Clinical trial NCT00582101: Family-Based HIV Prevention for Latinos
Official title: Family-Based HIV Prevention for Latinos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV
prevention
families
Latinos
communication
sexuality
monitoring
health promotion
HIV Prevention
HIV Seronegativity
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Based on a thorough review of the literature, the following is anticipated:

1. The revised intervention will be feasible, acceptable, and appropriate for Latino families and will be enthusiastically received.
2. 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.

Detailed description: Latinos are disproportionately represented among those diagnosed with HIV and Latino adolescents are at risk for engaging in sexual behaviors that can lead to HIV. However, data regarding HIV prevention interventions for Latino adolescents, as distinct from other ethnic groups, have not been published to date. This K Award will conduct an initial study of a family-based intervention specifically for Latino families. With the support of a NIMH Minority Supplement Award, Dr. Lescano has adapted a family-based intervention from a multi-site trial for non-minority youth. Using a qualitative approach, Dr. Lescano has added to the intervention family context issues relevant to Latinos such as acculturation, religiosity, gender role and sexual socialization, parent-child communication, and monitoring practices. The initial phase of the K Award will be a run-through of the adapted family-based intervention with three cohorts (8 families per group) to further assess participant reaction and appropriateness. The intervention will then be revised based on feedback using structured exit interviews. Next, 100 Latino families with an adolescent between the ages of 13 and 18 will be randomized into either the family based HIV prevention intervention or a general health promotion (GHP) condition that focuses on healthy behaviors such as diet and exercise. Groups consist of 6 to 8 parent and youth dyads in a one-day, 7-hour workshop. Both interventions employ activities for youth and parents separately (e.g., focus on adolescent vulnerability) and parents and adolescents together. The project will estimate the effect size of the Latino Family-based HIV prevention intervention from assessment of changes in the adolescents' HIV-related sexual behavior and attitudes, gender and sexual socialization, parent-child communication, and parental monitoring. Measures will be completed at baseline and at 3 and 6 months post-intervention. The work done in this K Award will provide pilot data that will lead to submission of an R01 to determine the efficacy of the intervention, compared to a adolescent-only, skills-based HIV prevention group and a general health promotion group, in a larger sample of Latinos. An efficacious intervention is urgently needed for Latino communities.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Adolescent HIV positive
* Adolescent pregnant or intending to get pregnant
* Active psychosis

Primary outcomes:
measure: Number (#) of unprotected sex acts
timeFrame: baseline, 3, and 6 months
Secondary outcomes:
measure: parent-child communication
timeFrame: baseline, 3, and 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Celia M Lescano, PhD
role: PRINCIPAL_INVESTIGATOR
References: