Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Theory-based HIV Disclosure Intervention for Parents
NCT04051177 · View on ClinicalTrials.gov ↗
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).
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 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04051177
The ClinicalTrials.gov registry entry for NCT04051177 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 791 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Carolina, which has 88 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04051177 reports 1 study location spanning 1 distinct geographic area — top geographies include South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04051177?
This trial is sponsored by University of South Carolina, which has 88 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.