver of HIV-associated co-morbidities.

Background: To address the need for improved virologic suppression among youth living with HIV (YLH) on antiretroviral treatment (ART), we evaluated peer navigation plus TXTXT daily text message ART reminders. Setting: YLH aged 15–24 years on ART for at least 3 months at 6 research sites in 4 Nigerian cities. Methods: Using a stepped-wedge design, cluster 1 was nonrandomized, whereas clusters 2 and 3 were randomized to sequences of routine care (control period) and 48 weeks of the combination intervention (intervention period). The primary end point was viral suppression (HIV-1 RNA <200 copies/mL) at week 48 of the intervention. Secondary end points included adherence measured by self-report (≥ 90% considered adherent). Post hoc analysis assessed virologic control at <50 copies per milliliter and <1000 copies per milliliter. Generalized estimating equations determined the difference between intervention and control periods in the intention-to-treat population. Results: We enrolled 558 YLH and followed 541 over time, mean age 18 years, 53.8% female, 71.7% perinatally infected, and 38.6% virologically nonsuppressed at enrollment. For the primary end point, the intervention periods displayed a small, nonsignificant increase in viral suppression < 200 copies per milliliter [odds ratio (OR) = 1.16 (0.88–1.54), P = 0.297]. There was a significant effect of the combination intervention on virologic control <1000 copies per milliliter (OR = 1.42 [1.03–1.94], P = 0.030). Self-reported adherence also improved (OR = 2.07 [1.46–2.95], P < 0.001). Conclusions: Peer navigation plus daily text message ART reminders demonstrated limited benefit among ART-experienced, predominantly perinatally infected YLH, with no significant effect on viral suppression below 200 copies per milliliter despite improvement in self-reported adherence. [ABSTRACT FROM AUTHOR]

Abstract Adherence to antiretroviral therapy (ART) is essential for the effective management of HIV, which includes keeping the HIV viral load undetectable. This study aimed to determine whether certain ART medications are more “forgiving” of poor adherence in achieving viral suppression. We identified subgroups of ART medication usage and determined the extent to which ART adherence is associated with viral suppression across those subgroups. Data came from claims and clinical records (2017–2019) of 3,552 HIV-positive adult members of a Medicaid managed care plan. Pharmacy fill data were examined to characterize ART medications using latent class analysis (LCA), which captures the complexity of real-world ART usage (i.e., multiple medications, ART switching). LCA yielded five ART medication patterns over three years, mostly characterized by recent medications and formulations of ART, though they varied in number of tablets and in medication class. Mixed effects logistic regression models were estimated to determine whether odds of viral suppression differed by ART adherence level. After adjusting for covariates, those with at least 90% adherence (i.e., 90 to

Abstract Background Protease inhibitor (PI)-based Antiretroviral Therapy (ART) regimens are key drugs in HIV management, especially when used as second line drugs. However, some PI-based ART have high adherence demands or tolerable adverse effects which may affect adherence and subsequently viral suppression. We assessed the extent of viral suppression, its determinants, and the experiences of clients on PI-based ART undergoing intensive adherence counselling (IAC) in a public HIV clinic. Methods Mixed methods sequential explanatory study involving a quantitative retrospective chart review for clients on PI-based ART who had received IAC from Dec 2016 to May 2023 and qualitative interviews for clients on PI-based ART who had received IAC in the past six months at an urban public HIV clinic in Uganda. Results In this study, a total of 189 client charts were included. The median number of IAC sessions received was three (interquartile range, IQR, of 3 to 4) with median time of receiving IAC of three ( IQR, of 2 to 4). One half (51%, 95/186) of the clients had achieved viral suppression and the odds of suppression increased by 30% for every additional month on IAC. Respondents perceived the effectiveness of PI-based ART and IAC in achieving and supporting viral suppression, respectively. Conclusion Despite the perceived effectiveness of PI-based ART and IAC, suboptimal levels of viral suppression were observed among clients on PI-based ART who had received IAC. Therefore, it is important to provide IAC for optimal duration as it increases the chances of viral suppression. Further investigation of the barriers of viral suppression for clients on PI-based ART undergoing IAC is needed.

Background: Protease inhibitor (PI)-based Antiretroviral Therapy (ART) regimens are key drugs in HIV management, especially when used as second line drugs. However, some PI-based ART have high adherence demands or tolerable adverse effects which may affect adherence and subsequently viral suppression. We assessed the extent of viral suppression, its determinants, and the experiences of clients on PI-based ART undergoing intensive adherence counselling (IAC) in a public HIV clinic. Methods: Mixed methods sequential explanatory study involving a quantitative retrospective chart review for clients on PI-based ART who had received IAC from Dec 2016 to May 2023 and qualitative interviews for clients on PI-based ART who had received IAC in the past six months at an urban public HIV clinic in Uganda. Results: In this study, a total of 189 client charts were included. The median number of IAC sessions received was three (interquartile range, IQR, of 3 to 4) with median time of receiving IAC of three (IQR, of 2 to 4). One half (51%, 95/186) of the clients had achieved viral suppression and the odds of suppression increased by 30% for every additional month on IAC. Respondents perceived the effectiveness of PI-based ART and IAC in achieving and supporting viral suppression, respectively. Conclusion: Despite the perceived effectiveness of PI-based ART and IAC, suboptimal levels of viral suppression were observed among clients on PI-based ART who had received IAC. Therefore, it is important to provide IAC for optimal duration as it increases the chances of viral suppression. Further investigation of the barriers of viral suppression for clients on PI-based ART undergoing IAC is needed. [ABSTRACT FROM AUTHOR]

Adherence to antiretroviral therapy (ART) is essential for the effective management of HIV, which includes keeping the HIV viral load undetectable. This study aimed to determine whether certain ART medications are more "forgiving" of poor adherence in achieving viral suppression. We identified subgroups of ART medication usage and determined the extent to which ART adherence is associated with viral suppression across those subgroups. Data came from claims and clinical records (2017–2019) of 3,552 HIV-positive adult members of a Medicaid managed care plan. Pharmacy fill data were examined to characterize ART medications using latent class analysis (LCA), which captures the complexity of real-world ART usage (i.e., multiple medications, ART switching). LCA yielded five ART medication patterns over three years, mostly characterized by recent medications and formulations of ART, though they varied in number of tablets and in medication class. Mixed effects logistic regression models were estimated to determine whether odds of viral suppression differed by ART adherence level. After adjusting for covariates, those with at least 90% adherence (i.e., 90 to < 95%) did not significantly differ from those with 95% adherence or greater in terms of viral suppression, which corroborates existing clinical recommendations. These findings can inform provider-patient communication for people with HIV, especially those who have difficulty maintaining adherence. This includes those experiencing unstable housing, mental health conditions, or substance use. [ABSTRACT FROM AUTHOR]

Objectives: This study aims to identify COVID-19 breakthrough infections among people with HIV (PWH) across different phases of the pandemic and explore whether differential immune dysfunctions are associated with breakthrough infections. Design and methods: This retrospective population-based cohort study used data from an integrated electronic health record (EHR) database in South Carolina (SC). Breakthrough infection was defined as the first COVID-19 diagnosis documented in the state agency after the date an individual was fully vaccinated (ie, 2 doses of Pfizer/BNT162b2 or Moderna/mRNA-1273, or 1 dose of Janssen/Ad26.COV2.S) through June 14, 2022. We analyzed the risk and associated factors of the outcome using Cox proportional hazards models. Results: Among 7596 fully vaccinated PWH, the overall rate of breakthrough infections was 118.95 cases per 1000 person-years. When compared with the alpha-dominant period, the breakthrough infection rate was higher during both delta-dominant (HR: 1.50; 95% CI: 1.25 to 1.81) and omicron-dominant (HR: 2.86; 95% CI: 1.73 to 4.73) periods. Individuals who received a booster dose had a lower likelihood of breakthrough infections (HR: 0.19; 95% CI: 0.15 to 0.24). There was no association of breakthrough infections with degree of HIV viral suppression, but a higher CD4 count was significantly associated with fewer breakthroughs among PWH (.500 vs,200 cells/mm3: HR: 0.68; 95% CI: 0.49 to 0.94). Conclusions: In our PWH population, the incidence of breakthrough infections was high (during both delta-dominant and omicron-dominant periods) and mainly associated with the absence of a booster dose in patients older than 50 years, with comorbidities and low CD4 count. [ABSTRACT FROM AUTHOR]

Bulevirtide (BLV), a first-in-class entry inhibitor, is approved in Europe for the treatment of chronic hepatitis delta (CHD). BLV monotherapy was superior to delayed treatment at week (W) 48, the primary efficacy endpoint, in the MYR301 study (NCT03852719). Here, we assessed if continued BLV therapy until W96 would improve virologic and biochemical response rates, particularly among patients who did not achieve virologic response at W24. In this ongoing, open-label, randomized phase III study, patients with CHD (N = 150) were randomized (1:1:1) to treatment with BLV 2 mg/day (n = 49) or 10 mg/day (n = 50), each for 144 weeks, or to delayed treatment for 48 weeks followed by BLV 10 mg/day for 96 weeks (n = 51). Combined response was defined as undetectable hepatitis delta virus (HDV) RNA or a decrease in HDV RNA by ≥2 log 10 IU/ml from baseline and alanine aminotransferase (ALT) normalization. Other endpoints included virologic response, ALT normalization, and change in HDV RNA. Of 150 patients, 143 (95%) completed 96 weeks of the study. Efficacy responses were maintained and/or improved between W48 and W96, with similar combined, virologic, and biochemical response rates between BLV 2 and 10 mg. Of the patients with a suboptimal early virologic response at W24, 43% of non-responders and 82% of partial responders achieved virologic response at W96. Biochemical improvement often occurred independently of virologic response. Adverse events were mostly mild, with no serious adverse events related to BLV. Virologic and biochemical responses were maintained and/or increased with longer term BLV therapy, including in those with suboptimal early virologic response. BLV monotherapy for CHD was safe and well tolerated through W96. In July 2023, bulevirtide was fully approved for the treatment of chronic hepatitis delta (CHD) in Europe based on clinical study results from up to 48 weeks of treatment. Understanding the efficacy and safety of bulevirtide over the longer term is important for healthcare providers. In this analysis, we demonstrate that bulevirtide monotherapy for 96 weeks in patients with CHD was associated with continued improvements in combined, virologic, and biochemical responses as well as liver stiffness from week 48 at both the 2 mg and 10 mg doses. Patients with suboptimal virologic responses to bulevirtide at week 24 also benefited from continued therapy, with the majority achieving virologic response or biochemical improvement by week 96. NCT03852719 [Display omitted] • BLV for 96 weeks maintained and/or improved responses compared to 48 weeks of treatment. • Efficacy was similar between the 2 mg and 10 mg doses of BLV. • In patients with a suboptimal early virologic response, improvements were observed with continued BLV. • Even in the absence of a virologic response, biochemical improvement can occur. • BLV was well tolerated with no discontinuations for adverse events through 96 weeks. [ABSTRACT FROM AUTHOR]

This article aimed at analyzing the acute impact and the longer-term recovery of COVID-19 pandemic effects on clinical encounter types, HIV viral load (VL) testing, and suppression (HIV VL\200 copies/mL). This study was a longitudinal cohort study of participants seen during 2019-2022 at nine HIV Outpatient Study (HOPS) sites. Generalized linear mixed models (GLMMs) estimated monthly rates of all encounters, office and telemedicine visits, and HIV VL tests using 2010-2022 data. We examined factors associated with nonsuppressed VL (VL ø 200 copies/mL) and not having ambulatory care visits during the pandemic using GLMM for logistic regression with 2017-2022 and 2019-2022 data, respectively. Of 2351 active participants, 76.0% were male, 57.6% aged ø 50 years, 40.7% non-Hispanic White, 38.2% non-Hispanic Black, 17.3% Hispanic/Latino, and 51.0% publicly insured. The monthly rates of in-person and telemedicine visits varied during 2020 through mid-year 2022. Multivariable logistic regression showed that persons with no encounters were more likely to be male or have VL ø 200 copies/mL. For participants with ø1 VL test, the prevalence rate of HIV VL ø 200 copies/mL during 2020 was close to the rates from 2014 to 2019. The change in probability of viral suppression was not associated with participant's age, sex, race/ethnicity, or insurance type. In the HOPS, overall patient encounters declined over 2 years during the pandemic with variations in telemedicine and in-person events, with relative maintenance of viral suppression. Ongoing recovery from the impact of COVID-19 on ambulatory care will require continued efforts to improve retention and patient access to medical services. [ABSTRACT FROM AUTHOR]

Introduction: Courier delivery has become a popular antiretroviral therapy (ART) distribution method in some HIV care settings, yet data on ART courier delivery and how it relates to ART outcomes are scarce. We studied the differences in viral suppression rates between individuals from a South African private sector HIV programme receiving ART by courier delivery and those receiving ART through traditional retail dispensing. Methods: Individuals aged 15 years or older who were actively enrolled in the Aid for AIDS programme between January 2011 and July 2022 were eligible for the analysis. The outcome of interest was viral suppression defined as a viral load (VL) <400 copies per ml. We calculated adjusted odds ratios (OR) for the association between the ART distribution method and viral suppression, comparing those receiving refills through courier pharmacies versus retail dispensing at the time of the VL testing. We used generalized estimating equations to account for repeated VL testing of the same individual. The models were adjusted for age, sex, calendar year, ART regimen, history of mental illness and medical insurance scheme. We computed adjusted ORs for the calendar periods 2011−2013, 2014−2016, 2017−2019, 2020−2022 and overall. Results: We extracted 442,619 VL measurements from 68,720 eligible individuals, 39,406 (57.3%) were women. The median number of VL measurements per individual was 6 (IQR 3−10). VL suppression was detected in 398,901 (90.1%) tests, and 185,701 (42.0%) of the tests were taken while the individual was receiving ART by courier delivery. Overall, courier delivery was associated with 5% higher odds of viral suppression than retail dispensing (adjusted OR 1.05, 95% CI 1.02−1.08). The strength and direction of this association varied by calendar period, with an adjusted OR of 1.37 (95% CI 1.27−1.48) in 2011−2013 and 1.02 (95% CI 0.97−1.07) in 2020−2022. Conclusions: Courier delivery of ART is a viable alternative to retail dispensing in the South African private sector, as it was associated with higher viral suppression until 2016 and similar suppression rates in recent years. Further research is needed to investigate the potential benefits and drawbacks of courier delivery of ART in both private and public healthcare settings. [ABSTRACT FROM AUTHOR]

Introduction Rapid initiation of ART after HIV diagnosis is recommended for individual and public health benefits. However, certain clinical and ART-related considerations hinder immediate initiation of therapy. Methods An open-label, single-arm, single-centre 48-week prospective clinical trial involving ART-naïve HIV-diagnosed adults who started bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) within a week from the first hospital visit, before the availability of baseline laboratory and genotype results. The primary aim was to determine the proportion of people with at least one condition that would hinder immediate initiation of any recommended ART regimen other than BIC/FTC/TAF. Clinicaltrials.gov : NCT04416906. Results We included 100 participants: 79% men, 64% from Latin America, median age 32 years. According to European AIDS Clinical Society (EACS) and US Department of Health and Human Services 2023 guidelines, 11% (95%CI 6; 19) of participants had at least one condition that made any ART different from BIC/FTC/TAF less appropriate for a rapid ART strategy. Seventy-nine percent of the people started BIC/FTC/TAF within the first 48 hours of their first hospital visit. There were 16 early discontinuations (11 lost to follow-up). By week 48, 92% (95%CI 86; 98) of the participants of the ITT population with observed data achieved viral suppression. Eight grade 3–4 adverse events (AEs), five serious AEs and six ART-related AEs were identified. Adherence remained high. Conclusions BIC/FTC/TAF is an optimal treatment for rapid initiation of ART. However, additional strategies to improve retention in care must be implemented. [ABSTRACT FROM AUTHOR]

Objective: AIDS Drug Assistance Programs (ADAPs) are state-administered programs that pay for medical care and medication for people living with HIV (PLWH) in the United States. In October 2021, the federal policy requiring that clients recertify for the program every 6 months was repealed, giving states the authority to set their own recertification policies. However, little data exist on the costs and health effects of alternative recertification schedules. We assessed the cost of changing the legacy 6-month recertification to a 12-month schedule in Washington State to inform policy decisions on recertification. Methods: We used a Markov model to simulate the population of PLWH in Washington State who are eligible or enrolled in ADAP. We obtained model inputs and validation data from the Washington State Ryan White database. We estimated the cost of 12-month and 6-month criteria over a 5-year time horizon. Model outputs included annual program costs, population sizes, and number of people virally suppressed, by scenario. Results: Under a continuation of the legacy 6-month recertification criteria, the annual cost of Washington ADAP would be $37 663 000 (95% CI, $34 570 000-$41 686 000) during the next 5 years, with a per-client cost of $7966 (95% CI, $7478-$8494). Under 12-month criteria, the annual cost would be $40 217 000 (95% CI, $36 243 000-$44 401 000) and the per-client cost would be $7543 (95% CI, $7084-$8042). Under the 12-month scenario, 245 more people will have been virally suppressed by the end of 2025. Conclusions: Switching to a less frequent recertification process may improve health outcomes at a modest increase in cost in Washington State. [ABSTRACT FROM AUTHOR]

Background: Adolescents and young adults (AYA) living with HIV have been shown to have lower rates of viral load testing and viral suppression as compared to older adults. We examined trends over time and predictors of HIV viral load monitoring and viral suppression among AYA in a large HIV treatment programme in Dar es Salaam, Tanzania. Methods: We analysed longitudinal data of AYA aged 10–24 years initiated on antiretroviral therapy between January 2017 and October 2022. Trend models were used to assess changes in HIV viral load testing and viral suppression by calendar year. Generalised estimating equations were used to examine the relationship of sociodemographic and clinical factors with HIV viral load testing and viral suppression. Results: Out of 15,759 AYA, the percentage of those who received a 6‐month HIV viral load testing increased from 40.6% in 2017 to 64.7% in 2022 and, a notable annual increase of 5.6% (p < 0.001). A higher HIV viral load testing uptake was observed among 20‐ to 24‐year‐olds (87.7%) compared to 10‐ to 19‐year‐olds (80.2%) (p < 0.001). The likelihood of not receiving an HIV viral load test within 12 months of antiretroviral therapy initiation was higher among 10‐ to 19‐year‐olds (adjusted odds ratio [aOR] = 1.7; 95% confidence interval [CI] = 1.4–2.0), advanced HIV disease (aOR = 1.3; 95% CI = 1.12–1.53), normal nutrition status at enrolment aOR 2.6 (95% CI = 1.59–4.26) and initiation of non‐nucleoside reverse transcriptase inhibitors regimen aOR 1.2 (95% CI = 1.08–1.34). The proportion of AYA with viral suppression increased from 83.0% in 2017 to 94.6% in 2022. Notably, the overall trend in viral suppression increased significantly at 2.4% annually. The risk of not achieving viral suppression was greater among 10‐ to 14‐year‐olds (aOR = 2; 95% CI = 1.75–2.43) and 15‐ to 19‐year‐olds (aOR = 1.4; 95% CI = 1.24–1.58) as compared to 20–24 years; being male (aOR = 1.16; 95% CI = 1.02–1.32); undernourished (aOR = 1.53; 95% CI = 1.17–1.99); in WHO Stage II (aOR = 1.16; 95% CI = 1.02–1.33) and III (aOR = 1.21; 95% CI = 1.03–1.42) and being on an non‐nucleoside reverse transcriptase inhibitors regimen (aOR = 1.32; 95% CI = 1.18–1.48). Conclusion: HIV viral load testing uptake at 6 months of antiretroviral therapy initiation and viral suppression increased from 2017 to 2022; however, overall HIV viral load testing was suboptimal. Demographic and clinical characteristics can be used to identify AYA at greater risk for not having HIV viral load test and not achieving viral suppression. [ABSTRACT FROM AUTHOR]

Background: Perinatally acquired HIV may lead to worse health outcomes than later acquisition. We compared the demographic and clinical characteristics of youth diagnosed with HIV in childhood and adulthood, as a proxy for acquisition route (perinatal vs. horizontal). Setting: Youth aged 18--24 years in 3 provinces in Zimbabwe were included. Methods: In a representative population-based survey, participants were asked their HIV status, date of HIV diagnosis if positive, and whether they were diagnosed in childhood. A dried blood spot was taken to measure viral load. Multilevel mixed-effects generalized linear modelling was used to estimate the association between HIV acquisition time and viral nonsuppression (≥1000 copies/mL). Results: A total of 17,682 participants (60.8% female) were enrolled, 17,553 (99.3%) gave a dried blood spot sample, 1200 (6.8%) tested HIV antibody--positive (7 indeterminate results), and 26 reported being HIV-positive without confirmation. Of the 1226 participants living with HIV, 435 (35.5%) self-reported that they were HIV-positive, of whom 196 (45.1%) were diagnosed in childhood (median age 7 years). A higher proportion of adult-diagnosed than child-diagnosed participants were female (91.2% vs. 76.5%), had ever had sex (93.3% vs. 61.5%), had been married/cohabiting (59.4% vs. 19.4%), and had been pregnant (78.9% of women vs. 40.0%). A lower proportion had viral suppression (39.3% vs. 52.5%). Adjusting for sex, age, marital status, and education, those diagnosed in childhood had higher odds of viral nonsuppression (adjusted odds ratio = 1.83, 95% confidence interval: 1.17 to 2.85, P = 0.008). Conclusions: Youth who acquired HIV perinatally have differentiated care needs and greater risk of viral nonsuppression compared with those who acquired HIV later. [ABSTRACT FROM AUTHOR]

Mortality in children accounts for 15% of all AIDS-related deaths globally, with a higher burden among Cameroonian children (25%), likely driven by poor virological response. We sought to evaluate viral suppression (VS) and its determinants in a nationally representative paediatric and young adult population receiving antiretroviral therapy (ART). A cross-sectional and multicentric study was conducted among Cameroonian children (<10 years), adolescents (10–19 years) and young adults (20–24 years). Data were collected from the databases of nine reference laboratories from December 2023 to March 2024. A conditional backward stepwise regression model was built to assess the predictors of VS, defined as a viral load (VL) <1000 HIV-RNA copies/mL. Overall, 7558 individuals (females: 73.2%) were analysed. Regarding the ART regimen, 17% of children, 80% of adolescents and 83% of young adults transitioned to dolutegravir (DTG)-based regimens. Overall VS was 82.3%, with 67.3% (<10 years), 80.5% (10–19 years) and 86.5% (20–24 years), and p < 0.001. VS was 85.1% on a DTG-based regimen versus 80.0% on efavirenz/nevirapine and 65.6% on lopinavir/ritonavir or atazanavir/ritonavir. VS was higher in females versus males (85.8% versus 78.2%, p < 0.001). The VS rate remained stable around 85% at 12 and 24 months but dropped to about 80% at 36 months after ART initiation, p < 0.009. Independent predictors of non-VS were younger age, longer ART duration (>36 months), backbone drug (non-TDF/3TC) and anchor drug (non-DTG based). In this Cameroonian paediatric population with varying levels of transition to DTG, overall VS remains below the 95% targets. Predictors of non-VS are younger age, non-TDF/3TC- and non-DTG-based regimens. Thus, efforts toward eliminating paediatric AIDS should prioritise the transition to a DTG-based regimen in this new ART era. [ABSTRACT FROM AUTHOR]

Introduction: Millions of people living with HIV (PLWH) take oral antiretroviral therapy (ART), which requires a lifetime of consistent medication adherence. The relationship between adherence and poor HIV outcomes is well documented. Newer ART regimens that include dolutegravir (DTG) could be more forgiving, but empirical evidence on the relationship between adherence and viral suppression under DTG is only emerging. Methods: In this observational cohort study (secondary analysis of data from a randomized trial), we used data from 313 ART clients from a large HIV clinic in Kampala, Uganda. Over the 4‐year study period (January 2018–January 2022), 91% switched from non‐DTG regimens to DTG regimens. We measured adherence using Medication Event Monitoring Systems‐caps and extracted prescription information and viral load measures from electronic health records. We estimated unadjusted linear regressions and adjusted models that included individual and time fixed‐effects. Results: Under non‐DTG regimens, 96% of participants were virally suppressed (defined as viral load < 200 copies/ml) when adherence was 90% or higher in the 3 months before viral load measurement. Viral suppression was 32 percentage points lower when adherence was between 0% and 49% (95% CI −0.44, −0.20, p < 0.01), 12 percentage points lower when adherence was between 50% and 79% (95% CI −0.23, −0.02, p < 0.01), and not significantly different when adherence was between 80% and 89% (effect of 0.00, 95% CI −0.06, 0.07, p = 0.81). In contrast, for participants taking DTG, there was no statistically significant difference in viral suppression among any of the four adherence levels; more than 95% were virally suppressed at each adherence level. On average, switching to DTG increased viral suppression by 6 percentage points in our adjusted models (95% CI 0.00, 0.13, p = 0.03). Conclusions: There was no significant association between adherence levels and viral suppression among PLWH taking DTG regimens, suggesting a high degree of forgiveness for missed doses. The use of DTG should be prioritized over older regimens, particularly for those with low adherence. Clinical Trial Number: NCT03494777. [ABSTRACT FROM AUTHOR]

Introduction: To assess the effectiveness of novel HIV curative strategies, "cure" trials require periods of closely monitored antiretroviral therapy (ART) analytical treatment interruptions (ATIs). We performed a systematic review and meta‐analysis to identify the impact of ATI with or without novel therapeutics in cure‐related studies on the time to viral re‐suppression following ART restart. Methods: Medline, Embase and Web of Science databases were searched for human studies involving ATIs from 1 January 2015 till 22 April 2024. The primary outcome was time to first viral re‐suppression (plasma HIV viral load [VL] <50 copies/ml) stratified by receipt of interventional drug with ATI (IA) or ATI‐only groups. Random‐effects proportional meta‐analysis and multivariable Cox proportional hazards analysis were performed using R. Results: Of 1073 studies screened, 13 were included that met the inclusion criteria with VL data available after restarting ART (n = 213 participants). There was no difference between time to viral suppression in IA or ATI‐only cohorts (p = 0.22). For 87% of participants, viral suppression within 12 weeks of ART restart was achieved, and all eventually had at least one VL <50 copies/ml during follow‐up. After adjusting for covariables, while participants in the IA cohort were associated with less rapid suppression (adjusted hazard ratio [aHR] 0.61, 95% CI 0.40–0.94, p = 0.026), other factors include greater log VL at ART restart (aHR 0.56, 95% CI 0.46–0.68, p<0.001), duration since HIV diagnosis (aHR 0.93, 95% CI 0.89–0.96) and longer intervals between HIV VL monitoring (aHR 0.66, 95% CI 0.59–0.74, p<0.001). However, the use of integrase inhibitors was associated with more rapid viral suppression (aHR 1.74, 95% CI 1.16–2.59). Discussion: When designing studies involving ATIs, information on time to viral re‐suppression after restarting ART is important to share with participants, and should be regularly monitored and reported, to assess the impact and safety of specific trial interventions in ATI studies. Conclusions: The majority of participants achieved viral suppression after restarting ART in ATI studies. ART regimens containing integrase inhibitors and frequent VL monitoring should be offered for people restarting ART after ATI studies to ensure rapid re‐suppression. [ABSTRACT FROM AUTHOR]

Supplemental Digital Content is Available in the Text. Background: As people with HIV grow older, stable engagement in care is essential for healthy aging. We evaluate the HIV care cascade for older adults in rural South Africa at 2 time points cross-sectionally and assess movement in the cascade over time. Setting: We evaluated the cascade stage at waves 1 (2014–2015) and 2 (2018–2019) of Health and Aging in Africa: A Longitudinal Study of an INDPETH Community in South Africa, a population-based longitudinal cohort study in Mpumalanga Province, South Africa. Methods: Biomarker screening defined cascade stages [HIV+/no antiretroviral therapy (ART); ART+/unsuppressed viral load; ART+/suppressed viral load]. Between-wave probability of death, cascade progression, regression, cascade transitions, and sociodemographic predictors were assessed with Poisson regression. The impact of death was considered using the Fine and Gray competing risk model. Results: We observed a higher prevalence of antiretroviral therapy with viral suppression over time (50% in wave 1 vs. 70% in wave 2). Among those alive, the oldest age group (70+ years old) was most likely to have cascade progression [adjusted risk ratio for treatment initiation vs. 40–49 years old: 1.38 (95% confidence interval: 1.02 to 1.86)]. However, there was a significant risk of death and cascade regression. Death between waves reached 40% for 70+-year-olds who were ART+/unsuppressed. In competing risk models, older age was associated with equivalent or less cascade progression. Conclusion: Older age groups who were unsuppressed on treatment and men had poorer cascade outcomes. Improvements observed in HIV treatment coverage over time for older adults must be interpreted in the context of the high risk of death for older HIV-positive adults, especially among those failing treatment. [ABSTRACT FROM AUTHOR]

ObjectivesDetermine whether patient-centered, streamlined HIV care achieves higher antiretroviral therapy (ART) uptake and viral suppression than the standard treatment model for people with HIV (PWH) reporting hazardous alcohol use.DesignCommunity cluster-randomized trial.MethodsThe Sustainable East Africa Research in Community Health trial (NCT01864603) compared an intervention of annual population HIV testing, universal ART, and patient-centered care with a control of baseline population testing with ART by country standard in 32 Kenyan and Ugandan communities. Adults (15 years or older) completed a baseline Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) and were classified as no/nonhazardous (AUDIT-C 0-2 women/0-3 men) or hazardous alcohol use (≥3 women/≥4 men). We compared year 3 ART uptake and viral suppression of PWH reporting hazardous use between intervention and control arms. We compared alcohol use as a predictor of year 3 ART uptake and viral suppression among PWH, by arm.ResultsOf 11,070 PWH with AUDIT-C measured, 1723 (16%) reported any alcohol use and 893 (8%) reported hazardous use. Among PWH reporting hazardous use, the intervention arm had higher ART uptake (96%) and suppression (87%) compared with control (74%, adjusted risk ratio [aRR] = 1.28, 95% CI: 1.19 to 1.38; and 72%, aRR = 1.20, 95% CI: 1.10 to 1.31, respectively). Within arm, hazardous alcohol use predicted lower ART uptake in control (aRR = 0.86, 95% CI: 0.78 to 0.96), but not intervention (aRR = 1.02, 95% CI: 1.00 to 1.04); use was not predictive of suppression in either arm.ConclusionsThe Sustainable East Africa Research in Community Health intervention improved ART uptake and viral suppression among PWH reporting hazardous alcohol use and eliminated gaps in ART uptake between PWH with hazardous and no/nonhazardous use. Patient-centered HIV care may decrease barriers to HIV care for PWH with hazardous alcohol use.

Intimate partner violence (IPV) has been associated with delays throughout the HIV care continuum. This study explored prospective associations between experiences of past-year IPV and two HIV care outcomes in the context of current universal test and treat guidelines using two consecutive rounds of an ongoing HIV surveillance study conducted in the Rakai region of Uganda. Longitudinal logistic regression models examined associations between IPV, use of antiretroviral therapy (ART) and viral load suppression (VS), adjusting for outcome variables at baseline. To address differences in ART retention by IPV, propensity scores were used to create inverse-probability-of-treatment-and-censoring-weighted (IPTCW) models. At baseline, of 1923 women with HIV (WWH), 34.6%, 26.5%, 13.5% reported past-year verbal, physical and sexual IPV; a lower proportion of persons who experienced physical IPV (79.4%) were VS than those who did not (84.3%; p = 0.01). The proportion VS at baseline also significantly differed by exposure to verbal IPV (p = 0.03). However, in adjusted longitudinal models, IPV was not associated with lower odds of ART use or VS at follow-up. Among WWH in the Rakai region, IPV does not appear to be a barrier to subsequent ART use or VS. However, given the prevalence of IPV in this population, interventions are needed.

Troubling disparities in viral suppression persist among transgender (trans) women living with HIV in the US. We utilized baseline data from a randomized controlled trial of a behavioral intervention among trans women living with HIV in San Francisco and Los Angeles, to identify the socio-ecological correlates of biologically confirmed viral suppression (

Abstract Introduction Perspectives on long‐acting injectable cabotegravir/rilpivirine (CAB/RPV‐LA) from HIV health disparity populations are under‐represented in current literature yet crucial to optimize delivery. Methods Between August 2022 and May 2023, we conducted in‐depth interviews with people with HIV (PWH) at four HIV clinics in Atlanta, Chicago and San Francisco. Eligibility criteria were current CAB/RPV‐LA use with receipt of ≥3 injections or CAB/RPV‐LA discontinuation. We purposefully sampled for PWH who initiated with viraemia (plasma HIV RNA >50 copies/ml) due to adherence challenges, discontinuers, and cis and trans women. Interviews were coded and analysed using thematic methods grounded in descriptive phenomenology. Clinical data were abstracted from the medical record. Results The sample (San Francisco n = 25, Atlanta n = 20, Chicago n = 14 for total n = 59, median number of injections = 6) consisted of 48 PWH using CAB/RPV‐LA and 11 who had discontinued. The median age was 50 (range 25–73) and 40 (68%) identified as racial/ethnic minorities, 19 (32%) cis or trans women, 16 (29%) were experiencing homelessness/unstable housing, 12 (20%) had recently used methamphetamine or opioids and 11 (19%) initiated with viraemia. All participants except one (who discontinued) had evidence of viral suppression at interview. Typical benefits of CAB/RPV‐LA included increased convenience, privacy and freedom from being reminded of HIV and reduced anxiety about forgetting pills. However, PWH who became virally suppressed through CAB/RPV‐LA use also experienced an amelioration of feelings of shame and negative self‐worth related to oral adherence challenges. Regardless of baseline viral suppression status, successful use of CAB/RPV‐LA amplified positive provider/clinic relationships, and CAB/RPV‐LA was often viewed as less “work” than oral antiretroviral therapy, which created space to attend to other aspects of health and wellness. For some participants, CAB/RPV‐LA remained “work,” particularly with regard to injection site pain and visit frequency. At times, these burdens outweighed the aforementioned benefits, resulting in discontinuation. Conclusions CAB/RPV‐LA offers a range of logistical, psychosocial and care engagement benefits, which are experienced maximally by PWH initiating with viraemia due to adherence challenges; however, benefits do not always outweigh treatment burdens and can result in discontinuation. Our findings on rationales for persistence versus discontinuation can inform both initial and follow‐up patient counselling.

ObjectiveTo longitudinally evaluate differences in HIV viral suppression (

Farai Kevin Munyayi, Brian van Wyk School of Public Health, University of the Western Cape, Cape Town, South AfricaCorrespondence: Farai Kevin Munyayi, Email 3417964@myuwc.ac.za; fmfanchom@gmail.comBackground: Adolescents living with HIV (ALHIV) face unique challenges that result in persistent gaps in achieving and maintaining suppressed viral load. Although effective evidence-based interventions to address treatment gaps in adolescents are readily available, health systems in resource-constrained, high HIV prevalence settings are challenged to implement them to achieve epidemic control. Here, we describe the health system responses to address the treatment gap of unsuppressed ALHIV on antiretroviral therapy in Windhoek, Namibia.Methods: We conducted a qualitative descriptive and exploratory study in Windhoek between June and October 2023. Nineteen purposively selected key informants, ranging from pediatric HIV program managers to healthcare providers, were interviewed. In-depth interviews were audio-recorded and transcribed verbatim. The transcripts were uploaded to ATLAS.ti and subjected to thematic analysis.Results: The four main themes elucidated challenges related to adherence and retention as well as health system responses in the form of interventions and support programs. The predominant adherence and retention challenges faced by ALHIV were mental health issues, behavioral and medication-related challenges, and inadequate care and social support. The health system responses to the identified challenges included providing psychosocial support, peer support, optimization of treatment and care, and the utilization of effective service delivery models. Key health system support elements identified included adequately capacitated human resources, efficient medication supply chain systems, creating and maintaining an enabling environment for optimum care, and robust monitoring systems as essential to program success.Conclusion: The health system responses to address the remaining treatment gaps of unsuppressed ALHIV in Windhoek are quite varied and, although evidence-based, appear to be siloed. We recommend harmonized, multifaceted guidance, integrating psychosocial, treatment, care, and peer-led support, and strengthening client-centred differentiated service delivery models for unsuppressed adolescents.Keywords: viral suppression, adolescents, antiretroviral therapy, interventions, HIV, fast-track city

Abstract Introduction The World Health Organisation has implemented multiple HIV prevention policies and strived to achieve the 90-90-90 goal by 2020, achieving the 95-95-95 goal by 2030, which refers to 95% of patients living with HIV knowing their HIV status, 95% of patients living with HIV receiving continual care and medication, and 95% of patients living with HIV exhibiting viral suppression. However, how to measure the status of viral suppression varies, and it is hard to indicate the quality of HIV care. The study aimed to examine the long-term viral load suppression in these cases and explore potential factors affecting the control of long-term viral load. Methods This study analyzed viral load testing data from HIV patients who are still alive during the period from notification up to 2019–2020. Three indicators were calculated, including durable viral suppression, Viremia copy-years, and Viral load > 1,500 copies/ml, to assess the differences between them. Results Among the 27,706 cases included in the study, the proportion of persistent viral load suppression was 87%, with 4% having viral loads exceeding 1,500 copies/ml. The average duration from notification to viral load suppression was 154 days, and the geometric mean of annual viral replication was 90 copies*years/ml. Regarding the last available viral load measurement, 96% of cases had an undetectable viral load. However, we observed that 9.3% of cases, while having an undetectable viral load for their last measurement, did not show consistent long-term viral load suppression. An analysis of factors associated with non-persistent viral load suppression revealed higher risk in younger age groups, individuals with an educational level of high school or below, injection drug users, cases from the eastern region, those seeking care at regional hospitals, cases with drug resistance data, individuals with lower healthcare continuity, and those with an initial CD4 count below 350 during the study period. Conclusions The recommendation is to combine it with the indicator of sustained viral load suppression for a more accurate assessment of the risk of HIV transmission within the infected community.

Summary: Background: In a recent randomized trial, six months of financial incentives contingent for recent alcohol abstinence led to lower levels of hazardous drinking, while incentives for recent isoniazid (INH) ingestion had no impact on INH adherence, during TB preventive therapy among persons with HIV (PWH). Whether the short-term incentives influence long-term alcohol use and HIV viral suppression post-intervention is unknown. Methods: We analyzed twelve-month HIV viral suppression and alcohol use in the Drinkers’ Intervention to Prevent Tuberculosis study, a randomized controlled trial among PWH with latent TB and unhealthy alcohol use in south-western Uganda. We randomly assigned 680 participants (1:1:1:1) initiating six months of INH to: Arm 1, no incentives (control); Arm 2, financial incentives contingent on recent alcohol abstinence; Arm 3, incentives contingent on recent INH use; and Arm 4, incentives for recent alcohol abstinence and INH use, rewarded separately. The 6 months post-intervention outcomes evaluated were pre-specified and included: HIV viral suppression (95%) at baseline and at 12 months: we found no effect of either 6-month alcohol reduction or INH adherence incentives on long-term viral suppression. Six months of alcohol reduction incentives were effective at promoting no/low alcohol use at 12 months, demonstrating persistent effects post-intervention. Funding: National Institutes of Health (NIH/NIAAA) U01AA026223 (PI: Hahn) and U01AA026221 (PI: Chamie), NIH/NIAAA K24 AA022586 (PI: Hahn), NIH/NIAAA K24 AA031211 (PI: Chamie), Providence/Boston Center for AIDS Research P30AI042853 (PI: Sara Lodi).

BACKGROUND: Alcohol use has been linked to worse human immunodeficiency virus (HIV) immunologic/virologic outcomes, yet few studies have explored the effects of alcohol use disorder (AUD). This study assessed whether AUD severity is associated with HIV viral suppression and CD4 count in the three cohorts of the Uganda Russia Boston Alcohol Network for Alcohol Research Collaboration on HIV/AIDS (URBAN ARCH) Consortium. METHODS: People with HIV (PWH) in Uganda (n = 301), Russia (n = 400), and Boston (n = 251), selected in-part based on their alcohol use, were included in analyses. Logistic and linear regressions were used to assess the cross-sectional associations between AUD severity (number of DSM-5 diagnostic criteria) and (1) HIV viral suppression, and (2) CD4 count (cells/mm3 ) adjusting for covariates. Analyses were conducted separately by site. RESULTS: The proportion of females was 51% (Uganda), 34% (Russia), and 33% (Boston); mean age (SD) was 40.7 (9.6), 38.6 (6.3), and 52.1 (10.5), respectively. All participants in Uganda and all but 27% in Russia and 5% in Boston were on antiretroviral therapy. In Uganda, 32% met criteria for AUD, 92% in Russia, and 43% in Boston. The mean (SD) number of AUD criteria was 1.6 (2.4) in Uganda, 5.6 (3.3) in Russia, and 2.4 (3.1) in Boston. Most participants had HIV viral suppression (Uganda 92%, Russia 57%, Boston 87%); median (IQR) CD4 count was 673 (506, 866), 351 (201, 542), and 591 (387, 881), respectively. In adjusted models, there were no associations between AUD severity and HIV viral suppression: adjusted odds ratios (AOR) (95%CI) per 1 additional AUD criterion in Uganda was 1.08 (0.87, 1.33); Russia 0.98 (0.92, 1.04); and Boston 0.95 (0.84, 1.08) or CD4 count: mean difference (95%CI) per 1 additional criterion: 5.78 (-7.47, 19.03), -3.23 (-10.91, 4.44), and -8.18 (-24.72, 8.35), respectively. CONCLUSIONS: In three cohorts of PWH, AUD severity was not associated with HIV viral suppression or CD4 count. PWH with AUD in the current era of antiretroviral therapy can achieve virologic control.

BACKGROUND: Adolescents and young adults living with HIV (AYAH) aged 14-24 years in Africa experience substantially higher rates of virological failure and HIV-related mortality than adults. We propose to utilize developmentally appropriate interventions with high potential for effectiveness, tailored by AYAH pre-implementation, in a sequential multiple assignment randomized trial (SMART) aimed at improving viral suppression for AYAH in Kenya. METHODS: Using a SMART design, we will randomize 880 AYAH in Kisumu, Kenya to either youth-centered education and counseling (standard of care) or electronic peer navigation in which a peer provides support, information, and counseling via phone and automated monthly text messages. Those with a lapse in engagement (defined as either a missed clinic visit by ≥14 days or HIV viral load ≥1000 copies/ml) will be randomized a second time to one of three higher-intensity re-engagement interventions: This study will evaluate which interventions and which dynamic sequence of interventions improve sustained viral suppression and HIV care engagement in AYAH at 24 months post-enrollment and assess the cost-effectiveness of successful strategies. DISCUSSION: The study utilizes promising interventions tailored to AYAH while optimizing resources by intensifying services only for those AYAH who need more support. Findings from this innovative study will offer evidence for public health programming to end the HIV epidemic as a public health threat for AYAH in Africa. TRIAL REGISTRATION: Clinicaltrials.govNCT04432571, registered June 16, 2020.

We found that urine tenofovir (TFV) levels >1500 ng/mL strongly predict virologic suppression among people with human immunodeficiency virus taking tenofovir alafenamide (odds ratio, 5.66; 95% confidence interval, 1.59-20.14; P = .007). This suggests an existing point-of-care assay developed for tenofovir disoproxil fumarate will support adherence monitoring for patients on all TFV-based antiretrovirals.

Research suggests that womens 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.

BackgroundLong-acting injectable antiretroviral therapy (LAI-ART) is approved for treatment-naive or experienced people with human immunodeficiency virus (HIV; PWH) based on trials that only included participants with viral suppression. We performed the first LAI-ART demonstration project to include PWH unable to achieve or maintain viral suppression due to challenges adhering to oral ART.MethodsWard 86 is a large HIV clinic in San Francisco that serves publicly insured and underinsured patients. We started patients on LAI-ART via a structured process of provider referral, multidisciplinary review (MD, RN, pharmacist), and monitoring for on-time injections. Inclusion criteria were willingness to receive monthly injections and a reliable contact method.ResultsBetween June 2021 and April 2022, 51 patients initiated LAI-ART, with 39 receiving at least 2 follow-up injections by database closure (median age, 46 years; 90% cisgender men, 61% non-White, 41% marginally housed, 54% currently using stimulants). Of 24 patients who initiated injections with viral suppression (median CD4 cell count, 706 cells/mm3), 100% (95% confidence interval [CI], 86%-100%) maintained viral suppression. Of 15 patients who initiated injections with detectable viremia (median CD4 cell count, 99 cells/mm3; mean log10 viral load, 4.67; standard deviation, 1.16), 12 (80%; 95% CI, 55%-93%) achieved viral suppression, and the other 3 had a 2-log viral load decline by a median of 22 days.ConclusionsThis small demonstration project of LAI-ART in a diverse group of patients with high levels of substance use and marginal housing demonstrated promising early treatment outcomes, including in those with detectable viremia due to adherence challenges. More data on LAI-ART in hard-to-reach populations are needed.

Background Children with human immunodeficiency virus (HIV, CWH) are at high risk of tuberculosis (TB) and face poor outcomes, despite antiretroviral therapy (ART). We evaluated outcomes in CWH and children not living with HIV treated for nonsevere TB in the SHINE trial. Methods SHINE was a randomized trial that enrolled children aged <16 years with smear-negative, nonsevere TB who were randomized to receive 4 versus 6 months of TB treatment and followed for 72 weeks. We assessed TB relapse/recurrence, mortality, hospitalizations, grade ≥3 adverse events by HIV status, and HIV virological suppression in CWH. Results Of 1204 children enrolled, 127 (11%) were CWH, of similar age (median, 3.6 years; interquartile range, 1.2, 10.3 versus 3.5 years; 1.5, 6.9; P =.07) but more underweight (weight-for-age z score, −2.3; (3.3, −0.8 versus −1.0; −1.8, −0.2; P <.01) and anemic (hemoglobin, 9.5 g/dL; 8.7, 10.9 versus 11.5 g/dL; 10.4, 12.3; P <.01) compared with children without HIV. A total of 68 (54%) CWH were ART-naive; baseline median CD4 count was 719 cells/mm3 (241–1134), and CD4% was 16% (10–26). CWH were more likely to be hospitalized (adjusted odds ratio, 2.4; 1.3–4.6) and to die (adjusted hazard ratio [aHR], 2.6; 95% confidence interval [CI], 1.2 to 5.8). HIV status, age <3 years (aHR, 6.3; 1.5, 27.3), malnutrition (aHR, 6.2; 2.4, 15.9), and hemoglobin <7 g/dL (aHR, 3.8; 1.3,11.5) independently predicted mortality. Among children with available viral load (VL), 45% and 61% CWH had VL <1000 copies/mL at weeks 24 and 48, respectively. There was no difference in the effect of randomized treatment duration (4 versus 6 months) on TB treatment outcomes by HIV status (P for interaction = 0.42). Conclusions We found no evidence of a difference in TB outcomes between 4 and 6 months of treatment for CWH treated for nonsevere TB. Irrespective of TB treatment duration, CWH had higher rates of mortality and hospitalization than their counterparts without HIV. Clinical Trials Registration.  ISRCTN63579542. [ABSTRACT FROM AUTHOR]

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]