Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
543 participants
INTERVENTIONAL
2005-02-28
2008-06-30
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention, mothers living with HIV
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)
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).
Control, mothers living with HIV
Mothers living with HIV, offered intervention at end of study (18 months after recruitment)
No interventions assigned to this group
Control, non-HIV-infected mothers
Neighborhood control mothers not infected with HIV, did not receive any intervention
No interventions assigned to this group
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Enrolled in HIV-related clinical cares
* At least one child between the age of 6 and 20 years
* Mother or primary female caregiver
* not HIV-positive
* At least one child between the age of 6 and 20 years
Exclusion Criteria
* Unable or willing to give informed consent
* Psychosis or neurological damage as judged by the investigator in consultation with clinical supervisor
18 Years
FEMALE
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of California, Los Angeles
OTHER
Responsible Party
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References
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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.
Other Identifiers
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TALKLA-MH068194
Identifier Type: -
Identifier Source: org_study_id