Trial record 10 of 31 for:    " July 17, 2013":" August 16, 2013"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01922206
Recruitment Status : Active, not recruiting
First Posted : August 14, 2013
Last Update Posted : August 11, 2017
University of California, Los Angeles
Information provided by (Responsible Party):
Lisa Armistead, Georgia State University

Brief 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; 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 or disease Intervention/treatment Phase
HIV Behavioral: TRACK Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 2/2-Maternal HIV: Multisite Trial to Assist Disclosure to Children
Study Start Date : March 2013
Actual Primary Completion Date : August 2016
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Wait-list Control
Participants in the wait-list control condition will receive a group-based version of the TRACK intervention after their 15-month follow up appointment.
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

Primary Outcome Measures :
  1. Disclosure of Maternal HIV status to child [ Time Frame: Change in disclosure status between time points 3-, 9-, & 15 month follow ups ]

Secondary Outcome Measures :
  1. Child Mental Health Functioning (Composite measure) [ Time Frame: 15- month follow up ]
    Self and Caregiver reported indicators, including the Child Depression Inventory, Piers-Harris Children's Self-Concept Scale, Penn State Worry Questionnaire

Other Outcome Measures:
  1. Maternal Functioning (composite measure) [ Time Frame: 15 month follow-up ]
    CES-D, GAD-7, Health-Related Anxiety Questionnaire, Medical Outcomes Study-Health Self-Report, Alcohol and Drug Assessment

  2. Family functioning (composite measure) [ Time Frame: 15 month follow-up ]
    Cohesiveness, routines, parent-child communication, parent-child relationship quality

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01922206

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

Responsible Party: Lisa Armistead, Distinguished Professor, Georgia State University Identifier: NCT01922206     History of Changes
Other Study ID Numbers: MH094233
1R01MH094233 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing protocols for the longitudinal data from 220 young children and 220 mothers will be in accordance with NIH Notice of Amendment to A-110, consistent with IRB-approved consent restrictions, and follow Inter-University Consortium for Political and Social Research guidelines for data preparation. Data will be stripped of identifiers and available under signed agreement for: (1) using data only for research; (2) securing date using appropriate technology; and (3) destroying or returning data after analyses. Notice of available data will be on both centers' websites, with data use restrictions.

Keywords provided by Lisa Armistead, Georgia State University:
Maternal Disclosure