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

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ClinicalTrials.gov Identifier: NCT00640653
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
John Jemmott, University of Pennsylvania

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
Enrollment 662
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Comprehensive-long Comprehensive-short Safer-sex Only Abstinence-only Health-promotion Control
Hide Arm/Group Description

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).

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.

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.

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.

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.

Period Title: Overall Study
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
Arm/Group Title Comprehensive-long Comprehensive-short Safer-sex Only Abstinence-only Health-promotion Control Total
Hide Arm/Group Description

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).

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 131 134 129 134 134 662
Hide Baseline Analysis Population Description
Sociodemographic Characteristics and Self-Reported Sexual Behaviors at Baseline of Participating African American Students in Grades 6 and 7 by Intervention Arm
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants 134 participants 129 participants 134 participants 134 participants 662 participants
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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 134 participants 129 participants 134 participants 134 participants 662 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 134 participants 129 participants 134 participants 134 participants 662 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 131 participants 134 participants 129 participants 134 participants 134 participants 662 participants
131 134 129 134 134 662
Grade in School  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 131 participants 134 participants 129 participants 134 participants 134 participants 662 participants
7th 68 71 73 77 77 366
8th 63 63 56 57 57 296
Live with both parents  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 131 participants 134 participants 129 participants 134 participants 134 participants 662 participants
Yes 46 46 40 43 46 221
No 85 88 89 91 88 441
Ever had sexual intercourse  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 131 participants 134 participants 129 participants 134 participants 134 participants 662 participants
Yes 31 28 32 27 35 153
No 100 106 97 107 99 509
1.Primary Outcome
Title Self-report of Ever Having Sexual Intercourse
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants reporting never having sexual intercourse at baseline (i.e., virgins) with follow-up data on self-reported sexual intercourse during the post-intervention assessments.
Arm/Group Title Comprehensive-long Comprehensive-short Safer-sex Only Abstinence-only Health-promotion Control
Hide Arm/Group Description:

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).

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.

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.

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.

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.

Overall Number of Participants Analyzed 92 97 85 95 88
Measure Type: Count of Participants
Unit of Measure: Participants
39
  42.4%
40
  41.2%
44
  51.8%
31
  32.6%
41
  46.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Abstinence-only, Health-promotion Control
Comments With alpha = .05, 2-tailed, and 37.4% of the control group initiating sexual intercourse by 24-month follow-up, a total sample size of 563 participants completing the trial was projected to provide power of 80% to detect a difference of 16.8% in self-reported sexual intercourse between an HIV intervention condition and the health promotion control condition.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .03
Comments The significance criterion was set at alpha = .05.
Method generalized linear regression
Comments Log link was specified
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.67
Confidence Interval (2-Sided) 95%
0.48 to 0.96
Estimation Comments Treatment was coded as 1 vs health control coded as 0.
2.Secondary Outcome
Title Self-reported Sexual Intercourse in the Past 3 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data at baseline and at least one post-intervention assessment.
Arm/Group Title Comprehensive-long Comprehensive-short Safer-sex Only Abstinence-only Health-promotion Control
Hide Arm/Group Description:

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).

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.

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.

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.

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.

Overall Number of Participants Analyzed 127 130 128 131 129
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 127 participants 130 participants 128 participants 131 participants 129 participants
14
  11.0%
13
  10.0%
15
  11.7%
16
  12.2%
18
  14.0%
3 months Number Analyzed 125 participants 126 participants 124 participants 129 participants 126 participants
12
   9.6%
19
  15.1%
22
  17.7%
15
  11.6%
26
  20.6%
6 months Number Analyzed 127 participants 130 participants 122 participants 130 participants 125 participants
18
  14.2%
19
  14.6%
21
  17.2%
13
  10.0%
27
  21.6%
12 months Number Analyzed 124 participants 121 participants 115 participants 121 participants 116 participants
24
  19.4%
33
  27.3%
34
  29.6%
27
  22.3%
25
  21.6%
18 months Number Analyzed 118 participants 112 participants 113 participants 117 participants 117 participants
32
  27.1%
32
  28.6%
40
  35.4%
39
  33.3%
35
  29.9%
24 months Number Analyzed 114 participants 116 participants 105 participants 112 participants 112 participants
35
  30.7%
38
  32.8%
42
  40.0%
33
  29.5%
42
  37.5%
3.Secondary Outcome
Title Self-report of Having Multiple Sexual Partners in the Past 3 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data at baseline and at least one post-intervention assessment.
Arm/Group Title Comprehensive-long Comprehensive-short Safer-sex Only Abstinence-only Health-promotion Control
Hide Arm/Group Description:

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).

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.

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.

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.

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.

Overall Number of Participants Analyzed 127 130 127 131 128
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 127 participants 130 participants 127 participants 131 participants 128 participants
11
   8.7%
9
   6.9%
6
   4.7%
4
   3.1%
10
   7.8%
3 months Number Analyzed 125 participants 125 participants 123 participants 128 participants 125 participants
7
   5.6%
6
   4.8%
12
   9.8%
5
   3.9%
14
  11.2%
6 months Number Analyzed 126 participants 128 participants 121 participants 129 participants 124 participants
7
   5.6%
6
   4.7%
7
   5.8%
4
   3.1%
18
  14.5%
12 months Number Analyzed 123 participants 120 participants 112 participants 121 participants 114 participants
13
  10.6%
9
   7.5%
14
  12.5%
11
   9.1%
10
   8.8%
18 months Number Analyzed 117 participants 111 participants 110 participants 114 participants 116 participants
9
   7.7%
16
  14.4%
17
  15.5%
21
  18.4%
17
  14.7%
24 months Number Analyzed 114 participants 115 participants 100 participants 111 participants 111 participants
16
  14.0%
13
  11.3%
17
  17.0%
14
  12.6%
17
  15.3%
4.Secondary Outcome
Title Self-reported Consistent Condom Use in the Past 3 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data at baseline and at least one post intervention assessment.
Arm/Group Title Comprehensive-long Comprehensive-short Safer-sex Only Abstinence-only Health-promotion Control
Hide Arm/Group Description:

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).

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.

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.

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.

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.

Overall Number of Participants Analyzed 53 54 63 52 59
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 10 participants 12 participants 14 participants 11 participants 17 participants
7
  70.0%
8
  66.7%
4
  28.6%
10
  90.9%
12
  70.6%
3-Months Number Analyzed 13 participants 18 participants 21 participants 15 participants 25 participants
8
  61.5%
15
  83.3%
16
  76.2%
12
  80.0%
20
  80.0%
6-Months Number Analyzed 17 participants 18 participants 20 participants 13 participants 26 participants
14
  82.4%
17
  94.4%
17
  85.0%
11
  84.6%
15
  57.7%
12-Months Number Analyzed 23 participants 31 participants 34 participants 26 participants 24 participants
16
  69.6%
25
  80.6%
24
  70.6%
19
  73.1%
17
  70.8%
18-Months Number Analyzed 30 participants 32 participants 40 participants 39 participants 34 participants
23
  76.7%
21
  65.6%
34
  85.0%
31
  79.5%
27
  79.4%
24-Months Number Analyzed 35 participants 37 participants 42 participants 33 participants 41 participants
26
  74.3%
29
  78.4%
31
  73.8%
25
  75.8%
32
  78.0%
5.Secondary Outcome
Title Self-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months
Hide Description [Not Specified]
Time Frame Measured at baseline and3, 6, 12, 18, and 24 months post-intervention
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with data at baseline and at least one post intervention assessment.
Arm/Group Title Comprehensive-long Comprehensive-short Safer-sex Only Abstinence-only Health-promotion Control
Hide Arm/Group Description:

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).

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.

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.

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.

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.

Overall Number of Participants Analyzed 127 129 127 131 129
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Number Analyzed 127 participants 129 participants 127 participants 131 participants 129 participants
3
   2.4%
2
   1.6%
7
   5.5%
1
   0.8%
5
   3.9%
3-Months Number Analyzed 125 participants 124 participants 123 participants 127 participants 126 participants
5
   4.0%
2
   1.6%
4
   3.3%
1
   0.8%
4
   3.2%
6-Months Number Analyzed 125 participants 128 participants 122 participants 128 participants 125 participants
2
   1.6%
1
   0.8%
3
   2.5%
1
   0.8%
11
   8.8%
12-Months Number Analyzed 123 participants 119 participants 109 participants 121 participants 116 participants
7
   5.7%
6
   5.0%
6
   5.5%
7
   5.8%
7
   6.0%
18-Months Number Analyzed 117 participants 109 participants 108 participants 116 participants 117 participants
6
   5.1%
10
   9.2%
3
   2.8%
8
   6.9%
7
   6.0%
24-Months Number Analyzed 113 participants 113 participants 101 participants 111 participants 110 participants
8
   7.1%
8
   7.1%
8
   7.9%
8
   7.2%
8
   7.3%
Time Frame 24 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Comprehensive-long Comprehensive-short Safer-sex Only Abstinence-only Health-promotion Control
Hide Arm/Group Description

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).

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.

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.

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.

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.

All-Cause Mortality
Comprehensive-long Comprehensive-short Safer-sex Only Abstinence-only Health-promotion Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Comprehensive-long Comprehensive-short Safer-sex Only Abstinence-only Health-promotion Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)   0/134 (0.00%)   0/129 (0.00%)   0/134 (0.00%)   0/134 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Comprehensive-long Comprehensive-short Safer-sex Only Abstinence-only Health-promotion Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/131 (0.00%)   0/134 (0.00%)   0/129 (0.00%)   0/134 (0.00%)   0/134 (0.00%) 
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.
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
Responsible Party: John Jemmott, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00640653     History of Changes
Other Study ID Numbers: R01MH062049 ( U.S. NIH Grant/Contract )
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