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Adolescent Safer Sex Social Network Intervention

Primary Purpose

Sexual Behavior, Alcohol Drinking, Marijuana Smoking

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adolescent Safer Sex Social Network Intervention
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sexual Behavior focused on measuring risk behavior, social networks, behavior

Eligibility Criteria

16 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Index Participant Inclusion Criteria Self-identifies as all or part "Latino" Age is between 16 years and 0 days and 19 years and 364 days at the time of study enrollment In the past 3 months, reports engaging in any type of heterosexual sex (vaginal, oral or anal) with an opposite-sex partner In the past 3 months, reports any of the following: alcohol use at least once; marijuana use at least once; having sex while drunk or high. Must understand spoken and written English sufficiently to provide consent/assent and be interviewed and attend intervention workshops delivered in English Must live in the Boston or Tampa area, and plan to be available for study appointments (vacation allowed if not interfering with the planned intervention or follow up dates) Network Participant Inclusion Criteria Age is between 16 years and 0 days to 19 years and 364 days at the time of study enrollment In the past 3 months, reports engaging in any type of heterosexual sex (vaginal, oral or anal) with an opposite-sex partner Must understand spoken and written English sufficiently to provide consent/assent and be interviewed and attend intervention workshops delivered in English Must live in the Boston or Tampa area, and plan to be available for study appointments (vacation allowed if not interfering with the planned intervention or follow up dates) Must be reported by an index as a friend who: has been known for at least 6 months; hangs out with, or is in contact with the index at least 2 times per week; has engaged in alcohol or marijuana use with the index during the last 3 months; and gave directive guidance (gave index information on how to do something) AND, had intimate interaction (i.e. listened to private feelings of index) AND, had positive social interaction with the index. Exclusion Criteria: Index Participant Exclusion Criteria Reports only same sex behavior Reports being HIV positive, as measured by self-report Reports having engaged in behaviors in the past year that are defined as "severe" physical abuse of others on the Conflict Tactics Scale In the past year, reports having made someone engage in sexual things that he or she did not want to do either by holding the partner down, hurting or by threatening them in some way Unable to nominate at least one eligible friend to participate in the intervention Reports having ever used heroin, crack, cocaine, or metamphetamines Reports alcohol dependence as measured by affirmative answers to 3 or more out of 7 questions on the Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) based criteria of substance dependence Reports marijuana dependence as measured by affirmative answers to 3 or more out of 7 questions on the DSM-IV based criteria of substance dependence Reports being an active member of a gang Reports or is known by staff to be currently participating in any other bio-medical or Adolescent Trial Network (ATN)-related intervention study or trial If female, reports being currently pregnant Unwilling to be screened for sexually transmitted infections (STIs) Prior participation in this study intervention as either an index or a network member as determined by review of study logs Network Participant Exclusion Criteria Is currently romantically involved with the index who named him/her Has ever had vaginal, oral or anal sex with the index Reports only same sex behavior Reports being HIV positive, as measured by self-report Reports having engaged in behaviors in the past year that are defined as "severe" physical abuse of others on the Conflict Tactics Scale In the past year, reports having made someone engage in sexual things that he or she did not want to do either by holding the partner down, hurting or by threatening him/her in some way Reports having ever used heroin, crack, cocaine, or metamphetamines Reports alcohol dependence as measured by affirmative answers to 3 or more out of 7 questions on the DSM-IV based criteria of substance dependence Reports marijuana dependence as measured by affirmative answers to 3 or more out of 7 questions on the DSM-IV based criteria of substance dependence Self-reports being an active member of a gang Reports or is known by staff to be currently participating in any other bio-medical or ATN-related intervention study or trial If female, reports being currently pregnant Unwilling to be screened for STIs Prior participation in this study intervention as either an index or a network participant as determined by review of study logs

Sites / Locations

  • University of South Florida College of Medicine
  • Children's Hospital of Boston

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

The cohort will be comprised of up to 4 index participants and from 1-4 of their network members for a possible range of 8-16 subjects in each cohort (average of 12 per cohort). The vast majority of the intervention will be delivered to both females and males together, but it would be beneficial, and appropriate for this adolescent population, to deliver certain exercises with the two genders separated.

Outcomes

Primary Outcome Measures

Test the feasibility, acceptability and preliminary effectiveness intervention
The objective of this Phase II study is to test the feasibility, acceptability and preliminary effectiveness of a 6-session, small-group, peer-network intervention among adolescent males and females and their friendship networks. The ultimate goal is to test the intervention in a randomized, attention-controlled, Phase III trial.

Secondary Outcome Measures

Full Information

First Posted
April 5, 2005
Last Updated
February 27, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00107562
Brief Title
Adolescent Safer Sex Social Network Intervention
Official Title
Adolescent Safer Sex Social Network Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Social networks are thought to hold the potential for shaping behavior on the grounds that social and situational factors more strongly influence behavior than do personality variables. This is a behavioral intervention study that will test a 6-session, small-group, peer-network intervention among adolescent males and females and their friends. The intervention primarily focuses on reducing risky sexual behavior and increasing condom use among adolescent males and females, aged 16-19. The concurrent use of alcohol and marijuana during sex is also a focus as these two substances are widely used among adolescents and fuel risky sexual behavior.
Detailed Description
The objective of this Phase II study is to test the feasibility, acceptability and preliminary effectiveness of a 6-session, small-group, peer-network intervention among adolescent males and females and their friendship networks. A one-arm intervention design with pre-test assessment within one month before the first intervention session, and with post-test assessments at three and six months following intervention completion will be used. The intervention will be delivered to cohorts of friendship groups comprised of an index friend and their social network. To ensure that baseline data reflect recent, pre-intervention behavior, index participants and their networks will be recruited in small 'cohorts' of 8-16 (average 12) adolescents at a time. These cohorts will then receive the group intervention at the same time. Each cohort of interested and eligible participants (index + network members) will be screened and consented, and will provide baseline data. The first intervention session must occur within one month of baseline data collection. A successive series of these small cohorts will be identified, enrolled and dispatched to receive the intervention with subsequent follow up timelines determined by the date of the final group session of each cohort. Preliminary effectiveness of the behavioral intervention will be measured as follows: The primary outcome related to sexual behavior is the self-reported number of unprotected (not protected with male or female condom) vaginal, oral and anal sex acts among all (index and network members) who receive the intervention. Sexual acts when drunk or high will be measured by counting the number of sexual encounters that occurred concurrently with a respondent reporting being "drunk" or "high". Alcohol use will be measured by calculating the mean number of drinks consumed. Data will be collected on: the overall frequency of alcohol consumption during the referent period (past 3 months); and the usual number of drinks consumed on days when the individual reported drinking alcohol. The network effect on sexual and drug-use behaviors will be measured as follows: Data at each of the three time points (baseline, 3 and 6 months) will be evaluated to determine whether sexual and drug-use behaviors within networks are more correlated than such behaviors between networks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Behavior, Alcohol Drinking, Marijuana Smoking
Keywords
risk behavior, social networks, behavior

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The cohort will be comprised of up to 4 index participants and from 1-4 of their network members for a possible range of 8-16 subjects in each cohort (average of 12 per cohort). The vast majority of the intervention will be delivered to both females and males together, but it would be beneficial, and appropriate for this adolescent population, to deliver certain exercises with the two genders separated.
Intervention Type
Behavioral
Intervention Name(s)
Adolescent Safer Sex Social Network Intervention
Primary Outcome Measure Information:
Title
Test the feasibility, acceptability and preliminary effectiveness intervention
Description
The objective of this Phase II study is to test the feasibility, acceptability and preliminary effectiveness of a 6-session, small-group, peer-network intervention among adolescent males and females and their friendship networks. The ultimate goal is to test the intervention in a randomized, attention-controlled, Phase III trial.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Index Participant Inclusion Criteria Self-identifies as all or part "Latino" Age is between 16 years and 0 days and 19 years and 364 days at the time of study enrollment In the past 3 months, reports engaging in any type of heterosexual sex (vaginal, oral or anal) with an opposite-sex partner In the past 3 months, reports any of the following: alcohol use at least once; marijuana use at least once; having sex while drunk or high. Must understand spoken and written English sufficiently to provide consent/assent and be interviewed and attend intervention workshops delivered in English Must live in the Boston or Tampa area, and plan to be available for study appointments (vacation allowed if not interfering with the planned intervention or follow up dates) Network Participant Inclusion Criteria Age is between 16 years and 0 days to 19 years and 364 days at the time of study enrollment In the past 3 months, reports engaging in any type of heterosexual sex (vaginal, oral or anal) with an opposite-sex partner Must understand spoken and written English sufficiently to provide consent/assent and be interviewed and attend intervention workshops delivered in English Must live in the Boston or Tampa area, and plan to be available for study appointments (vacation allowed if not interfering with the planned intervention or follow up dates) Must be reported by an index as a friend who: has been known for at least 6 months; hangs out with, or is in contact with the index at least 2 times per week; has engaged in alcohol or marijuana use with the index during the last 3 months; and gave directive guidance (gave index information on how to do something) AND, had intimate interaction (i.e. listened to private feelings of index) AND, had positive social interaction with the index. Exclusion Criteria: Index Participant Exclusion Criteria Reports only same sex behavior Reports being HIV positive, as measured by self-report Reports having engaged in behaviors in the past year that are defined as "severe" physical abuse of others on the Conflict Tactics Scale In the past year, reports having made someone engage in sexual things that he or she did not want to do either by holding the partner down, hurting or by threatening them in some way Unable to nominate at least one eligible friend to participate in the intervention Reports having ever used heroin, crack, cocaine, or metamphetamines Reports alcohol dependence as measured by affirmative answers to 3 or more out of 7 questions on the Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) based criteria of substance dependence Reports marijuana dependence as measured by affirmative answers to 3 or more out of 7 questions on the DSM-IV based criteria of substance dependence Reports being an active member of a gang Reports or is known by staff to be currently participating in any other bio-medical or Adolescent Trial Network (ATN)-related intervention study or trial If female, reports being currently pregnant Unwilling to be screened for sexually transmitted infections (STIs) Prior participation in this study intervention as either an index or a network member as determined by review of study logs Network Participant Exclusion Criteria Is currently romantically involved with the index who named him/her Has ever had vaginal, oral or anal sex with the index Reports only same sex behavior Reports being HIV positive, as measured by self-report Reports having engaged in behaviors in the past year that are defined as "severe" physical abuse of others on the Conflict Tactics Scale In the past year, reports having made someone engage in sexual things that he or she did not want to do either by holding the partner down, hurting or by threatening him/her in some way Reports having ever used heroin, crack, cocaine, or metamphetamines Reports alcohol dependence as measured by affirmative answers to 3 or more out of 7 questions on the DSM-IV based criteria of substance dependence Reports marijuana dependence as measured by affirmative answers to 3 or more out of 7 questions on the DSM-IV based criteria of substance dependence Self-reports being an active member of a gang Reports or is known by staff to be currently participating in any other bio-medical or ATN-related intervention study or trial If female, reports being currently pregnant Unwilling to be screened for STIs Prior participation in this study intervention as either an index or a network participant as determined by review of study logs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Latka, PhD
Organizational Affiliation
New York Academy of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University of South Florida College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Children's Hospital of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Adolescent Safer Sex Social Network Intervention

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