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NCT02572401 · ClinicalTrials.gov registry record · NA

Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men

A NA study, sponsored by University of Pennsylvania.

Completed
Registry status
NA
Development phase
391
Enrollment target

NCT02572401: Completed NA study, sponsored by University of Pennsylvania.

NCT02572401 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 391 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02572401, a NA study, has completed, sponsored by University of Pennsylvania.

COMPLETED
Registry status
NA
Development phase
391 participants
Enrollment target

Study Summary

African American men have by far the highest rates of HIV in the US, but there are few randomized controlled trials (RCTs) of interventions to dissuade heterosexually active African American men from engaging sexual risk behavior. This research seeks to address this gap in the behavioral intervention literature. That self-initiated behavior change, as well as intervention-induced behavior change, is often short-lived, eroding over time, is widely known; accordingly, this research also seeks to test a strategy to sustain intervention efficacy. In a RCT, African American men 18 to 45 years reporting recent unprotected intercourse with a woman will be randomized to the Steering Together in a New Direction (STAND) HIV Risk Reduction Intervention or a No-Intervention Control Condition. To test a strategy to sustain intervention effects, the men also will be randomized to receive or not receive individually tailored text messages. The theoretical basis of the interventions is social cognitive theory and the reasoned action approach, which is an extension of the theory of planned behavior and the theory of reasoned action. Men will complete self-report measures via audio computer-assisted self-interviewing at baseline and immediately post and 6 and 12 months post-intervention. The trial will test whether the STAND HIV Risk Reduction Intervention as compared with the No-Intervention Control Condition, increases consistent condom use, the primary outcome. Secondary outcomes include unprotected intercourse, multiple sexual partners, insertive anal intercourse, and proportion condom-protected intercourse. The trial will also test whether STAND's efficacy is greater among men in the Text Messaging Intervention compared with men not receiving text messages. This will provide information on the utility of a low-cost strategy to extend an intervention's efficacy. Finally, the study will test for mediation of intervention effects: the hypothesis that STAND affects outcome expectanc

Interventions

  • BEHAVIORAL Text Messaging Intervention
  • BEHAVIORAL STAND HIV Risk Reduction Intervention

Trial Details

FieldValue
Enrollment Target 391 participants
Start Date 2011-10
Est. Completion 2015-06
Phase NA

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT02572401

The ClinicalTrials.gov registry entry for NCT02572401 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 391 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Text Messaging Intervention is the first listed.

NCT02572401 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02572401 about?

NCT02572401 is a clinical study titled "Steering Together in a New Direction: Reducing the Risk of HIV/STD Among African American Men". African American men have by far the highest rates of HIV in the US, but there are few randomized controlled trials (RCTs) of interventions to dissuade heterosexually active African American men from engaging sexual risk behavior. This research seeks to address this gap in the behavioral interventio...

What is the current status of trial NCT02572401?

This trial is currently completed. It is a NA study. The enrollment target is 391 participants. The study started on 2011-10. Estimated completion is 2015-06.

What interventions are being tested in trial NCT02572401?

The interventions under investigation include: Text Messaging Intervention (BEHAVIORAL), STAND HIV Risk Reduction Intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT02572401?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.