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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640653
• Other study ID #: R01MH062049
• Secondary ID: R01MH062049DAHBR
• Status: Completed
• Phase: N/A
• First received: March 19, 2008
• Last updated: November 15, 2017
• Start date: September 2001
• Est. completion date: August 2004

Study information

• Verified date: November 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 662
• Est. completion date: August 2004
• Est. primary completion date: August 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV Infections
• Sexually Transmitted Diseases

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.
• 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.
• 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).
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 months post-intervention
Secondary	Self-reported Sexual Intercourse in the Past 3 Months	Self-report of having sexual intercourse in the past 3 months	Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention
Secondary	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.	Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention
Secondary	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	Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention
Secondary	Self-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months		Measured at baseline and3, 6, 12, 18, and 24 months post-intervention