HIVPhase 2LatinoSTYLENCT01635335
Randomized Control Trial of Family-Based HIV Prevention for Latinos
A Phase 2 study testing Latino STYLE in people with HIV and Sexually Transmitted Infections, run by University of South Florida at 1 site in United States.
Trial summary
The proposed project will test an HIV prevention intervention for Latino parent-adolescents dyads. This randomized controlled trial will: 1. Recruit and randomize 320 parent-adolescent dyads into a Latino family-based HIV prevention intervention or a family-based General Health Promotion condition. 2. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Infections
- What is being tested?
- Latino STYLE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Sep 2016
- Phase
- Phase 2
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adolescents and parents self-identify as Latino/Hispanic
- Adolescents between the ages of 14 and 17
- Parent is Spanish-Speaking and feels comfortable speaking Spanish in groups
- Adolescent is English-speaking and feels comfortable speaking English in groups
- Adolescent meets behavioral inclusion criteria (not disclosed)
Who cannot join
- Adolescent self-discloses HIV positive status
- Currently or intending to be pregnant during the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Family-Based HIV Prevention for Latino Youth
The proposed project will test an HIV prevention intervention for Latino parent-adolescents dyads. This randomized controlled trial will:
- Recruit and randomize 320 parent-adolescent dyads into a Latino family-based HIV prevention intervention or a family-based General Health Promotion condition.
- Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in HIV-related sexual behavior and attitudes over 18 months among a sample of 320 Latino parent-adolescent dyads.
- Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in family relationships and parental monitoring/supervision over 18 months among a sample of 320 Latino parent-adolescent dyads.
- Examine the association of other important constructs, such as religiosity, acculturation, cultural values, and sexual socialization with the primary outcomes.
Read more
Based on a thorough review of the literature and preliminary data from a recent, small pilot study, the investigators hypotheses are:
- Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to primary outcome measures of safer sexual behavior (recent sexual activity, the number of unprotected sex acts, and intentions to use condoms) and safer HIV-related attitudes.
- Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to family relationships and parental monitoring/supervision through improved parent-child communication skills and they will mediate the intervention impact.
- Religiosity, acculturation, cultural values, and sexual socialization will have meaningful associations with the primary outcomes and will act as moderators of intervention impact.
Read the detailed description
Latinos are disproportionately represented among those diagnosed with HIV and Latino adolescents are at risk for engaging in sexual behaviors that can lead to HIV. To date, data regarding HIV prevention interventions for Latino adolescents, as distinct from other ethnic groups, have been rare. Thus, an efficacious HIV prevention intervention is urgently needed for Latino adolescents. The current proposal is aimed at filling that gap by evaluating a newly developed family-based intervention that incorporates cultural constructs into the Social-Personal Framework.
This R01 builds on the Principal Investigator's NIMH-funded K Award, which piloted a culturally-specific family-based intervention with 80 Latino parent-adolescent dyads and demonstrates promising results. Extending this work, 320 Latino parent-adolescent dyads with an adolescent between the ages of 14 and 17 will be randomized into either the family based HIV prevention intervention or a family-based general health promotion control condition. In both conditions, the interventions will use a multi-family group format consisting of 6 to 8 parent and youth dyads in a one-day, 7-hour workshop. Both interventions employ activities for youth and parents separately (e.g., focus on adolescent vulnerability) and parents and adolescents together (e.g., address parent/adolescent communication). The project will determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in the adolescents' HIV-related sexual behavior and attitudes, gender and sexual socialization, parent-child communication, and parental monitoring. Measures will be completed at baseline and at 3, 6, 12, and 18 months post-intervention.
HIV/AIDS is a significant problem in the Latino community. Developing culturally sensitive HIV prevention interventions for Latino youth, in particular, is a public health priority. Family-based interventions are likely to be well received by the Latino population. Therefore, this project will examine the efficacy of a family-based HIV prevention intervention for Latino youth and parents to decrease the incidence of HIV among Latinos. Its innovation is in being one of the first to work with Latinos specifically in a family-based intervention where parents and adolescents come together to discuss important sexuality-related topics.
- Conditions
- HIV, Sexually Transmitted Infections
- Being tested
- Latino STYLE
- Keywords
- HIV prevention, adolescents, Latinos, Hispanics, family, health promotion, disease prevention, family communication, parental supervision
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latino STYLEBehavioural
7-hour family-based workshop with 3-hour follow-up booster 3 months later
| Study group | Role | What they receive |
|---|---|---|
| HIV-specific | Experimental | 7-hour multiple family workshop focused on providing information and skills related to HIV prevention. Specific focus on parent-adolescent communication and parental monitoring. Receives: Behavioral: Latino STYLE |
| General Health Promotion | Active comparator | 7-hour multiple family workshop focused on providing information related to various adolescent health risk behaviors, including smoking, alcohol, violence, nutrition, and exercise. Receives: Behavioral: Latino STYLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sexual activity status
Measured: baseline and 3, 6, 12, and 18 months post-intervention
Secondary outcomes (4)
Change in Unprotected Sex Acts
change in the number of incidences of unprotected vaginal or anal intercourse
Measured: baseline and 3, 6, 12, and 18 months post-intervention
Change in intentions to use condoms
Measured: baseline and 3, 6, 12, and 18 months post-intervention
Change in parent-adolescent communication
Measured: baseline and 3, 6, 12, and 18 months post-intervention
change in parental monitoring of adolescent
Measured: baseline and 3, 6, 12, and 18 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 posted9 Jul 2012 (estimated)
- Study startAug 2010
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Celia Lescano, University of South Florida
- Investigators
- Celia Lescano, Ph.D., Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635335
- Sponsor's protocol ID
- 5R01MH087232
- Other IDs
- 5R01MH087232
- Acronym
- LatinoSTYLE
- Status last verified
- Sep 2016
- First submitted
- 30 Jun 2012
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lescano CM, Castillo HL, Calcano E, Mayor M, Porter M, Rivera-Torgerson Y, Dion C, Marhefka SL, Barker D, Brown LK; Latino STYLE Research Group. Latino STYLE: Preliminary Findings From an HIV Prevention RCT Among Latino Youth. J Pediatr Psychol. 2020 May 1;45(4):411-422. doi: 10.1093/jpepsy/jsaa019.
PubMed 32330945
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Family-Based HIV Prevention for Latino Youth
- ClinicalTrials.gov ID
- NCT01635335
- Acronym / sponsor ID
- LatinoSTYLE / 5R01MH087232
- Conditions
- HIV, Sexually Transmitted Infections
- Keywords
- HIV prevention, adolescents, Latinos, Hispanics, family, health promotion, disease prevention, family communication
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2010
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Jul 2012 (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 proposed project will test an HIV prevention intervention for Latino parent-adolescents dyads. This randomized controlled trial will:
- Recruit and randomize 320 parent-adolescent dyads into a Latino family-based HIV prevention intervention or a family-based General Health Promotion condition.
- Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in HIV-related sexual behavior and attitudes over 18 months among a sample of 320 Latino parent-adolescent dyads.
- Determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in family relationships and parental monitoring/supervision over 18 months among a sample of 320 Latino parent-adolescent dyads.
- Examine the association of other important constructs, such as religiosity, acculturation, cultural values, and sexual socialization with the primary outcomes.
Based on a thorough review of the literature and preliminary data from a recent, small pilot study, the investigators hypotheses are:
- Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to primary outcome measures of safer sexual behavior (recent sexual activity, the number of unprotected sex acts, and intentions to use condoms) and safer HIV-related attitudes.
- Compared to the General Health Promotion Control condition, the Family-Based HIV Prevention intervention will result in greater change with regard to family relationships and parental monitoring/supervision through improved parent-child communication skills and they will mediate the intervention impact.
- Religiosity, acculturation, cultural values, and sexual socialization will have meaningful associations with the primary outcomes and will act as moderators of intervention impact.
Detailed description
Latinos are disproportionately represented among those diagnosed with HIV and Latino adolescents are at risk for engaging in sexual behaviors that can lead to HIV. To date, data regarding HIV prevention interventions for Latino adolescents, as distinct from other ethnic groups, have been rare. Thus, an efficacious HIV prevention intervention is urgently needed for Latino adolescents. The current proposal is aimed at filling that gap by evaluating a newly developed family-based intervention that incorporates cultural constructs into the Social-Personal Framework.
This R01 builds on the Principal Investigator's NIMH-funded K Award, which piloted a culturally-specific family-based intervention with 80 Latino parent-adolescent dyads and demonstrates promising results. Extending this work, 320 Latino parent-adolescent dyads with an adolescent between the ages of 14 and 17 will be randomized into either the family based HIV prevention intervention or a family-based general health promotion control condition. In both conditions, the interventions will use a multi-family group format consisting of 6 to 8 parent and youth dyads in a one-day, 7-hour workshop. Both interventions employ activities for youth and parents separately (e.g., focus on adolescent vulnerability) and parents and adolescents together (e.g., address parent/adolescent communication). The project will determine the efficacy of the Latino Family-based HIV prevention intervention from assessment of changes in the adolescents' HIV-related sexual behavior and attitudes, gender and sexual socialization, parent-child communication, and parental monitoring. Measures will be completed at baseline and at 3, 6, 12, and 18 months post-intervention.
HIV/AIDS is a significant problem in the Latino community. Developing culturally sensitive HIV prevention interventions for Latino youth, in particular, is a public health priority. Family-based interventions are likely to be well received by the Latino population. Therefore, this project will examine the efficacy of a family-based HIV prevention intervention for Latino youth and parents to decrease the incidence of HIV among Latinos. Its innovation is in being one of the first to work with Latinos specifically in a family-based intervention where parents and adolescents come together to discuss important sexuality-related topics.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-specific | Experimental | Behavioral: Latino STYLE7-hour multiple family workshop focused on providing information and skills related to HIV prevention. Specific focus on parent-adolescent communication and parental monitoring. |
| General Health Promotion | Active comparator | Behavioral: Latino STYLE7-hour multiple family workshop focused on providing information related to various adolescent health risk behaviors, including smoking, alcohol, violence, nutrition, and exercise. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adolescents and parents self-identify as Latino/Hispanic
- Adolescents between the ages of 14 and 17
- Parent is Spanish-Speaking and feels comfortable speaking Spanish in groups
- Adolescent is English-speaking and feels comfortable speaking English in groups
- Adolescent meets behavioral inclusion criteria (not disclosed)
Key exclusion criteria (2 listed)
- Adolescent self-discloses HIV positive status
- Currently or intending to be pregnant during the course of 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 |
|---|---|---|
| Latino STYLE7-hour family-based workshop with 3-hour follow-up booster 3 months later | Behavioural | General Health Promotion, HIV-specific |
Primary outcome
Change in sexual activity status
Time frame: baseline and 3, 6, 12, and 18 months post-intervention
4 secondary outcomes
Change in Unprotected Sex Acts
Time frame: baseline and 3, 6, 12, and 18 months post-intervention
Change in intentions to use condoms
Time frame: baseline and 3, 6, 12, and 18 months post-intervention
Change in parent-adolescent communication
Time frame: baseline and 3, 6, 12, and 18 months post-intervention
change in parental monitoring of adolescent
Time frame: baseline and 3, 6, 12, and 18 months post-intervention
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 21 Sep 2016.
- Derived from this study: PubMed 32330945Lescano CM, Castillo HL, Calcano E, Mayor M, Porter M, Rivera-Torgerson Y, Dion C, Marhefka SL, Barker D, Brown LK; Latino STYLE Research Group. Latino STYLE: Preliminary Findings From an HIV Prevention RCT Among Latino Youth. J Pediatr Psychol. 2020 May 1;45(4):411-422. doi: 10.1093/jpepsy/jsaa019.
- related infoLink 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.
Celia Lescano, Ph.D. principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Latino STYLE in people with HIV and Sexually Transmitted Infections, run by University of South Florida 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 5 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 21 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in sexual activity status (time frame: baseline and 3, 6, 12, and 18 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 NCT01635335, which also lists 1 linked publication.
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 21 Sep 2016.