ISRCTN35514212
Completed
未知
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 sites372 target enrollmentFebruary 21, 2014
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Topic: Infection
- Sponsor
- Brighton and Sussex University Hospitals NHS Trust (UK)
- Enrollment
- 372
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2019 protocol in https://pubmed.ncbi.nlm.nih.gov/31286908/ (added 17/12/2020)
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •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
Outcomes
Primary Outcomes
Not specified
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