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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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
A binary variable reflecting whether or not the participant reports using a condom every time he had vaginal or anal intercourse with a woman in the previous 3 months. It will be based on a comparison of the number of protected intercourse acts and the number of intercourse acts. Men who report at least one intercourse act and whose number of reported protected acts equals their number of acts use condoms during 100% of intercourse acts and will be defined as practicing consistent condom use. Me
Interventions
- BEHAVIORAL Text Messaging Intervention
- BEHAVIORAL STAND HIV Risk Reduction Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 391 participants |
| Start Date | 2011-10 |
| Est. Completion | 2015-06 |
| Phase | NA |
What the finished NCT02572401 record still lists
NCT02572401 is an interventional study that assigns participants to a tested intervention. The registered 391 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Text Messaging Intervention is the first listed.
NCT02572401 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02572401's enrollment target sits among peer trials
391 269th of 2000 higher than 1,732 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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