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NCT01922206 · ClinicalTrials.gov registry record · NA
Maternal HIV: Trial to Assist Disclosure to Children
A NA study, sponsored by Georgia State University.
- Completed
- Registry status
- NA
- Development phase
- 362
- Enrollment target
NCT01922206 is a NA study that has completed, run by Georgia State University. The registered enrollment target is 362 participants.
The verdict
NCT01922206, a NA study, has completed, sponsored by Georgia State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 362 participants
- Enrollment target
Study Summary
The purpose of this Collaborative R01, under Program Announcement PAR-09-153, is to conduct a full-scale trial of an intervention to assist mothers living with HIV (MLH) with disclosing their serostatus to their young age 6 - 14 year old), well children. A pilot study of the intervention has recently been completed (R01 MH077493) and met its major aims. The basis for development of the pilot intervention was work from three R01s (MH057207, currently Yr. 14) designed to longitudinally assess MLH and their children. Within that work, several studies were conducted on maternal disclosure, suggesting disclosure is difficult, and outcomes for MLH and children could be improved by intervention. The pilot study, known in the community as Teaching, Raising, And Communicating with Kids (TRACK), was based on integrative disclosure theory. Results of the pilot trial indicate that those in the intervention group were six times more likely to disclose their HIV/AIDS status to their child than those in the control group (O.R. 6.33); by the 9-month follow-up 33% of intervention MLH disclosed, compared to only 7.3% of the control group. Perhaps more importantly, the intervention group's emotional functioning and their satisfaction improved significantly following the intervention, compared to the control group. Similarly, child mental health indicators among children of intervention MLH were significantly better than control group children at follow-ups. In this study, TRACK II, we propose to conduct a full-scale trial of the intervention in two sites: (1) Los Angeles county (Site 1, where the pilot trial was conducted), which will include a high proportion of Latina families and a smaller proportion of African-American and White families; and (2) Atlanta, Georgia (Site 2, where the primary consultant on the pilot trial conducts research), which will include a high proportion of Southern African-American families, as well as White families. MLH and their children (N = 440 total; 11
Interventions
- BEHAVIORAL TRACK Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2013-03 |
| Est. Completion | 2019-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01922206
The ClinicalTrials.gov registry entry for NCT01922206 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 362 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgia State University, which has 45 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which TRACK Intervention is the first listed.
NCT01922206 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01922206 about?
NCT01922206 is a clinical study titled "Maternal HIV: Trial to Assist Disclosure to Children". The purpose of this Collaborative R01, under Program Announcement PAR-09-153, is to conduct a full-scale trial of an intervention to assist mothers living with HIV (MLH) with disclosing their serostatus to their young age 6 - 14 year old), well children. A pilot study of the intervention has recentl...
What is the current status of trial NCT01922206?
This trial is currently completed. It is a NA study. The enrollment target is 362 participants. The study started on 2013-03. Estimated completion is 2019-11.
What interventions are being tested in trial NCT01922206?
The interventions under investigation include: TRACK Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01922206?
This trial is sponsored by Georgia State University, which has 45 total clinical trials registered on ClinicalTrials.gov.
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