HIV InfectionsNCT01084395
Reducing HIV Risk Among Mexican Youth
A study testing Adolescent Safer Sex Intervention and Parent Safer Sex Communication Intervention in people with HIV Infections and AIDS, run by University of Michigan at 1 site in Mexico.
Trial summary
The broad objective of this project is to test the efficacy of a theory-based HIV risk-reduction intervention, which includes both an adolescent component and parental component, designed to reduce the adolescents' risk of sexually transmitted HIV. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV Infections, AIDS, Sexually Transmitted Diseases
- What is being tested?
- Adolescent Safer Sex Intervention and Parent Safer Sex Communication Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,620 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2002to Sep 2006
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Families (adolescents [aged 14 to 17 years of age] and one of their parents)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The broad objective of this project is to test the efficacy of a theory-based HIV risk-reduction intervention, which includes both an adolescent component and parental component, designed to reduce the adolescents' risk of sexually transmitted HIV.
Read the detailed description
Sexually transmitted HIV infection among adolescents is a growing and significant problem in Mexico. Given the high mortality rate associated with AIDS, the lack of available treatment, and the social stigma associated with the disease, prevention is the key to reducing the threat of AIDS among this important subgroup in Mexico. The study has four specific aims including 1) to determine whether the HIV risk-reduction intervention causes a greater increase in adolescents' intentions to abstain from intercourse and/or avoid unprotected intercourse at post-intervention and decreased self-reported intercourse and unprotected intercourse at 3, 6, 12, and 48 month follow-ups, compared with the general health promotion control intervention; 2) to determine whether the effects of the intervention are moderated by individual, microsystem, and macrosystem variables; 3) to identify theory-based variables that mediate effects of the HIV intervention on adolescents' self-reported behavior; and 4) to determine whether the HIV risk-reduction intervention causes a greater increase in parents' comfort with, and quantity of communication (general and HIV specific) with adolescents at post-intervention, 3, 6, 12, and 48 month follow-up compared with the general health promotion control intervention.
- Conditions
- HIV Infections, AIDS, Sexually Transmitted Diseases
- Being tested
- Adolescent Safer Sex Intervention, Parent Safer Sex Communication Intervention, Adolescent Health Promotion Control Condition, Parent Health Promotion Control Condition
- Keywords
- Parent, Adolescent, Mexico, Safer Sex Communication, Randomized Controlled Trial, HIV/AIDS, STD, Sexual Behavior
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Sexually Transmitted Diseases, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adolescent Safer Sex InterventionBehavioural
Also called Cuidate
Adolescents are randomly assigned to the HIV risk-reduction intervention condition. Adolescents receive a theory-based intervention designed to reduce HIV risk-associated behavior. The intervention consists of six 50-minute modules implemented over the course of two days. The intervention is highly interactive and includes games, videos, discussion, and role-plays.
Parent Safer Sex Communication InterventionBehavioural
Parents are randomly assigned to the Safer Sex Communication Intervention. Parents learn about HIV and other consequences of unprotected sexual behavior. The intervention contains content that focuses on enhancing parent-adolescent communication.
Adolescent Health Promotion Control ConditionOther
Adolescents are randomly assigned to the Health Promotion control condition. Adolescents receive an intervention aimed at significant health problems affecting Mexicans that are related, not to sexual behavior, but to other behaviors. These health problems include heart disease, certain cancers, and diabetes. Adolescents are taught that these health problems can be prevented by changing personal behaviors, primarily exercise, diet, cigarette smoking, and alcohol and drug use.
Parent Health Promotion Control ConditionOther
Parents are randomly assigned to the Health Promotion control condition. Parents receive an intervention aimed at significant health problems affecting Mexicans that are related, not to sexual behavior, but to other behaviors. These health problems include heart disease, certain cancers, and diabetes. Parents will be taught that these health problems can be prevented by changing personal behaviors, primarily exercise, diet, cigarette smoking, and alcohol and drug use. The intervention also provides content that emphasizes the importance of families.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Safer Sex Intervention | Experimental | Not described Receives: Behavioral: Adolescent Safer Sex Intervention |
| Parent Safer Sex Intervention | Experimental | Not described Receives: Behavioral: Parent Safer Sex Communication Intervention |
| Adolescent Health Promotion Control | Other | Not described Receives: Other: Adolescent Health Promotion Control Condition |
| Parent Health Promotion Control | Other | Not described Receives: Other: Parent Health Promotion Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
General Parent-Adolescent Communication
Measured: pretest, posttest, 6 month follow-up, 12 month follow-up
Parent-Adolescent Sexual Risk Communication
Measured: Pretest, Posttest, 6 month follow-up, 12 month follow-up
Comfort With Communication
Measured: Pretest, Posttest, 6 month follow-up, 12 month follow-up
Intentions To Have Sexual Intercourse
Questions regarding this measure were asked to adolescent participants only
Measured: Pretest, Posttest, 6 month follow-up, 12 month follow-up
Intentions to Use Condoms and Contraceptives
Questions regarding this measure were asked to adolescent participants only
Measured: Pretest, Posttest, 6 month follow-up, 12 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 posted10 Mar 2010 (estimated)
- Study startSep 2002
- Primary completionSep 2006
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 MichiganThe 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
- 1,620 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Investigators
- Antonia M. Villarruel, PhD, FAAN, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084395
- Sponsor's protocol ID
- H03-00001528-MI
- Other IDs
- R01NR008059
- Status last verified
- Mar 2010
- First submitted
- 9 Mar 2010
- Last updated
- 19 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Villarruel AM, Cherry CL, Cabriales EG, Ronis DL, Zhou Y. A parent-adolescent intervention to increase sexual risk communication: results of a randomized controlled trial. AIDS Educ Prev. 2008 Oct;20(5):371-83. doi: 10.1521/aeap.2008.20.5.371.
PubMed 18956979Gallegos EC, Villarruel AM, Loveland-Cherry C, Ronis DL, Yan Zhou M. [Intervention to reduce adolescents sexual risk behaviors: a randomized controlled trial]. Salud Publica Mex. 2008 Jan-Feb;50(1):59-66. doi: 10.1590/s0036-36342008000100012. Spanish.
PubMed 18297183Gallegos EC, Villarruel AM, Gomez MV, Onofre DJ, Zhou Y. Research brief: sexual communication and knowledge among Mexican parents and their adolescent children. J Assoc Nurses AIDS Care. 2007 Mar-Apr;18(2):28-34. doi: 10.1016/j.jana.2007.01.007.
PubMed 17403494
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing HIV Risk Among Mexican Youth
- ClinicalTrials.gov ID
- NCT01084395
- Acronym / sponsor ID
- H03-00001528-MI
- Conditions
- HIV Infections, AIDS, Sexually Transmitted Diseases
- Keywords
- Parent, Adolescent, Mexico, Safer Sex Communication, Randomized Controlled Trial, HIV/AIDS, STD, Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,620 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2002
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 10 Mar 2010 (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.
The broad objective of this project is to test the efficacy of a theory-based HIV risk-reduction intervention, which includes both an adolescent component and parental component, designed to reduce the adolescents' risk of sexually transmitted HIV.
Detailed description
Sexually transmitted HIV infection among adolescents is a growing and significant problem in Mexico. Given the high mortality rate associated with AIDS, the lack of available treatment, and the social stigma associated with the disease, prevention is the key to reducing the threat of AIDS among this important subgroup in Mexico. The study has four specific aims including 1) to determine whether the HIV risk-reduction intervention causes a greater increase in adolescents' intentions to abstain from intercourse and/or avoid unprotected intercourse at post-intervention and decreased self-reported intercourse and unprotected intercourse at 3, 6, 12, and 48 month follow-ups, compared with the general health promotion control intervention; 2) to determine whether the effects of the intervention are moderated by individual, microsystem, and macrosystem variables; 3) to identify theory-based variables that mediate effects of the HIV intervention on adolescents' self-reported behavior; and 4) to determine whether the HIV risk-reduction intervention causes a greater increase in parents' comfort with, and quantity of communication (general and HIV specific) with adolescents at post-intervention, 3, 6, 12, and 48 month follow-up compared with the general health promotion control intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adolescent Safer Sex Intervention | Experimental | Behavioral: Adolescent Safer Sex Intervention |
| Parent Safer Sex Intervention | Experimental | Behavioral: Parent Safer Sex Communication Intervention |
| Adolescent Health Promotion Control | Other | Other: Adolescent Health Promotion Control Condition |
| Parent Health Promotion Control | Other | Other: Parent Health Promotion Control Condition |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Families (adolescents [aged 14 to 17 years of age] and one of their parents)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Adolescent Safer Sex InterventionAlso: CuidateAdolescents are randomly assigned to the HIV risk-reduction intervention condition. Adolescents receive a theory-based intervention designed to reduce HIV risk-associated behavior. The intervention consists of six 50-minute modules implemented over the course of two days. The intervention is highly interactive and includes games, videos, discussion, and role-plays. | Behavioural | Adolescent Safer Sex Intervention |
| Parent Safer Sex Communication InterventionParents are randomly assigned to the Safer Sex Communication Intervention. Parents learn about HIV and other consequences of unprotected sexual behavior. The intervention contains content that focuses on enhancing parent-adolescent communication. | Behavioural | Parent Safer Sex Intervention |
| Adolescent Health Promotion Control ConditionAdolescents are randomly assigned to the Health Promotion control condition. Adolescents receive an intervention aimed at significant health problems affecting Mexicans that are related, not to sexual behavior, but to other behaviors. These health problems include heart disease, certain cancers, and diabetes. Adolescents are taught that these health problems can be prevented by changing personal behaviors, primarily exercise, diet, cigarette smoking, and alcohol and drug use. | Other | Adolescent Health Promotion Control |
| Parent Health Promotion Control ConditionParents are randomly assigned to the Health Promotion control condition. Parents receive an intervention aimed at significant health problems affecting Mexicans that are related, not to sexual behavior, but to other behaviors. These health problems include heart disease, certain cancers, and diabetes. Parents will be taught that these health problems can be prevented by changing personal behaviors, primarily exercise, diet, cigarette smoking, and alcohol and drug use. The intervention also provides content that emphasizes the importance of families. | Other | Parent Health Promotion Control |
Primary outcome
General Parent-Adolescent Communication
Time frame: pretest, posttest, 6 month follow-up, 12 month follow-up
Parent-Adolescent Sexual Risk Communication
Time frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up
Comfort With Communication
Time frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up
Intentions To Have Sexual Intercourse
Time frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up
Questions regarding this measure were asked to adolescent participants only
Intentions to Use Condoms and Contraceptives
Time frame: Pretest, Posttest, 6 month follow-up, 12 month follow-up
Questions regarding this measure were asked to adolescent participants only
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 19 Mar 2010.
- Results publication: PubMed 18956979Villarruel AM, Cherry CL, Cabriales EG, Ronis DL, Zhou Y. A parent-adolescent intervention to increase sexual risk communication: results of a randomized controlled trial. AIDS Educ Prev. 2008 Oct;20(5):371-83. doi: 10.1521/aeap.2008.20.5.371.
- Results publication: PubMed 18297183Gallegos EC, Villarruel AM, Loveland-Cherry C, Ronis DL, Yan Zhou M. [Intervention to reduce adolescents sexual risk behaviors: a randomized controlled trial]. Salud Publica Mex. 2008 Jan-Feb;50(1):59-66. doi: 10.1590/s0036-36342008000100012. Spanish.
- Results publication: PubMed 17403494Gallegos EC, Villarruel AM, Gomez MV, Onofre DJ, Zhou Y. Research brief: sexual communication and knowledge among Mexican parents and their adolescent children. J Assoc Nurses AIDS Care. 2007 Mar-Apr;18(2):28-34. doi: 10.1016/j.jana.2007.01.007.
- Curriculum materials (designed for Latino youth), overview of the curriculum, goals of the curriculum, types of activities, format and length, module outline, recommended trainingLink provided by the sponsor.
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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.
Antonia M. Villarruel, PhD, FAAN principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adolescent Safer Sex Intervention and Parent Safer Sex Communication Intervention in people with HIV Infections and AIDS, run by University of Michigan at 1 site in Mexico.
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 0 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 19 Mar 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 Mexico. 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?
General Parent-Adolescent Communication (time frame: pretest, posttest, 6 month follow-up, 12 month follow-up). The study lists 5 primary outcomes in all. 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 NCT01084395, which also lists 3 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 19 Mar 2010.