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Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial.

ABSTRACT: High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART) initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit.RapIT (Rapid Initiation of Treatment) was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa, a primary health clinic (PHC) and a hospital-based HIV clinic. Adult (?18 y old), non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Patients in the rapid-initiation arm of the study ("rapid arm") received a point-of-care (POC) CD4 count if needed; those who were ART-eligible received a POC tuberculosis (TB) test if symptomatic, POC blood tests, physical exam, education, counseling, and antiretroviral (ARV) dispensing. Patients in the standard-initiation arm of the study ("standard arm") followed standard clinic procedures (three to five additional clinic visits over 2-4 wk prior to ARV dispensing). Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (?400 copies/ml) within 10 mo of study enrollment. Secondary outcomes included initiation of ART ?90 d of study enrollment, retention in care, time to ART initiation, patient-level predictors of primary outcomes, prevalence of TB symptoms, and the feasibility and acceptability of the intervention. A survival analysis was conducted comparing attrition from care after ART initiation between the groups among those who initiated within 90 d. Three hundred and seventy-seven patients were enrolled in the study between May 8, 2013 and August 29, 2014 (median CD4 count 210 cells/mm3). In the rapid arm, 119/187 patients (64%) initiated treatment and were virally suppressed at 10 mo, compared to 96/190 (51%) in the standard arm (relative risk [RR] 1.26 [1.05-1.50]). In the rapid arm 182/187 (97%) initiated ART ?90 d, compared to 136/190 (72%) in the standard arm (RR 1.36, 95% confidence interval [CI], 1.24-1.49). Among 318 patients who did initiate ART within 90 d, the hazard of attrition within the first 10 mo did not differ between the treatment arms (hazard ratio [HR] 1.06; 95% CI 0.61-1.84). The study was limited by the small number of sites and small sample size, and the generalizability of the results to other settings and to non-research conditions is uncertain.Offering single-visit ART initiation to adult patients in South Africa increased uptake of ART by 36% and viral suppression by 26%. This intervention should be considered for adoption in the public sector in Africa.ClinicalTrials.gov NCT01710397, and South African National Clinical Trials Register DOH-27-0213-4177.

SUBMITTER: Rosen S

PROVIDER: S-EPMC4862681 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial.

Rosen Sydney S Maskew Mhairi M Fox Matthew P MP Nyoni Cynthia C Mongwenyana Constance C Malete Given G Sanne Ian I Bokaba Dorah D Sauls Celeste C Rohr Julia J Long Lawrence L

PLoS medicine 20160510 5

<h4>Background</h4>High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART) initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm ...[more]

PMID: 27163694

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Project description:BACKGROUND:Inconsistent literature evidence suggests that sociodemographic, economic, and system- and patient-related factors are associated with clinic attendance among the HIV-positive population receiving antiretroviral therapy (ART) around the world. We examined the factors that predict outpatient clinic attendance among a cohort of HIV-positive patients initiating ART in Selangor, Malaysia. PATIENTS AND METHODS:This cross-sectional study analyzed secondary data on outpatient clinic attendance and sociodemographic, economic, psychosocial, and patient-related factors among 242 adult Malaysian patients initiating ART in Selangor, Malaysia. Study cohort was enrolled in a parent randomized controlled trial (RCT) in Hospital Sungai Buloh Malaysia between January and December 2014, during which peer counseling, medication, and clinic appointment reminders were provided to the intervention group through short message service (SMS) and telephone calls for 24 consecutive weeks. Data on outpatient clinic attendance were extracted from the hospital electronic medical records system, while other patient-level data were extracted from pre-validated Adult AIDS Clinical Trial Group (AACTG) adherence questionnaires in which primary data were collected. Outpatient clinic attendance was categorized into binary outcome - regular attendee and defaulter categories - based on the number of missed scheduled outpatient clinic appointments within a 6-month period. Multivariate regression models were fitted to examine predictors of outpatient clinic attendance using SPSS version 22 and R software. RESULTS:A total of 224 (93%) patients who completed 6-month assessment were included in the model. Out of those, 42 (18.7%) defaulted scheduled clinic attendance at least once. Missed appointments were significantly more prevalent among females (n=10, 37.0%), rural residents (n=10, 38.5%), and bisexual respondents (n=8, 47.1%). Multivariate binary logistic regression analysis showed that Indian ethnicity (adjusted odds ratio [AOR] =0.235; 95% CI [0.063-0.869]; P=0.030) and heterosexual orientation (AOR =4.199; 95% CI [1.040-16.957]; P=0.044) were significant predictors of outpatient clinic attendance among HIV-positive patients receiving ART in Malaysia. CONCLUSION:Ethnicity and sexual orientation of Malaysian patients may play a significant role in their level of adherence to scheduled clinic appointments. These factors should be considered during collaborative adherence strategy planning at ART initiation.

Project description:In sub-Saharan Africa (SSA), antiretroviral therapy (ART) can prolong life for HIV-infected patients. However, patients initiating ART, especially in routine treatment programs, commonly dropout from care either due to death or loss to follow-up.In a cohort of HIV-infected patients initiating ART at a public sector clinic in Uganda, we assessed predictors of dropout from care (a composite outcome combining death and loss to follow-up). From a large set of socio-demographic, clinical, and laboratory variables routinely collected at ART initiation, we selected those predicting dropout at P <0.1 in unadjusted analyses for inclusion into a multivariable proportional hazards regression model. We then used a stepwise backward selection procedure to identify variables which independently predicted dropout at P <0.05.Data from 5,057 patients were analyzed. The median age was 33 years (IQR 28 to 40) and 27.4% had CD4+ T-cell counts <100 cells/μL at ART initiation. The median duration of follow-up was 24 months (IQR = 14 to 42, maximum follow-up = 64 months). Overall dropout was 26.9% (established cumulative mortality = 2.3%, loss to follow-up = 24.6%), 5.6% were transferred to other service providers, and 67.5% were retained in care. A diagnosis of Kaposi's sarcoma (hazard ratio (HR) = 3.3, 95% CI 2.5 to 4.5); HIV-associated dementia (HR = 2.6, 95% CI 1.5 to 4.6); history of cryptococcosis (HR = 2.2, 95% CI 1.4 to 3.3); and reduced hemoglobin concentration (<11 g/dl versus ≥13.8 g/dl (HR = 1.9, 95% CI 1.6 to 2.2) were strong predictors of dropout. Other independent predictors of dropout were: year of ART initiation; weight loss ≥10%; reduced total lymphocyte count; chronic diarrhea; male sex; young age (≤28 years); and marital status.Among HIV-infected patients initiating ART at a public sector clinic in SSA, biological factors that usually predict death were especially predictive of dropout. As most of the dropouts were lost to follow-up, this observation suggests that many losses to follow-up may have died. Future studies are needed to identify appropriate interventions that may improve both individual-level patient outcomes and outcome ascertainment among HIV-infected ART initiators in this setting.

Dataset Information

Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial.

Publications

Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial.

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