Mothers Living With HIV and Their Adolescent Children (TALK LA)

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Substance Use; Family Relations; Physical Health; Risky Sexual Behavior; HIV Infections; Mental Health

Treatments: Behavioral: Cognitive-behavioral, small-group format sessions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00988390

TALKLA-MH068194

5R01MH068194 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

• 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.

Enrollment: 543 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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543 participants in 3 patient groups

Intervention, mothers living with HIV

Other group

Description:

Mothers living with HIV, Cognitive-behavioral intervention 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)

Treatment:

Behavioral: Cognitive-behavioral, small-group format sessions

Control, mothers living with HIV

No Intervention group

Description:

Mothers living with HIV, offered intervention at end of study (18 months after recruitment)

Control, non-HIV-infected mothers

No Intervention group

Description:

Neighborhood control mothers not infected with HIV, did not receive any intervention