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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00640653
First Posted: March 21, 2008
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
John Jemmott, University of Pennsylvania
Results First Submitted: September 23, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: HIV Infections
Sexually Transmitted Diseases
Interventions: 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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Comprehensive-long

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

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).

Comprehensive-short

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

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.

Safer-sex Only

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

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.

Abstinence-only

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

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.

Health-promotion Control

Participants will receive the health promotion control intervention.

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.


Participant Flow:   Overall Study
    Comprehensive-long   Comprehensive-short   Safer-sex Only   Abstinence-only   Health-promotion Control
STARTED   131   134   129   134   134 
Followed-up at 3 mo   126   127   125   129   126 
Followed-up at 6 mo   127   130   124   130   125 
Followed-up at 12 mo   124   121   115   122   116 
Followed-up at 18 mo   118   112   113   117   117 
Followed-up at 24 mo   114   116   105   112   112 
COMPLETED   128   131   129   132   129 
NOT COMPLETED   3   3   0   2   5 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Sociodemographic Characteristics and Self-Reported Sexual Behaviors at Baseline of Participating African American Students in Grades 6 and 7 by Intervention Arm

Reporting Groups
  Description
Comprehensive-long

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

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).

Comprehensive-short

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

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.

Safer-sex Only

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

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.

Abstinence-only

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

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.

Health-promotion Control

Participants will receive the health promotion control intervention.

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.

Total Total of all reporting groups

Baseline Measures
   Comprehensive-long   Comprehensive-short   Safer-sex Only   Abstinence-only   Health-promotion Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 131   134   129   134   134   662 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.0  (0.8)   11.9  (0.8)   11.9  (0.8)   12.0  (0.8)   12.0  (0.8)   12.0  (0.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      69  52.7%      72  53.7%      70  54.3%      70  52.2%      73  54.5%      354  53.5% 
Male      62  47.3%      62  46.3%      59  45.7%      64  47.8%      61  45.5%      308  46.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
           
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      131 100.0%      134 100.0%      129 100.0%      134 100.0%      134 100.0%      662 100.0% 
White      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
           
United States   131   134   129   134   134   662 
Grade in School 
[Units: Participants]
           
7th   68   71   73   77   77   366 
8th   63   63   56   57   57   296 
Live with both parents 
[Units: Participants]
           
Yes   46   46   40   43   46   221 
No   85   88   89   91   88   441 
Ever had sexual intercourse 
[Units: Participants]
           
Yes   31   28   32   27   35   153 
No   100   106   97   107   99   509 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Self-report of Ever Having Sexual Intercourse   [ Time Frame: 24 months post-intervention ]

2.  Secondary:   Self-reported Sexual Intercourse in the Past 3 Months   [ Time Frame: Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. John B. Jemmott III
Organization: University of Pennsylvania
phone: 215-573-9366
e-mail: jjemmott@asc.upenn.edu


Publications of Results:

Responsible Party: John Jemmott, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00640653     History of Changes
Other Study ID Numbers: R01MH062049 ( U.S. NIH Grant/Contract )
DAHBR 9A-ASPA ( Other Identifier: National Institute of Mental Health )
First Submitted: March 19, 2008
First Posted: March 21, 2008
Results First Submitted: September 23, 2015
Results First Posted: December 13, 2017
Last Update Posted: December 13, 2017