NCT01170260

Brief Summary

This research is studying behaviors that young people engage in that may place them at risk for contracting a sexually transmitted disease like HIV/AIDS, and what kind of educational program works best to reduce these risky behaviors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 23, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

April 23, 2024

Completed
Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

3.8 years

First QC Date

July 23, 2010

Results QC Date

February 14, 2024

Last Update Submit

April 1, 2024

Conditions

Risk Reduction BehaviorHealth BehaviorSexual BehaviorAdolescent BehaviorCannabis

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Risky Sexual Behavior Measured for 1 Year

    1 year

Study Arms (3)

Info-only sexual risk reduction

ACTIVE COMPARATOR

Corresponding intervention gives information only on STDs/HIV

Behavioral: INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)

Sex plus alcohol risk reduction

EXPERIMENTAL

Corresponding intervention gives info focusing on sex and alcohol risk reduction only

Behavioral: SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH)

Sex + alcohol + marijuana risk reduction

EXPERIMENTAL

Corresponding intervention gives info on sex, alcohol, and marijuana risk reduction

Behavioral: SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION

Interventions

INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)BEHAVIORAL

Intervention includes presentation of STD facts, safe sex activities, condom demonstration, video about sexual decision making, group discussion

Also known as: INFO-ONLY
Info-only sexual risk reduction
SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH)BEHAVIORAL

Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussion

Also known as: (SRRI+ETOH)
Sex plus alcohol risk reduction
SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTIONBEHAVIORAL

Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion

Also known as: (SRRI+ETOH+THC)
Sex + alcohol + marijuana risk reduction

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 14-18
  • Involved in Juvenile Justice System (living in the Detention Center when recruited)

You may not qualify if:

  • Currently taking anti-psychotics
  • Involved in similar intervention-based study (2 similar studies being conducted simultaneously by this lab)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juvenile Detention Center (JDC)

Albuquerque, New Mexico, 87107, United States

Location

Related Publications (2)

  • Schmiege SJ, Magnan RE, Yeater EA, Feldstein Ewing SW, Bryan AD. Randomized Trial to Reduce Risky Sexual Behavior Among Justice-Involved Adolescents. Am J Prev Med. 2021 Jan;60(1):47-56. doi: 10.1016/j.amepre.2020.07.009.

    PMID: 33341180DERIVED

  • Bryan AD, Magnan RE, Gillman AS, Yeater EA, Feldstein Ewing SW, Kong AS, Schmiege SJ. Effect of Including Alcohol and Cannabis Content in a Sexual Risk-Reduction Intervention on the Incidence of Sexually Transmitted Infections in Adolescents: A Cluster Randomized Clinical Trial. JAMA Pediatr. 2018 Apr 2;172(4):e175621. doi: 10.1001/jamapediatrics.2017.5621. Epub 2018 Apr 2.

    PMID: 29435591DERIVED

MeSH Terms

Conditions

Risk Reduction BehaviorHealth BehaviorSexual BehaviorAdolescent BehaviorMarijuana Abuse

Interventions

SexEthanol

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaAlcoholsOrganic Chemicals

Results Point of Contact

Title
Hadya Khawaja
Organization
University of New Mexico Health Sciences
hkhawaja@salud.unm.edu
505-272-7028

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 27, 2010

Study Start

August 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 23, 2024

Results First Posted

April 23, 2024

Record last verified: 2024-04

Locations

US(1)