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

Primary Purpose

HIV Infections, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abstinence-only HIV/STD risk-reduction intervention
Safer-sex-only HIV/STD risk-reduction intervention
Long comprehensive HIV/STD risk-reduction intervention
Short comprehensive HIV/STD risk-reduction intervention
Health promotion control intervention
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Sexual Behavior, Abstinence, Intervention Studies, HIV, Sexually Transmitted Infection, Theory of Planned Behavior, HIV Seronegativity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Abstinence-only

Safer-sex only

Comprehensive-long

Comprehensive-short

Health-promotion control

Arm Description

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

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

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

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

Participants will receive the health promotion control intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Self-reported Sexual Intercourse in the Past 3 Months
Self-report of having sexual intercourse in the past 3 months
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.
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
Self-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months

Full Information

First Posted
March 19, 2008
Last Updated
November 15, 2017
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00640653
Brief Title
Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents
Official Title
HIV/Sexually Transmitted Disease (STD) Prevention Interventions for Black Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
August 2004 (Actual)
Study Completion Date
August 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases
Keywords
Sexual Behavior, Abstinence, Intervention Studies, HIV, Sexually Transmitted Infection, Theory of Planned Behavior, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
662 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Abstinence-only
Arm Type
Experimental
Arm Description
Participants will receive the abstinence-only HIV/STD risk-reduction intervention.
Arm Title
Safer-sex only
Arm Type
Experimental
Arm Description
Participants will receive the safer-sex-only HIV/STD risk-reduction intervention.
Arm Title
Comprehensive-long
Arm Type
Experimental
Arm Description
Participants will receive the 12-h long comprehensive HIV/STD risk-reduction intervention.
Arm Title
Comprehensive-short
Arm Type
Experimental
Arm Description
Participants will receive the 8-h short comprehensive HIV/STD risk-reduction intervention.
Arm Title
Health-promotion control
Arm Type
Active Comparator
Arm Description
Participants will receive the health promotion control intervention.
Intervention Type
Behavioral
Intervention Name(s)
Abstinence-only HIV/STD risk-reduction intervention
Other Intervention Name(s)
Abstinence
Intervention Description
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
Intervention Name(s)
Safer-sex-only HIV/STD risk-reduction intervention
Other Intervention Name(s)
Condom-use intervention
Intervention Description
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
Intervention Name(s)
Long comprehensive HIV/STD risk-reduction intervention
Other Intervention Name(s)
Abstinence and condom-use intervention, Abstinence-plus intervention
Intervention Description
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
Intervention Name(s)
Short comprehensive HIV/STD risk-reduction intervention
Other Intervention Name(s)
Abstinence and condom-use intervention, Abstinence-plus intervention
Intervention Description
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
Intervention Name(s)
Health promotion control intervention
Other Intervention Name(s)
Chronic disease prevention intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-report of Ever Having Sexual Intercourse
Description
Self-reported sexual initiation during the follow-up period among participants who reported never having sexual intercourse at baseline.
Time Frame
24 months post-intervention
Secondary Outcome Measure Information:
Title
Self-reported Sexual Intercourse in the Past 3 Months
Description
Self-report of having sexual intercourse in the past 3 months
Time Frame
Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention
Title
Self-report of Having Multiple Sexual Partners in the Past 3 Months
Description
Self-report of having sexual intercourse with more than one partner in the pat 3 months.
Time Frame
Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention
Title
Self-reported Consistent Condom Use in the Past 3 Months
Description
Self-report of using a condom during every sexual intercourse act in the past 3 months
Time Frame
Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John B. Jemmott III, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20124144
Citation
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.
Results Reference
result
PubMed Identifier
26214076
Citation
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.
Results Reference
result

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

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