Adolescent Safer Sex Social Network Intervention
Behavioral: Adolescent Safer Sex Social Network Intervention
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Adolescent Safer Sex Social Network Intervention|
- Test the feasibility, acceptability and preliminary effectiveness intervention [ Time Frame: 6 Months ] [ Designated as safety issue: No ]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.
|Study Start Date:||February 2005|
|Study Completion Date:||March 2006|
|Primary Completion Date:||March 2006 (Final data collection date for primary outcome measure)|
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.
|Behavioral: Adolescent Safer Sex Social Network 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00107562
|United States, Florida|
|University of South Florida College of Medicine|
|Tampa, Florida, United States, 33606|
|United States, Massachusetts|
|Children's Hospital of Boston|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Mary Latka, PhD||New York Academy of Medicine|