Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00640653 |
|
Recruitment Status :
Completed
First Posted : March 21, 2008
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| HIV Infections Sexually Transmitted Diseases | 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 | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 662 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | HIV/Sexually Transmitted Disease (STD) Prevention Interventions for Black Adolescents |
| Study Start Date : | September 2001 |
| Actual Primary Completion Date : | August 2004 |
| Actual Study Completion Date : | August 2004 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Abstinence-only
Participants will receive the abstinence-only HIV/STD risk-reduction intervention.
|
Behavioral: Abstinence-only HIV/STD risk-reduction intervention
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 Name: Abstinence |
|
Experimental: Safer-sex only
Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.
|
Behavioral: Safer-sex-only HIV/STD risk-reduction intervention
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 Name: Condom-use intervention |
|
Experimental: Comprehensive-long
Participants will receive the 12-h long comprehensive HIV/STD risk-reduction intervention.
|
Behavioral: Long comprehensive HIV/STD risk-reduction intervention
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:
|
|
Experimental: Comprehensive-short
Participants will receive the 8-h short comprehensive HIV/STD risk-reduction intervention.
|
Behavioral: Short comprehensive HIV/STD risk-reduction intervention
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:
|
|
Active Comparator: Health-promotion control
Participants will receive the health promotion control intervention.
|
Behavioral: Health promotion control intervention
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 Name: Chronic disease prevention intervention |
- 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.
- 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
- 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.
- 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
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640653
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: | John B. Jemmott III, PhD | University of Pennsylvania |
Publications of Results:
| Responsible Party: | John Jemmott, Kenneth B. Clark Professor of Communication and Psychiatry, University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT00640653 History of Changes |
| Other Study ID Numbers: |
R01MH062049 ( U.S. NIH Grant/Contract ) R01MH062049 ( U.S. NIH Grant/Contract ) DAHBR 9A-ASPA ( Other Identifier: National Institute of Mental Health ) |
| First Posted: | March 21, 2008 Key Record Dates |
| Results First Posted: | December 13, 2017 |
| Last Update Posted: | December 13, 2017 |
| Last Verified: | November 2017 |
Keywords provided by John Jemmott, University of Pennsylvania:
|
Sexual Behavior Abstinence Intervention Studies HIV |
Sexually Transmitted Infection Theory of Planned Behavior HIV Seronegativity |
Additional relevant MeSH terms:
|
HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Immunologic Deficiency Syndromes Immune System Diseases Infection Genital Diseases, Male Genital Diseases, Female |