Trial Outcomes & Findings for Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents (NCT NCT00640653)

Last Updated: 2017-12-13

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

662 participants

Primary outcome timeframe

24 months post-intervention

Results posted on

2017-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	131	134	129	134	134
Overall Study Followed-up at 3 mo	126	127	125	129	126
Overall Study Followed-up at 6 mo	127	130	124	130	125
Overall Study Followed-up at 12 mo	124	121	115	122	116
Overall Study Followed-up at 18 mo	118	112	113	117	117
Overall Study Followed-up at 24 mo	114	116	105	112	112
Overall Study COMPLETED	128	131	129	132	129
Overall Study NOT COMPLETED	3	3	0	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Comprehensive-long n=131 Participants 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 n=134 Participants 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 n=129 Participants 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 n=134 Participants 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 n=134 Participants 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 n=662 Participants Total of all reporting groups
Age, Continuous	12.0 years STANDARD_DEVIATION 0.8 • n=5 Participants	11.9 years STANDARD_DEVIATION 0.8 • n=7 Participants	11.9 years STANDARD_DEVIATION 0.8 • n=5 Participants	12.0 years STANDARD_DEVIATION 0.8 • n=4 Participants	12.0 years STANDARD_DEVIATION 0.8 • n=21 Participants	12.0 years STANDARD_DEVIATION 0.8 • n=10 Participants
Sex: Female, Male Female	69 Participants n=5 Participants	72 Participants n=7 Participants	70 Participants n=5 Participants	70 Participants n=4 Participants	73 Participants n=21 Participants	354 Participants n=10 Participants
Sex: Female, Male Male	62 Participants n=5 Participants	62 Participants n=7 Participants	59 Participants n=5 Participants	64 Participants n=4 Participants	61 Participants n=21 Participants	308 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	131 Participants n=5 Participants	134 Participants n=7 Participants	129 Participants n=5 Participants	134 Participants n=4 Participants	134 Participants n=21 Participants	662 Participants n=10 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Region of Enrollment United States	131 participants n=5 Participants	134 participants n=7 Participants	129 participants n=5 Participants	134 participants n=4 Participants	134 participants n=21 Participants	662 participants n=10 Participants
Grade in School 7th	68 participants n=5 Participants	71 participants n=7 Participants	73 participants n=5 Participants	77 participants n=4 Participants	77 participants n=21 Participants	366 participants n=10 Participants
Grade in School 8th	63 participants n=5 Participants	63 participants n=7 Participants	56 participants n=5 Participants	57 participants n=4 Participants	57 participants n=21 Participants	296 participants n=10 Participants
Live with both parents Yes	46 participants n=5 Participants	46 participants n=7 Participants	40 participants n=5 Participants	43 participants n=4 Participants	46 participants n=21 Participants	221 participants n=10 Participants
Live with both parents No	85 participants n=5 Participants	88 participants n=7 Participants	89 participants n=5 Participants	91 participants n=4 Participants	88 participants n=21 Participants	441 participants n=10 Participants
Ever had sexual intercourse Yes	31 participants n=5 Participants	28 participants n=7 Participants	32 participants n=5 Participants	27 participants n=4 Participants	35 participants n=21 Participants	153 participants n=10 Participants
Ever had sexual intercourse No	100 participants n=5 Participants	106 participants n=7 Participants	97 participants n=5 Participants	107 participants n=4 Participants	99 participants n=21 Participants	509 participants n=10 Participants

PRIMARY outcome

Timeframe: 24 months post-intervention

Population: 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.

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

Outcome measures

Outcome measures
Measure	Comprehensive-long n=92 Participants 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 n=97 Participants 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 n=85 Participants 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 n=95 Participants 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 n=88 Participants 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.
Self-report of Ever Having Sexual Intercourse	39 Participants	40 Participants	44 Participants	31 Participants	41 Participants

SECONDARY outcome

Timeframe: Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention

Population: Participants with data at baseline and at least one post-intervention assessment.

Self-report of having sexual intercourse in the past 3 months

Outcome measures

Outcome measures
Measure	Comprehensive-long n=127 Participants 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 n=130 Participants 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 n=128 Participants 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 n=131 Participants 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 n=129 Participants 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.
Self-reported Sexual Intercourse in the Past 3 Months Baseline	14 Participants	13 Participants	15 Participants	16 Participants	18 Participants
Self-reported Sexual Intercourse in the Past 3 Months 3 months	12 Participants	19 Participants	22 Participants	15 Participants	26 Participants
Self-reported Sexual Intercourse in the Past 3 Months 6 months	18 Participants	19 Participants	21 Participants	13 Participants	27 Participants
Self-reported Sexual Intercourse in the Past 3 Months 12 months	24 Participants	33 Participants	34 Participants	27 Participants	25 Participants
Self-reported Sexual Intercourse in the Past 3 Months 18 months	32 Participants	32 Participants	40 Participants	39 Participants	35 Participants
Self-reported Sexual Intercourse in the Past 3 Months 24 months	35 Participants	38 Participants	42 Participants	33 Participants	42 Participants

SECONDARY outcome

Timeframe: Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention

Population: Participants with data at baseline and at least one post-intervention assessment.

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

Outcome measures

Outcome measures
Measure	Comprehensive-long n=127 Participants 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 n=130 Participants 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 n=127 Participants 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 n=131 Participants 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 n=128 Participants 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.
Self-report of Having Multiple Sexual Partners in the Past 3 Months Baseline	11 Participants	9 Participants	6 Participants	4 Participants	10 Participants
Self-report of Having Multiple Sexual Partners in the Past 3 Months 3 months	7 Participants	6 Participants	12 Participants	5 Participants	14 Participants
Self-report of Having Multiple Sexual Partners in the Past 3 Months 6 months	7 Participants	6 Participants	7 Participants	4 Participants	18 Participants
Self-report of Having Multiple Sexual Partners in the Past 3 Months 12 months	13 Participants	9 Participants	14 Participants	11 Participants	10 Participants
Self-report of Having Multiple Sexual Partners in the Past 3 Months 18 months	9 Participants	16 Participants	17 Participants	21 Participants	17 Participants
Self-report of Having Multiple Sexual Partners in the Past 3 Months 24 months	16 Participants	13 Participants	17 Participants	14 Participants	17 Participants

SECONDARY outcome

Timeframe: Measured at baseline and 3, 6, 12, 18, and 24 months post-intervention

Population: Participants with data at baseline and at least one post intervention assessment.

Self-report of using a condom during every sexual intercourse act in the past 3 months

Outcome measures

Outcome measures
Measure	Comprehensive-long n=53 Participants 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 n=54 Participants 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 n=63 Participants 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 n=52 Participants 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 n=59 Participants 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.
Self-reported Consistent Condom Use in the Past 3 Months Baseline	7 Participants	8 Participants	4 Participants	10 Participants	12 Participants
Self-reported Consistent Condom Use in the Past 3 Months 3-Months	8 Participants	15 Participants	16 Participants	12 Participants	20 Participants
Self-reported Consistent Condom Use in the Past 3 Months 6-Months	14 Participants	17 Participants	17 Participants	11 Participants	15 Participants
Self-reported Consistent Condom Use in the Past 3 Months 12-Months	16 Participants	25 Participants	24 Participants	19 Participants	17 Participants
Self-reported Consistent Condom Use in the Past 3 Months 18-Months	23 Participants	21 Participants	34 Participants	31 Participants	27 Participants
Self-reported Consistent Condom Use in the Past 3 Months 24-Months	26 Participants	29 Participants	31 Participants	25 Participants	32 Participants

SECONDARY outcome

Timeframe: Measured at baseline and3, 6, 12, 18, and 24 months post-intervention

Population: Participants with data at baseline and at least one post intervention assessment.