META Trial - a Mixed Methods Process Evaluation

NCT ID: NCT06743698

Last Updated: 2025-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-02-28

Brief Summary

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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.

Detailed Description

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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).

Conditions

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HIV Pre-diabetes

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

Patients that participated in the META trial.

No interventions assigned to this group

Healthcare staff

Healthcare staff that were involved in the META trial.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participants who participated in the META Trial
* Participants who have the capacity to provide written informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University College London Institute for Global Health

UNKNOWN

Sponsor Role collaborator

National Institute for Medical Research, Tanzania

OTHER_GOV

Sponsor Role collaborator

Shree Hindu Mandal Hospital, Tanzania

UNKNOWN

Sponsor Role collaborator

Barcelona Institute for Global Health

OTHER

Sponsor Role collaborator

University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Walter Cullen, MD

Role: PRINCIPAL_INVESTIGATOR

UCD NUI: University College Dublin

Central Contacts

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John M Broughan, MSc

Role: CONTACT

+353868928972

Walter Cullen, MD

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 37460828 (View on PubMed)

Related Links

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Other Identifiers

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ISRCTN77382043

Identifier Type: OTHER

Identifier Source: secondary_id

101145764

Identifier Type: -

Identifier Source: org_study_id

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