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NCT01635335 · ClinicalTrials.gov registry record · Phase 2
Randomized Control Trial of Family-Based HIV Prevention for Latinos
A Phase 2 study, sponsored by University of South Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 542
- Enrollment target
NCT01635335 is a Phase 2 study that has completed, run by University of South Florida. The registered enrollment target is 542 participants.
The verdict
NCT01635335, a Phase 2 study, has completed, sponsored by University of South Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 542 participants
- Enrollment target
Study 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. 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. 3. 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. 4. 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: 1. 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. 2. 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. 3. Religiosity, acculturation, cultural values, and sexual socialization will have meaningful associations with the primary outcomes and will act as moderators of intervention impact.
Interventions
- BEHAVIORAL Latino STYLE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 542 participants |
| Start Date | 2010-08 |
| Est. Completion | 2016-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01635335
The ClinicalTrials.gov registry entry for NCT01635335 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 542 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of South Florida, which has 252 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Latino STYLE is the first listed.
NCT01635335 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01635335 about?
NCT01635335 is a clinical study titled "Randomized Control Trial of Family-Based HIV Prevention for Latinos". 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....
What is the current status of trial NCT01635335?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 542 participants. The study started on 2010-08. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01635335?
The interventions under investigation include: Latino STYLE (BEHAVIORAL).
Who is sponsoring clinical trial NCT01635335?
This trial is sponsored by University of South Florida, which has 252 total clinical trials registered on ClinicalTrials.gov.
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