Mothers Living With HIV and Their Adolescent Children

HIV Infections Clinical Trial

— TALK LA  

Official title:

Mothers Living With HIV and Their Adolescent Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00988390
• Other study ID #: TALKLA-MH068194
• Secondary ID: 5R01MH068194
• Status: Completed
• Phase: N/A
• First received: October 1, 2009
• Last updated: November 23, 2016
• Start date: February 2005
• Est. completion date: June 2008

Study information

• Verified date: November 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

• Context: Mothers living with HIV (MLH) and their children face predictable challenges:

maintaining physical and mental health, parenting while ill, and addressing HIV-related stressors.

• Objective: To evaluate the efficacy of a family-based intervention over time; to contrast the life adjustments of HIV-affected families and their non-HIV-affected neighbors in the current treatment era.

• Design: Randomized controlled trial of MLH and a longitudinal comparison of MLH to a neighborhood cohort using random effect regression.

• Participants and Intervention: MLH (n = 339) and their school-age children (n = 259) were randomly assigned to receive 1) an intervention of 16 sessions in a cognitive-behavioral, small-group format; or 2) control. MLH and their children were compared to non-HIV-affected families recruited at shopping markets. Participant retention was high: 84% at 6 months, 83% at 12 months, and 78% at 18 months.

• Main Outcome Measures: Family functioning and conflict, mental and physical health, sexual behavior, and substance use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 543
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for Intervention/Control, mother living with HIV:

• Mother or primary female caregiver

• Enrolled in HIV-related clinical cares

• At least one child between the age of 6 and 20 years

Inclusion Criteria for neighborhood control, non-HIV-affected mother:

• Mother or primary female caregiver

• not HIV-positive

• At least one child between the age of 6 and 20 years

Exclusion Criteria (Intervention/Control/Neighborhood):

• Mother less than 18 years old

• Unable or willing to give informed consent

• Psychosis or neurological damage as judged by the investigator in consultation with clinical supervisor

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Family Relations
• HIV Infections
• Mental Health
• Physical Health
• Risky Sexual Behavior
• Substance Use

Intervention

Behavioral:
• Cognitive-behavioral, small-group format sessions
The intervention was delivered in either English- or Spanish-speaking groups of 5 to 8 mothers living with HIV twice weekly for 1.5 to 2 hours each over eight weeks (n = 16 sessions).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

References & Publications (1)

Rotheram-Borus MJ, Rice E, Comulada WS, Best K, Elia C, Peters K, Li L, Green S, Valladares E. Intervention outcomes among HIV-affected families over 18 months. AIDS Behav. 2012 Jul;16(5):1265-75. doi: 10.1007/s10461-011-0075-z. — View Citation