Optimizing Counceling on Feeding Options of Babies From Mothers Living With HIV (ROMI)

October 2, 2023 updated by: Radboud University Medical Center

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Insufficient command of Dutch or English language (oral)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Health care providers involved in care for people living with hiv
Semi-structured interviews with health care providers
Behavioral: Semistructured interview
Semistructured interview and validated quality of life assesment using EQ5-DL
Other: People living with HIV with prior pregnancy or desire to have children
Semi-structured interviews with people living with HIV with prior pregnancy or desire to have children
Behavioral: Semistructured interview
Semistructured interview and validated quality of life assesment using EQ5-DL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Experiences and attitudes on subject
Time Frame: Explore during semistructured interview during 1 to 2 hours
Experiences and attitudes on subject
Explore during semistructured interview during 1 to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Angela Colbers, Radboud University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

September 22, 2023

First Submitted That Met QC Criteria

October 2, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2023-16739

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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