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

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University of Pennsylvania

Status

Completed

Conditions

Sexually Transmitted Diseases
HIV Infections

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00640653
DAHBR 9A-ASPA
R01MH062049 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

662 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

662 participants in 5 patient groups

Abstinence-only
Experimental group
Description:
Participants will receive the abstinence-only HIV/STD risk-reduction intervention.
Treatment:
Behavioral: Abstinence-only HIV/STD risk-reduction intervention
Safer-sex only
Experimental group
Description:
Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.
Treatment:
Behavioral: Safer-sex-only HIV/STD risk-reduction intervention
Comprehensive-long
Experimental group
Description:
Participants will receive the 12-h long comprehensive HIV/STD risk-reduction intervention.
Treatment:
Behavioral: Long comprehensive HIV/STD risk-reduction intervention
Comprehensive-short
Experimental group
Description:
Participants will receive the 8-h short comprehensive HIV/STD risk-reduction intervention.
Treatment:
Behavioral: Short comprehensive HIV/STD risk-reduction intervention
Health-promotion control
Active Comparator group
Description:
Participants will receive the health promotion control intervention.
Treatment:
Behavioral: Health promotion control intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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