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

NCT ID: NCT00640653

Last Updated: 2017-12-13

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

662 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2004-08-31

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.

Conditions

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HIV Infections Sexually Transmitted Diseases

Keywords

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Sexual Behavior Abstinence Intervention Studies HIV Sexually Transmitted Infection Theory of Planned Behavior HIV Seronegativity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Abstinence-only

Participants will receive the abstinence-only HIV/STD risk-reduction intervention.

Group Type EXPERIMENTAL

Abstinence-only HIV/STD risk-reduction intervention

Intervention Type 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.

Safer-sex only

Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Comprehensive-long

Participants will receive the 12-h long comprehensive HIV/STD risk-reduction intervention.

Group Type EXPERIMENTAL

Long comprehensive HIV/STD risk-reduction intervention

Intervention Type 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).

Comprehensive-short

Participants will receive the 8-h short comprehensive HIV/STD risk-reduction intervention.

Group Type EXPERIMENTAL

Short comprehensive HIV/STD risk-reduction intervention

Intervention Type 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.

Health-promotion control

Participants will receive the health promotion control intervention.

Group Type ACTIVE_COMPARATOR

Health promotion control intervention

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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).

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Abstinence Condom-use intervention Abstinence and condom-use intervention Abstinence-plus intervention Abstinence and condom-use intervention Abstinence-plus intervention Chronic disease prevention intervention

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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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John Jemmott

Kenneth B. Clark Professor of Communication and Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John B. Jemmott III, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Jemmott JB 3rd, Jemmott LS, Fong GT. Efficacy of a theory-based abstinence-only intervention over 24 months: a randomized controlled trial with young adolescents. Arch Pediatr Adolesc Med. 2010 Feb;164(2):152-9. doi: 10.1001/archpediatrics.2009.267.

Reference Type RESULT
PMID: 20124144 (View on PubMed)

Zhang J, Jemmott JB 3rd, Jemmott LS. Mediation and moderation of an efficacious theory-based abstinence-only intervention for African American adolescents. Health Psychol. 2015 Dec;34(12):1175-84. doi: 10.1037/hea0000244. Epub 2015 Jul 27.

Reference Type RESULT
PMID: 26214076 (View on PubMed)

Other Identifiers

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R01MH062049

Identifier Type: NIH

Identifier Source: secondary_id

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DAHBR 9A-ASPA

Identifier Type: OTHER

Identifier Source: secondary_id

R01MH062049

Identifier Type: NIH

Identifier Source: org_study_id

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