Evaluating the impact of an intervention providing support with ART

Not Applicable

Completed

• Conditions: Topic: Infection; Subtopic: Infection (all Subtopics); Disease: Infectious diseases and microbiology; Infections and Infestations

• Registration Number: ISRCTN35514212
• Lead Sponsor: Brighton and Sussex University Hospitals NHS Trust (UK)

Brief Summary

2019 protocol in https://pubmed.ncbi.nlm.nih.gov/31286908/ (added 17/12/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-21
• Study Completion: 2019-04-30
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 372

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of months under follow-up where adherence = 90% using AARDEX MEMS; Timepoint(s): 12 months post randomisation

Secondary Outcome Measures

Name	Time	Method
<br> 1. Change in perceptual and practical barriers; Timepoint(s): Baseline, 3, 6, 12 months post randomisation<br> 2. Disengagement from care at 12 months; Timepoint(s): 12 months post randomisation<br> 3. Health and social service use; Timepoint(s): Baseline, 3, 6, 12 months post randomisation<br> 4. Quality of life; Timepoint(s): Baseline, 3, 6, 12 months post randomisation<br> 5. Rate of ARV regimen switching; Timepoint(s): 12 months post baseline<br> 6. Ratings of anxiety and depression; Timepoint(s): Baseline, 3, 6, 12 months post randomisation<br> 7. Referral out of the intervention; Timepoint(s): 12 months post baseline<br> 8. Treatment failure; Timepoint(s): 12 months post randomisation<br>