META Trial - a Mixed Methods Process Evaluation

University College Dublin

Status: Not yet enrolling

Conditions: Pre-diabetes; HIV

Study type: Observational

Funder types: Other

Identifiers

NCT06743698

101145764

ISRCTN77382043 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

60 participants in 2 patient groups

Patients

Description:

Patients that participated in the META trial.

Healthcare staff

Description:

Healthcare staff that were involved in the META trial.