Abstract
Introduction: Middle East and North Africa (MENA) has a rising rate of new HIV infections and AIDS-related mortality. Consistent adherence to antiretroviral therapy (ART) leads to viral suppression, preventing HIV transmission and treatment failure. Mobile health (mHealth) interventions can improve ART adherence by providing tailored support and directing patients to existing healthcare services. HamRaah (Persian for ‘together-in-path’) is the first mHealth-based intervention in a MENA country and is designed to improve adherence through two-way mobile messaging for people recently diagnosed with HIV in Tehran, Iran. The objectives of this pilot RCT are to examine the feasibility, acceptability, and preliminary effectiveness of HamRaah, and to develop an explanatory theory for any observed effects through a nested realist evaluation.
Methods: A feasibility study and two-arm randomized controlled trial of HamRaah, with an embedded realist evaluation will be conducted. Participants will be randomised 1:1 to HamRaah or routine care for a six-month intervention. The initial effectiveness of HamRaah will be assessed through the primary outcome of self-reported ART adherence and several secondary outcomes: retention in care, CD4 count, and viral suppression. A theory-driven realist evaluation framework will be used to develop an explanatory theory regarding what works, for whom, how, and in what context.
Ethics and Dissemination: The study received ethical clearance from Tehran University of Medical Sciences Ethics Committee and Oxford Tropical Research Ethics Committee. The trial is registered with the Iranian Registry of Clinical Trials (ID: IRCT20100601004076N23). People living with HIV (PLHIV) in Tehran and key country stakeholders in HIV policy and programming have been involved in the development of HamRaah and this pilot trial. Participants will provide informed consent prior to study enrolment. The results will be disseminated to all stakeholders and presented in peer-reviewed journal publications and conferences.
Methods: A feasibility study and two-arm randomized controlled trial of HamRaah, with an embedded realist evaluation will be conducted. Participants will be randomised 1:1 to HamRaah or routine care for a six-month intervention. The initial effectiveness of HamRaah will be assessed through the primary outcome of self-reported ART adherence and several secondary outcomes: retention in care, CD4 count, and viral suppression. A theory-driven realist evaluation framework will be used to develop an explanatory theory regarding what works, for whom, how, and in what context.
Ethics and Dissemination: The study received ethical clearance from Tehran University of Medical Sciences Ethics Committee and Oxford Tropical Research Ethics Committee. The trial is registered with the Iranian Registry of Clinical Trials (ID: IRCT20100601004076N23). People living with HIV (PLHIV) in Tehran and key country stakeholders in HIV policy and programming have been involved in the development of HamRaah and this pilot trial. Participants will provide informed consent prior to study enrolment. The results will be disseminated to all stakeholders and presented in peer-reviewed journal publications and conferences.
| Original language | English |
|---|---|
| Article number | e042296 |
| Pages (from-to) | 1-10 |
| Number of pages | 10 |
| Journal | BMJ Open |
| Volume | 11 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - 23 Jun 2021 |