Zidovudine, a brief history before the first antirretroviral in Mexico.

In the 1980s in Mexico, that of the «moral renewal¼, there was the opening to the market and the manifestation of human immunodeficiency virus (HIV) and AIDS. In this writing, the historical and therapeutic conditions are related to alleviate the syndrome until the arrival of the first antiretroviral. It is a reconstruction of the events, of which the medical-social, main clinical manifestations and of course the pharmacological therapy, until de the development zidovudina or azidotimidina of AZT, the first antiretroviral to be approved. Nevertheless, in the Mexican context, this event wasn't decisive to significantly change the morbility and the mortality.

En el México de la década de 1980, el de la «renovación moral¼, se vivió la apertura al mercado y la manifestación del virus de la inmunodeficiencia humana (VIH) y el sida. En este escrito se relatan las condiciones históricas y terapéuticas del síndrome en los pacientes mexicanos, hasta la llegada del primer antirretroviral. Se trata de una reconstrucción de los hechos, de los cuales se ha profundizado en aspectos médico-sociales, principales manifestaciones clínicas y terapéutica farmacológica, hasta que interviene en la patogenia del VIH/sida el desarrollo de la zidovudina o azidotimidina (AZT), primer antirretroviral en ser aprobado. No obstante, en el contexto mexicano este suceso no fue determinante para cambiar de manera significativa la morbimortalidad de los infectados.

Potential for high dynamic range Sedia Limiting Antigen antibody assay to support viral load monitoring during antiretroviral therapy.

INTRODUCTION: Viral Load (VL) monitoring is a crucial component of patient care during antiretroviral therapy (ART) but is not routinely available in many resource-constrained settings, where millions of patients will require care for decades to come. We hypothesise a serologic 'recent infection' test (Sedia LAg assay) which has a high dynamic range for detecting antigen-driven antibody response can provide informative proxies for VL trajectories. METHODS: A retrospective study where we analysed data linked via specimens in a well-described repository for recent infection test benchmarking (CEPHIA collaboration). Patient panels were comprised of 1) observations straddling ART start; 2) observations from a period of stable viral suppression; 3) observations straddling rebound after a period of viral suppression. We analysed an individual's Sedia LAg ELISA normalised optical density (ODn) trends within these categories. Using groups 2) and 3) we evaluated the specificity and sensitivity of a proposed proxy for "the latest observation is at a time of VL rebound"; proxy was defined as follows: we estimated patient-specific mean-previous-ODn for all observations with at least two preceding virally suppressed observations. We considered various thresholds to define both "VL suppression" and "ODn uptick". RESULTS: In regression analysis by category: 1) ODn gradients are statistically significantly negative just after ART-start (p = 0.010); 2) During periods of stable viral suppression, ODn tended to decline, but not statistically significantly, for a range of clinically meaningful "VL suppression" thresholds; 3) comparing ODn values just before, versus at, "VL rebound", ODn changes were statistically significantly increasing at rebound (p = 0.001). In the analysis comparing groups 2) and 3), at a Z score threshold of 0.8, the proposed proxy for a first viral rebound had an observed specificity and sensitivity both close to 90%. CONCLUSION: The high dynamic range of serological tests previously investigated for defining 'recent infection' has potential, as demonstrated using the Sedia LAg ELISA, to provide meaningful information about the success of ART, during treatment initiation, at times of stable suppression, and to flag possible viral rebound. It should be investigated how this can be combined with patient management workflows and (clinical and) other data, to provide efficiencies in long-term monitoring viral control in resource-limited settings.

Level of antiretroviral therapy adherence and associated factors during COVID-19 pandemic era in public hospitals of Jigjiga City eastern Ethiopia: a cross-sectional study.

Background: Coronavirus-19 disease is more severe in patients on antiretroviral therapy (ART). Low-income countries, such as those in Sub-Saharan Africa, are particularly vulnerable to the virus' spread. However, there is little information on antiretroviral therapy (ART) use in Ethiopia during the pandemic, particularly in the study area. Therefore, this study aimed to assess the level of antiretroviral treatment adherence and associated factors during the COVID-19 pandemic era in public hospitals in Jigjiga City, Somalia, and Eastern Ethiopia. Methods: An institution-based cross-sectional study was conducted among 382 randomly selected HIV patients on antiretroviral therapy (ART) follow-up in public hospitals in Jigjiga City from March 1-30, 2022. The data was collected through face-to-face interviews and a review of the patient's record. To explore the relationship between variables, both bivariate and multivariable logistic regression analyses were performed. The adjusted odds ratio (AOR) was utilized, along with a 95% confidence interval, to assess the strength and direction of the association. Statistical significance was considered at p < 0.05. Results: The antiretroviral therapy (ART) adherence rate of HIV patients was 76.9% (95% CI, 71.9-82). Disclosing HIV status to sexual partners [AOR = 2.3, (95% CI (1.22-4.19)], having communication with health care providers' [AOR = 3.2, (95% CI (1.57-6.53)], having no history of current substance use [AOR = 2.6, (95% CI (1.45-4.63)], and patients who did not fear COVID-19 infection [AOR = 5.8 (95% CI (11-10.98)] were significantly associated with antiretroviral therapy (ART) adherence. Conclusion: In this study, the level of antiretroviral therapy (ART) adherence was poor in comparison to the expected level. Patients' adherence status was favorably related to disclosing their status to families and having contact with their healthcare providers, whereas worrying about COVID-19 pandemic infection and current substance use was adversely associated.

Cohort profile: longitudinal and population comparison of children who are HIV-exposed uninfected and children who are HIV unexposed in Kenya (HOPE study).

PURPOSE: Globally, the number of children/adolescents exposed to HIV but uninfected (HIV-exposed uninfected, HEU) is growing. The HEU outcomes: population-evaluation and screening strategies study was designed to provide population-level evidence of the impact of HIV and recent antiretroviral therapy regimen exposure on neurodevelopmental, hearing and mental health outcomes from infancy to adolescence. PARTICIPANTS: The study includes a prospective mother-infant cohort and cross-sectional child/youth-caregiver cohorts conducted in Kenya.Between 2021 and 2022, the study enrolled 2000 mother-infant pairs (1000 HEU and 1000 HIV-unexposed uninfected (HUU)) for longitudinal follow-up. Infants were eligible if they were aged 4-10 weeks and healthy. Mothers were eligible if their HIV status was known and were ≥18 years. Study visits are 6 monthly until the child reaches age 3 years.Cross-sectional cohorts spanning ages 3-18 years started enrolment in 2022. Target enrolment is 4400 children/youth (4000 HEU and 400 HUU). Children and youth are eligible if they are HIV negative, maternal HIV status and timing of diagnosis is known, and caregivers are ≥18 years.Data on infant/child/youth growth, neurodevelopment, mental health, morbidity and hearing are collected at enrolment using standardised tools. Dry blood spots samples are collected for telomere length assessment at baseline and yearly for the longitudinal cohort. Growth z-scores, neurodevelopmental scores, telomere length and prevalence of developmental and hearing problems will be compared between HEU/HUU populations. FINDINGS TO DATE: Full cohort enrolment for the longitudinal cohort is complete and participants are in follow-up. At 1 year of age, comparing HEU to HUU neurodevelopment using the Malawi developmental assessment tool, we found that HEU infants had higher language scores and comparable scores in fine motor, gross motor and social scores. The cross-sectional cohort has enrolled over 2000 participants and recruitment is ongoing. FUTURE PLANS: Longitudinal cohort follow-up and enrolment to the cross-sectional study will be completed in June 2024.

Supporting young women's health through girl-friendly drug vendors in Lake Zone, Tanzania: protocol for the AmbassADDOrs for Health cluster-randomised controlled trial.

INTRODUCTION: Adverse sexual and reproductive health (SRH) outcomes, such as unplanned pregnancies and HIV infection, disproportionately affect adolescent girls and young women (AGYW; aged 15-24 years) in east Africa. Increasing uptake of preventive SRH services via innovative, youth-centred interventions is imperative to addressing disparities in SRH outcomes. METHODS AND ANALYSIS: From 2018 to 2019, we used human-centred design to co-develop a theoretically driven HIV and pregnancy prevention intervention for AGYW at private drug shops called Accredited Drug Dispensing Outlets (ADDOs) in Tanzania. The result, Malkia Klabu (Queen Club), was a customer loyalty programme designed to strengthen ADDOs' role as SRH providers while encouraging uptake of critical SRH prevention products among AGYW. Malkia Klabu members had access to free contraceptives and oral HIV self-test (HIVST) kits and earned punches on a loyalty card for other shop purchases; punches were redeemable for small prizes. Our pilot among 40 shops showed that intervention ADDOs had higher AGYW patronage and distributed more HIVST kits and contraceptives to AGYW relative to business-as-usual (ie, client purchasing) comparison shops. We will conduct a cluster-randomised controlled trial (c-RCT) among 120-140 ADDOs in 40 health catchment areas in Shinyanga and Mwanza Regions (Lake Zone), Tanzania. ADDO shop recruitment includes a 1-month run-in with a tablet-based electronic inventory management system for tracking shop transactions, followed by enrolment, randomisation and a 24-month trial period. Our c-RCT evaluating the human-centred design-derived intervention will assess population impact on the primary outcomes of HIV diagnoses and antenatal care registrations, measured with routine health facility data. We will also assess secondary outcomes focusing on mechanisms of action, evaluate programme exposure and AGYW behaviour change in interviews with AGYW, and assess shop-level implementation strategies and fidelity. ETHICS AND DISSEMINATION: Ethical approval was granted from both the University of California, San Francisco and the Tanzanian National Institute for Medical Research. Study progress and final outcomes will be posted annually to the National Clinical Trials website; study dissemination will occur at conferences, peer-reviewed manuscripts and local convenings of stakeholders. TRIAL REGISTRATION NUMBER: NCT05357144.

Consensus recommendations for the use of novel antiretrovirals in persons with HIV who are heavily treatment-experienced and/or have multidrug-resistant HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy: An executive summary.

Treatment options are currently limited for persons with HIV-1 (PWH) who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. Three agents have been approved by the U.S. Food and Drug Administration (FDA) since 2018, representing a significant advancement for this population: ibalizumab, fostemsavir, and lenacapavir. However, there is a paucity of recommendations endorsed by national and international guidelines describing the optimal use (e.g., selection and monitoring after initiation) of these novel antiretrovirals in this population. To address this gap, a modified Delphi technique was used to develop these consensus recommendations that establish a framework for initiating and managing ibalizumab, fostemsavir, or lenacapavir in PWH who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. In addition, future areas of research are also identified and discussed in the main document.

Consensus recommendations for the use of novel antiretrovirals in persons with HIV who are heavily treatment-experienced and/or have multidrug-resistant HIV-1: Endorsed by the American Academy of HIV Medicine, American College of Clinical Pharmacy.

Treatment options are currently limited for persons with HIV-1 (PWH) who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. Three agents have been approved by the U.S. Food and Drug Administration (FDA) since 2018, representing a significant advancement for this population: ibalizumab, fostemsavir, and lenacapavir. However, there is a paucity of recommendations endorsed by national and international guidelines describing the optimal use (e.g., selection and monitoring after initiation) of these novel antiretrovirals in this population. To address this gap, a modified Delphi technique was used to develop these consensus recommendations that establish a framework for initiating and managing ibalizumab, fostemsavir, or lenacapavir in PWH who are heavily treatment-experienced and/or have multidrug-resistant HIV-1. In addition, future areas of research are also identified and discussed.

Clinical Outcomes of Coronavirus Disease 2019 in People Living With Human Immunodeficiency Virus in South Korea: A Nationwide Population-Based Cohort Study.

BACKGROUND: We aimed to compare the epidemiological and clinical characteristics of coronavirus disease 2019 (COVID-19) in people living with human immunodeficiency virus (HIV) (PLWH) with those in people living without HIV (PLWoH). METHODS: This nationwide descriptive epidemiological study was conducted in South Korea between January 2020 and February 2022. The National Health Insurance claim data, comprising the data of the entire Korean population, were collected through the Health Insurance Review and Assessment Service. RESULTS: Among 3,653,808 individuals who were diagnosed with COVID-19, 1311 (0.04%) were PLWH. All PLWH received antiretroviral therapy, and 26.47% had more than one underlying disease other than HIV infection. The overall in-hospital mortality rates of PLWH and PLWoH were 0.76% and 0.25%, respectively (P = 0.002). According to the Cox proportional hazard model, no significant difference was observed in the in-hospital mortality rate (hazard ratio [HR]: 1.80, 95% confidence interval [CI]: 0.70-4.67) between the PLWH and PLWoH. However, progression to severe or critical COVID-19 was more common in PLWH (HR: 2.70, 95% CI: 1.37-5.33). In PLWH diagnosed with COVID-19, a multivariable Cox regression analysis found old age (≥ 60 years) (HR: 6.9, 95% CI: 2.57-18.56) and diabetes mellitus (HR: 5.13, 95% CI: 2.02-13.00) as the independent risk factors for severe or critical COVID-19. CONCLUSIONS: PLWH had a significantly higher risk of developing severe or critical COVID-19 compared with PLWoH. Our findings suggest the need for implementing tailored strategies to decrease the impact of COVID-19 on PLWH.

Long-term safety and impact of immune recovery in heavily treatment-experienced adults receiving fostemsavir for up to 5 years in the phase 3 BRIGHTE study.

Introduction: Fostemsavir is a gp120-directed attachment inhibitor approved for heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1. We provide detailed week 240 safety results from the BRIGHTE study and evaluate the impact of immune recovery on safety outcomes. Methods: The phase 3 BRIGHTE trial is ongoing; data for this analysis were collected from the first participant's first visit (February 23, 2015) through the last participant's last visit for week 240 (March 22, 2021). Safety endpoints were assessed in participants who received fostemsavir + optimized background therapy. In participants with baseline CD4+ T-cell count <200 cells/mm3, exposure-adjusted adverse event (AE) rates were assessed among subgroups with or without CD4+ T-cell count ≥200 cells/mm3 at any time during 48-week analysis periods through week 192. Results: Through a median of 258 weeks (range, 0.14-319) of treatment, discontinuations due to AEs occurred in 30/371 (8%) participants. Serious AEs were reported in 177/371 (48%) participants, including 16 drug-related events in 13 (4%) participants. Thirty-five (9%) deaths occurred, primarily related to AIDS or acute infections. COVID-19-related events occurred in 25 (7%) participants; all resolved without sequelae. Among participants with baseline CD4+ T-cell count <200 cells/mm3, 122/162 (75%) achieved CD4+ T-cell count ≥200 cells/mm3 at week 192. Exposure-adjusted AE rates were markedly lower among participants achieving CD4+ T-cell count ≥200 cells/mm3 at any time vs those sustaining <200 cells/mm3. No new AIDS-defining events were reported after week 48 in participants with CD4+ T-cell count ≥200 cells/mm3. Conclusions: Cumulative safety findings through the BRIGHTE 240-week interim analysis are consistent with other trials in HTE participants with advanced HIV-1 and comorbid disease. Reduced rates of AIDS-defining events and AEs were observed in participants with immunologic recovery on fostemsavir-based treatment. Clinical trial number: NCT02362503, https://clinicaltrials.gov/study/NCT02362503.

Factors influencing patients on antiretroviral therapy loss to follow up: A qualitative analysis of healthcare workers perspective.

Despite expanded and successful antiretroviral therapy program coverage, a large proportion of people drop out at different stages along their treatment course. As a result, treatment gains do not reach a large proportion of these groups. It has been demonstrated that around half of the patients who test Human immunodeficiency virus (HIV) positive in Sub-Saharan Africa are lost between testing and being considered for eligibility for therapy. The purpose of this study was to determine the factors that influence patients on antiretroviral therapy who lost to follow up in HIV treatment clinics in Asunafo South District, Ahafo Region. We used phenomenological qualitative research approach in conducting this study. Purposive sampling was used to select respondents, while key informant interview was used to collect the data. The major identified challenges in carrying out follow-up visits of patients on antiretroviral therapy were wrong addresses and phone numbers of clients, coupled with poor telecommunication networks, geographical relocation of clients, poor documentation of patients' information, and non-availability of means of transport. The preferred reengagement strategies identified in this study were: supply of drugs through home visits, intensive education, engaging the services of community-based surveillance officers, enhanced regular phone calls visits, adoption and use of an integrated antiretroviral therapy clinic, intensified education on HIV, and involvement of religious leaders. In conclusion, all clinicians and stakeholders should consider the identified challenges and reengagement strategies when providing antiretroviral services.

Long-acting prescriptions and therapy for HIV-1 from market launch to the present in Germany (May 2021 to December 2023).

Background: In Europe, the combination of cabotegravir (CAB) with rilpivirine (RPV) has been approved as a dual injection long-acting (LA) therapy for the treatment of human immunodeficiency virus type 1 (HIV-1) infections in adults since December 2020. Studies have shown that between 36 and 61% of people living with HIV (PLWHIV) prefer LA therapy. However, there are no real-world data on the number of people receiving LA therapy, in Germany or internationally. The aim of this study was to assess the current situation and trends in usage of LA therapy for the treatment of HIV-1 in Germany. Methods: Based on pharmacy prescription data derived from Insight Health, the monthly number of prescriptions for oral CAB, CAB-LA, and RPV-LA over the entire period of availability in Germany was analyzed and evaluated (May 2021 to December 2023). The number of 1st and 2nd initiation injections and subsequent maintenance injections was calculated on the basis of the prescriptions for oral CAB initiation. Results: The bimonthly schedule resulted in two growing cohorts from September 2021 with an estimated 14,523 CAB-LA prescriptions over the entire period. Accordingly, in December 2023, there were approximately 1,364 PLWHIV receiving LA therapy, of whom 1,318 were receiving maintenance therapy. Only treatments with bimonthly regimens were carried out. Accounting for people not covered by statutory health insurance (~13%), a total of ~1,600 PLWHIV were receiving LA therapy in Germany in December 2023. The average rounded annual cost of therapy in 2023 was €11,940 (maintenance therapy with initiation) and €10,950 (maintenance therapy without initiation). Conclusion: To our knowledge, this is the first study of real-world use and number of people receiving LA therapy. A strength of our study is the nearly complete coverage of people with statutory health insurance in Germany. The predicted demand for LA therapy does not match the actual number of people receiving LA therapy. Although the number of PLWHIV receiving LA therapy increased steadily, they accounted for just under 2% of the estimated total number of people receiving HIV therapy in Germany in 2023, almost 2 years after the market launch. No significant increase in prescriptions is expected; on the contrary, the trend is leveling off and is unlikely to change drastically in the near future. Hence, the need for this mode of therapy in Germany appears to be limited. Follow-up studies at regular intervals on the further course would be useful and are recommended, as well as investigations into the possible reasons for the slow uptake to inform public health experts and possibly broaden treatment options.

Periodontal inflammation as a potential driver of HIV low level viremia.

HIV can be successfully suppressed to undetectable levels by antiretroviral therapy (ART) in most people with HIV (PWH). However, a small proportion continues to have persistent low-level viremia (LLV) during ART. A presumed source of LLV is production or replication from viral reservoirs, which are maintained in the presence of ART. It is unknown whether the oral cavity can be considered an HIV reservoir. As periodontal inflammation is a common problem in PWH, we hypothesize that periodontal inflammation in the oral cavity activates (latently) infected cells and thus might be associated with LLV. We included 11 individuals with HIV LLV, and compared HIV-RNA levels in saliva and plasma at baseline and at week 24 after switch of ART. We compared the LLV-group at baseline with 11 age-matched controls with suppressed viremia. To investigate the severity of periodontitis we used Periodontal Inflamed Surface Areas (PISA) by measuring probing depth, gingival recession, bleeding on probing and clinical attachment level. Severity of periodontitis was classified according to the CDC-AAP case definition. Additional insights in periodontal inflammation were obtained by comparing immune activation markers and the presence of periodontal pathogens. In four individuals of the LLV group, residual levels of HIV-RNA were detected in saliva at baseline (N = 1) or at week 24 (N = 2) or both (N = 1). Of the four individuals with LLV, three had residual levels of HIV-RNA in saliva. All 22 individuals had moderate to severe periodontitis. PISA was not significantly different between cases with LLV and controls. Similarly, periodontal pathogens were frequently observed in both groups. Total activated HLA-DR+CD38+ CD4+ cells and CD8+ cells were significantly higher in the LLV group than in the control group (p = <0.01). No immune markers were associated with LLV. In conclusion, periodontal inflammation is an unlikely driver of HIV LLV compared to HIV suppressed individuals.

Urinary α 1-microglobulin and ß 2-microglobulin as markers of early kidney injury in HIV-positive male patients on tenofovir-based antiretroviral therapy.

BACKGROUND: A retrospective study was conducted to explore the urinary expression of α 1-microglobulin (α1MG) and ß2-microglobulin (ß2MG) in patients with human immunodeficiency virus (HIV) infection, aiming to evaluate their predictive capability for renal injury. METHOD: One hundred and five male HIV-infected patients treated with Tenofovir (TDF) regimen (TDF+3TC or the third drug TDF/FTC+) were selected between March 1, 2021, and March 1, 2022, in Wuhan Jinyintan Hospital. Three months after TDF treatment, the renal function injury was evaluated with the standard creatinine clearance rate. The urinary levels of α1MG and ß2MG were compared between the initiation of TDF treatment and three months thereafter. Spearman correlation was utilized to analyze the correlation between the urinary expression of α1MG and ß2MG and renal injury in HIV patients. The logistic regression was used to analyze the predictive value of urinary α1MG and ß 2-microglobulin expression in renal injury. RESULTS: Up to the first follow-up, 29 (27.6%) cases of the 105 male HIV patients had varying degrees of renal function injury, including 14 (13.3%) mild injury, 9 (8.6%) moderate injury, and 6 (5.7%) severe injury cases. Patients with severe renal injury had the highest levels of urinary α1MG and ß2MG expression while those with mild injury demonstrated higher levels compared to the non-injury group (P < 0.05). Spearman correlation analysis indicated that urinary α1MG and ß2MG were positively correlated with renal impairment in HIV patients (Rho = -0.568, and -0.732; P < 0.001). The ROC curve analysis demonstrated that the area under the curve (AUC) for urine α1MG and ß2MG in predicting kidney damage among HIV patients were 0.928, 0.916, and 0.889, respectively. The sensitivity values were 96.55%, 82.76%, and 89.66% while the specificity values were 84.07%, 94.51%, and 89.29% for urine α1MG and ß2MG, respectively. CONCLUSION: The expression level of urinary α1MG and ß2MG in HIV patients was significantly higher compared to normal people. Detection of these two indexes can enable early determination of renal injury and its severity in HIV patients.

Tuberculosis immune reconstitution syndrome (TB-IRIS) followed by recurring lymphadenitis up to 8 years post-antituberculous treatment.

We present the case of a patient with HIV and tuberculosis (TB) coinfection who initially developed paradoxical TB immune reconstitution inflammatory syndrome (TB-IRIS) post-antituberculous treatment and post-antiretroviral therapy initiation. Despite being managed effectively, lymphadenitis recurred as many as three times over the course of several years. Due to consistent culture-negative lymph node biopsies, the recurring lymphadenitis was eventually deemed inflammatory rather than microbiological recurrences. Cessation of anti-TB treatment led to symptom remission followed by a long asymptomatic period, corroborating the immunological nature of the episodes. However, 5 and 6 years after cessation of anti-TB treatment, respectively, lymphadenitis returned. In both instances, her symptoms regressed without treatment with anti-TB drugs. This case underscores the complexities of managing TB-IRIS and the necessity of differentiating between paradoxical TB-IRIS and other paradoxical reactions for appropriate treatment decisions. Recognition of such distinctions is crucial in guiding effective therapeutic interventions in TB-HIV coinfection scenarios.

Patient-reported outcomes and experiences of migrants enrolled in a multidisciplinary HIV clinic with rapid, free, and onsite treatment dispensation: the 'ASAP' study.

BACKGROUND: Scholars recommend providing migrants living with HIV (MLWH) with free treatment, rapidly, once linked to care to optimize their HIV-related experiences and health outcomes. Quantitative evaluations of patient-reported measures for MLWH in such models are necessary to explore the viability of these recommendations. METHODS: Within a 96-week prospective cohort study at a multidisciplinary HIV clinic, participants received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for free and rapidly following care linkage. Eight patient-reported measures were administered at weeks 4, 24, and 48: (1) mMOS-SS to measure perceived social support; (2) IA-RSS to measure internalized stigma; (3) K6 to measure psychological distress; (4) PROMIS to measure self-efficacy with treatment taking; (5) G-MISS to measure perceived compliance with clinicians' treatment plans; (6) HIVTSQ to measure treatment satisfaction; (7) CARE to measure perceived provider empathy; and (8) PRPCC to measure perceived clinician cultural competence. Linear mixed modelling with bootstrapping was conducted to identify significant differences by sociodemographics and time. RESULTS: Across weeks 4, 24, and 48, results suggest that MLWH enrolled in this study experienced moderate levels of social support; elevated levels of HIV-related stigma; moderate levels of distress; high self-efficacy with daily medication self-management; great compliance with clinicians' treatment plans; high treatment satisfaction; high perceived empathy; and high perceived cultural competence. Experience of social support (i.e., mMOS-SS scores) differed significantly by birth region. Experience of HIV-related stigma (i.e., IA-RSS scores) differed significantly by birth region, age, and language. Experience of distress (i.e., K6 scores) differed significantly by sexual orientation. Experience of treatment satisfaction (i.e., HIVTSQ scores) differed significantly by birth region and age. No significant differences were identified by time for any measure. CONCLUSION: Overall, participants expressed positive experiences around treatment and care, alongside comparably lower perceptions of social support, internalized stigma, and distress, potentially underscoring a need to embed targeted, well-funded, and accessible mental health support within HIV care models.

Systematic review and meta-analysis on the effect of depression on ART adherence among women living with HIV.

BACKGROUND: Depression is a very common psychiatric disorder in worldwide. Globally, Human Immunodeficiency Virus (HIV) is highly prevalent among women, and are disproportionately affected by depression. Antiretroviral Therapy (ART) adherence which could highly be affected by depression is yet to be explored effectively. Depression affects overall poor HIV clinical outcomes, socioeconomic and social interactions. However, it is not well understood specifically how depression affects ART adherence in women living with HIV (WLWHIV). Investigating the effects of depression on ART adherence is critical in order to develop nuanced new evidence to address non-adherence in WLWHIV. OBJECTIVE: To conduct a meta-analysis on the correlation between depression and adherence to antiretroviral therapy among women living with HIV in the globe. METHOD: Using population, exposed and outcome approach, we searched Scopus, PubMed, EMBASE, Cochrane Library, Psych info, Web of science and google scholar for cohort and cross-sectional studies globally. The search strategy was structured comprising terms associated with antiretroviral therapy and adherence, women living with HIV and depression. We evaluated the paper quality, using the Newcastle-Ottawa Scales (NOS). The fixed effect model was used to analysis the effect of depression on ART adherence. RESULT: A total of 8 articles comprise 6474 participants were included in this study. There were controversial findings related to the effect of depression to ART adherence. Among three cross-sectional study, one article demonstrating, depression was associated with ART adherence. Of the five cohort studies, four cohort studies reported association. The overall pooled estimated effect of depression on ART adherence was 1.02 [RR = 1.015 with 95% CI (1.004, 1.026)] with a p-value of 0.005. CONCLUSION AND RECOMMENDATION: Depression was the risk factor for ART adherence among women living with HIV. It is therefore, necessary for clinician to note this and perform screening for ART adherence. TRIAL REGISTRATION: The review protocol was developed with prospero registration: CRD42023415935.

Modeling the HIV Cascade of Care Using Routinely Collected Clinical Data to Guide Programmatic Interventions and Policy Decisions.

BACKGROUND: The HIV care cascade is a framework to examine effectiveness of HIV programs and progress toward global targets to end the epidemic but has been conceptualized as a unidirectional process that ignores cyclical care patterns. We present a dynamic cascade that accounts for patient "churn" and apply novel analytic techniques to readily available clinical data to robustly estimate program outcomes and efficiently assess progress toward global targets. METHODS: Data were assessed for 35,649 people living with HIV and receiving care at 78 clinics in East Africa between 2014 and 2020. Patients were aged ≥15 years and had ≥1 viral load measurements. We used multi-state models to estimate the probability of being in 1 of 5 states of a dynamic HIV cascade: (1) in HIV care but not on antiretroviral therapy (ART), (2) on ART, (3) virally suppressed, (4) in a gap-in-care, and (5) deceased and compared these among subgroups. To assess progress toward global targets, we summed those probabilities across patients and generated population-level proportions of patients on ART and virally suppressed in mid-2020. RESULTS: One year after enrollment, 2.8% of patients had not initiated ART, 86.7% were receiving ART, 57.4% were virally suppressed, 10.2% were disengaged from care, and 0.3% had died. At 5 years, the proportion on ART remained steady but viral suppression increased to 77.2%. Of those aged 15-25, >20% had disengaged from care and <60% were virally suppressed. In mid-2020, 90.1% of the cohort was on ART, 90.7% of whom had suppressed virus. CONCLUSIONS: Novel analytic approaches can characterize patient movement through a dynamic HIV cascade and, importantly, by capitalizing on readily available data from clinical cohorts, offer an efficient approach to estimate population-level proportions of patients on ART and virally suppressed. Significant progress toward global targets was observed in our cohort but challenges remain among younger patients.

Effects of Multimonth Dispensing on Viral Suppression and Continuity in Treatment Among Children Living With HIV Aged 2-9 Years: A Cohort Study in Western Kenya.

BACKGROUND: In Kenya, of the 82,000 children living with HIV, only 59% are receiving ART and 67% are virally suppressed. Early in the COVID-19 pandemic, the Ministry of Health recommended 3 multimonth dispensing (3MMD) of ART to all people living with HIV, including children. This study assesses the association between 3 MMD and clinical outcomes among children in Western Kenya. SETTINGS: and Methods: We conducted a retrospective cohort study using routinely collected deidentified patient-level data from 43 facilities in Kisii and Migori Counties. The study included children aged 2-9 years who had been previously initiated on ART and sought HIV services between March 01, 2020, and March 30, 2021. We used generalized linear models with Poisson regression models to assess the association between MMD on retention at 6 months and viral suppression (<1000 copies/mL). RESULTS: Among the 963 children, 65.2% were aged 5-9 years and 50.7% were female patients. Seventy-eight percent received 3MMD at least once during the study period. Children who received 3MMD were 12% (adjusted risk ratio [aRR] 1.12, 95% CI: 1.01 to 1.24) more likely to be retained and 22% (aRR 1.22, 1.12 to 1.34) more likely to be virally suppressed than those on <3MMD. When stratified by viral suppression at entry, the association between 3MMD and retention (aRR 1.22, 95% CI: 1.02 to 1.46) and viral suppression (aRR 1.76, 95% CI: 1.30-2.37) was significant among individuals who were unsuppressed at baseline. CONCLUSIONS: 3MMD was associated with comparable or improved HIV health outcomes among children.