Maternal HIV: Trial to Assist Disclosure to Children

NCT01922206 | Completed DMC

• 2 other identifiers: MH0942331R01MH094233
• Study Type: interventional
• Target: 362
• Locations: 1 country
• Sites: 1

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

Conditions

HIV

Keywords

HIV; Maternal Disclosure

Outcome Measures

Primary Outcomes (1)

• Disclosure of Maternal HIV status to child

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

Secondary Outcomes (1)

• Child Mental Health Functioning (Composite measure)

  15- month follow up

Other Outcomes (2)

• Maternal Functioning (composite measure)

  15 month follow-up

• Family functioning (composite measure)

  15 month follow-up

Study Arms (2)

Wait-list Control

NO INTERVENTION

Participants in the wait-list control condition will receive a group-based version of the TRACK intervention after their 15-month follow up appointment.

TRACK Intervention

EXPERIMENTAL

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

Behavioral: TRACK Intervention

Interventions

TRACK Intervention BEHAVIORAL

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

TRACK Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia State University: lead
• University of California, Los Angeles: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30302, United States

Location

Related Publications (2)

• Marelich WD, Ali B, Murphy DA, Schulte MT, Armistead L. Predictors of serostatus nondisclosure in mothers living with human immunodeficiency virus receiving a disclosure intervention: Analysis of a randomized clinical trial intervention arm. Health Psychol. 2024 Sep;43(9):663-672. doi: 10.1037/hea0001390. Epub 2024 Apr 25.

  PMID: 38661649 DERIVED

• 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.

  PMID: 33705165 DERIVED

Study Officials

• Lisa P Armistead, Ph.D.

  Georgia State University

  PRINCIPAL INVESTIGATOR

• Debra Murphy, Ph.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Distinguished Professor

Study Record Dates

• First Submitted: August 2, 2013
• First Posted: August 14, 2013
• Study Start: March 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)