Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents

Not Applicable

Completed

Conditions: Sexually Transmitted Diseases
HIV Infections

Interventions: Behavioral: Abstinence-only HIV/STD risk-reduction intervention
Behavioral: Safer-sex-only HIV/STD risk-reduction intervention
Behavioral: Long comprehensive HIV/STD risk-reduction intervention
Behavioral: Health promotion control intervention
Behavioral: Short comprehensive HIV/STD risk-reduction intervention

Registration Number: NCT00640653

Lead Sponsor: University of Pennsylvania

Brief Summary: This study will develop and evaluate the effectiveness of culturally appropriate HIV/sexually transmitted disease risk-reduction interventions in reducing sexual risk behavior among young African-American adolescents.

Detailed Description: Adolescents risk the negative consequences of early sexual involvement, including not only HIV, but other sexually transmitted diseases (STDs) and unintended pregnancies. Compared with older adults, young people, especially African-American young people, are at higher risk of acquiring an STD. Specifically, people 15 to 24 years of age acquire nearly 50% of all new STDs in the United States, but this age group represents only 25% of the sexually active population. Adolescents are especially vulnerable to STD infections because of a lack of education about proper condom use and consequences of sexual risk behaviors. Previous research has suggested that behavioral interventions can reduce adolescents' sexual behaviors tied to risk of acquiring STDs. Nevertheless, there is continuous debate over the appropriateness and effectiveness of different types of adolescent sexual-risk-reduction interventions, including abstinence education or comprehensive sexual education. Few studies have tested the long-term effectiveness of abstinence education, which emphasizes delaying sexual initiation for sexually inexperienced adolescents. This study will compare the effectiveness of an abstinence-only HIV/STD risk-reduction intervention with other types of interventions in reducing sexual risk behavior among young African-American adolescents.

Participation in this study will last 24 months. Participants at participating schools will be randomly assigned to one of five treatment groups:

* Abstinence-only group participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. This is not an abstinence-until-marriage intervention; the target behavior is abstaining from sexual activity until later in life when the adolescent is more prepared to handle the consequences. The intervention is not designed to affect condom use.

* Safer-sex-only group participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for using condoms during sexual intercourse. The intervention is not designed to influence abstinence.

* Long comprehensive group participants will attend three sessions consisting of twelve 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active. The intervention will consist of 4 hours each of the safer-sex-specific content, the abstinence-specific content, and the general content that is common to both of the single-component interventions.

* Short comprehensive group participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence and for using condoms if participants decide to be sexually active.

* Health promotion control participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for avoiding cigarette smoking and for incorporating a healthful diet, aerobic exercise, and breast and testicular self-examinations. The control intervention will focus on reducing risk of heart disease, hypertension, diabetes, and certain cancers.

Sessions for all groups will be led by trained adult facilitators and will include group discussions, videos, games, brainstorming, experiential exercises, and skill-building activities designed to be educational, interactive, and entertaining. All participants will complete self-reports concerning sexual behaviors, condom use, and knowledge about STDs at baseline and Months 3, 6, 12, 18, and 24 of follow-up.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 662

Inclusion Criteria

Grade 6 or 7 student at a participating school
Written parent or guardian consent to participate
Self-identifies as African American or black

Exclusion Criteria

Those not meeting inclusion criteria were excluded.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Abstinence-only	Abstinence-only HIV/STD risk-reduction intervention	Participants will receive the abstinence-only HIV/STD risk-reduction intervention.
Safer-sex only	Safer-sex-only HIV/STD risk-reduction intervention	Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.
Comprehensive-long	Long comprehensive HIV/STD risk-reduction intervention	Participants will receive the 12-h long comprehensive HIV/STD risk-reduction intervention.
Health-promotion control	Health promotion control intervention	Participants will receive the health promotion control intervention.
Comprehensive-short	Short comprehensive HIV/STD risk-reduction intervention	Participants will receive the 8-h short comprehensive HIV/STD risk-reduction intervention.

Primary Outcome Measures

Name	Time	Method
Self-report of Ever Having Sexual Intercourse	24 months post-intervention	Self-reported sexual initiation during the follow-up period among participants who reported never having sexual intercourse at baseline.

Secondary Outcome Measures

Name	Time	Method
Self-reported Sexual Intercourse in the Past 3 Months	Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention	Self-report of having sexual intercourse in the past 3 months
Self-report of Having Multiple Sexual Partners in the Past 3 Months	Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention	Self-report of having sexual intercourse with more than one partner in the pat 3 months.
Self-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months	Measured at baseline and3, 6, 12, 18, and 24 months post-intervention
Self-reported Consistent Condom Use in the Past 3 Months	Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention	Self-report of using a condom during every sexual intercourse act in the past 3 months