HivROMINCT06067646
Optimizing Counceling on Feeding Options of Babies From Mothers Living With HIV
A study testing Semistructured interview in people with Hiv, run by Radboud University Medical Center.
Trial summary
Semi structured interviews will be performed to determine attitudes and experiences of people living with HIV and health care providers on counseling on feeding options of babies from mothers living with HIV in order to optimize counseling in the future Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hiv
- What is being tested?
- Semistructured interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Health care provider involved in care for people living with HIV in Duth HIV treatment facility or
- Person living with HIV + age 18-45 + prior pregnancy/desire to have children
Who cannot join
- Insufficient command of Dutch or English language (oral)
Trial locations and contacts
No sites are listed yet.
Angela Colbers contact
About this study
Official title: From Guidelines to Clinical Care: What is Needed for Optimizing Counceling on Feeding Options of Babies From Mothers Living With HIV?
Semi structured interviews will be performed to determine attitudes and experiences of people living with HIV and health care providers on counseling on feeding options of babies from mothers living with HIV in order to optimize counseling in the future
- Conditions
- Hiv
- Being tested
- Semistructured interview
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semistructured interviewBehavioural
Semistructured interview and validated quality of life assesment using EQ5-DL
| Study group | Role | What they receive |
|---|---|---|
| Health care providers involved in care for people living with hiv | Other | Semi-structured interviews with health care providers Receives: Behavioral: Semistructured interview |
| People living with HIV with prior pregnancy or desire to have children | Other | Semi-structured interviews with people living with HIV with prior pregnancy or desire to have children Receives: Behavioral: Semistructured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences and attitudes on subject
Experiences and attitudes on subject
Measured: Explore during semistructured interview during 1 to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Colbers, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067646
- Sponsor's protocol ID
- 2023-16739
- Other IDs
- 2023
- Acronym
- ROMI
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Guidelines to Clinical Care: What is Needed for Optimizing Counceling on Feeding Options of Babies From Mothers Living With HIV?
- ClinicalTrials.gov ID
- NCT06067646
- Acronym / sponsor ID
- ROMI / 2023-16739
- Conditions
- Hiv
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Oct 2023 (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.
Semi structured interviews will be performed to determine attitudes and experiences of people living with HIV and health care providers on counseling on feeding options of babies from mothers living with HIV in order to optimize counseling in the future
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health care providers involved in care for people living with hiv | Other | Behavioral: Semistructured interviewSemi-structured interviews with health care providers |
| People living with HIV with prior pregnancy or desire to have children | Other | Behavioral: Semistructured interviewSemi-structured interviews with people living with HIV with prior pregnancy or desire to have children |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Health care provider involved in care for people living with HIV in Duth HIV treatment facility or
- Person living with HIV + age 18-45 + prior pregnancy/desire to have children
Key exclusion criteria (1 listed)
- Insufficient command of Dutch or English language (oral)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semistructured interviewSemistructured interview and validated quality of life assesment using EQ5-DL | Behavioural | Health care providers involved in care for people living with hiv, People living with HIV with prior pregnancy or desire to have children |
Primary outcome
Experiences and attitudes on subject
Time frame: Explore during semistructured interview during 1 to 2 hours
Experiences and attitudes on subject
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Angela Colbers contact
Angela Colbers principal investigator
Radboud University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Semistructured interview in people with Hiv, run by Radboud University Medical Center.
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 1 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: status not confirmed, as of the sponsor's last update on 5 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wendy van der Wekken-Pas, MD (+31681485606, wendy.vanderwekken-pas@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experiences and attitudes on subject (time frame: Explore during semistructured interview during 1 to 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2023.