Sexual BehaviorNCT00107562
Adolescent Safer Sex Social Network Intervention
A study testing Adolescent Safer Sex Social Network Intervention in people with Sexual Behavior and Alcohol Drinking, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Alcohol Drinking, Marijuana Smoking
- What is being tested?
- Adolescent Safer Sex Social Network Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2005to Mar 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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;
Show all 20Show fewer
- 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.
Who cannot join
- 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
Show all 29Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Boston
Boston, Massachusetts, 02115
University of South Florida College of Medicine
Tampa, Florida, 33606
About this study
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.
Read the 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.
- Conditions
- Sexual Behavior, Alcohol Drinking, Marijuana Smoking
- Being tested
- Adolescent Safer Sex Social Network Intervention
- Keywords
- risk behavior, social networks, behavior
- Medical subject headings
- Sexual Behavior, Alcohol Drinking, Marijuana Smoking, Risk-Taking, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent Safer Sex Social Network InterventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Adolescent Safer Sex Social Network Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2005 (estimated)
- Study startFeb 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Mary Latka, PhD, Study chair, New York Academy of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107562
- Sponsor's protocol ID
- ATN 032
- Status last verified
- Feb 2016
- First submitted
- 5 Apr 2005
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent Safer Sex Social Network Intervention
- ClinicalTrials.gov ID
- NCT00107562
- Acronym / sponsor ID
- ATN 032
- Conditions
- Sexual Behavior, Alcohol Drinking, Marijuana Smoking
- Keywords
- risk behavior, social networks, behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Feb 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 6 Apr 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Adolescent Safer Sex Social Network InterventionThe 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. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (20 listed)
- 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:
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adolescent Safer Sex Social Network Intervention | Behavioural | Intervention |
Primary outcome
Test the feasibility, acceptability and preliminary effectiveness intervention
Time frame: 6 Months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- description of the Adolescent Trials Network and contact informationLink provided by the sponsor.
Related trials for Sexual Behavior
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Not yet recruitingPhase 2
Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
Aggressive Behavior in Fragile X Syndome
Recruiting
Demographic Data Collection in Healthcare
Implementation Strategies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary Latka, PhD study chair
New York Academy of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adolescent Safer Sex Social Network Intervention in people with Sexual Behavior and Alcohol Drinking, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test the feasibility, acceptability and preliminary effectiveness intervention (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.