CompletedNCT00640653Updated Dec 13, 2017Results posted

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

An interventional study of Abstinence-only HIV/STD risk-reduction intervention and Safer-sex-only HIV/STD risk-reduction intervention in HIV Infections and Sexually Transmitted Diseases, sponsored by University of Pennsylvania. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2017-12-13.

Sponsored by University of Pennsylvania · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 662
Allocation: Randomized
Sex: All

Study 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.

Read the 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.

Conditions studied

HIV Infections
Sexually Transmitted Diseases

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Keywords

Sexual Behavior
Abstinence
Intervention Studies
HIV
Sexually Transmitted Infection
Theory of Planned Behavior
HIV Seronegativity

In context

HIV Infections

4,340 studies on the registry are indexed under HIV Infections; 240 are open to participants now.

This study's enrollment of 662 is above the median of 83 across 3,312 interventional studies indexed under HIV Infections.

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Lead sponsor

University of Pennsylvania is the lead sponsor of 1,664 studies on the registry; 236 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 107 (69%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

- Those not meeting inclusion criteria were excluded.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 662 participants (actual)

Study arms

Experimental
Abstinence-only
Participants will receive the abstinence-only HIV/STD risk-reduction intervention.
Behavioral: Abstinence-only HIV/STD risk-reduction intervention
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
Experimental
Comprehensive-long
Participants will receive the 12-h long comprehensive HIV/STD risk-reduction intervention.
Behavioral: Long comprehensive HIV/STD risk-reduction 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
Active comparator
Health-promotion control
Participants will receive the health promotion control intervention.
Behavioral: Health promotion control intervention

Interventions

BehavioralAbstinence-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.
Also known as: Abstinence
BehavioralSafer-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.
Also known as: Condom-use intervention
BehavioralLong 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).
Also known as: Abstinence and condom-use intervention, Abstinence-plus intervention
BehavioralShort 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.
Also known as: Abstinence and condom-use intervention, Abstinence-plus intervention
BehavioralHealth 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.
Also known as: Chronic disease prevention intervention

What researchers measure

Primary outcomes

Self-report of Ever Having Sexual Intercourse
Self-reported sexual initiation during the follow-up period among participants who reported never having sexual intercourse at baseline.
Time frame: 24 months post-intervention

Secondary outcomes

Self-reported Sexual Intercourse in the Past 3 Months
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
Self-report of Having Multiple Sexual Partners in the Past 3 Months
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
Self-reported Consistent Condom Use in the Past 3 Months
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
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

Results

Posted Dec 13, 2017

Limitations and caveats

The data were based on self-reports, which can be inaccurate because of poor memory or socially desirability bias. The results may be limited to African American grade 6 and 7 students willing to take part in a health program on weekends.

Participant flow

Participant flow — Overall Study
Milestone	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control
Started	131	134	129	134	134
Followed-up at 3 mo	126	127	125	129	126
Followed-up at 6 mo	127	130	124	130	125
Followed-up at 12 mo	124	121	115	122	116
Followed-up at 18 mo	118	112	113	117	117
Followed-up at 24 mo	114	116	105	112	112
Completed	128	131	129	132	129
Not completed	3	3	0	2	5

Outcome measures

PrimarySelf-report of Ever Having Sexual Intercourse

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

Time frame:: 24 months post-intervention
Reported as:: Count of participants · Participants

Self-report of Ever Having Sexual Intercourse
Participants	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control
Self-report of Ever Having Sexual Intercourse	39	40	44	31	41

Statistical analysis

Abstinence-only vs Health-promotion Control · generalized linear regression · p = .03 (The significance criterion was set at alpha = .05.) · Risk ratio (rr): 0.67 · 95% CI 0.48 to 0.96Treatment was coded as 1 vs health control coded as 0.

SecondarySelf-reported Sexual Intercourse in the Past 3 Months

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
Reported as:: Count of participants · Participants

Self-reported Sexual Intercourse in the Past 3 Months
Participants	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control
Baseline	14	13	15	16	18
3 months	12	19	22	15	26
6 months	18	19	21	13	27
12 months	24	33	34	27	25
18 months	32	32	40	39	35
24 months	35	38	42	33	42

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

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
Reported as:: Count of participants · Participants

Self-report of Having Multiple Sexual Partners in the Past 3 Months
Participants	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control
Baseline	11	9	6	4	10
3 months	7	6	12	5	14
6 months	7	6	7	4	18
12 months	13	9	14	11	10
18 months	9	16	17	21	17
24 months	16	13	17	14	17

SecondarySelf-reported Consistent Condom Use in the Past 3 Months

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
Reported as:: Count of participants · Participants

Self-reported Consistent Condom Use in the Past 3 Months
Participants	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control
Baseline	7	8	4	10	12
3-Months	8	15	16	12	20
6-Months	14	17	17	11	15
12-Months	16	25	24	19	17
18-Months	23	21	34	31	27
24-Months	26	29	31	25	32

SecondarySelf-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
Reported as:: Count of participants · Participants

Self-report of Having Sexual Intercourse Without Using a Condom During the Past 3 Months
Participants	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control
Baseline	3	2	7	1	5
3-Months	5	2	4	1	4
6-Months	2	1	3	1	11
12-Months	7	6	6	7	7
18-Months	6	10	3	8	7
24-Months	8	8	8	8	8

Adverse events

Collected over 24 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Comprehensive-long	—	0/131 (0%)	0/131 (0%)
Comprehensive-short	—	0/134 (0%)	0/134 (0%)
Safer-sex Only	—	0/129 (0%)	0/129 (0%)
Abstinence-only	—	0/134 (0%)	0/134 (0%)
Health-promotion Control	—	0/134 (0%)	0/134 (0%)

Baseline characteristics

Sociodemographic Characteristics and Self-Reported Sexual Behaviors at Baseline of Participating African American Students in Grades 6 and 7 by Intervention Arm

Age, Continuous
Age, Continuous(years)	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control	Total
Mean	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
Sex: Female, Male(Participants)	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control	Total
Female	69	72	70	70	73	354
Male	62	62	59	64	61	308

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control	Total
American Indian or Alaska Native	0	0	0	0	0	0
Asian	0	0	0	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	131	134	129	134	134	662
White	0	0	0	0	0	0
More than one race	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control	Total
United States	131	134	129	134	134	662

Grade in School
Grade in School(participants)	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control	Total
7th	68	71	73	77	77	366
8th	63	63	56	57	57	296

Live with both parents
Live with both parents(participants)	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control	Total
Yes	46	46	40	43	46	221
No	85	88	89	91	88	441

Ever had sexual intercourse
Ever had sexual intercourse(participants)	Comprehensive-long	Comprehensive-short	Safer-sex Only	Abstinence-only	Health-promotion Control	Total
Yes	31	28	32	27	35	153
No	100	106	97	107	99	509

Study locations

1 site

University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States

References and documents

Publications

Jemmott JB 3rd, Jemmott LS, Fong GT. Efficacy of a theory-based abstinence-only intervention over 24 months: a randomized controlled trial with young adolescents. Arch Pediatr Adolesc Med. 2010 Feb;164(2):152-9. doi: 10.1001/archpediatrics.2009.267. PubMed 20124144 ↗
Zhang J, Jemmott JB 3rd, Jemmott LS. Mediation and moderation of an efficacious theory-based abstinence-only intervention for African American adolescents. Health Psychol. 2015 Dec;34(12):1175-84. doi: 10.1037/hea0000244. Epub 2015 Jul 27. PubMed 26214076 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2001, a primary completion of Aug 2004 and a completion of Aug 2004. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2017, 13 years 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 19, 2008
First posted: Mar 21, 2008
Start: Sep 2001
Primary completionActual: Aug 2004
CompletionActual: Aug 2004
Results first posted: Dec 13, 2017
Last update: Dec 13, 2017

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00640653
Lead sponsor: University of Pennsylvania
Collaborators: National Institute of Mental Health (NIMH)
Responsible party: John Jemmott (Kenneth B. Clark Professor of Communication and Psychiatry, University of Pennsylvania) — Principal investigator
First posted: Mar 21, 2008
Start date: Sep 2001
Primary completion: Aug 2004
Completion: Aug 2004
Results posted: Dec 13, 2017
Last update: Dec 13, 2017

Study contacts

John B. Jemmott III, PhD

principal investigator · University of Pennsylvania

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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