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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: Completed Phase 2 study, sponsored by University of South Florida.

NCT01635335 is a Phase 2 study that has completed, run by University of South Florida. The registered enrollment target is 542 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (308% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 542 participants
Start Date 2010-08
Est. Completion 2016-09
Phase Phase 2
University of South Florida

252 total trials

What the finished NCT01635335 record still lists

NCT01635335 is an interventional study that assigns participants to a tested intervention. The registered 542 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (308% higher).

The record links to 0 conditions, and to 1 intervention - of which Latino STYLE is the first listed.

NCT01635335 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01635335's enrollment target sits among peer trials

542 62nd of 2000 higher than 1,939 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01635335, the US trial registry maintained by the National Library of Medicine. NCT01635335 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.