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

Completed · Not applicable

Conditions studied: Human Immunodeficiency Virus (HIV), Sexually Transmitted Disease (STD)

In brief

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 expectancies and self-efficacy, which, in turn, affect consistent condom use.

Key facts

Study ID

NCT02572401

Run by

University of Pennsylvania

People needed

391

Starts

2011-10-01

Expected to finish

2015-06-01

Last updated by the study team

2019-10-15

Who can join

Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Ages 18 to 45 years
• Self-identify as African American or Black
• Born a male
• Report having intercourse with a woman in the past 60 days without using a condom

You may not qualify if…

• Report having intercourse with only 1 female partner in the past 60 days and being in a committed relationship with her for 6 or more months
• Plan to relocate beyond a reasonable distance from the study in the next 18 months or do not have an address where he can receive mail
• Report participating in an intervention research study on how to reduce HIV risks or negotiate safer sex in the previous 12 months

Where it is running

• University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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