Maternal HIV: Trial to Assist Disclosure to Children (TRACK II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Georgia State University
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by (Responsible Party):
Lisa Armistead, Georgia State University
ClinicalTrials.gov Identifier:
NCT01922206
First received: August 2, 2013
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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; 110 mothers and 110 children per site, n = 220 per site) will be assessed at baseline and at 3, 9, and 15-month follow-ups. MLH will be randomly assigned to the intervention or control. Aims are to:

  1. facilitate disclosure of the mothers' HIV status to the children, which will include secondary aims of:

    1. increasing mothers' self-efficacy to disclose and respond to child questions regarding HIV;
    2. reducing mothers' fears regarding disclosure and stigma;
    3. improving maternal knowledge of child development and how to provide appropriate levels of information given the age of the child;
  2. improve MLH mental health indicators over time (i.e., depression, anxiety, quality of life);
  3. improve child mental health indicators over time (i.e., depression, anxiety, acting out behaviors); and
  4. improve family functioning indicators (e.g., cohesion, perceived closeness between mother and child).

Condition Intervention
HIV
Behavioral: TRACK Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 2/2-Maternal HIV: Multisite Trial to Assist Disclosure to Children

Resource links provided by NLM:


Further study details as provided by Georgia State University:

Primary Outcome Measures:
  • Disclosure of Maternal HIV status to child [ Time Frame: Change in disclosure status between time points 3-, 9-, & 15 month follow ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Child Mental Health Functioning (Composite measure) [ Time Frame: 15- month follow up ] [ Designated as safety issue: No ]
    Self and Caregiver reported indicators, including the Child Depression Inventory, Piers-Harris Children's Self-Concept Scale, Penn State Worry Questionnaire


Other Outcome Measures:
  • Maternal Functioning (composite measure) [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]
    CES-D, GAD-7, Health-Related Anxiety Questionnaire, Medical Outcomes Study-Health Self-Report, Alcohol and Drug Assessment

  • Family functioning (composite measure) [ Time Frame: 15 month follow-up ] [ Designated as safety issue: No ]
    Cohesiveness, routines, parent-child communication, parent-child relationship quality


Estimated Enrollment: 440
Study Start Date: March 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Wait-list Control
Experimental: TRACK Intervention
3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child
Behavioral: TRACK Intervention

TRACK Intervention

3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child


  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mother is HIV+
  • ability of mother and child to speak and understand English or Spanish
  • child is not HIV+
  • Child is 6-14 years old
  • Child is unaware of maternal HIV status
  • child resides with mother

Exclusion Criteria:

  • Mother does not consent
  • Child does not assent
  • Psychosis of mother or child
  • Child diagnosed with depression
  • child is developmentally delayed
  • Recent or anticipated death in the family
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01922206

Contacts
Contact: Lisa P Armistead, Ph.D. 404 413 6205 lparmistead@gsu.edu
Contact: Debra Murphy, Ph.D. 310 267-5233 dmurphy@mednet.ucla.edu

Locations
United States, Georgia
Georgia State University Recruiting
Atlanta, Georgia, United States, 30302
Principal Investigator: Lisa P Armistead, Ph.D.         
Principal Investigator: Debra Murphy, Ph.D.         
Sponsors and Collaborators
Georgia State University
University of California, Los Angeles
Investigators
Principal Investigator: Lisa P Armistead, Ph.D. Georgia State University
Principal Investigator: Debra Murphy, Ph.D. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Lisa Armistead, Distinguished Professor, Georgia State University
ClinicalTrials.gov Identifier: NCT01922206     History of Changes
Other Study ID Numbers: MH094233
Study First Received: August 2, 2013
Last Updated: August 13, 2013
Health Authority: United States: Federal Government

Keywords provided by Georgia State University:
HIV
Maternal Disclosure

ClinicalTrials.gov processed this record on September 18, 2014