Effectiveness of an Abstinence-Only HIV/Sexually Transmitted Disease Risk-Reduction Intervention for Young African-American Adolescents

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00640653
First received: March 19, 2008
Last updated: April 7, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention 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
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV/STD Prevention Interventions for Black Adolescents

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Self-report of ever having sexual intercourse [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Self-report of sexual intercourse in the past 3 months [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]
  • Self-report of having multiple sexual partners in the past 3 months [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]
  • Self-report of using a condom during every sexual intercourse act in the past 3 months [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]
  • Self-report of having sexual intercourse without using a condom during the past 3 months [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]
  • Intention to have sexual intercourse in the next 3 months [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]
  • Belief that abstinence reduces the risk of pregnancy and sexually transmitted disease [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]
  • Belief that the practice of abstinence increases the likelihood of achieving one's career goals [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]
  • Intention to use a condom if the respondent has sexual intercourse in the next 3 months [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]
  • Belief that condoms reduce the risk of pregnancy and sexually transmitted infection, including HIV [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]
  • Self-efficacy to use condoms [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]
  • HIV/STI risk-reduction knowledge [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]
  • Condom-use knowledge [ Time Frame: Measured at baseline and Months 3, 6, 12, 18, and 24 of follow-up ] [ Designated as safety issue: No ]

Enrollment: 662
Study Start Date: September 2001
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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: 2
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: 3
Participants will receive the 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: 4
Participants will receive the 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: 5
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640653

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: John B. Jemmott III, PhD University of Pennsylvania
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John B. Jemmott III, PhD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00640653     History of Changes
Other Study ID Numbers: R01 MH062049, DAHBR 9A-ASPA
Study First Received: March 19, 2008
Last Updated: April 7, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Sexual Behavior
Abstinence
Intervention Studies
HIV
Sexually Transmitted Infection
Theory of Planned Behavior
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 31, 2014