MedTrace Logo

Mothers Living With HIV and Their Adolescent Children

NCT00988390 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 543

Last updated 2016-11-28

No results posted yet for this study

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.

Conditions

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

Interventions

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).

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2008-06-30
Completion
2008-06-30

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00988390 on ClinicalTrials.gov