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We describe the results of a pilot randomized clinical trial of a mobile phone-based intervention, InTSHA: Interactive Transition Support for Adolescents with HIV, compared to standard care. Encrypted, closed group chats delivered via WhatsApp provided peer support and improved communication between adolescents with HIV, their caregivers, and healthcare providers. We randomized 80 South African adolescents ages 15 to 19 years with perinatally-acquired HIV to receive either the intervention (n=40) or standard of care (n=40). We measured acceptability (Acceptability of Intervention Measure [AIM]) and feasibility (Feasibility of Intervention Measure [FIM]) as primary outcomes. We evaluated impact on retention in care and viral suppression six months after randomization as secondary endpoints. We performed bivariable and multivariable analyses using logistic regression models to assess the effect of the InTSHA intervention compared to standard of care. Among the adolescents randomized to the InTSHA intervention, the median AIM was 4.1/5.0 (82%) and median FIM was 3.9/5.0 (78%). We found no difference in retention in care or in viral suppression comparing intervention and control groups. Among adolescents who attended three or more sessions, retention in care was 100% at 6 months. InTSHA is an acceptable and feasible mHealth intervention warranting further study in a larger population.
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Estudos de Viabilidade , Infecções por HIV , Aceitação pelo Paciente de Cuidados de Saúde , Retenção nos Cuidados , Telemedicina , Humanos , Adolescente , Infecções por HIV/psicologia , Masculino , África do Sul , Feminino , Projetos Piloto , Adulto Jovem , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Carga Viral , Telefone CelularRESUMO
We created a transition readiness score for adolescents with perinatally-acquired HIV as they transition from pediatric to adult care. Of the 199 adolescents who transitioned to adult care, 84 (42%) had viral suppression (< 200 copies/ml) one year after transition. Adolescents on first-line ART, with documented HIV status disclosure, and higher rating on the HIV Adolescent Readiness to Transition Scale had significantly higher odds of viral suppression after transition. Conversely, females, those with older age at ART initiation, and those with prior alcohol use had significantly lower odds of viral suppression after transition. Using these data, we created a transition readiness score organized into low, intermediate, and high levels of transition readiness. This transition readiness score can be used to identify adolescents who are likely ready to transition to adult care and identify additional areas for intervention to improve the likelihood of successful transition for those with lower transition readiness scores.
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Infecções por HIV , Transição para Assistência do Adulto , Adolescente , Adulto , Criança , Revelação , Feminino , Infecções por HIV/epidemiologia , Infecções por HIV/terapia , HumanosRESUMO
BACKGROUND: South Africa has one of the highest burdens of adolescents with perinatally-acquired HIV (APHIV) in the world. APHIV in South Africa have limited access to sexual and reproductive health (SRH) education and services specific to their HIV status. When lacking comprehensive SRH education, APHIV are prone to sexual risk behaviors that can lead to unintended pregnancy, sexually transmitted infections, and HIV transmission. The use of mHealth interventions has been shown to deliver information, foster social support, and improve decision-making skills. In this study, we evaluate how an mHealth intervention influences sexual health knowledge and behaviors in APHIV. METHODS: We purposively enrolled adolescents from the intervention arm of a randomized clinical trial assessing a multi-module, moderated WhatsApp-based intervention-Interactive Transition Support for Adolescents Living with HIV (InTSHA)-within a government supported clinic in KwaMashu, an urban township of KwaZulu-Natal, South Africa. We conducted in-depth interviews based on World Health Organization guidelines for asking adolescents about SRH. We thematically analyzed data through an iterative, team-based coding approach combining deductive and inductive elements to contextualize SRH attitudes, knowledge, and behaviors before and after receiving the InTSHA intervention. RESULTS: Of the 21 participants, 13 (61.9%) were female and the mean age was 16.6 years. Most participants reported first learning about SRH as young teenagers in school through non-targeted and negative ways, seeking clarification through peers and the internet rather than clinicians or caregivers. Participants reported that InTSHA provided a holistic perspective on relationships, gender, and sexuality specific to growing up with HIV in South Africa. They praised the ability to give and receive information from peers in a moderated setting through the mHealth intervention, building their confidence, decision-making skills, and communication with partners and caregivers throughout their everyday lives. Despite reporting some technological challenges, adolescents agreed that InTSHA was convenient, confidential, and user-friendly. CONCLUSIONS: South African APHIV receive incomplete and conflicting sexual education from peers, caregivers, teachers, and technology that can be supplemented by mHealth curricula targeted for the unique needs of APHIV. Future, scaled-up mHealth interventions can lower SRH stigma by expanding access to sexual education and peer support, supplementing adolescents' existing SRH education.
South African adolescents with perinatally-acquired HIV (APHIV)teenagers who were born with HIVlack access to sexual and reproductive health (SRH) education specific to their HIV status. Ineffective SRH education often leads to risky behaviors (such as unprotected sex), teenage pregnancy, and the spread of HIV. Mobile health (mHealth) interventions, such as phone apps, can help improve adolescent SRH knowledge and decision-making. In this study, we evaluate how a WhatsApp-based interventionInteractive Transition Support for Adolescents Living with HIV (InTSHA)influences SRH attitudes and behaviors of APHIV. InTSHA involved long-term, weekly group chats of APHIV, run by trained facilitators, that included two modules discussing SRH. This study analyzes in-depth interviews we conducted with adolescents who completed InTSHA, asking them about their SRH knowledge and behaviors before and after the intervention. The interviews took place in a government-supported clinic in an urban township of KwaZulu-Natal. Interviews were recorded, transcribed, translated, coded, and analyzed. Of 21 participants, 13 were female and the average age was 16.6 years. Most participants reported first learning about SRH as young teenagers in school, through peers, or on the internet, rather than through healthcare workers or family members. Participants reported that InTSHA provided a comfortable platform to discuss relationships, gender, and sexuality as APHIV. Adolescents enjoyed giving and receiving information from peers in a moderated setting. They reported that InTSHA built their confidence, decision-making skills, and communication with partners and caregivers. South African SRH education for APHIV can be supplemented by targeted mHealth interventions.
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Infecções por HIV , Saúde Sexual , Telemedicina , Gravidez , Adolescente , Feminino , Humanos , Masculino , África do Sul , Conhecimentos, Atitudes e Prática em Saúde , Infecções por HIV/prevenção & controleRESUMO
Adolescents living with perinatally acquired HIV in South Africa face significant barriers to successful transition from pediatric to adult care. We performed in-depth qualitative interviews with 41 adolescents living with HIV and 18 of their caregivers to investigate modifiable factors to improve engagement in care prior to transition to adult care. Based on dyadic, inductive content analysis, findings suggest that HIV status disclosure, social support, and mental health are targets for improvement in engagement in care. Early disclosure and a sense of belonging facilitated engagement in care, while barriers included delayed or inadequate disclosure, denial, and lack of disclosure to others. Adherence support improved by having a biological mother as a direct supervisor. Barriers to care included changing caregivers, abandonment, undiagnosed mental health problems and learning difficulties. Despite these factors, the majority of adolescents showed resilience and remained engaged in care despite difficult circumstances.
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Infecções por HIV , Saúde Mental , Apoio Social , Transição para Assistência do Adulto , Revelação da Verdade , Adolescente , Adulto , Idoso , Cuidadores , Feminino , Infecções por HIV/psicologia , Infecções por HIV/terapia , Acessibilidade aos Serviços de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Estigma Social , África do Sul , Adulto JovemRESUMO
AIMS: Describe the pharmacokinetics (PK) of the antiretroviral drugs abacavir and lamivudine in malnourished paediatric patients and relate to viral load outcomes after 12 and 48 weeks of treatment. METHODS: Severely malnourished human immunodeficiency virus-infected children were randomized to early (within 14 days) or delayed (after nutritional recovery) initiation of antiretroviral treatment (ART) using World Health Organization weight-band dosages. Abacavir and lamivudine concentrations were measured as a secondary objective on day 1 and day 14 and patients were followed-up to week 48. Population PK of abacavir and lamivudine were described using NONMEM. RESULTS: In total, 623 abacavir and 627 lamivudine concentrations were collected from 75 paediatric patients aged 0.1-10.8 (median 1.4) years. Abacavir PK was described by a 2-compartment model, patients randomized to early ART showed increased bioavailability of 31%. Apparent clearance (CL/F, L/h/7 kg) of abacavir increased from day 1 to day 14 from 3.33 (95% confidence interval 2.71-4.12) to 5.86 (95% confidence interval 4.78-7.3). A 1-compartment model described lamivudine PK, variability on CL/F was explained by maturation with age, with age at half-matured CL/F being 4 months. For both drugs allometrically scaled total body weight was related to CL/F and apparent volume of distribution. PK exposure did not correlate with virological outcomes or death at 12 or 48 weeks. CONCLUSION: Increases in Abacavir's CL/F between day 1 to day 14, bioavailability and PK variability with early start of ART was found in this cohort of severely malnourished children; however, these changes did not influence virological outcomes. The study supports the use of weight-band dosage tables.
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Fármacos Anti-HIV/farmacocinética , Transtornos da Nutrição Infantil/metabolismo , Didesoxinucleosídeos/farmacocinética , Infecções por HIV/tratamento farmacológico , Lamivudina/farmacocinética , Fármacos Anti-HIV/administração & dosagem , Fármacos Anti-HIV/efeitos adversos , Disponibilidade Biológica , Peso Corporal , Criança , Transtornos da Nutrição Infantil/diagnóstico , Transtornos da Nutrição Infantil/etiologia , Transtornos da Nutrição Infantil/reabilitação , Pré-Escolar , Didesoxinucleosídeos/administração & dosagem , Didesoxinucleosídeos/efeitos adversos , Relação Dose-Resposta a Droga , Esquema de Medicação , Cálculos da Dosagem de Medicamento , Feminino , Seguimentos , HIV/isolamento & purificação , Infecções por HIV/sangue , Infecções por HIV/complicações , Infecções por HIV/mortalidade , Humanos , Lactente , Lamivudina/administração & dosagem , Lamivudina/efeitos adversos , Masculino , Modelos Biológicos , Apoio Nutricional , Índice de Gravidade de Doença , África do Sul/epidemiologia , Fatores de Tempo , Tempo para o Tratamento , Resultado do Tratamento , Carga ViralRESUMO
To assess facilitators and barriers to retention in care for adolescents living with HIV, we conducted in-depth, semi-structured interviews with adolescents ages 13 to 24 years who were living with HIV and being cared for in either an adolescent-friendly or standard government-supported clinic in KwaZulu-Natal, South Africa. We used inductive content analysis approach based on grounded theory derived from reviewing, coding, and interpreting data. We interviewed 28 adolescents living with HIV (16 in the adolescent clinic and 12 from the pediatric clinic) and 14 of their caregivers. Barriers to retention in care included having to attend clinic during school hours, fear of disclosure to others, social isolation, and conflict with clinical staff. Facilitators to retention in care seen in the adolescent-friendly services clinic included after school clinic hours, peer support, and connection to the clinical staff. Adolescent-friendly services are facilitators of HIV care and warrant prioritization in treatment programs.
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Atitude do Pessoal de Saúde , Cuidadores/psicologia , Atenção à Saúde/métodos , Infecções por HIV/tratamento farmacológico , Infecções por HIV/psicologia , Relações Profissional-Paciente , Retenção nos Cuidados , Adolescente , Adulto , Instituições de Assistência Ambulatorial , Criança , Aconselhamento , Revelação , Feminino , Infecções por HIV/epidemiologia , Acessibilidade aos Serviços de Saúde , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Pesquisa Qualitativa , Isolamento Social , África do Sul/epidemiologia , Confiança , Adulto JovemRESUMO
Short message service (SMS) text messages have been used to remind and encourage patients to take ART in research studies. However, few studies have assessed the feasibility and acceptability of SMS in routine clinical practice. We report patient perspectives on a weekly SMS adherence support program after implementation into clinical care at an HIV clinic in KwaZulu-Natal, South Africa. We conducted structured interviews with a cross-sectional convenience sample of 100 adult patients who were invited to join the program, 88 of whom had received a program SMS. Of these respondents, 81 (92 %) would recommend the program to a friend. Sixty-eight (77 %) felt the program helped them remember clinic appointments, a response associated with male gender [odds ratio (OR) 5.88, 95 % confidence interval (CI) 1.52-23.26, P = 0.011] and HIV disclosure outside the home [OR 3.40, 95 %CI 1.00-11.60, P = 0.050]. This clinical SMS adherence program was found to have high patient-perceived usefulness.
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Fármacos Anti-HIV/uso terapêutico , Países em Desenvolvimento , Infecções por HIV/tratamento farmacológico , Infecções por HIV/psicologia , Adesão à Medicação/psicologia , Aceitação pelo Paciente de Cuidados de Saúde/psicologia , Envio de Mensagens de Texto , Adulto , Feminino , Humanos , Entrevista Psicológica , Masculino , Razão de Chances , África do SulRESUMO
South Africa has the highest burden of adolescents living with HIV (ALHIV) in the world. The transition from pediatric to adult centered HIV care is a vulnerable period during which many clinical outcomes of ALHIV suffer. Transition readiness assessments may help ALHIV transition from pediatric to adult care to improve their health outcomes. Here, we evaluated the perceived acceptability and feasibility of a mobile health (mHealth) application, eHARTS, to determine transition readiness for ALHIV in South Africa. We conducted in-depth interviews with adolescents (n = 15) and healthcare providers (n = 15) at three government-supported hospitals in KwaZulu-Natal, South Africa. We used a semi-structured interview guide comprising of open-ended questions based on the unified theory of acceptance and use of technology. We did a thematic analysis of the data using an iterative, team-based coding approach to develop themes that were representative of the participants' perspectives on the acceptability and feasibility of eHARTS. We found that most participants found eHARTS to be acceptable because of its simplicity and lack of stigma. Participants believed eHARTS was feasible as it could easily be administered within a hospital setting and integrated into regular clinic activity without disrupting patient care. Additionally, eHARTS was found to have great utility for adolescents and healthcare providers. Clinicians saw it as a valuable tool to engage adolescents and prepare them for transition. Despite concerns that eHARTS may give adolescents a wrong impression about immediate transition, participants suggested that eHARTS be framed in an empowering way as they prepare for transition to adult care. Our data showed that eHARTS is a simple, mobile transition assessment tool with perceived acceptability and feasibility for use in HIV clinics in South Africa for ALHIV. It is particularly useful for ALHIV and transitioning to adult care as it can help identify gaps in readiness for transition.
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INTRODUCTION: Compared with adults, adolescents in South Africa have larger gaps at each step of the HIV continuum of care resulting in low levels of viral suppression. METHODS: We conducted a systematic review and modified Delphi analysis of interventions addressing the HIV continuum of care for adolescents in South Africa. We searched PubMed, Science Direct, and Google Scholar and online conference proceedings from the International AIDS Society, the International AIDS Conference, and the Conference on Retrovirology and Opportunistic Infections from 1 January 2010 to 30 September 2020. We then conducted a modified Delphi analysis with 29 researchers involved in the National Institutes of Health's Fogarty International-supported Adolescent HIV Implementation Science Alliance-South Africa to evaluate interventions for efficacy, feasibility and potential for scale-up. RESULTS: We identified nine initial published articles containing interventions addressing the adolescent HIV continuum of care in South Africa, including five interventions focused on HIV diagnosis, two on antiretroviral therapy adherence and two on retention in care. No studies addressed linkage to care or transition from paediatric to adult care. Two studies discussed intervention costs. In-home and HIV self-testing, community-based adherence support, and provision of adolescent-friendly services were the most impactful and scalable interventions addressing the adolescent HIV continuum of care. CONCLUSION: Future interventions should work comprehensively across the adolescent HIV continuum of care and be tailored to the specific needs of adolescents.
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Síndrome da Imunodeficiência Adquirida , Infecções por HIV , Transição para Assistência do Adulto , Adolescente , Adulto , Antirretrovirais/uso terapêutico , Criança , Infecções por HIV/diagnóstico , Infecções por HIV/prevenção & controle , Humanos , África do Sul , Estados UnidosRESUMO
BACKGROUND: Adolescents living with perinatally acquired HIV often have poor retention in care and viral suppression during the transition from pediatric to adult-based care. OBJECTIVE: The aim of this study is to evaluate a mobile phone-based intervention, Interactive Transition Support for Adolescents Living With HIV using Social Media (InTSHA), among adolescents living with perinatally acquired HIV as they transition from pediatric to adult care in South Africa. METHODS: InTSHA uses encrypted, closed group chats delivered via WhatsApp (Meta Platforms Inc) to develop peer support and improve communication between adolescents, their caregivers, and health care providers. The intervention is based on formative work with adolescents, caregivers, and health care providers and builds on several existing adolescent support programs as well as the Social-ecological Model of Adolescent and Young Adult Readiness for Transition (SMART). The final InTSHA intervention involves 10 modules conducted weekly through moderated WhatsApp group chats with adolescents and separately with their caregivers. We will randomly assign 80 South African adolescents living with perinatally acquired HIV who are aware of their HIV status and aged between 15 and 19 years to receive either the intervention (n=40) or standard of care (n=40). RESULTS: We will measure acceptability of the intervention as the primary outcome and evaluate feasibility and preliminary effectiveness for retention in care and viral suppression after completion of the intervention and at least 6 months after randomization. In addition, we will measure secondary outcomes evaluating the impact of the InTSHA intervention on peer support, self-esteem, depression, stigma, sexual education, connection to health care providers, and transition readiness. Enrollment began on April 15, 2021. As of December 31, 2021 a total of 78 out of expected 80 participants have been enrolled. CONCLUSIONS: If successful, the intervention will be evaluated in a fully powered randomized controlled trial with a larger number of adolescents from urban and rural populations to further evaluate the generalizability of InTSHA. TRIAL REGISTRATION: ClinicalTrials.gov NCT03624413; https://clinicaltrials.gov/ct2/show/NCT03624413. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/35455.
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OBJECTIVE: To determine facilitators and barriers to successful transition to adult care for adolescents living with perinatally-acquired HIV in South Africa. METHODS: We prospectively enrolled 30 adolescents living with perinatally-acquired HIV after their pediatrician deemed them ready for transition to adult care but prior to their transition. Eighteen months after enrollment, we measured transition status, engagement in care (i.e., viral load within 12 months of transition), and viral suppression (<200 copies/ml). Additionally, we conducted in-depth interviews with adolescents before and after transition to explore facilitators and barriers to successful transition. RESULTS: A total of 19/30 (63%) adolescents transitioned to adult care. Of those who transitioned, 11 (58%) were retained in care and 7 (37%) were virally suppressed one year after transition to adult care. Insufficient staff training, lack of availability of pediatric ART formulations in adult clinics, and insufficient clinical monitoring contributed to delayed transition. Rigid clinical scheduling that interfered with school and loss of clinic relationships with peers and clinical staff were major factors in contributing to poor engagement in care after transition. Maturity of the adolescent, reduced distance to clinic, and reduced length of time in the clinic were seen as facilitators to transition to adult care. CONCLUSION: Improved preparation for transition by pediatric and adult clinical staff, including restructuring of care delivery, may improve successful transition of adolescents living with perinatally acquired HIV to adult care. Transition readiness assessments are needed to determine optimal timing of transition and which adolescents are ready to transition to adult care.
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BACKGROUND: Delays in early infant diagnosis and antiretroviral treatment (ART) initiation in developing countries frequently result in malnutrition at initial presentation with associated higher mortality and delayed immune recovery. The optimal timing of ART initiation is yet to be established. METHODS: Eighty-two children admitted with HIV and severe acute malnutrition (SAM) between July 2012 and December 2015 were enrolled. Patients were randomized to initiate ART within 14 days from admission (early arm) or delay ART initiation until nutritional recovery andâ >14 days after admission (delayed arm). All patients received a standardized treatment and feeding protocol and were followed to 48 weeks. RESULTS: The mean age of the patients at baseline was 23.3 months (standard deviation [SD], 27.9; range, 1.6-129 months). The mean time from admission to ART initiation was 5.6 days (SD, 4.4) in the early arm and 23 days (SD, 5.8) in the delayed arm (Pâ <â .001). There was no significant difference in mortality (Pâ =â .62), virologic response (Pâ =â .53), and anthropometric response (Pâ =â .57) between the 2 groups at 48 weeks. However, the rates of change in CD4, viral load, weight for age z score, and height for age z score occurred earlier and favored the delayed arm at early time points but were not significant at 24 and 48 months. CONCLUSIONS: Despite initial improved responses in the delayed arm, lack of difference in outcome at 48 weeks supports a pragmatic approach with earlier ART initiation in children living with HIV admitted with SAM.In this randomised controlled study of ART initiation in children admitted with HIV and severe acute malnutrition (SAM), despite initial improved responses in the delayed arm, lack of difference in outcome at 48 weeks supports a pragmatic approach with earlier ART initiation in children living with HIV admitted with SAM. CLINICAL TRIALS REGISTRATION: PACTR 21609001751384.
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Infecções por HIV , Desnutrição Aguda Grave , Criança , Pré-Escolar , Humanos , Lactente , Antirretrovirais/uso terapêutico , HIV , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Carga Viral , África do SulRESUMO
INTRODUCTION: Adolescents living with perinatally acquired HIV have low rates of retention in care and viral suppression after the transition from paediatric to adult care. In this study, we developed and validated a tool to identify adolescent transition readiness. METHODS: We developed the HIV Adolescent Readiness for Transition Scale (HARTS) from June 2016 to May 2019 by iteratively adapting existing transition readiness scales for other chronic illnesses by conducting focus groups with 11 healthcare providers and 20 adolescents in South Africa. We administered a preliminary questionnaire to 131 adolescents to determine psychometric properties and assess test-retest variability. We used confirmatory factor analysis to verify the proposed scale structure using the underlying variable approach. We correlated responses to self-described transition readiness and age using linear regression. We subsequently validated the scale by prospectively administering it to 199 adolescents in a second South African setting before their transition. We then used multivariable logistic regression to assess the effects of the HARTS and relevant socio-behavioural covariates on viral suppression one year after transition. RESULTS: We identified four domains relevant to transition readiness: disclosure, health navigation, self-advocacy and health literacy. Fifteen questions with a significant factor loading of 0.3 to 0.9 were identified. No significant test-retest variability was seen among 10% of participants. Positive correlations with self-described transition readiness were significant with the overall HARTS and domains of health navigation, self-advocacy and health literacy. In the prospective analysis, for adolescents not using drugs, each 10-point increase in the HARTS was associated with 0.62 odds of viral failure (95% CI 0.45 to 0.86; p = 0.004). The individual domains of self-advocacy (AOR 0.56; 95% CI 0.33 to 0.94; p = 0.029), disclosure (AOR 0.02; 95% CI 0.01 to 0.25; p = 0.002), health navigation (AOR 0.51; 95%CI 0.25 to 1.02; p = 0.056) and health literacy (AOR 0.37; 95% CI 0.10 to 1.30; p = 0.121) were associated with viral failure adjusting for age at antiretroviral therapy initiation, ART regimen, sex, disclosure status, and alcohol use in both analyses. CONCLUSIONS: The HARTS is a validated scale that can be used to identify which adolescents may require additional interventions prior to transitioning to adult care to improve viral suppression after transition.
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Infecções por HIV , Transição para Assistência do Adulto , Adolescente , Adulto , Criança , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Humanos , Modelos Logísticos , África do Sul/epidemiologia , Inquéritos e QuestionáriosRESUMO
OBJECTIVE: To determine rates of retention and viral suppression among adolescents living with perinatally-acquired HIV who remained in pediatric care compared to those who transitioned to adult care. METHODS: We evaluated a natural experiment involving adolescents living with perinatally-acquired HIV who were attending a government-supported antiretroviral clinic in KwaZulu-Natal, South Africa. Prior to 2011, all adolescents transitioned to adult care at 12 years of age. Due to a policy change, all adolescents were retained in pediatric care after 2011. We analyzed adolescents two years before and two years after this policy change. Outcomes were retention in care and HIV viral suppression one year after transition to adult care or the 13th birthday if remaining in pediatric care. RESULTS: In the natural experiment, 180 adolescents who turned 12 years old between 2011 and 2014 were evaluated; 35 (20%) transitioned to adult care under the old policy and 145 (80%) remained in pediatric care under the new policy. Adolescents who transitioned to the adult clinic had lower rates of retention in care (49%; 17/35) compared to adolescents remaining in the pediatric clinic (92%; 134/145; p<0.001). Retention in care was lower (ARR 0.59; 95%CI 0.43-0.82; p = 0.001) and viral suppression was similar (ARR = 1.06, 95%CI 0.89-1.26; p = 0.53) for adolescents who transitioned to adult care compared to adolescents remaining in pediatric care. CONCLUSION: Adolescents living with perinatally-acquired HIV appear to have higher retention in care when cared for in pediatric clinics compared to adult clinics. Longer-term follow-up is needed to fully assess viral suppression.
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Fármacos Anti-HIV/uso terapêutico , Infecções por HIV/tratamento farmacológico , Retenção nos Cuidados/estatística & dados numéricos , Transição para Assistência do Adulto/estatística & dados numéricos , Adolescente , Adulto , Instituições de Assistência Ambulatorial , Criança , Feminino , Política de Saúde , Humanos , Masculino , África do Sul , Análise de Sobrevida , Transição para Assistência do Adulto/legislação & jurisprudência , Resultado do TratamentoRESUMO
BACKGROUND: In developing countries, malnutrition remains a common clinical syndrome at antiretroviral treatment (ART) initiation. Physiologic changes because of malnutrition and during nutritional recovery could affect the pharmacokinetics of antiretroviral drugs. METHODS: HIV-infected children admitted with severe acute malnutrition were randomized to early or delayed initiation of lopinavir (LPV)/ritonavir, abacavir and lamivudine using World Health Organization weight band dosage charts. LPV concentrations were measured on day 1 and day 14. Thereafter, patients were followed-up to week 48. The population pharmacokinetics of LPV was described using NONMEM v7.3. Covariates were screened to assess their influence on the pharmacokinetics of LPV, and the relationship between pharmacokinetic variability and treatment outcomes were assessed. RESULTS: Five hundred and two LPV concentrations were collected from 62 pediatric patients 0.1-3.9 years of age (median: 0.9 years). Rifampin-based antituberculosis treatment and "super-boosted" LPV/ritonavir were prescribed in 20 patients. LPV disposition was well described by a one-compartment model with first-order elimination. Neither randomization to early or delayed ART, tuberculosis comedications nor anthropometrical measurements explained the pharmcokinetic variability. Allometrically scaled fat-free mass influenced apparent clearance (CL/F) and volume of distribution (Vd/F). Pharmacokinetic exposure did not correlate with virologic outcomes or death at 12 or 48 weeks. CONCLUSIONS: LPV pharmacokinetics was influenced by fat-free mass and not by timing of ART initiation or tuberculosis comedication in severely malnourished HIV-infected children. LPV pharmacokinetics was found to be highly variable and bioavailability greatly reduced, resulting in a high CL estimate in this population. The role of LPV dose adjustment should be further evaluated in severely malnourished children initiating ART.
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Infecções por HIV/tratamento farmacológico , Inibidores da Protease de HIV/farmacocinética , Lopinavir/farmacocinética , Desnutrição , Terapia Antirretroviral de Alta Atividade/métodos , Índice de Massa Corporal , Criança , Pré-Escolar , Feminino , Infecções por HIV/complicações , Inibidores da Protease de HIV/administração & dosagem , Humanos , Lactente , Lopinavir/administração & dosagem , Masculino , Plasma/química , Resultado do TratamentoRESUMO
This observational study aimed to describe immunopathogenesis and treatment outcomes in children with and without severe acute malnutrition (SAM) and HIV-infection. We studied markers of microbial translocation (16sDNA), intestinal damage (iFABP), monocyte activation (sCD14), T-cell activation (CD38, HLA-DR) and immune exhaustion (PD1) in 32 HIV-infected children with and 41 HIV-infected children without SAM prior to initiation of antiretroviral therapy (ART) and cross-sectionally compared these children to 15 HIV-uninfected children with and 19 HIV-uninfected children without SAM. We then prospectively measured these markers and correlated them to treatment outcomes in the HIV-infected children at 48 weeks following initiation of ART. Plasma levels of 16sDNA, iFABP and sCD14 were measured by quantitative real time PCR, ELISA and Luminex, respectively. T cell phenotype markers were measured by flow cytometry. Multiple regression analysis was performed using generalized linear models (GLMs) and the least absolute shrinkage and selection operator (LASSO) approach for variable selection. Microbial translocation, T cell activation and exhaustion were increased in HIV-uninfected children with SAM compared to HIV-uninfected children without SAM. In HIV-infected children microbial translocation, immune activation, and exhaustion was strongly increased but did not differ by SAM-status. SAM was associated with increased mortality rates early after ART initiation. Malnutrition, age, microbial translocation, monocyte, and CD8 T cell activation were independently associated with decreased rates of CD4% immune recovery after 48 weeks of ART. SAM is associated with increased microbial translocation, immune activation, and immune exhaustion in HIV-uninfected children and with worse prognosis and impaired immune recovery in HIV-infected children on ART.
Assuntos
Terapia Antirretroviral de Alta Atividade , Infecções por HIV/tratamento farmacológico , Desnutrição/virologia , Doença Aguda , Translocação Bacteriana , Biomarcadores/sangue , Contagem de Linfócito CD4 , Criança , Pré-Escolar , Estudos Transversais , Feminino , Citometria de Fluxo , Infecções por HIV/complicações , HIV-1 , Humanos , Lactente , Ativação Linfocitária , Masculino , Desnutrição/imunologia , Índice de Gravidade de Doença , Resultado do Tratamento , Carga ViralRESUMO
OBJECTIVE: To determine retention in care and virologic suppression among HIV-infected adolescents and young adults attending an adolescent-friendly clinic compared to those attending the standard pediatric clinic at the same site. DESIGN: Retrospective cohort analysis. SETTING: Government supported, hospital-based antiretroviral clinic in KwaZulu-Natal, South Africa. PARTICIPANTS: Two hundred forty-one perinatally HIV-infected adolescents and young adults aged 13 to 24 years attending an adolescent-friendly clinic or the standard pediatric clinic from April 2007 to November 2015. INTERVENTION: Attendance in an adolescent-friendly clinic compared to a standard pediatric clinic. OUTCOMES MEASURES: Retention in care defined as one clinic visit or pharmacy refill in the prior 6 months; HIV-1 viral suppression defined as < 400 copies/ml. RESULTS: Overall, among 241 adolescents and young adults, retention was 89% (214/241) and viral suppression was 81% (196/241). Retention was higher among those attending adolescent clinic (95%) versus standard pediatric clinic (85%; OR 3.7; 95% confidence interval (CI) 1.2-11.1; p = 0.018). Multivariable logistic regression adjusted for age at ART initiation, gender, pre-ART CD4 count, months on ART, and tuberculosis history indicated higher odds of retention in adolescents and young adults attending adolescent compared to standard clinic (AOR = 8.5; 95% CI 2.3-32.4; p = 0.002). Viral suppression was higher among adolescents and young adults attending adolescent (91%) versus standard pediatric clinic (80%; OR 2.5; 95% CI 1.1-5.8; p = 0.028). A similar multivariable logistic regression model indicated higher odds of viral suppression in adolescents and young adults attending adolescent versus standard pediatric clinic (AOR = 3.8; 95% CI 1.5-9.7; p = 0.005). CONCLUSION: Adolescents and young adults attending an adolescent-friendly clinic had higher retention in care and viral suppression compared to adolescents attending the standard pediatric clinic. Further studies are needed to prospectively assess the impact of adolescent-friendly services on these outcomes.