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NCT04051177 · ClinicalTrials.gov registry record · NA
Theory-based HIV Disclosure Intervention for Parents
A NA study of HIV/AIDS and Disclosure, sponsored by University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 791
- Enrollment target
- 1
- Study location
NCT04051177: Completed NA study of HIV/AIDS and Disclosure, sponsored by University of South Carolina.
NCT04051177 is a NA study of HIV/AIDS and Disclosure that has completed, run by University of South Carolina. The registered enrollment target is 791 participants, below the 33,168-participant average among 61 other HIV/AIDS trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04051177, a NA study of HIV/AIDS and Disclosure, has completed, sponsored by University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 791 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators propose to develop, implement, and evaluate a theory-driven parental disclosure intervention to assist parents living with HIV (PLH) to make a planned, developmentally appropriate disclosure of their HIV status to their uninfected children or, for PLH with younger children, to articulate a clear plan for disclosure to their children when developmentally appropriate. The majority of the 33.4 million individuals living with HIV worldwide reside in low-resource settings and are also of reproductive and child-rearing age. It is therefore important to the field of public health to develop an evidence-based parental disclosure intervention that can be effectively delivered to parents by a broad range of paraprofessionals. The investigators hypothesize that the proposed intervention will demonstrate efficacy in helping PLH to make developmentally appropriate disclosure to children or make a developmentally appropriate plan of disclosure and will demonstrate short, medium, and long-term efficacy in improving the well-being of parents, children, and families. The proposed scientifically rigorous evaluation includes mixed methods of data collection, a cluster randomized controlled trial, multiple data sources, and a 36-month longitudinal follow-up involving a large sample of parents, children, and providers. The intervention program to be developed and the evaluation data to be collected in the current study will inform the practice and clinic guidelines aimed at improving both parental HIV disclosure and the well-being of PLH, children and families in China and other low-and middle-income countries (LMICs).
Primary Outcome
question in questionnaire "have you disclosed your HIV serostatus to your children"?
Conditions Studied
Interventions
- BEHAVIORAL Interactive Communication with Openness, Passion, and Empowerment "ICOPE"
- BEHAVIORAL Nutrition Curriculum
Study Locations (1)
South Carolina
- University of South Carolina - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 791 participants |
| Start Date | 2012-08 |
| Est. Completion | 2018-12 |
| Phase | NA |
What the finished NCT04051177 record still lists
NCT04051177 is an interventional study that assigns participants to a tested intervention. The registered 791 participants enrollment target is mid-sized for trials with a published cap, below the 33,168-participant average among 61 other HIV/AIDS trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with HIV/AIDS appearing as the primary indexed condition, and to 2 interventions - of which Interactive Communication with Openness, Passion, and Empowerment "ICOPE" is the first listed.
NCT04051177 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT04051177 about?
NCT04051177 is a clinical study titled "Theory-based HIV Disclosure Intervention for Parents". The investigators propose to develop, implement, and evaluate a theory-driven parental disclosure intervention to assist parents living with HIV (PLH) to make a planned, developmentally appropriate disclosure of their HIV status to their uninfected children or, for PLH with younger children, to arti...
What is the current status of trial NCT04051177?
This trial is currently completed. It is a NA study. The enrollment target is 791 participants. The study started on 2012-08. Estimated completion is 2018-12.
What conditions does trial NCT04051177 study?
This clinical trial studies the following conditions: HIV/AIDS, Disclosure.
What interventions are being tested in trial NCT04051177?
The interventions under investigation include: Interactive Communication with Openness, Passion, and Empowerment "ICOPE" (BEHAVIORAL), Nutrition Curriculum (BEHAVIORAL).
Who is sponsoring clinical trial NCT04051177?
This trial is sponsored by University of South Carolina, which has 157 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04051177 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04051177's enrollment target sits among peer trials
791 6th of 61 higher than 56 of 61 other HIV/AIDS trials
participants (enrollment target), bucketed by value
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