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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT00640653
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 662
• Location: 1
• Arms: 5
• Duration (Months): 35
• Patients Per Site Per Month: 18.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	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	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 662 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: HIV/Sexually Transmitted Disease (STD) Prevention Interventions for Black Adolescents
• Study Start Date: Sep 1, 2001
• Actual Primary Completion Date: Aug 1, 2004
• Actual Study Completion Date: Aug 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Abstinence-only 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 Names: Abstinence
Experimental: Safer-sex only 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 Names: Condom-use intervention
Experimental: Comprehensive-long Participants will receive the 12-h 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: Comprehensive-short Participants will receive the 8-h 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: Health-promotion control 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 Names: Chronic disease prevention intervention

Outcome Measures

Primary Outcome Measures

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

   Self-reported sexual initiation during the follow-up period among participants who reported never having sexual intercourse at baseline.

Secondary Outcome Measures

1. 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 sexual intercourse in the past 3 months

2. 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-report of having sexual intercourse with more than one partner in the pat 3 months.

3. 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 using a condom during every sexual intercourse act in the past 3 months

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: John B. Jemmott III, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: John Jemmott, Kenneth B. Clark Professor of Communication and Psychiatry, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT00640653
• Other Study ID Numbers: R01MH062049; R01MH062049; DAHBR 9A-ASPA
• First Posted: Mar 21, 2008
• Last Update Posted: Dec 13, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by John Jemmott, Kenneth B. Clark Professor of Communication and Psychiatry, University of Pennsylvania: Sexual Behavior; Abstinence; Intervention Studies; HIV; Sexually Transmitted Infection; Theory of Planned Behavior; HIV Seronegativity
• Additional relevant MeSH terms: Sexually Transmitted Diseases

Study Results

Participant Flow

Arm/Group Title	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control
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

Baseline Characteristics

Arm/Group Title	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control	Total
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 Participants	131	134	129	134	134	662
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	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 (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) (Count of Participants)
American Indian or Alaska Native	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%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	131 100%	134 100%	129 100%	134 100%	134 100%	662 100%
White	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%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	131 100%	134 100%	129 100%	134 100%	134 100%	662 100%
Grade in School (participants) [Number]
7th	68 51.9%	71 53%	73 56.6%	77 57.5%	77 57.5%	366 55.3%
8th	63 48.1%	63 47%	56 43.4%	57 42.5%	57 42.5%	296 44.7%
Live with both parents (participants) [Number]
Yes	46 35.1%	46 34.3%	40 31%	43 32.1%	46 34.3%	221 33.4%
No	85 64.9%	88 65.7%	89 69%	91 67.9%	88 65.7%	441 66.6%
Ever had sexual intercourse (participants) [Number]
Yes	31 23.7%	28 20.9%	32 24.8%	27 20.1%	35 26.1%	153 23.1%
No	100 76.3%	106 79.1%	97 75.2%	107 79.9%	99 73.9%	509 76.9%

Outcome Measures

1. Primary Outcome

Title	Self-report of Ever Having Sexual Intercourse
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

Outcome Measure Data

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
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.
Measure Participants	92	97	85	95	88
Count of Participants [Participants]	39 29.8%	40 29.9%	44 34.1%	31 23.1%	41 30.6%

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
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
	Parameter Dispersion	Type: Value:
	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
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

Outcome Measure Data

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
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.
Measure Participants	127	130	128	131	129
Baseline	14 10.7%	13 9.7%	15 11.6%	16 11.9%	18 13.4%
3 months	12 9.2%	19 14.2%	22 17.1%	15 11.2%	26 19.4%
6 months	18 13.7%	19 14.2%	21 16.3%	13 9.7%	27 20.1%
12 months	24 18.3%	33 24.6%	34 26.4%	27 20.1%	25 18.7%
18 months	32 24.4%	32 23.9%	40 31%	39 29.1%	35 26.1%
24 months	35 26.7%	38 28.4%	42 32.6%	33 24.6%	42 31.3%

3. Secondary Outcome

Title	Self-report of Having Multiple Sexual Partners in the Past 3 Months
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

Outcome Measure Data

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
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.
Measure Participants	127	130	127	131	128
Baseline	11 8.4%	9 6.7%	6 4.7%	4 3%	10 7.5%
3 months	7 5.3%	6 4.5%	12 9.3%	5 3.7%	14 10.4%
6 months	7 5.3%	6 4.5%	7 5.4%	4 3%	18 13.4%
12 months	13 9.9%	9 6.7%	14 10.9%	11 8.2%	10 7.5%
18 months	9 6.9%	16 11.9%	17 13.2%	21 15.7%	17 12.7%
24 months	16 12.2%	13 9.7%	17 13.2%	14 10.4%	17 12.7%

4. Secondary Outcome

Title	Self-reported Consistent Condom Use in the Past 3 Months
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

Outcome Measure Data

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
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.
Measure Participants	53	54	63	52	59
Baseline	7 5.3%	8 6%	4 3.1%	10 7.5%	12 9%
3-Months	8 6.1%	15 11.2%	16 12.4%	12 9%	20 14.9%
6-Months	14 10.7%	17 12.7%	17 13.2%	11 8.2%	15 11.2%
12-Months	16 12.2%	25 18.7%	24 18.6%	19 14.2%	17 12.7%
18-Months	23 17.6%	21 15.7%	34 26.4%	31 23.1%	27 20.1%
24-Months	26 19.8%	29 21.6%	31 24%	25 18.7%	32 23.9%

5. Secondary Outcome

Title	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

Outcome Measure Data

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
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.
Measure Participants	127	129	127	131	129
Baseline	3 2.3%	2 1.5%	7 5.4%	1 0.7%	5 3.7%
3-Months	5 3.8%	2 1.5%	4 3.1%	1 0.7%	4 3%
6-Months	2 1.5%	1 0.7%	3 2.3%	1 0.7%	11 8.2%
12-Months	7 5.3%	6 4.5%	6 4.7%	7 5.2%	7 5.2%
18-Months	6 4.6%	10 7.5%	3 2.3%	8 6%	7 5.2%
24-Months	8 6.1%	8 6%	8 6.2%	8 6%	8 6%

Adverse Events

Time Frame	24 months
Arm/Group Title	Comprehensive-long		Comprehensive-short		Safer-sex Only		Abstinence-only		Health-promotion Control
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Comprehensive-long		Comprehensive-short		Safer-sex Only		Abstinence-only		Health-promotion Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/131 (0%)		0/134 (0%)		0/129 (0%)		0/134 (0%)		0/134 (0%)
Other (Not Including Serious) Adverse Events
	Comprehensive-long		Comprehensive-short		Safer-sex Only		Abstinence-only		Health-promotion Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/131 (0%)		0/134 (0%)		0/129 (0%)		0/134 (0%)		0/134 (0%)

Limitations/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.

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Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.