Sexually Transmitted DiseasesNCT00167505
All About Youth: Evaluation of Sexual Risk Avoidance and Risk Reduction Programs for Middle School Students
A study testing Risk Avoidance Intervention and Risk Reduction Intervention in people with Sexually Transmitted Diseases and Pregnancy, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study will evaluate the efficacy of two curricula relative to standard care. The first is a sexual risk avoidance curriculum for middle school students that included abstinence until marriage and complies with Title V Section 510 A-H abstinence education requirements. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexually Transmitted Diseases, Pregnancy, HIV Infections
- What is being tested?
- Risk Avoidance Intervention and Risk Reduction Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,742 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 7th graders attending regular classes in Houston Independent School District
Who cannot join
- No students will be excluded based on race/ethnicity, age, or gender
- Students will be informed that the surveys and intervention materials will only be available in English and will be asked to consider their comfort level with participating in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Houston School of Public Health
Houston, Texas, 77030
About this study
Official title: SIP 4-04 Evaluation of Abstinence-Only and Abstinence-Plus Program to Prevent HIV, STD, and Pregnancy Among Middle School Students
This study will evaluate the efficacy of two curricula relative to standard care. The first is a sexual risk avoidance curriculum for middle school students that included abstinence until marriage and complies with Title V Section 510 A-H abstinence education requirements. The second is a sexual risk reduction curriculum for middle school students that included abstinence and condom/contraceptive information and skills. Each intervention consists of an age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in 7th and 8th grade. The overall goal of the study is to identify common elements of effective sexuality education curricula that will be of benefit to youth.
Read the detailed description
This study will evaluate the efficacy of a risk avoidance program for middle school students and a theoretically-comparable risk reduction program relative to standard care. The study design is a randomized controlled trial conducted in fifteen inner-city middle schools in Houston, Texas. Five schools were randomly assigned to a risk avoidance intervention, five to a risk reduction intervention, and five to a comparison (standard care) condition. Approximately, 1,800 7th grade students were recruited into the study and will be followed over a three-year period. Based on a formative study, a pilot study, and input from community groups and a national panel of experts, two comparable curricula were developed. The risk avoidance curriculum emphasizes sexual abstinence until marriage and includes the requirements for abstinence education as defined in Title V, Section 510. The risk reduction curriculum emphasizes abstinence and addresses condom and contraceptive use. The risk avoidance and risk reduction interventions each consist of an age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in 7th and 8th grade. Each intervention was delivered by trained facilitators. The effect of the interventions will be evaluated by assessing sexual risk-taking behaviors of participants in each intervention (proportion of students initiating sexual intercourse, proportion that are sexually active, number of times of unprotected sex, number of sexual partners) relative to the comparison group. Risk assessment data from students was collected by using an audio computer-assisted self-interview (ACASI) approach for the collection of baseline, 6-, 18-, and 24-month data. Parental permission and child assent were required prior to participation. In addition, we will conduct a 36-month follow-up survey and a one-time urine-based test for chlamydia, gonorrhea, and trichomonas which will provide additional longitudinal data to assess the impact of each curriculum, relative to standard care.
- Conditions
- Sexually Transmitted Diseases, Pregnancy, HIV Infections
- Being tested
- Risk Avoidance Intervention, Risk Reduction Intervention
- Keywords
- adolescents, sexual health, HIV, STD, pregnancy prevention, abstinence education, HIV Seronegativity, human immunodeficiency virus
- Medical subject headings
- Sexually Transmitted Diseases, HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risk Avoidance InterventionBehavioural
The risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.
Risk Reduction InterventionBehavioural
The risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills.
| Study group | Role | What they receive |
|---|---|---|
| Risk Avoidance | Experimental | The risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes both classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills. Receives: Behavioral: Risk Avoidance Intervention |
| Risk Reduction | Experimental | The risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes both classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills. Receives: Behavioral: Risk Reduction Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
delay onset of sex
Measured: baseline, 6,18, 24, and 36 month follow-up
Secondary outcomes (8)
knowledge
Measured: baseline, 6,18, 24, and 36 month follow-up
skills
Measured: baseline, 6, 18, 24, and 36 month follow-up
self-efficacy
Measured: baseline, 6, 18, 24, and 36 month follow-up
attitudes
Measured: baseline, 6, 18, 24, and 36 month follow-up
condom use
Measured: baseline, 6, 18, 24, and 36 month follow-up
alcohol/drug use
Measured: baseline, 6, 18, 24, and 36 month follow-up
number of sexual partners
Measured: baseline, 6, 18, 24, and 36 month follow-up
prevalence of chlamydia, gonorrhea, and trichomonas
Measured: 36-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2006
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexually Transmitted DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- None (open label)
- Enrolment
- 1,742 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Department of Health and Human Services
- Investigators
- Christine Markham, PhD, Principal investigator, University of Texas Houston School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167505
- Sponsor's protocol ID
- U48DP000057
- Other IDs
- NCT00167505
- Status last verified
- Oct 2010
- First submitted
- 9 Sep 2005
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SIP 4-04 Evaluation of Abstinence-Only and Abstinence-Plus Program to Prevent HIV, STD, and Pregnancy Among Middle School Students
- ClinicalTrials.gov ID
- NCT00167505
- Acronym / sponsor ID
- U48DP000057
- Conditions
- Sexually Transmitted Diseases, Pregnancy, HIV Infections
- Keywords
- adolescents, sexual health, HIV, STD, pregnancy prevention, abstinence education, HIV Seronegativity, human immunodeficiency virus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,742 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Department of Health and Human Services
- Study start
- Sep 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
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 evaluate the efficacy of two curricula relative to standard care. The first is a sexual risk avoidance curriculum for middle school students that included abstinence until marriage and complies with Title V Section 510 A-H abstinence education requirements. The second is a sexual risk reduction curriculum for middle school students that included abstinence and condom/contraceptive information and skills. Each intervention consists of an age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in 7th and 8th grade. The overall goal of the study is to identify common elements of effective sexuality education curricula that will be of benefit to youth.
Detailed description
This study will evaluate the efficacy of a risk avoidance program for middle school students and a theoretically-comparable risk reduction program relative to standard care. The study design is a randomized controlled trial conducted in fifteen inner-city middle schools in Houston, Texas. Five schools were randomly assigned to a risk avoidance intervention, five to a risk reduction intervention, and five to a comparison (standard care) condition. Approximately, 1,800 7th grade students were recruited into the study and will be followed over a three-year period. Based on a formative study, a pilot study, and input from community groups and a national panel of experts, two comparable curricula were developed. The risk avoidance curriculum emphasizes sexual abstinence until marriage and includes the requirements for abstinence education as defined in Title V, Section 510. The risk reduction curriculum emphasizes abstinence and addresses condom and contraceptive use. The risk avoidance and risk reduction interventions each consist of an age-appropriate classroom curriculum and a CD-ROM-based tailored intervention delivered in 7th and 8th grade. Each intervention was delivered by trained facilitators. The effect of the interventions will be evaluated by assessing sexual risk-taking behaviors of participants in each intervention (proportion of students initiating sexual intercourse, proportion that are sexually active, number of times of unprotected sex, number of sexual partners) relative to the comparison group. Risk assessment data from students was collected by using an audio computer-assisted self-interview (ACASI) approach for the collection of baseline, 6-, 18-, and 24-month data. Parental permission and child assent were required prior to participation. In addition, we will conduct a 36-month follow-up survey and a one-time urine-based test for chlamydia, gonorrhea, and trichomonas which will provide additional longitudinal data to assess the impact of each curriculum, relative to standard care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk Avoidance | Experimental | Behavioral: Risk Avoidance InterventionThe risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes both classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills. |
| Risk Reduction | Experimental | Behavioral: Risk Reduction InterventionThe risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes both classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills. |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 7th graders attending regular classes in Houston Independent School District
Key exclusion criteria (2 listed)
- No students will be excluded based on race/ethnicity, age, or gender
- Students will be informed that the surveys and intervention materials will only be available in English and will be asked to consider their comfort level with participating in the study.
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 |
|---|---|---|
| Risk Avoidance InterventionThe risk avoidance intervention is a Title V compliant curriculum emphasizing abstinence until marriage and strong character development. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills. | Behavioural | Risk Avoidance |
| Risk Reduction InterventionThe risk reduction intervention is a curriculum providing skills for abstinence and condom and other contraceptive use. The curriculum includes 12 classroom and CD-ROM based lessons delivered in the 7th and 8th grade. Lessons include topics such as puberty, reproduction, healthy relationships, consequences of sex, and refusal skills. | Behavioural | Risk Reduction |
Primary outcome
delay onset of sex
Time frame: baseline, 6,18, 24, and 36 month follow-up
8 secondary outcomes
knowledge
Time frame: baseline, 6,18, 24, and 36 month follow-up
skills
Time frame: baseline, 6, 18, 24, and 36 month follow-up
self-efficacy
Time frame: baseline, 6, 18, 24, and 36 month follow-up
attitudes
Time frame: baseline, 6, 18, 24, and 36 month follow-up
condom use
Time frame: baseline, 6, 18, 24, and 36 month follow-up
alcohol/drug use
Time frame: baseline, 6, 18, 24, and 36 month follow-up
number of sexual partners
Time frame: baseline, 6, 18, 24, and 36 month follow-up
prevalence of chlamydia, gonorrhea, and trichomonas
Time frame: 36-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2010.
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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.
Christine Markham, PhD principal investigator
University of Texas Houston School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Risk Avoidance Intervention and Risk Reduction Intervention in people with Sexually Transmitted Diseases and Pregnancy, run by The University of Texas Health Science Center, Houston 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 1 inclusion and 2 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 26 Oct 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
delay onset of sex (time frame: baseline, 6,18, 24, and 36 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2010.