scholarly journals The Stepped Care Intervention to Suppress Viral Load in Youth Living With HIV: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Elizabeth Mayfield Arnold ◽  
Dallas Swendeman ◽  
Danielle Harris ◽  
Jasmine Fournier ◽  
Leslie Kozina ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Stepped Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Youth Living With Hiv ◽  
Living With Hiv

BACKGROUND Among youth living with HIV (YLH) aged 12-24 years who have health care in the United States, only 30% to 40% are virally suppressed. YLH must achieve viral suppression in order to reduce the probability of infecting others as well as increasing the length and quality of their own life. OBJECTIVE This randomized controlled trial aimed to evaluate the efficacy of an Enhanced Standard Care condition (n=110) compared to an Enhanced Stepped Care intervention condition (n=110) to increase viral suppression among YLH aged 12-24 years with established infection (not acutely infected). METHODS YLH (N=220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community-based organizations in Los Angeles, CA, and New Orleans, LA. Informed consent will be obtained from all participants. YLH will be randomly assigned to one of two study conditions: Enhanced Standard Care, which includes standard clinical care plus an automated messaging and monitoring intervention (AMMI), or an Enhanced Stepped Care, which includes three levels of intervention (AMMI, Peer Support via social media plus AMMI, or Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at 4-month intervals for 24 months. For the Enhanced Stepped Care intervention group, those who do not achieve viral suppression (via blood draw, viral load<200 copies/mL) at any 4-month assessment will “step up” to the next level of intervention. Secondary outcomes will be retention in care, antiretroviral therapy adherence, alcohol use, substance use, sexual behavior, and mental health symptoms. RESULTS Recruitment for this study began in June 2017 and is ongoing. We estimate data collection to be completed by the end of 2020. CONCLUSIONS This is the first known application of an Enhanced Stepped Care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost-effective method of helping YLH achieve viral suppression and improve their quality of life. CLINICALTRIAL ClinicalTrials.gov NCT03109431; https://clinicaltrials.gov/ct2/show/NCT03109431 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/10791

scholarly journals The Stepped Care Intervention to Suppress Viral Load in Youth Living With HIV: Protocol for a Randomized Controlled Trial

10.2196/10791 ◽  
2019 ◽  
Vol 8 (2) ◽  
pp. e10791 ◽  
Author(s):  
Elizabeth Mayfield Arnold ◽  
Dallas Swendeman ◽  
Danielle Harris ◽  
Jasmine Fournier ◽  
Leslie Kozina ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Viral Load ◽  
Controlled Trial ◽  
Stepped Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Youth Living With Hiv ◽  
Living With Hiv

Evaluation of a telephone-based stepped care intervention for alcohol-related disorders: A randomized controlled trial

2008 ◽  
Vol 93 (3) ◽  
pp. 244-251 ◽  
Author(s):  
Gallus Bischof ◽  
Janina M. Grothues ◽  
Susa Reinhardt ◽  
Christian Meyer ◽  
Ulrich John ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Stepped Care ◽  
Randomized Controlled ◽  
Care Intervention

scholarly journals Treatment of early hypertension among persons living with HIV in Haiti: Protocol for a randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (8) ◽  
pp. e0254740
Author(s):  
Lily D. Yan ◽  
Vanessa Rouzier ◽  
Eliezer Dade ◽  
Collette Guiteau ◽  
Jean Lookens Pierre ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Randomized Controlled Trial ◽  
Antihypertensive Treatment ◽  
Viral Suppression ◽  
Controlled Trial ◽  
Standard Of Care ◽  
People Living With Hiv ◽  
Cvd Risk ◽  
Randomized Controlled ◽  
Living With Hiv

Background People living with HIV (PLWH) are at increased risk of cardiovascular disease (CVD) and death, with greater burdens of both HIV and CVD in lower-middle income countries. Treating prehypertension in PLWH may reduce progression to hypertension, CVD risk and potentially mortality. However, no trial has evaluated earlier blood pressure treatment for PLWH. We propose a randomized controlled trial to assess the feasibility, benefits, and risks of initiating antihypertensive treatment among PLWH with prehypertension, comparing prehypertension treatment to standard of care following current WHO guidelines. Methods A total of 250 adults 18–65 years and living with HIV (PLWH) with viral suppression in the past 12 months, who have prehypertension will be randomized to prehypertension treatment versus standard of care. Prehypertension is defined as having a systolic blood pressure (SBP) 120–139 mmHg or diastolic blood pressure (DBP) 80–89 mmHg. In the prehypertension treatment arm, participants will initiate amlodipine 5 mg daily immediately. In the standard of care arm, participants will initiate amlodipine only if they develop hypertension defined as SBP ≥ 140 mmHg or DBP ≥ 90 mmHg. The primary outcome is the difference in mean change of SBP from enrollment to 12 months. Secondary outcomes include feasibility, acceptability, adverse effects, HIV viral suppression, and medication adherence. Qualitative in-depth interviews with providers and participants will explore attitudes about initiating amlodipine, satisfaction, perceived CVD risk, and implementation challenges. Discussion PLWH have a higher CVD risk and may benefit from a lower BP threshold for initiation of antihypertensive treatment. Trial registration Clinicaltrials.gov registration number NCT04692467, registration date December 15, 2020, protocol ID 20–03021735.

scholarly journals Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Edyta Ryczek ◽  
Judith White ◽  
Ruth Louise Poole ◽  
Nicola Laura Reeves ◽  
Jared Torkington ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Standard Care ◽  
Controlled Trial ◽  
Small Scale ◽  
Perioperative Hypothermia ◽  
Quality Of Recovery ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Patient Reported

BACKGROUND Perioperative hypothermia during laparoscopy for bowel resection is a risk factor for postoperative medical complications and surgical wound infections. Despite various warming methods used during surgery, a significant number of patients experience perioperative hypothermia. Use of dry, unwarmed insufflation carbon dioxide (CO<sub>2</sub>) during laparoscopic procedures may contribute to this problem. Evidence exists that the HumiGard device, which humidifies and heats CO<sub>2</sub> for insufflation, can reduce the risk of perioperative hypothermia. OBJECTIVE The aim is to determine if insufflation with warmed, humidified CO<sub>2</sub> using the HumiGard device, alongside standard perioperative warming techniques, can improve patient recovery, including pain, surgical site infections, complications, and the use of analgesia compared with standard care alone. METHODS The study is a multicenter, randomized, blinded (patient, surgeon, and assessor), sham device-controlled, parallel group-controlled trial of 232 patients. The study aims to recruit patients undergoing elective laparoscopic, segmental, or total colectomy. Patients will be randomized to receive HumiGard plus standard care or standard care alone (1:1 ratio). The primary outcome is patient-reported quality of recovery, measured by the validated QoR-40 (quality of recovery) questionnaire, from baseline to postoperative day 1. Secondary outcomes include postoperative pain, the incidence of hypothermia, and the rate of postoperative complications. RESULTS The information gathered during a small-scale service evaluation at a single hospital was used to inform this study protocol. Before applying for a grant for this full randomized controlled trial, the authors will conduct a feasibility study of 40 patients to ensure that the protocol is feasible and to inform our sample size calculation. CONCLUSIONS The randomized controlled trial is designed to provide high-quality evidence on the effectiveness of the HumiGard device in potentially reducing the risk of perioperative hypothermia in patients scheduled for laparoscopic colectomy. The results will be used to improve the maintenance of adequate patient body temperature during surgery.

scholarly journals A randomized trial of a specialist palliative care intervention for patients undergoing surgery for cancer: rationale and design of the Surgery for Cancer with Option of Palliative Care Expert (SCOPE) Trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Myrick C. Shinall ◽  
Aimee Hoskins ◽  
Alexander T. Hawkins ◽  
Christina Bailey ◽  
Alaina Brown ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Palliative Care ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Specialist Palliative Care ◽  
Randomized Controlled ◽  
Care Intervention ◽  
Scope Trial

Abstract Background In medical oncology settings, early specialist palliative care interventions have demonstrated improvements in patient quality of life and survival compared with usual oncologic care. However, the effect of early specialist palliative care interventions in surgical oncology settings is not well studied. Methods The Surgery for Cancer with Option for Palliative Care Expert (SCOPE) Trial is a single-center, prospective, single-blind, randomized controlled trial of a specialist palliative care intervention for cancer patients undergoing non-palliative surgery. It will enroll 236 patients scheduled for major abdominal operations for malignancy, who will be randomized 1:1 at enrollment to receive usual care (control arm) or specialist palliative care consultation (intervention arm). Intervention arm patients will receive consultations from a palliative care specialist (physician or nurse practitioner) preoperatively and postoperatively. The primary outcome is physical and functional wellbeing at 90 days postoperatively. Secondary outcomes are quality of life at 90 days postoperatively, posttraumatic stress disorder symptoms at 180 days postoperatively, days alive at home without an emergency room visit in the first 90 postoperative days, and overall survival at 1 year postoperatively. Participants will be followed for 3 years after surgery for exploratory analyses of their ongoing quality of life, healthcare utilization, and mortality. Discussion SCOPE is an ongoing randomized controlled trial evaluating specialist palliative care interventions for cancer patients undergoing non-palliative oncologic surgery. Findings from the study will inform ways to identify and improve care of surgical patients who will likely benefit from specialist palliative care services. Trial registration ClinicalTrials.gov Identifier: NCT03436290 First Registered: 16 February 2018 Enrollment Began: 1 March 2018 Last Update: 20 December 2018

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