## Protocol Section
### Identification Module
**NCT ID:** NCT01633879

**Brief Title:** Addressing Proven Factors in HIV Prevention for Latino Youth

**Official Title:** Health and Success: Addressing Proven Factors in HIV Prevention for Latino Youth

#### Organization Study ID Info
**ID:** 5R01HD062084
**Link:** https://reporter.nih.gov/quickSearch/5R01HD062084
**Type:** NIH
#### Organization
**Class:** INDUSTRY
**Full Name:** Education Development Center, Inc.
### Status Module
#### Completion Date
**Date:** 2014-07

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ENROLLING_BY_INVITATION
#### Last Update Post Date
**Date:** 2012-07-04

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-07-03

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2013-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2009-07

**Status Verified Date:** 2012-07

#### Study First Post Date
**Date:** 2012-07-04
**Type:** ESTIMATED
**Study First Submit Date:** 2012-06-29
**Study First Submit QC Date:** 2012-07-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Education Development Center, Inc.

#### Responsible Party

**Investigator Affiliation:** Education Development Center, Inc.

**Investigator Full Name:** Lydia O'Donnell

**Investigator Title:** Senior Scientist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study tests the effectiveness of the bilingual Health and Success program, which aims to support Latino parents and schools in their efforts to promote the academic success and healthy choices of youth, with the goal of reducing barriers that lead to elevated levels of HIV/AIDS in urban Latino communities.

### Conditions Module

**Conditions:**

- HIV

- Sexually Transmitted Infections

**Keywords:**

- parenting, prevention, HIV/AIDS, adolescents, Latino

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 3400

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** audio-CD parent EDC supporting positive parenting practices

**Intervention Names:**

- Behavioral: audio-CD parent education

**Label:** parent education

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** health and success parent and school intervention

**Intervention Names:**

- Behavioral: health and success parent and school

**Label:** parent and school intervention

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** brochures to parents

**Label:** print materials

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- parent education

**Description:** audio CD stories in English and Spanish that support positive parenting practices

**Name:** audio-CD parent education

**Other Names:**

- health and success

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- parent and school intervention

**Description:** Parenting education and school intervention

**Name:** health and success parent and school

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The study will examine whether there is a reduction in risky sexual behavior among youth exposed to the two treatment conditions compared to the control condition.

**Measure:** reduction in risk behavior

**Time Frame:** 18 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* youth attend school selected as study site
* youth in 6-7th grade

Exclusion Criteria:

* parent/youth non-English or Spanish speakers

**Healthy Volunteers:** True

**Maximum Age:** 14 Years

**Minimum Age:** 10 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M18250

- Name: HIV Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: HIGH

- As Found: Sexually Transmitted Infections

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012749

- Term: Sexually Transmitted Diseases

### Misc Info Module

- Version Holder: 2024-05-24
