HIV InfectionsNCT00640653
Efficacy of an Abstinence-Only HIV Risk-Reduction Intervention for Young African-American Adolescents
A study testing Abstinence-only HIV/STD risk-reduction intervention, Safer-sex-only HIV/STD risk-reduction intervention and Long comprehensive HIV/STD risk-reduction intervention in people with HIV Infections and Sexually Transmitted Diseases, run by University of Pennsylvania at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, Sexually Transmitted Diseases
- What is being tested?
- Abstinence-only HIV/STD risk-reduction intervention, Safer-sex-only HIV/STD risk-reduction intervention and Long comprehensive HIV/STD risk-reduction intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 662 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Aug 2004
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Grade 6 or 7 student at a participating school
- Written parent or guardian consent to participate
- Self-identifies as African American or black
Who cannot join
- Those not meeting inclusion criteria were excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: HIV/Sexually Transmitted Disease (STD) Prevention Interventions for Black Adolescents
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
- HIV Infections, Sexually Transmitted Diseases
- Being tested
- Abstinence-only HIV/STD risk-reduction intervention, Safer-sex-only HIV/STD risk-reduction intervention, Long comprehensive HIV/STD risk-reduction intervention, Short comprehensive HIV/STD risk-reduction intervention, Health promotion control intervention
- Keywords
- Sexual Behavior, Abstinence, Intervention Studies, HIV, Sexually Transmitted Infection, Theory of Planned Behavior, HIV Seronegativity
- Medical subject headings
- HIV Infections, Sexually Transmitted Diseases, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abstinence-only HIV/STD risk-reduction interventionBehavioural
Also called Abstinence
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.
Safer-sex-only HIV/STD risk-reduction interventionBehavioural
Also called Condom-use 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.
Long comprehensive HIV/STD risk-reduction interventionBehavioural
Also called Abstinence and condom-use intervention, Abstinence-plus 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).
Short comprehensive HIV/STD risk-reduction interventionBehavioural
Also called Abstinence and condom-use intervention, Abstinence-plus 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.
Health promotion control interventionBehavioural
Also called Chronic disease prevention 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.
| Study group | Role | What they receive |
|---|---|---|
| Abstinence-only | Experimental | Participants will receive the abstinence-only HIV/STD risk-reduction intervention. Receives: Behavioral: Abstinence-only HIV/STD risk-reduction intervention |
| Safer-sex only | Experimental | Participants will receive the safer-sex-only HIV/STD risk-reduction intervention. Receives: Behavioral: Safer-sex-only HIV/STD risk-reduction intervention |
| Comprehensive-long | Experimental | Participants will receive the 12-h long comprehensive HIV/STD risk-reduction intervention. Receives: Behavioral: Long comprehensive HIV/STD risk-reduction intervention |
| Comprehensive-short | Experimental | Participants will receive the 8-h short comprehensive HIV/STD risk-reduction intervention. Receives: Behavioral: Short comprehensive HIV/STD risk-reduction intervention |
| Health-promotion control | Active comparator | Participants will receive the health promotion control intervention. Receives: Behavioral: Health promotion control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months post-intervention
Secondary outcomes (4)
Self-reported Sexual Intercourse in the Past 3 Months
Self-report of having sexual intercourse in the past 3 months
Measured: 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.
Measured: 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
Measured: 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
Measured: Measured at baseline and3, 6, 12, 18, and 24 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startSep 2001
- Primary completionAug 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 662 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, John Jemmott, University of Pennsylvania
- Investigators
- John B. Jemmott III, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640653
- Sponsor's protocol ID
- R01MH062049
- Other IDs
- R01MH062049, DAHBR 9A-ASPA
- Status last verified
- Nov 2017
- First submitted
- 19 Mar 2008
- Last updated
- 13 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 20124144Zhang 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV/Sexually Transmitted Disease (STD) Prevention Interventions for Black Adolescents
- ClinicalTrials.gov ID
- NCT00640653
- Acronym / sponsor ID
- R01MH062049
- Conditions
- HIV Infections, Sexually Transmitted Diseases
- Keywords
- Sexual Behavior, Abstinence, Intervention Studies, HIV, Sexually Transmitted Infection, Theory of Planned Behavior, HIV Seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 662 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2001
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Posted 13 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Abstinence-only | Experimental | Behavioral: Abstinence-only HIV/STD risk-reduction interventionParticipants will receive the abstinence-only HIV/STD risk-reduction intervention. |
| Safer-sex only | Experimental | Behavioral: Safer-sex-only HIV/STD risk-reduction interventionParticipants will receive the safer-sex-only HIV/STD risk-reduction intervention. |
| Comprehensive-long | Experimental | Behavioral: Long comprehensive HIV/STD risk-reduction interventionParticipants will receive the 12-h long comprehensive HIV/STD risk-reduction intervention. |
| Comprehensive-short | Experimental | Behavioral: Short comprehensive HIV/STD risk-reduction interventionParticipants will receive the 8-h short comprehensive HIV/STD risk-reduction intervention. |
| Health-promotion control | Active comparator | Behavioral: Health promotion control interventionParticipants will receive the health promotion control intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Grade 6 or 7 student at a participating school
- Written parent or guardian consent to participate
- Self-identifies as African American or black
Key exclusion criteria (1 listed)
- Those not meeting inclusion criteria were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abstinence-only HIV/STD risk-reduction interventionAlso: AbstinenceParticipants 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. | Behavioural | Abstinence-only |
| Safer-sex-only HIV/STD risk-reduction interventionAlso: Condom-use interventionParticipants 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. | Behavioural | Safer-sex only |
| Long comprehensive HIV/STD risk-reduction interventionAlso: Abstinence and condom-use intervention, Abstinence-plus interventionParticipants 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). | Behavioural | Comprehensive-long |
| Short comprehensive HIV/STD risk-reduction interventionAlso: Abstinence and condom-use intervention, Abstinence-plus interventionParticipants 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. | Behavioural | Comprehensive-short |
| Health promotion control interventionAlso: Chronic disease prevention interventionParticipants 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. | Behavioural | Health-promotion control |
Primary outcome
Self-report of Ever Having Sexual Intercourse
Time frame: 24 months post-intervention
Self-reported sexual initiation during the follow-up period among participants who reported never having sexual intercourse at baseline.
4 secondary outcomes
Self-reported 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
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
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 and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20124144Jemmott 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.
- Results publication: PubMed 26214076Zhang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John B. Jemmott III, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abstinence-only HIV/STD risk-reduction intervention, Safer-sex-only HIV/STD risk-reduction intervention and Long comprehensive HIV/STD risk-reduction intervention in people with HIV Infections and Sexually Transmitted Diseases, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report of Ever Having Sexual Intercourse (time frame: 24 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00640653, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.