Training Community Members to Deliver HIV Prevention Programs to Urban Youth

NCT00859144 | Completed Phase 3

• 3 other identifiers: GCO 03-0888R01MH069934DAHBR 9A-ASPA
• Study Type: interventional
• Target: 901
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine methods for involving local community members in programs to teach urban youth about how to prevent transmission of HIV.

Conditions

HIV; HIV Infections

Keywords

HIV Prevention; Youth; Adolescent; Community Collaboration; Community Mentorship; Minority; Urban; Sexual Risk Behaviors; HIV seronegativity

Outcome Measures

Primary Outcomes (17)

• Youth sexual risk behaviors

  Measured at baseline, after 3 to 4 months, and after 15 months

  Measured at baseline

• Youth sexual risk behaviors

  Measured at baseline, after 3 to 4 months, and after 15 months

  Measured after 3 to 4 months

• Youth sexual risk behaviors

  Measured at baseline, after 3 to 4 months, and after 15 months

  Measured after 15 months

• HIV educators' intentions to collaborate

  Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  Measured at baseline

• HIV educators' intentions to collaborate

  Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  Measured at post-intervention

• HIV educators' intentions to collaborate

  Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  Measured at 3-month follow-up

• HIV educators' intentions to collaborate

  Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  Measured at 15-month follow-up

• Collaboration by HIV educators

  Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  Measured at baseline

• Collaboration by HIV educators

  Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  Measured at post-intervention

• Collaboration by HIV educators

  Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  Measured at 3-month follow-up

• Collaboration by HIV educators

  Measured at baseline, post-intervention, and at 3- and 15-month follow-ups

  Measured at 15-month follow-up

• Youth sexual behavior

  Measured at baseline, after 3 to 4 months, and after 15 months

  Measured at baseline

• Youth sexual behavior

  Measured at baseline, after 3 to 4 months, and after 15 months

  Measured after 3 to 4 months

• Youth sexual behavior

  Measured at baseline, after 3 to 4 months, and after 15 months

  Measured after 15 months

• Youth negotiation of sexual risk situations

  Measured at baseline, after 3 to 4 months, and after 15 months

  Measured at baseline

• Youth negotiation of sexual risk situations

  Measured at baseline, after 3 to 4 months, and after 15 months

  Measured after 3 to 4 months

• Youth negotiation of sexual risk situations

  Measured at baseline, after 3 to 4 months, and after 15 months

  Measured after 15 months

Secondary Outcomes (11)

• Leadership skills of HIV educators

  Measured at baseline

• Leadership skills of HIV educators

  Measured at post-intervention

• Leadership skills of HIV educators

  Measured at 3-month follow-up

• Leadership skills of HIV educators

  Measured at 15-month follow-up

• HIV/AIDS knowledge and attitudes of educators and youth

  Measured at baseline

Study Arms (3)

BART

EXPERIMENTAL

Participants will complete the Becoming a Responsible Teen (BART) program.

Behavioral: Becoming A Responsible Teen (BART)

Reducing the Risk

EXPERIMENTAL

Participants will complete the Reducing the Risk program.

Behavioral: Reducing the Risk

Be Proud Be Responsible

ACTIVE COMPARATOR

Participants will complete the Be Proud! Be Responsible! program.

Behavioral: Be Proud! Be Responsible!

Interventions

Be Proud! Be Responsible! BEHAVIORAL

This intervention consists of highly structured modules that involve group discussions, videos, games, brainstorming, experiential exercises, and skill building activities. The program encourages participants to be proud of themselves and their community, to behave responsibly for themselves and their community, and to consider their goals for the future and how risk behaviors may interfere with the attainment of their goals.

Be Proud Be Responsible

Becoming A Responsible Teen (BART) BEHAVIORAL

This program consists of highly structured modules administered using intervention manuals in community-based settings. Each intervention session involves group discussion, videos, games, presentations, demonstrations, role plays, and practice. Youth learn problem solving, decision-making, communication, condom negotiation and use skills, and behavioral self-management. Youth also meet with HIV infected peers to promote risk recognition and improve their perception of vulnerability.

BART

Reducing the Risk BEHAVIORAL

This program consists of instruction on developing social skills to reduce sexual risk-taking behavior and role plays to practice and model skills. Additional activities-such as teaching decision making and assertive communication skills, offering encouragement to obtain relevant health information from stores and clinics, and asking parents about their views on abstinence and birth control-support the premise that students should avoid unprotected intercourse, either by remaining abstinent or using contraceptives.

Reducing the Risk

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adult community HIV educators who are parents of a middle or high school aged child
• Adult participants must be between 25 and 60 years of age
• Youth participants must be between 12 and 15 years of age
• Residents of target communities in Bronx, NY

You may not qualify if:

• Parent or guardian is excluded if youth participant cannot provide informed consent because of mental health or substance abuse diagnosis
• Significant cognitive impairment that might interfere with understanding of program content or informed consent process

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mary M. McKay, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 10, 2009
• Study Start: March 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 8, 2012

Record last verified: 2012-03

Locations

US (1)