META Trial - a Mixed Methods Process Evaluation

NCT06743698 | Not Yet Recruiting DMC

• 2 other identifiers: 101145764ISRCTN77382043
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV; Pre-diabetes

Keywords

Qualitative Research; Process evaluation; Metformin; Africa; HIV; Pre-diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients

Patients that participated in the META trial.

Healthcare staff

Healthcare staff that were involved in the META trial.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Participants who participated in the META Trial
• Participants who have the capacity to provide written informed consent

Sponsors & Collaborators

• University College Dublin: lead
• University College London Institute for Global Health: collaborator
• National Institute for Medical Research, Tanzania: collaborator
• Shree Hindu Mandal Hospital, Tanzania: collaborator
• Barcelona Institute for Global Health: collaborator

Related Publications (1)

• 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.

  PMID: 37460828 BACKGROUND

Related Links

• What is The META Trial? (webpage)
• Metformin treatment in Africa (META) (webpage)

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Walter Cullen, MD

  UCD NUI: University College Dublin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John M Broughan, MSc

CONTACT

+353868928972; john.broughan@ucd.ie

Walter Cullen, MD

CONTACT

walter.cullen@ucd.ie

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: June 1, 2025
• Primary Completion: July 1, 2025
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 11, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share