Applying the Medical Research Council guidance to evaluate an intervention to support uptake and adherence to antiretroviral therapy for HIV

Brighton and Sussex University Hospitals NHS Trust (UK)0 个研究点目标入组 372 人开始时间: 2014年2月21日最近更新: 2021年1月5日

适应症

试验速览

•1. Male or female, aged 18 years and above
•2. Known HIV infection
•3. Have never been prescribed ART in outpatient clinic care
•4. Being offered antiretroviral therapy treatment according to the BHIVA guidelines (may be subject to change throughout duration of study) OR as deemed appropriate by the patient?s clinician.
•5. If patients are pregnant, treatment should be recommended following pregnancy for at least 12 months following enrolment, according to BHIVA guidelines.
•6. Able to provide written informed consent and available for long-term follow-up
•7. If the patient is assessed as being at high risk for nonadherence on the Beliefs about Medicines Questionnaire-Highly Active Antiretorivral Therapy BMQ-HAART, they are eligible to participate in the intervention trial.

•Exclusion criteria for both observational and interventional components:
•1. Patients who do not speak English
•2. Patients who will be leaving the country for 12 months after their treatment offer and hence will not be available for the follow-up appointments or telephone follow-ups
•3. Patients who lack capacity to consent for themselves
•4. Patients who have been hospitalised for a mental disorder in the past 2 years
•5. Current suicidality or self harm
•6. Pervasive developmental disorders
•7. Active substance misuse/dependence in last three months which renders the patient unable to adhere to the study protocol in the opinion of the physician or investigator
•8. Patients who have ever received antiretroviral therapy in outpatient care
•9. Psychiatric or addictive disorders which could preclude obtaining informed consent
•Criteria for discontinuation
•Participants may be discontinued from participation in either the observational or interventional components of the study at any time, at the discretion of the Investigator. Specific reasons for discontinuing a participant from the study are:
•1. Withdrawal of informed consent
•2. Development of exclusion criteria or other safety reasons during the study
•3. Incorrect enrolment or randomisation of the subject

发起方

Brighton and Sussex University Hospitals NHS Trust (UK)