HIV/AIDSNCT01084421
A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos
A study testing Computer-based parent-adolescent HIV communication in people with HIV/AIDS and STD, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of a brief culturally appropriate and theory-based parental communication intervention designed to improve parent-adolescent sexual communication and reduce adolescent sexual risk behavior. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Computer-based parent-adolescent HIV communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Latino parents who have adolescents 14 to 17 years of age
- Spanish dominant or bilingual
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Detroit Hispanic Development Corporation (DHDC)
Detroit, Michigan, 48216
About this study
The purpose of this study is to examine the efficacy of a brief culturally appropriate and theory-based parental communication intervention designed to improve parent-adolescent sexual communication and reduce adolescent sexual risk behavior.
Read the detailed description
Latino adolescents are at high risk for contracting HIV/AIDS. Few individual and even fewer parent interventions have been developed to address this persistent problem. Parent communication interventions provide an opportunity to enhance individual adolescent based approaches. However, there is a need for theory and culture based interventions focused on Latino parents. The program implemented in this study was designed for parents, to indirectly help reduce the health risks of their adolescents, including unintended pregnancy and STDs, including HIV/AIDS. The study has three aims regarding the examination of whether the computer based parental communication intervention is 1) associated with a greater increase in parents' comfort with, and quantity of communication; 2) associated with a greater increase in adolescents' intentions to abstain from sex and/or avoid unprotected intercourse and decreased self-reported intercourse and unprotected intercourse; and 3) feasible and acceptable to Spanish dominant Latino parents and their adolescent children.
- Being tested
- Computer-based parent-adolescent HIV communication
- Keywords
- Adolescents, Parents, Computer Based, Latino, Sexual Communication
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-based parent-adolescent HIV communicationBehavioural
Also called Cuidalos
The parental intervention consists of a 60 minute computer-based program delivered in two sessions (one per week). The DVD ROM provides information about adolescent sexual risk and HIV prevention, strategies to support sexual specific communication and parent-adolescent communication in general. The computer based education program is provided in Spanish.
| Study group | Role | What they receive |
|---|---|---|
| Computer based intervention | Experimental | Participants receive content about adolescent sexual risk and HIV prevention, strategies to support sexual specific communication and parent-adolescent communication in general. Receives: Behavioral: Computer-based parent-adolescent HIV communication |
| Wait list control group | No intervention | Participants will receive the computer based intervention at 3 months follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
general parent-adolescent communication, parent-adolescent sexual risk communication, comfort with communication
Measured: pretest, 1 week, 3 months
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 2007
- Primary completionSep 2008
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV/AIDSStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Antonia M. Villarruel, University of Michigan
- Investigators
- Antonia M Villarruel, PhD,RN,FAAN, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084421
- Sponsor's protocol ID
- HUM00020148
- Other IDs
- R21NR010457
- Status last verified
- Aug 2016
- First submitted
- 9 Mar 2010
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Computer-Based Parent/Adolescent HIV Communication Intervention for Latinos
- ClinicalTrials.gov ID
- NCT01084421
- Acronym / sponsor ID
- HUM00020148
- Keywords
- Adolescents, Parents, Computer Based, Latino, Sexual Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Jun 2010 (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 purpose of this study is to examine the efficacy of a brief culturally appropriate and theory-based parental communication intervention designed to improve parent-adolescent sexual communication and reduce adolescent sexual risk behavior.
Detailed description
Latino adolescents are at high risk for contracting HIV/AIDS. Few individual and even fewer parent interventions have been developed to address this persistent problem. Parent communication interventions provide an opportunity to enhance individual adolescent based approaches. However, there is a need for theory and culture based interventions focused on Latino parents. The program implemented in this study was designed for parents, to indirectly help reduce the health risks of their adolescents, including unintended pregnancy and STDs, including HIV/AIDS. The study has three aims regarding the examination of whether the computer based parental communication intervention is 1) associated with a greater increase in parents' comfort with, and quantity of communication; 2) associated with a greater increase in adolescents' intentions to abstain from sex and/or avoid unprotected intercourse and decreased self-reported intercourse and unprotected intercourse; and 3) feasible and acceptable to Spanish dominant Latino parents and their adolescent children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer based intervention | Experimental | Behavioral: Computer-based parent-adolescent HIV communicationParticipants receive content about adolescent sexual risk and HIV prevention, strategies to support sexual specific communication and parent-adolescent communication in general. |
| Wait list control group | No intervention | –Participants will receive the computer based intervention at 3 months follow-up |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Latino parents who have adolescents 14 to 17 years of age
- Spanish dominant or bilingual
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 |
|---|---|---|
| Computer-based parent-adolescent HIV communicationAlso: CuidalosThe parental intervention consists of a 60 minute computer-based program delivered in two sessions (one per week). The DVD ROM provides information about adolescent sexual risk and HIV prevention, strategies to support sexual specific communication and parent-adolescent communication in general. The computer based education program is provided in Spanish. | Behavioural | Computer based intervention |
Primary outcome
general parent-adolescent communication, parent-adolescent sexual risk communication, comfort with communication
Time frame: pretest, 1 week, 3 months
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 31 Aug 2016.
- Individual participant dataSharing planned: No
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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,RN,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 Computer-based parent-adolescent HIV communication in people with HIV/AIDS and STD, run by University of Michigan 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 2 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 31 Aug 2016. 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?
general parent-adolescent communication, parent-adolescent sexual risk communication, comfort with communication (time frame: pretest, 1 week, 3 months). 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 31 Aug 2016.