Randomized Control Trial of Family-Based HIV Prevention for Latinos

NCT01635335 | Completed Phase 2 DMC

• 1 other identifier: 5R01MH087232
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed project will test an HIV prevention intervention for Latino parent-adolescents dyads. This randomized controlled trial will:

1. 1.Recruit and randomize 320 parent-adolescent dyads into a Latino family-based HIV prevention intervention or a family-based General Health Promotion condition.
2. 2.Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in HIV-related sexual behavior and attitudes over 18 months among a sample of 320 Latino parent-adolescent dyads.
3. 3.Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in family relationships and parental monitoring/supervision over 18 months among a sample of 320 Latino parent-adolescent dyads.
4. 4.Examine the association of other important constructs, such as religiosity, acculturation, cultural values, and sexual socialization with the primary outcomes.
5. 5.Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to primary outcome measures of safer sexual behavior (recent sexual activity, the number of unprotected sex acts, and intentions to use condoms) and safer HIV-related attitudes.
6. 6.Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to family relationships and parental monitoring/supervision through improved parent-child communication skills and they will mediate the intervention impact.
7. 7.Religiosity, acculturation, cultural values, and sexual socialization will have meaningful associations with the primary outcomes and will act as moderators of intervention impact.

Conditions

HIV; Sexually Transmitted Infections

Keywords

HIV prevention; adolescents; Latinos; Hispanics; family; health promotion; disease prevention; family communication; parental supervision

Outcome Measures

Primary Outcomes (1)

• Change in sexual activity status

  baseline and 3, 6, 12, and 18 months post-intervention

Secondary Outcomes (4)

• Change in Unprotected Sex Acts

  baseline and 3, 6, 12, and 18 months post-intervention

• Change in intentions to use condoms

  baseline and 3, 6, 12, and 18 months post-intervention

• Change in parent-adolescent communication

  baseline and 3, 6, 12, and 18 months post-intervention

• change in parental monitoring of adolescent

  baseline and 3, 6, 12, and 18 months post-intervention

Study Arms (2)

HIV-specific

EXPERIMENTAL

7-hour multiple family workshop focused on providing information and skills related to HIV prevention. Specific focus on parent-adolescent communication and parental monitoring.

Behavioral: Latino STYLE

General Health Promotion

ACTIVE COMPARATOR

7-hour multiple family workshop focused on providing information related to various adolescent health risk behaviors, including smoking, alcohol, violence, nutrition, and exercise.

Behavioral: Latino STYLE

Interventions

Latino STYLE BEHAVIORAL

7-hour family-based workshop with 3-hour follow-up booster 3 months later

General Health Promotion; HIV-specific

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adolescents and parents self-identify as Latino/Hispanic
• Adolescents between the ages of 14 and 17
• Parent is Spanish-Speaking and feels comfortable speaking Spanish in groups
• Adolescent is English-speaking and feels comfortable speaking English in groups

You may not qualify if:

• Adolescent self-discloses HIV positive status
• Currently or intending to be pregnant during the course of the study

Sponsors & Collaborators

• University of South Florida: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• Lescano CM, Castillo HL, Calcano E, Mayor M, Porter M, Rivera-Torgerson Y, Dion C, Marhefka SL, Barker D, Brown LK; Latino STYLE Research Group. Latino STYLE: Preliminary Findings From an HIV Prevention RCT Among Latino Youth. J Pediatr Psychol. 2020 May 1;45(4):411-422. doi: 10.1093/jpepsy/jsaa019.

  PMID: 32330945 DERIVED

Related Links

• related info

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Celia Lescano, Ph.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: June 30, 2012
• First Posted: July 9, 2012
• Study Start: August 1, 2010
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 21, 2016

Record last verified: 2016-09

Locations

US (1)