NCT00988390

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
543

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

October 1, 2009

Last Update Submit

November 23, 2016

Conditions

Family RelationsMental HealthPhysical HealthRisky Sexual BehaviorSubstance UseHIV Infections

Keywords

mothers living with HIVfamily interventionfamily functioningconflictMental healthand physical healthFamily relationships (functioning and conflict)

Study Arms (3)

Intervention, mothers living with HIV

OTHER

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

Control, mothers living with HIV

NO INTERVENTION

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

Control, non-HIV-infected mothers

NO INTERVENTION

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

Interventions

Cognitive-behavioral, small-group format sessionsBEHAVIORAL

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).

Intervention, mothers living with HIV

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Mother or primary female caregiver
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 22020758RESULT

MeSH Terms

Conditions

Psychological Well-BeingSubstance-Related DisordersHIV Infections

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorChemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

February 1, 2005

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

November 28, 2016

Record last verified: 2016-11