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ROAD (ROtterdam ADherence) project; Improvement of treatment adherence among immigrants with HIV.


- candidate number21279
- NTR NumberNTR4941
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jan-2015
- Secondary IDsMEC-2012-399 2011107 (Aids Fonds)
- Public TitleROAD (ROtterdam ADherence) project; Improvement of treatment adherence among immigrants with HIV.
- Scientific TitleVerbeteren van therapietrouw en –respons bij immigranten met HIV middels een combinatie van interventies; het Rotterdams Adherence (ROAD) project.
- ACRONYMROAD-project
- hypothesisProject goal: To increase the percentage of HIV-infected immigrant patients with an HIV-RNA <20 copies/ml (successful treatment) and to reduce the transmission of HIV within this ‘key population’(non-European immigrants). Additionally, improvement of the individuals’ health at a micro-level.
- Healt Condition(s) or Problem(s) studiedHIV infection, Immigrant, internalized stigma, social support, Compliance, lost to follow-up
- Inclusion criteria• HIV-infected • ≥18 years of age • 1st generation immigrant: Born outside of Europe • 2nd generation immigrant: One of both parents born outside of Europe
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupFactorial
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-nov-2012
- planned closingdate1-aug-2015
- Target number of participants480
- InterventionsActivities: • Identify patients who miss their clinical appointments and take actions to improve their outpatient clinic visit compliance. • Early screening and treatment of depression • Modified Directly Observed Therapy (m-DOT) • Group consult • Peer-support
- Primary outcomeHigher percentage of immigrant patients with a HIV-RNA <20 copies/ml.
- Secondary outcomePatient level: Better self-reported adherence, less missed outpatient clinic appointments, more retrieved pharmacy prescriptions, lower percentage of patients lost to follow up, high percentage of successful depression treatments. Program level: Information about the feasibility and acceptance of the developed interventions (process-evaluation) and securing the sub-projects if successful.
- TimepointsNovember 2012 - August 2014
- Trial web siteNot applicable
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIESProf. dr. A Verbon
- CONTACT for SCIENTIFIC QUERIESProf. dr. A Verbon
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
AIDS fund
- PublicationsIn progress
- Brief summaryResearch and experience show that non-European HIV-infected immigrants have worse health- and treatment outcomes than Dutch HIV-infected patients. Reasons for this difference in outcomes seem to be caused by (among others) internalized stigma, depression and low social support. This project aims to raise the percentage of HIV-infected patients with HIV RNA <20 copies/ml by testing several interventions. These include (1) Identify patients who miss their clinical appointments and take actions to improve their outpatient clinic visit compliance,(2) modified Directly Observed Therapy (m-DOT), (3) group consult, (4) peer-support and (5) early screening and treatment of depression. We believe that incorporating these interventions in usual care, the patients’ treatment outcomes and quality of live will improve and this will lead to a decrease in transmission of HIV. In addition, reasons for non-adherence will be investigated in the different groups of HIV-infected immigrants.
- Main changes (audit trail)
- RECORD5-jan-2015 - 16-feb-2015


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