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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN77382043 | Other Identifier | International Standard Randomised Controlled Trial Number (ISRCTN) |
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| Name | Class |
|---|---|
| University College London Institute for Global Health | UNKNOWN |
| National Institute for Medical Research, Tanzania | OTHER_GOV |
| Shree Hindu Mandal Hospital, Tanzania | UNKNOWN |
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The aim of this study is to conduct a mixed methods process evaluation of the META trial. Semi-structured interviews, focus groups, and brief questionnaires will be conducted with a purposive sample of participants (patients and healthcare providers) who were involved in the trial to explore the feasibility, acceptability and perceived effectiveness of the trial intervention.
The META trial was a phase II randomised double-blind placebo-controlled trial that is being conducted in Dar es Salaam, Tanzania to evaluate the use of metformin in HIV-positive persons on antiretroviral therapy (ART) with pre-diabetes.
This study aims to explore the feasibility, acceptability and perceived effectiveness of the META trial intervention by conducting qualitative interviews, focus groups, and brief questionnaires with a purposive sample of participants (patients and healthcare providers) in Tanzania who are involved in the META trial.
Data collection will commence during June-July 2025 with a purposive sample of patients and health care professionals who were involved in the trial (n=50-60).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients that participated in the META trial. | ||
| Healthcare staff | Healthcare staff that were involved in the META trial. |
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| Measure | Description | Time Frame |
|---|---|---|
| Qualitative interview, focus group, and brief questionnaire findings | The primary outcome will the findings of in-depth semi-structured qualitative interviews, focus groups, and brief questionnaires with a purposive sample of patients and HCPs who participated in the META trial (n=50-60). | 8 weeks |
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Inclusion Criteria:
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All participants that took part in the META trial will be able to participate in this study. Not all participants involved in the META trial will be included in this study. However, participants will be purposefully sampled to be reflective of the population who participated in the META trial.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John M Broughan, MSc | Contact | +353868928972 | john.broughan@ucd.ie | |
| Walter Cullen, MD | Contact | walter.cullen@ucd.ie |
| Name | Affiliation | Role |
|---|---|---|
| Walter Cullen, MD | UCD NUI: University College Dublin | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37460828 | Background | Garrib A, Kivuyo S, Bates K, Ramaiya K, Wang D, Majaliwa E, Simbauranga R, Charles G, van Widenfelt E, Luo H, Alam U, Nyirenda MJ, Jaffar S, Mfinanga S; META trial team. Metformin for the prevention of diabetes among people with HIV and either impaired fasting glucose or impaired glucose tolerance (prediabetes) in Tanzania: a Phase II randomised placebo-controlled trial. Diabetologia. 2023 Oct;66(10):1882-1896. doi: 10.1007/s00125-023-05968-7. Epub 2023 Jul 18. |
| Label | URL |
|---|---|
| What is The META Trial? (webpage) | View source |
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The study data is likely to include details that would render participants' identifiable and therefore cannot be shared publicly.
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Barcelona Institute for Global Health |
| OTHER |
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| Metformin treatment in Africa (META) (webpage) | View source |