Mothers Living With HIV and Their Adolescent Children

Study Overview
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Brief Summary
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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.

Official Title
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Mothers Living With HIV and Their Adolescent Children

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

Intervention / Treatment
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* Behavioral: Cognitive-behavioral, small-group format sessions


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention, mothers living with HIV<br>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) | Behavioral: Cognitive-behavioral, small-group format sessions<br>* 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).<br>|
| No Intervention: Control, mothers living with HIV<br>Mothers living with HIV, offered intervention at end of study (18 months after recruitment) | |
| No Intervention: Control, non-HIV-infected mothers<br>Neighborhood control mothers not infected with HIV, did not receive any intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mothers living with HIV, family intervention, family functioning, conflict, Mental health, and physical health, Family relationships (functioning and conflict)