Family-Based HIV Prevention for Latinos
1 other identifier
interventional
80
1 country
1
Brief Summary
The proposed project will develop and test an HIV prevention intervention for Latino families. This study will:
- 1.Conduct a pilot "run-through" of an adapted family-based intervention with three cohorts (about 24 families) to determine the feasibility, acceptability, and appropriateness for the target population.
- 2.Revise the family-based HIV prevention intervention based on the results of the pilot "run-through" and structured exit interviews.
- 3.Recruit and randomize 100 families into the Latino family-based HIV prevention intervention or a general health promotion condition.
- 4.Estimate the effect size of the Latino family-based HIV prevention intervention from assessment of changes in HIV-related sexual behavior and attitudes and parental monitoring/supervision over 6 months.
- 5.The revised intervention will be feasible, acceptable, and appropriate for Latino families and will be enthusiastically received.
- 6.The family-based HIV prevention intervention will result in safer adolescent sexual behavior, greater change with regard to primary outcome measures of behavior (recent sexual activity, the number of unprotected sex acts, proportion of condom use, and intentions to use condoms), safer HIV-related attitudes, improved parent-child communication skills, and greater parental monitoring than the Latino families in the general health promotion condition.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 hiv-infections
Started May 2007
Typical duration for phase_1 hiv-infections
1 active site
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
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 19, 2007
CompletedFirst Posted
Study publicly available on registry
December 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedJune 6, 2012
June 1, 2012
3.3 years
December 19, 2007
June 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number (#) of unprotected sex acts
baseline, 3, and 6 months
Secondary Outcomes (1)
parent-child communication
baseline, 3, and 6 months
Study Arms (2)
Family-based HIV
EXPERIMENTALFamily-based HP
ACTIVE COMPARATORInterventions
7-hour one-day workshop with adolescents and parents in separate and joint sessions
7 hour one-day workshop on general health promotion topics
Eligibility Criteria
You may qualify if:
- Adolescent must be English-speaking and can converse in Spanish with parent
- Parent must be Spanish-speaking
- Adolescent and parent must be living together for at least 3 months prior to workshop
- Both parent and adolescent self-identify as being of Hispanic/Latino origin
You may not qualify if:
- Adolescent HIV positive
- Adolescent pregnant or intending to get pregnant
- Active psychosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Celia M Lescano, PhD
Rhode Island Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor (Research)
Study Record Dates
First Submitted
December 19, 2007
First Posted
December 28, 2007
Study Start
May 1, 2007
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
June 6, 2012
Record last verified: 2012-06