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NCT Number: NCT06743698

META Trial - a Mixed Methods Process Evaluation

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.

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Key information

Conditions

HIV Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pre-diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Qualitative interview, focus group, and brief questionnaire findings

    Time frame: 8 weeks

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

John M Broughan, MSc

CONTACT

[email protected]

+353868928972

Walter Cullen, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Collaborators

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

Registry information

Official study title

A Mixed Methods Process Evaluation of a Randomised Controlled Trial (META Trial) to Evaluate the Use of Metformin in HIV-Positive Persons With Pre-Diabetes

Acronym: META

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Dec 20, 2024
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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