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Completed

NCT Number: NCT00640653

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abstinence-only HIV/STD risk-reduction intervention

Behavioral

Participants will attend two sessions consisting of eight 1-hour modules that are designed to increase knowledge, motivation, and skill for practicing abstinence. The intervention 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 does not contain inaccurate information, portray sex in a negative light, or employ a moralistic tone. It is not designed to affect condom use.

Other names: Abstinence

Safer-sex-only HIV/STD risk-reduction intervention

Behavioral

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.

Other names: Condom-use intervention

Long comprehensive HIV/STD risk-reduction intervention

Behavioral

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 consists of the safer-sex-specific content (4 hours), the abstinence-specific content (4 hours), and the general content that is common to both of the single-component interventions (4 hours).

Other names: Abstinence and condom-use intervention, Abstinence-plus intervention

Short comprehensive HIV/STD risk-reduction intervention

Behavioral

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.

Other names: Abstinence and condom-use intervention, Abstinence-plus intervention

Health promotion control intervention

Behavioral

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. The intervention provides a control for "Hawthorne effects" to reduce the likelihood that the HIV/STD interventions' effects can be attributed to group interaction and special attention.

Other names: Chronic disease prevention intervention

Primary outcomes

  1. Self-report of Ever Having Sexual Intercourse

    Time frame: 24 months post-intervention

    Self-reported sexual initiation during the follow-up period among participants who reported never having sexual intercourse at baseline.

Secondary outcomes

  1. Self-reported Sexual Intercourse in the Past 3 Months

    Time frame: Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention

    Self-report of having sexual intercourse in the past 3 months

  2. Self-report of Having Multiple Sexual Partners in the Past 3 Months

    Time frame: 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.

  3. Self-reported Consistent Condom Use in the Past 3 Months

    Time frame: 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

  4. Self-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months

    Time frame: Measured at baseline and3, 6, 12, 18, and 24 months post-intervention

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

HIV/Sexually Transmitted Disease (STD) Prevention Interventions for Black Adolescents

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Mar 21, 2008
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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