Maternal HIV: Trial to Assist Disclosure to Children

NCT ID: NCT01922206

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2019-11-30

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).

Conditions

HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

TRACK Intervention

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

Group Type: EXPERIMENTAL

TRACK Intervention

Intervention Type: BEHAVIORAL

TRACK Intervention

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

Interventions

TRACK Intervention

TRACK Intervention

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Georgia State University

OTHER

Sponsor Role: lead

Responsible Party

Lisa Armistead

Distinguished Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa P Armistead, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Debra Murphy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

Georgia State University

Atlanta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38661649 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33705165 (View on PubMed)

Other Identifiers

1R01MH094233

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MH094233

Identifier Type: -

Identifier Source: org_study_id