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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV Infections, Sexually Transmitted Diseases

Intervention / Treatment
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* 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: Short comprehensive HIV/STD risk-reduction intervention
* Behavioral: Health promotion control intervention


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Abstinence-only<br>Participants will receive the abstinence-only HIV/STD risk-reduction intervention. | Behavioral: Abstinence-only HIV/STD risk-reduction intervention<br>* 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.<br>* Other names: Abstinence;|
| Experimental: Safer-sex only<br>Participants will receive the safer-sex-only HIV/STD risk-reduction intervention. | Behavioral: Safer-sex-only HIV/STD risk-reduction intervention<br>* 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.<br>* Other names: Condom-use intervention;|
| Experimental: Comprehensive-long<br>Participants will receive the 12-h long comprehensive HIV/STD risk-reduction intervention. | Behavioral: Long comprehensive HIV/STD risk-reduction intervention<br>* 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).<br>* Other names: Abstinence-plus intervention;|
| Experimental: Comprehensive-short<br>Participants will receive the 8-h short comprehensive HIV/STD risk-reduction intervention. | Behavioral: Short comprehensive HIV/STD risk-reduction intervention<br>* 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.<br>* Other names: Abstinence-plus intervention;|
| Active Comparator: Health-promotion control<br>Participants will receive the health promotion control intervention. | Behavioral: Health promotion control intervention<br>* 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.<br>* Other names: Chronic disease prevention intervention;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported Sexual Intercourse in the Past 3 Months | Self-report of having sexual intercourse in the past 3 months | Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention | 
| Self-report of Having Multiple Sexual Partners in the Past 3 Months | Self-report of having sexual intercourse with more than one partner in the pat 3 months. | Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention | 
| Self-reported Consistent Condom Use in the Past 3 Months | Self-report of using a condom during every sexual intercourse act in the past 3 months | Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Sexual Behavior, Abstinence, Intervention Studies, Sexually Transmitted Infection, Theory of Planned Behavior, HIV Seronegativity