Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents
HIV/Sexually Transmitted Disease (STD) Prevention Interventions for Black Adolescents
2 other identifiers
interventional
662
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Sep 2001
Typical duration for not_applicable hiv-infections
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
March 19, 2008
CompletedFirst Posted
Study publicly available on registry
March 21, 2008
CompletedResults Posted
Study results publicly available
December 13, 2017
CompletedDecember 13, 2017
November 1, 2017
2.9 years
March 19, 2008
September 23, 2015
November 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Self-reported 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
Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention
Self-reported Consistent Condom Use 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
Measured at baseline and3, 6, 12, 18, and 24 months post-intervention
Study Arms (5)
Abstinence-only
EXPERIMENTALParticipants will receive the abstinence-only HIV/STD risk-reduction intervention.
Safer-sex only
EXPERIMENTALParticipants will receive the safer-sex-only HIV/STD risk-reduction intervention.
Comprehensive-long
EXPERIMENTALParticipants will receive the 12-h long comprehensive HIV/STD risk-reduction intervention.
Comprehensive-short
EXPERIMENTALParticipants will receive the 8-h short comprehensive HIV/STD risk-reduction intervention.
Health-promotion control
ACTIVE COMPARATORParticipants will receive the health promotion control intervention.
Interventions
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.
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.
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).
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.
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.
Eligibility Criteria
You may qualify if:
- Grade 6 or 7 student at a participating school
- Written parent or guardian consent to participate
- Self-identifies as African American or black
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related 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.
PMID: 20124144RESULTZhang 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.
PMID: 26214076RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The data were based on self-reports, which can be inaccurate because of poor memory or socially desirability bias. The results may be limited to African American grade 6 and 7 students willing to take part in a health program on weekends.
Results Point of Contact
- Title
- Dr. John B. Jemmott III
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
John B. Jemmott III, PhD
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Kenneth B. Clark Professor of Communication and Psychiatry
Study Record Dates
First Submitted
March 19, 2008
First Posted
March 21, 2008
Study Start
September 1, 2001
Primary Completion
August 1, 2004
Study Completion
August 1, 2004
Last Updated
December 13, 2017
Results First Posted
December 13, 2017
Record last verified: 2017-11