scholarly journals Feasibility and Acceptability of the Modified Antiretroviral Treatment Access Study (MARTAS) Intervention Based on a Pilot Study in Ukraine

2019 ◽  
Vol 18 ◽  
pp. 232595821882325 ◽  
Author(s):  
Oleksandr Neduzhko ◽  
Oleksandr Postnov ◽  
Trista Bingham ◽  
Janet J. Myers ◽  
Timothy Flanigan ◽  
...  
Keyword(s):  
Antiretroviral Treatment ◽  
Controlled Trial ◽  
Hiv Treatment ◽  
Small Sample ◽  
Hiv Care ◽  
Treatment Intervention ◽  
Treatment Access ◽  
Individual Level ◽  
Randomized Controlled ◽  
High Satisfaction

We conducted a pilot of the Modified Antiretroviral Treatment Access Study (MARTAS), a linkage to HIV treatment intervention, prior to implementing a multisite randomized controlled trial (RCT) in Ukraine. The objectives of the pilot were to assess the feasibility and acceptability of the MARTAS intervention among a small sample of adults recently diagnosed with HIV at specialty clinics in the Mykolaiv region of Ukraine in 2015. The adapted intervention consisted of up to 6 individual-level sessions with a linkage coordinator (nurse) over a 90-day period. Overall, 22 persons participated in the pilot. On average, participants received 4.2 sessions and 14 participants linked to HIV care within 3 months of study enrollment. All 18 participants who completed the acceptability survey expressed high satisfaction with their interaction with their linkage coordinator. The results of the pilot demonstrated feasibility and acceptability of the MARTAS intervention in advance of a larger scale RCT in Ukraine.

scholarly journals An Intervention by and for Transgender Women Living With HIV: Study Protocol for a Two-Arm Randomized Controlled Trial Testing the Efficacy of “Healthy Divas” to Improve HIV Care Outcomes

2021 ◽  
Vol 3 ◽  
Author(s):  
Jae M. Sevelius ◽  
Torsten B. Neilands ◽  
Cathy J. Reback ◽  
Danielle Castro ◽  
Samantha E. Dilworth ◽  
...  
Keyword(s):  
Social Services ◽  
San Francisco ◽  
Controlled Trial ◽  
Transgender Women ◽  
Hiv Treatment ◽  
Hiv Care ◽  
Randomized Controlled ◽  
Women Living With Hiv ◽  
Institutional Review ◽  
Living With Hiv

Introduction: Transgender women (assigned “male” at birth but who do not identify as male) are disproportionately impacted by HIV and experience unique barriers and facilitators to HIV care engagement. In formative work, we identified culturally specific and modifiable barriers to HIV treatment engagement among transgender women living with HIV (TWH), including prioritizing transition-related healthcare over HIV treatment, avoiding HIV care settings due to gender-related and HIV stigma, concerns about potential drug interactions with hormones, and inadequate social support. Grounded in the investigators' Models of Gender Affirmation and Health Care Empowerment, we developed the Healthy Divas intervention to optimize engagement in HIV care among TWH at risk for treatment failure and consequential morbidity, mortality, and onward transmission of HIV.Methods and Analysis: We conducted a 2-arm randomized controlled trial (RCT) of the intervention's efficacy in Los Angeles and San Francisco to improve engagement in care among TWH (N = 278). The primary outcome was virologic control indicated by undetectable HIV-1 level (undetectability = < 20 copies/mL), at baseline and follow-up assessment for 12 months at 3-month intervals.Ethics and Dissemination: This study was approved by University of California, San Francisco Institutional Review Board (15-17910) and Western Institutional Review Board (20181370). Participants provided informed consent before enrolment in the study. We are committed to collaboration with National Institutes of Health officials, other researchers, and health and social services communities for rapid dissemination of data and sharing of materials. The results will be published in peer-reviewed academic journals and scientific presentations. We will make our results available to researchers interested in transgender health to avoid unintentional duplication of research, as well as to others in health and social services communities, including HIV clinics, LGBT community-based organizations, and AIDS service organizations.Clinical Trial Registration:Clinicaltrials.gov, identifier NCT03081559.

scholarly journals Impact of Xpert MTB/RIF on Antiretroviral Therapy-Associated Tuberculosis and Mortality: A Pragmatic Randomized Controlled Trial

2014 ◽  
Vol 1 (1) ◽  
Author(s):  
L. Mupfumi ◽  
B. Makamure ◽  
M. Chirehwa ◽  
T. Sagonda ◽  
S. Zinyowera ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Limited Resource ◽  
Hiv Treatment ◽  
Treatment Programs ◽  
Sputum Smear ◽  
Smear Microscopy ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Art Initiation

Abstract Introduction.  GeneXpert® MTB/RIF (Xpert) is now widely distributed in high human immunodeficiency virus (HIV)/tuberculosis (TB)-burden countries. Yet, whether the test improves patient-important outcomes within HIV treatment programs in limited resource settings is unknown. Methods.  To investigate whether use of Xpert for TB screening prior to initiation of antiretroviral treatment (ART) improves patient-important outcomes, in a pragmatic randomized controlled trial we assigned 424 patients to Xpert or fluorescence sputum smear microscopy (FM) at ART initiation. The primary endpoint was a composite of 3-month mortality and ART-associated TB. Results.  There was no difference in overall TB diagnosis at ART initiation (20% [n = 43] Xpert vs 21% [n = 45] FM; P = .80), with most patients in both groups treated empirically. There was no difference in time to TB treatment initiation {5 days (interquartile range [IQR], 3–13) vs 8 days [IQR, 3–23; P = .26]} or loss to follow-up (32 [15%] vs 38 [18%]; P = 0.38). Although a nonsignificant reduction in mortality occurred in the Xpert group (11 [6%] vs 17 [10%]; 95% CI, −9% to 2%; P = .19), there was no difference in the composite outcome (9% [n = 17] Xpert vs 12% [n = 21] FM; difference −3%; 95% CI, −9% to 4%). Conclusions.  Among HIV-infected initiating ART, centralized TB screening with Xpert did not reduce the rate of ART-associated TB and mortality, compared with fluorescence microscopy.

Disseminating Behavioural Activation for Depression via Online Training: Preliminary Steps

2014 ◽  
Vol 43 (2) ◽  
pp. 224-238 ◽  
Author(s):  
Sam Hubley ◽  
Eric A. Woodcock ◽  
Linda A. Dimeff ◽  
Sona Dimidjian
Keyword(s):  
Controlled Trial ◽  
Treatment Strategies ◽  
Online Training ◽  
Behavioural Activation ◽  
Randomized Controlled ◽  
High Satisfaction ◽  
Evidence Based Treatments ◽  
Training Format ◽  
Preliminary Version ◽  
Pilot Randomized Controlled Trial

Background: Despite the availability of evidence-based treatments for depression, large gaps exist between empirical research and clinical practice. Aims: To make preliminary steps toward the dissemination of Behavioural Activation (BA) via online training by examining clinicians’ interest in learning BA via online training and the effects of a preliminary version of BA online training. Method: In study 1, practising clinicians (n = 540) completed a survey that assessed attitudes towards learning BA using an online training format. In study 2, we conducted a small, pilot randomized controlled trial (n = 46) to examine preliminary efficacy of teaching BA principles and treatment strategies with a precursor version of BA online training. Results: Study findings suggest that clinicians have interest in learning about BA via online training and that clinicians participating in BA online training evidence high satisfaction and significant gains in self-efficacy using BA and knowledge of BA terms and concepts. Conclusions: These results support the importance of efforts to disseminate BA and the viability of online training as an easily accessible and affordable training option.

scholarly journals Starch or Saline After Cardiac Surgery: A Double-Blinded Randomized Controlled Trial

2020 ◽  
Vol 7 ◽  
pp. 205435812094043
Author(s):  
A. Dave Nagpal ◽  
Andrea Cowan ◽  
Linna Li ◽  
Graeme Nusca ◽  
Linrui Guo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Cardiac Surgery ◽  
Weight Gain ◽  
Controlled Trial ◽  
Coronary Revascularization ◽  
Small Sample ◽  
Resource Limitations ◽  
Randomized Controlled ◽  
Surgery Patient ◽  
Double Blinded

Background: Despite decades of investigation, the balance of clinical risks and benefits of fluid supplementation with starch remain unresolved. Patient-centered outcomes have not been well explored in a “real-world” trial in cardiac surgery. Objective: We sought to compare a starch-based fluid strategy with a saline-based fluid strategy in the cardiac surgery patient. Design: A pragmatic blinded randomized controlled trial comparing starch-based with saline-based fluid strategy. Setting: A large tertiary academic center in London Ontario between September 2009 and February 2011. Participants: Patients undergoing planned, isolated coronary revascularization. Measurements: Serum creatinine and patient weight were measured daily postoperatively. Methods: Patients were randomized to receive 6% hydroxyethyl starch (Voluven) or saline for perioperative fluid requirements. Fluid administration was not protocolized. Co-primary outcomes were incidence of acute kidney injury (AKI) and maximum postoperative weight gain. Secondary outcomes included bleeding, transfusion, inotropic and ventilator support, and fluid utilization. Results: The study was prematurely terminated due to resource limitations. A total of 69 patients (19% female, mean age = 65) were randomized. Using RIFLE criteria for AKI, “risk” occurred in 12 patients in each group (risk ratio [RR] = 1.0; 95% confidence interval [CI] = 0.5-1.9; P = 1.00), whereas “injury” occurred in 7 of 35 (20%) and 3 of 34 (9%) of patients in the starch and saline groups, respectively (RR = 2.3; 95% CI = 0.6-8.1; P = .31). Maximum weight gain, bleeding and blood product usage, and overall fluid requirement were similar between groups. Limitations: The study had to be prematurely terminated due to resource limitations which led to a small sample size which was not sufficiently powered to detect a difference in the primary outcomes. Conclusions: This pragmatic double-blinded randomized controlled trial revealed a number of interesting hypothesis-generating trends and confirmed the feasibility of undertaking a logistically complex trial in a pragmatic fashion.

Gut Microbiota Shifts Favorably with Delivery of Handwashing with Soap and Water Treatment Intervention in a Prospective Cohort (CHoBI7 Trial)

2021 ◽  
Author(s):  
Shirajum Monira ◽  
Indrajeet Barman ◽  
Fatema Tuz Jubyda ◽  
Sk. Imran Ali ◽  
Aminul Islam ◽  
...  
Keyword(s):  
Gut Microbiota ◽  
Relative Abundance ◽  
Controlled Trial ◽  
Elevated Risk ◽  
Great Promise ◽  
Treatment Intervention ◽  
Bacterial Phyla ◽  
Household Contacts ◽  
Randomized Controlled ◽  
Handwashing With Soap

Abstract Cholera can result in the expulsion of important microbiota from the gut and result in death if left untreated. The disease transmits mainly via drinking water carrying Vibrio cholerae; and household contacts (HHC) of cholera patients are at elevated risk during the first week of infection. The gut microbiota profiles of HHC-children of cholera patients at Dhaka city slums were investigated before (day 0) and after (day 8) delivery of chlorinated water as part of the cholera-hospital-based intervention for 7 days (CHoBI7), a randomized controlled trial. Results of sequencing and analysis of bacterial community DNA revealed the predominance of two bacterial phyla: Bacteroidetes and Firmicutes at day 0 with a relative abundance of 62 ± 6 (mean ± SEM %) and 32 ± 7, respectively. The pattern reversed at day 8 with a decreased relative abundance of Bacteroidetes (39 ± 12) and an increased abundance of Firmicutes (49 ± 12). Of 65 bacterial families confirmed at day 0, six belonging to Proteobacteria including Vibrionaceae disappeared at day 8. Interestingly, the relative abundance of four Firmicutes families– Lachnospiraceae, Bifidobacteriaceae, Clostridiaceae, and Ruminococcaceae was increased in all five study children at day 8. The observed exclusion of pathogenic Proteobacteria and enhancement of beneficial Firmicutes in the gut of children delivered with chlorinated water as part of WASH intervention reflect a great promise of the CHoBI7 program in preventing cholera and improving child health.

Acceptance-enhanced behavior therapy for trichotillomania: Randomized controlled trial rationale, method, and strategies for recruiting minority participants

2019 ◽  
Vol 83 (4) ◽  
pp. 399-431
Author(s):  
Angela Neal-Barnett ◽  
Douglas W. Woods ◽  
Flint M. Espil ◽  
Martale Davis ◽  
Jennifer R. Alexander ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Therapy ◽  
Controlled Trial ◽  
Small Sample ◽  
Randomized Controlled ◽  
Promising Treatment ◽  
Current Article ◽  
Small Sample Sizes ◽  
Fidelity Measures ◽  
Minority Participants

Trichotillomania (TTM) involves the chronic pulling out of hair to the point of hair loss or thinning, which continues despite repeated attempts to stop. Behavior therapy is a promising treatment for the condition, but studies have been limited by the lack of a credible control condition, small sample sizes, follow-up periods of short duration, and low participation by underrepresented populations. In the current article, the authors describe the theoretical rationale for an acceptance-enhanced form of behavior therapy for TTM in adults and describe the methodology used to test the efficacy of this intervention against a psychoeducation and supportive control condition. In addition, the authors discuss the importance of and difficulties encountered with enrolling minority participants into TTM research, as well as strategies used to enhance minority recruitment. Finally, the authors discuss the instruments, procedures, and related outcomes of the fidelity measures used in the randomized controlled trial.

scholarly journals Effectiveness of Psychological Capital Intervention and Its Influence on Work-Related Attitudes: Daily Online Self-Learning Method and Randomized Controlled Trial Design

2020 ◽  
Vol 17 (23) ◽  
pp. 8754
Author(s):  
Shu Da ◽  
Yue He ◽  
Xichao Zhang
Keyword(s):  
Randomized Controlled Trial ◽  
Trial Design ◽  
Psychological Capital ◽  
Controlled Trial ◽  
Small Sample ◽  
Full Time ◽  
Work Related ◽  
Randomized Controlled ◽  
Small Effect Size ◽  
Self Learning

Research on positive psychology intervention is in its infancy; only a few empirical studies have proved the effectiveness and benefits of psychological capital interventions in workplaces. From a practical perspective, a more convenient intervention approach is needed for when organizations have difficulties in finding qualified trainers. This study aims to extend the psychological capital intervention (PCI) model and examine its influence on work-related attitudes. A daily online self-learning approach and a randomized controlled trial design are utilized. A final sample of 104 full-time employees, recruited online, is randomly divided into three groups to fill in self-report questionnaires immediately before (T1), immediately after (T2), and one week after (T3) the intervention. The results indicate that the intervention is effective at improving psychological capital (PsyCap), increasing job satisfaction, and reducing turnover intention. The practical implications for human resource managers conducting a flexible and low-cost PsyCap intervention in organizations are discussed. Limitations related to sample characteristics, short duration effect, small sample size, and small effect size are also emphasized. Due to these non-negligible drawbacks of the study design, this study should only be considered as a pilot study of daily online self-learning PsyCap intervention research.

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