Clinical trial NCT06743698: META Trial - a Mixed Methods Process Evaluation
Official 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV
Pre-diabetes
Keywords: Qualitative Research
Process evaluation
Metformin
Africa
HIV
Pre-diabetes
Lead sponsor: University College Dublin
Sponsor class: OTHER
Collaborators: name: University College London Institute for Global Health
name: National Institute for Medical Research, Tanzania
name: Shree Hindu Mandal Hospital, Tanzania
name: Barcelona Institute for Global Health
First posted: 2024-12-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Qualitative interview, focus group, and brief questionnaire findings
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UCD NUI: University College Dublin
name: Walter Cullen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.