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

November 15, 2017 updated by: John Jemmott, University of Pennsylvania

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
662

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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:
  • Abstinence and condom-use intervention
  • Abstinence-plus intervention
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:
  • Abstinence and condom-use intervention
  • Abstinence-plus intervention
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 Names:
  • Chronic disease prevention intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 months post-intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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.
Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention
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
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
Time Frame: Measured at baseline and3, 6, 12, 18, and 24 months post-intervention
Measured at baseline and3, 6, 12, 18, and 24 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: John B. Jemmott III, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2001

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R01MH062049 (U.S. NIH Grant/Contract)
  • DAHBR 9A-ASPA (National Institute of Mental Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on Abstinence-only HIV/STD risk-reduction intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings