HIVMETANCT06743698
META Trial - a Mixed Methods Process Evaluation
An observational study of HIV and Pre-diabetes, run by University College Dublin.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV, Pre-diabetes
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participants who participated in the META Trial
- Participants who have the capacity to provide written informed consent
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Walter Cullen, MD contact
About this study
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
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.
Read the 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).
- Conditions
- HIV, Pre-diabetes
- Keywords
- Qualitative Research, Process evaluation, Metformin, Africa, HIV, Pre-diabetes
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients that participated in the META trial. | |
| Healthcare staff | Healthcare staff that were involved in the META trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start1 Jun 2025 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Institute for Global Health, National Institute for Medical Research, Tanzania, Shree Hindu Mandal Hospital, Tanzania, Barcelona Institute for Global Health
- Responsible party
- Sponsor
- Investigators
- Walter Cullen, MD, Principal investigator, UCD NUI: University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743698
- Sponsor's protocol ID
- 101145764
- Other IDs
- ISRCTN77382043
- Acronym
- META
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study data is likely to include details that would render participants' identifiable and therefore cannot be shared publicly.
Publications
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.
PubMed 37460828
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06743698
- Acronym / sponsor ID
- META / 101145764
- Conditions
- HIV, Pre-diabetes
- Keywords
- Qualitative Research, Process evaluation, Metformin, Africa, HIV, Pre-diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- University College London Institute for Global Health, National Institute for Medical Research, Tanzania, Shree Hindu Mandal Hospital, Tanzania, Barcelona Institute for Global Health
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients that participated in the META trial. |
| Healthcare staff | – | –Healthcare staff that were involved in the META trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Participants who participated in the META Trial
- Participants who have the capacity to provide written informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
- Background: PubMed 37460828Garrib 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.
- What is The META Trial? (webpage)Link provided by the sponsor.
- Metformin treatment in Africa (META) (webpage)Link provided by the sponsor.
- Individual participant dataSharing planned: No. The study data is likely to include details that would render participants' identifiable and therefore cannot be shared publicly.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Walter Cullen, MD contact
Walter Cullen, MD principal investigator
UCD NUI: University College Dublin
Questions about this trial
What is this clinical trial studying?
An observational study of HIV and Pre-diabetes, run by University College Dublin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John M Broughan, MSc (+353868928972, john.broughan@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative interview, focus group, and brief questionnaire findings (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06743698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.