CClinicalTrials.gg
CompletedNCT01922206TRACK IIUpdated Jan 18, 2020

Maternal HIV: Trial to Assist Disclosure to Children

An interventional study of TRACK Intervention in HIV, sponsored by Georgia State University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by Georgia State University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
362
Allocation
Randomized
Sex
All
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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; 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).
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Conditions studied

  • HIV

Keywords

  • HIV
  • Maternal Disclosure
03

In context

Lead sponsor

Georgia State University is the lead sponsor of 52 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Outcomes assessor)
Enrollment
362 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralTRACK Intervention

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

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What researchers measure

Primary outcomes

  1. Disclosure of Maternal HIV status to child

    Time frame: Change in disclosure status between time points 3-, 9-, & 15 month follow ups

Secondary outcomes

  1. Child Mental Health Functioning (Composite measure)

    Self and Caregiver reported indicators, including the Child Depression Inventory, Piers-Harris Children's Self-Concept Scale, Penn State Worry Questionnaire

    Time frame: 15- month follow up

Other outcomes

  1. Maternal Functioning (composite measure)

    CES-D, GAD-7, Health-Related Anxiety Questionnaire, Medical Outcomes Study-Health Self-Report, Alcohol and Drug Assessment

    Time frame: 15 month follow-up

  2. Family functioning (composite measure)

    Cohesiveness, routines, parent-child communication, parent-child relationship quality

    Time frame: 15 month follow-up

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Study locations

1 site
  • Georgia State University
    Atlanta, Georgia 30302, United States
08

References and documents

Publications

  • Schulte MT, Armistead L, Murphy DA, Marelich W. Multisite longitudinal efficacy trial of a disclosure intervention (TRACK) for HIV+ mothers. J Consult Clin Psychol. 2021 Feb;89(2):81-95. doi: 10.1037/ccp0000622. PubMed 33705165 ↗

Individual participant data

Plan to share: Yes — 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.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01922206
Lead sponsor
Georgia State University
Collaborators
University of California, Los Angeles, National Institute of Mental Health (NIMH)
Responsible party
Lisa Armistead (Distinguished Professor, Georgia State University) — Principal investigator
First posted
Aug 14, 2013
Start date
Mar 2013
Primary completion
Nov 2017
Completion
Nov 2019
Last update
Jan 18, 2020

Study contacts

Lisa P Armistead, Ph.D.
principal investigator · Georgia State University
Debra Murphy, Ph.D.
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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