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BACKGROUND: Same-day HIV testing and antiretroviral therapy (ART) initiation is being widely implemented. However, the optimal timing of ART among patients with tuberculosis (TB) symptoms is unknown. We hypothesized that same-day treatment (TB treatment for those diagnosed with TB; ART for those not diagnosed with TB) would be superior to standard care in this population. METHODS AND FINDINGS: We conducted an open-label trial among adults with TB symptoms at initial HIV diagnosis at GHESKIO in Haiti; participants were recruited and randomized on the same day. Participants were randomized in a 1:1 ratio to same-day treatment (same-day TB testing with same-day TB treatment if TB diagnosed; same-day ART if TB not diagnosed) versus standard care (initiating TB treatment within 7 days and delaying ART to day 7 if TB not diagnosed). In both groups, ART was initiated 2 weeks after TB treatment. The primary outcome was retention in care with 48-week HIV-1 RNA <200 copies/mL, with intention to treat (ITT) analysis. From November 6, 2017 to January 16, 2020, 500 participants were randomized (250/group); the final study visit occurred on March 1, 2021. Baseline TB was diagnosed in 40 (16.0%) in the standard and 48 (19.2%) in the same-day group; all initiated TB treatment. In the standard group, 245 (98.0%) initiated ART at median of 9 days; 6 (2.4%) died, 15 (6.0%) missed the 48-week visit, and 229 (91.6%) attended the 48-week visit. Among all who were randomized, 220 (88.0%) received 48-week HIV-1 RNA testing; 168 had <200 copies/mL (among randomized: 67.2%; among tested: 76.4%). In the same-day group, 249 (99.6%) initiated ART at median of 0 days; 9 (3.6%) died, 23 (9.2%) missed the 48-week visit, and 218 (87.2%) attended the 48-week visit. Among all who were randomized, 211 (84.4%) received 48-week HIV-1 RNA; 152 had <200 copies/mL (among randomized: 60.8%; among tested: 72.0%). There was no difference between groups in the primary outcome (60.8% versus 67.2%; risk difference: -0.06; 95% CI [-0.15, 0.02]; p = 0.14). Two new grade 3 or 4 events were reported per group; none were judged to be related to the intervention. The main limitation of this study is that it was conducted at a single urban clinic, and the generalizability to other settings is uncertain. CONCLUSIONS: In patients with TB symptoms at HIV diagnosis, we found that same-day treatment was not associated with superior retention and viral suppression. In this study, a short delay in ART initiation did not appear to compromise outcomes. TRIAL REGISTRATION: This study is registered with ClinicalTrials.gov NCT03154320.
Assuntos
Fármacos Anti-HIV , Infecções por HIV , Tuberculose , Adulto , Humanos , Fármacos Anti-HIV/uso terapêutico , Haiti/epidemiologia , Infecções por HIV/complicações , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Tuberculose/complicações , Tuberculose/diagnóstico , Tuberculose/tratamento farmacológico , RNARESUMO
INTRODUCTION: Women play an essential role in health care delivery, and it is vital that they have equal representation in health leadership for equity, innovation, and the strengthening of health systems globally. Yet women remain vastly underrepresented in global health leadership positions, providing a clear example of the deeply rooted power imbalances that are central to the calls to decolonize global health. We conducted a multi-country study in Haiti, Tanzania, India, and the USA to examine gender-based challenges to career advancement for women in the global health workforce. Quantitative data on the type and prevalence of gender-based challenges has been previously reported. In this study, we analyze qualitative data collected through focus group discussions and in-depth interviews to understand women's experiences of gender-based obstacles to career advancement, their perceptions of underlying drivers, and perspectives on effective solutions. Guided by an adaptation of the Social Action Theory, we conducted focus group discussions and in-depth interviews with women at 4 major academic centers for clinical care and research in Haiti, India, Tanzania, and the United States. In total, 85 women participated in focus groups and 15 also participated in in-depth interviews. Discussions and interviews were conducted in the local language, by an experienced local facilitator unaffiliated with the participating institution, between 2017 and 2018. Discussions were recorded, transcribed, and translated. Data were analyzed by interpretive phenomenological methods for emergent themes. Three transcendent themes on gender-based challenges were identified: 1) cultural power imbalance, referring to the prevailing norms and engrained assumptions that women are less capable than men and that women's primary responsibility should be to their families; 2) institutional power imbalance, referring to the systematic gender bias upheld by existing leadership and power structures, and ranging from exclusion from career development opportunities to sexual harassment and assault; and 3) restricted agency, referring to women's limited ability to change their circumstances because of unequal cultural and institutional structures. Participants also described local, actionable solutions to address these barriers. These included: 1) formal reporting systems for sexual harassment and assault; 2) peer support and mentorship; and 3) accessible leadership training and mandatory gender equity training. Participants proposed feasible strategies to address gender-based challenges that could improve women's retention in health careers and foster their rise to leadership. Increasing the representation of women in global health leadership positions responds directly to efforts to decolonize global health and is integral to strengthening health systems and improving health outcomes for women and children worldwide.
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HIV viral load (VL) monitoring can reinforce antiretroviral therapy (ART) adherence. Standard VL testing requires high laboratory capacity and coordination between clinic and laboratory which can delay results. A randomized trial comparing point-of-care (POC) VL testing to standard VL testing among 150 adolescents and young adults, ages 10-24 years, living with HIV in Haiti determined if POC VL testing could return faster results and improve ART adherence and viral suppression. Participants received a POC VL test with same-day result (POC arm) or a standard VL test with result given 1 month later (SOC arm). POC arm participants were more likely to receive a test result within 6 weeks than SOC arm participants (94.7% vs. 80.1%; p1000 copies/ml and low self-reported ART adherence was stronger in the POC arm (OR: 6.57; 95%CI: 2.12-25.21) than the SOC arm (OR: 2.62; 95%CI: 0.97-7.44) suggesting more accurate self-report in the POC arm. POC VL testing was effectively implemented in this low-resource setting with faster results and is a pragmatic intervention that may enable clinicians to identify those with high VL to provide enhanced counseling or regimen changes sooner.Trial registration: ClinicalTrials.gov identifier: NCT03288246.
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Fármacos Anti-HIV , Infecções por HIV , Adolescente , Adulto , Fármacos Anti-HIV/uso terapêutico , Antirretrovirais/uso terapêutico , Criança , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Haiti , Humanos , Sistemas Automatizados de Assistência Junto ao Leito , Carga Viral , Adulto JovemRESUMO
INTRODUCTION: Adolescents living with HIV have poor antiretroviral therapy (ART) adherence and viral suppression outcomes. Viral load (VL) monitoring could reinforce adherence but standard VL testing requires strong laboratory capacity often only available in large central laboratories. Thus, coordinated transport of samples and results between the clinic and laboratory is required, presenting opportunities for delayed or misplaced results. Newly available point-of-care (POC) VL testing systems return test results the same day and could simplify VL monitoring so that adolescents receive test results faster which could strengthen adherence counselling and improve ART adherence and viral suppression. METHODS AND ANALYSIS: This non-blinded randomised clinical trial is designed to evaluate the implementation and effectiveness of POC VL testing compared with standard laboratory-based VL testing among adolescents and youth living with HIV in Haiti. A total of 150 participants ages 10-24 who have been on ART for >6 months are randomised 1:1 to intervention or standard arms. Intervention arm participants receive a POC VL test (Cepheid Xpert HIV-1 Viral Load system) with same-day result and immediate ART adherence counselling. Standard care participants receive a laboratory-based VL test (Abbott m2000sp/m2000rt) with the result available 1 month later, at which time they receive ART adherence counselling. VL testing is repeated 6 months later for both arms. The primary objective is to describe the implementation of POC VL testing compared with standard laboratory-based VL testing. The secondary objective is to evaluate the effect of POC VL testing on VL suppression at 6 months and participant comprehension of the correlation between VL and ART adherence. ETHICS AND DISSEMINATION: This study is approved by GHESKIO, Weill Cornell Medicine and Columbia University ethics committees. This trial will provide critical data to understand if and how POC VL testing may impact adolescent ART adherence and viral suppression. If effective, POC VL testing could routinely supplement standard laboratory-based VL testing among high-risk populations living with HIV. TRIAL REGISTRATION NUMBER: NCT03288246.
Assuntos
Infecções por HIV , Sistemas Automatizados de Assistência Junto ao Leito , Adolescente , Adulto , Antirretrovirais/uso terapêutico , Criança , Infecções por HIV/diagnóstico , Infecções por HIV/tratamento farmacológico , Haiti , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Carga Viral , Adulto JovemAssuntos
Centros Comunitários de Saúde , Infecções por HIV/terapia , Modelos Organizacionais , Adolescente , Fármacos Anti-HIV/uso terapêutico , Contagem de Linfócito CD4 , Estudos de Coortes , Serviços de Saúde Comunitária/organização & administração , Feminino , Haiti , Humanos , Masculino , Retenção nos Cuidados , Adulto JovemRESUMO
In 2003, the Haitian Study Group on Kaposi's Sarcoma and Opportunistic Infections (GHESKIO), a nonprofit organization, began administering antiretroviral therapy (ART) to its patients. This practice transformed HIV from a fatal disease to a more manageable chronic condition. However, relatively few studies focus on the experiences of survivors. This study provided a unique opportunity to interview patients who survived at least 10 years after being treated with ART at GHESKIO. The goal of the study was to elicit from patients their perspectives on what enabled them to survive with AIDS. Grounded Theory, a qualitative research method was used to guide data collection, coding, and analysis. Individual interviews were conducted, audio-taped, transcribed and analyzed in Creole, and translated into English. Data saturation was reached at 25 participants. Of which, 64% were women, the mean age was 49, range of 43-55 years, 24% were married, 44% had not completed elementary school, and 72% had no income, the remaining participants had incomes ranging from $1000 to $5000 annually. Qualitative analysis resulted in 681 codes, which were grouped into six categories: being spiritually grounded, having supportive interactions with providers, caring for children, setting personal goals, persevering and living life as usual, and maintaining strict medication adherence practices. The overarching theory was that having a reason to live despite one's circumstances and living life as usual enabled one to survive. Having a strong spiritual foundation coupled with supportive family and providers motivated participants to live and adhere to their ART. As the number of patients who are living longer with HIV in Haiti increases, results from this study will be important in helping tailor interventions that enhance their overall quality of life.
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Antirretrovirais/uso terapêutico , Infecções por HIV/psicologia , Conhecimentos, Atitudes e Prática em Saúde , Adesão à Medicação , Qualidade de Vida , Sobreviventes/psicologia , Adolescente , Adulto , Antirretrovirais/administração & dosagem , Criança , Aconselhamento , Feminino , Teoria Fundamentada , Infecções por HIV/tratamento farmacológico , Haiti , Pessoal de Saúde , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Motivação , Pesquisa Qualitativa , Apoio Social , EspiritualidadeRESUMO
Adolescents account for 40% of new HIV infections, and HIV testing strategies to increase uptake of testing are needed. A community-based adolescent and youth HIV and health testing campaign was conducted in seven slum neighborhoods of Port-au-Prince, Haiti, from December 2014 to September 2015. Community health workers provided community sensitization and recruited 10- to 24-year-olds to test for HIV, syphilis, gonorrhea/chlamydia, and to screen for tuberculosis (TB) and pregnancy. HIV-infected individuals were escorted to the GHESKIO HIV clinic for same-day enrollment in care. Among 3425 individuals eligible for testing, 3348 (98%) accepted an HIV test. HIV prevalence was 2.65% (n = 89). Median age was 19 [interquartile range (IQR) 17-20]; 73% were female. HIV prevalence was 0.6-7.4% across slum neighborhoods. All HIV-infected individuals enrolled in care the same day as testing; median CD4 was 529 cells/µL [IQR 363-761]. Syphilis prevalence was 2.60% (65/2536) and gonorrhea/chlamydia prevalence was 6.25% (96/1536). Among 168 (5%) individuals who reported TB symptoms, 7.7% (13/168) had microbiologically confirmed disease. One hundred twenty-nine females (5% of all females) were pregnant. This community-based testing campaign identified an adolescent and youth population with an HIV prevalence six times higher than the estimated national adolescent HIV prevalence (0.4%) in Haiti, including perinatally infected adolescents. This type of community-based campaign for HIV testing within a package of services can serve as a model for other resource-poor settings to identify high-risk adolescents and youth, and curb the global HIV epidemic among adolescents.
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Infecções por HIV/diagnóstico , Promoção da Saúde , Programas de Rastreamento/organização & administração , Áreas de Pobreza , Populações Vulneráveis , Adolescente , Adulto , Instituições de Assistência Ambulatorial , Serviços de Saúde Comunitária , Feminino , Infecções por HIV/epidemiologia , Haiti/epidemiologia , Humanos , Masculino , Gravidez , Prevalência , Risco , Sífilis/diagnóstico , Sífilis/epidemiologia , Tuberculose/diagnósticoRESUMO
INTRODUCTION: Adolescents account for over 40% of new HIV infections in Haiti. This analysis compares outcomes among HIV-positive adolescents before and after implementation of an adolescent HIV clinic in Port-au-Prince, Haiti. METHODS: We conducted a cohort study using programmatic data among HIV-positive adolescents aged 13 to 19. Data from 41,218 adolescents who were HIV tested from January 2003 to December 2012 were included. Outcomes across the HIV care cascade were assessed before and after implementation of an adolescent clinic (2009), including HIV testing, enrolment in care, assessment for antiretroviral therapy (ART) eligibility, ART initiation and 12-month retention. Pre-ART outcomes were assessed 12 months after HIV testing. Factors associated with pre-ART and ART attrition were identified through multivariable competing risk and Cox proportional hazards regression modelling. RESULTS: Cumulatively, 1672 (4.1%) adolescents tested HIV positive (80% female, median age 16 years). Retention by cascade step comparing pre- and post-clinic included the following: 86% versus 87% of patients enrolled in care, 61% versus 79% were assessed for ART eligibility, 85% versus 92% initiated ART and 68% versus 66% were retained 12 months after ART initiation. Pre-ART attrition decreased from 61% pre-clinic to 50% post-clinic (p<0.001). Pre-ART attrition was associated with being female (sub-distributional hazard ratio (sHR): 1.59; CI: 1.31-1.93), syphilis diagnosis (sHR: 1.47; CI: 1.16-1.85) and slum residence (sHR: 0.84; CI: 0.72-0.97). ART attrition was associated with syphilis diagnosis (hazard ratio (HR): 2.23; CI: 1.35-3.68) and CD4 <50 cells/µL (HR: 1.88; CI: 1.15-3.06). CONCLUSIONS: Implementation of a youth-friendly adolescent clinic improved retention in HIV care among adolescents, particularly in the assessment of ART eligibility and ART initiation. Additional interventions are needed to improve retention among pre-ART patients and support long-term retention among ART patients.