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

January 14, 2020 updated by: Lisa Armistead, Georgia State University

2/2-Maternal HIV: Multisite 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 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

362

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30302
        • Georgia State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

TRACK Intervention

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disclosure of Maternal HIV status to child
Time Frame: Change in disclosure status between time points 3-, 9-, & 15 month follow ups
Change in disclosure status between time points 3-, 9-, & 15 month follow ups

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15- month follow up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15 month follow-up
Family functioning (composite measure)
Time Frame: 15 month follow-up
Cohesiveness, routines, parent-child communication, parent-child relationship quality
15 month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Lisa P Armistead, Ph.D., Georgia State University
  • Principal Investigator: Debra Murphy, Ph.D., University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

November 1, 2017

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

August 2, 2013

First Submitted That Met QC Criteria

August 13, 2013

First Posted (Estimate)

August 14, 2013

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • MH094233
  • 1R01MH094233 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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