Tailored mHealth intervention for improving treatment adherence for people living with HIV in Iran (HamRaah): protocol for a feasibility study and randomised pilot trial with a nested realist evaluation
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. mHealth interventions can improve ART adherence by...
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BMJ Publishing Group
2021-06-01
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| Series: | BMJ Open |
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| author | Jessica Haberer Minoo Mohraz Jane Barlow Franziska Meinck Lora Sabin Vira Ameli Leila Taj |
| author_facet | Jessica Haberer Minoo Mohraz Jane Barlow Franziska Meinck Lora Sabin Vira Ameli Leila Taj |
| author_sort | Jessica Haberer |
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| description | 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. 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 randomised controlled trial (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 RCT of HamRaah, with an embedded realist evaluation will be conducted. Participants will be randomised 1:1 to HamRaah or routine care for a 6-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 People living with HIV 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.Trial registration number IRCT20100601004076N23; Pre-results. |
| format | Article |
| id | doaj-art-45f9d527e77f449b82e35661af0be42a |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2021-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-45f9d527e77f449b82e35661af0be42a2024-11-19T05:10:13ZengBMJ Publishing GroupBMJ Open2044-60552021-06-0111610.1136/bmjopen-2020-042296Tailored mHealth intervention for improving treatment adherence for people living with HIV in Iran (HamRaah): protocol for a feasibility study and randomised pilot trial with a nested realist evaluationJessica Haberer0Minoo Mohraz1Jane Barlow2Franziska Meinck3Lora Sabin4Vira Ameli5Leila Taj614 Medicine, Harvard Medical School, Boston, Massachusetts, USAprofessorDepartment of Social Policy, University of Oxford, Oxford, UK3 The University of Edinburgh School of Social and Political Science, Edinburgh, UKDepartment of Global Health, Boston University School of Public Health, Boston, Massachusetts, USASocial Policy and Intervention, Oxford University, Oxford, UKIranian Research Center for HIV / AIDS, Tehran University of Medical Sciences, Tehran, Iran (the Islamic Republic of)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. 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 randomised controlled trial (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 RCT of HamRaah, with an embedded realist evaluation will be conducted. Participants will be randomised 1:1 to HamRaah or routine care for a 6-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 People living with HIV 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.Trial registration number IRCT20100601004076N23; Pre-results.https://bmjopen.bmj.com/content/11/6/e042296.full |
| spellingShingle | Jessica Haberer Minoo Mohraz Jane Barlow Franziska Meinck Lora Sabin Vira Ameli Leila Taj Tailored mHealth intervention for improving treatment adherence for people living with HIV in Iran (HamRaah): protocol for a feasibility study and randomised pilot trial with a nested realist evaluation BMJ Open |
| title | Tailored mHealth intervention for improving treatment adherence for people living with HIV in Iran (HamRaah): protocol for a feasibility study and randomised pilot trial with a nested realist evaluation |
| title_full | Tailored mHealth intervention for improving treatment adherence for people living with HIV in Iran (HamRaah): protocol for a feasibility study and randomised pilot trial with a nested realist evaluation |
| title_fullStr | Tailored mHealth intervention for improving treatment adherence for people living with HIV in Iran (HamRaah): protocol for a feasibility study and randomised pilot trial with a nested realist evaluation |
| title_full_unstemmed | Tailored mHealth intervention for improving treatment adherence for people living with HIV in Iran (HamRaah): protocol for a feasibility study and randomised pilot trial with a nested realist evaluation |
| title_short | Tailored mHealth intervention for improving treatment adherence for people living with HIV in Iran (HamRaah): protocol for a feasibility study and randomised pilot trial with a nested realist evaluation |
| title_sort | tailored mhealth intervention for improving treatment adherence for people living with hiv in iran hamraah protocol for a feasibility study and randomised pilot trial with a nested realist evaluation |
| url | https://bmjopen.bmj.com/content/11/6/e042296.full |
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