Human Immunodeficiency Virus (HIV) Clinical Trial
— STANDOfficial title:
Reducing the Risk of HIV/STD Infection Among African American Men
Verified date | October 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 391 |
Est. completion date | June 2015 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | National Institute on Minority Health and Health Disparities (NIMHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Consistent (100%) Condom Use | 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. Men who report at least one intercourse act and whose reported number of protected acts is less than their number of acts will be coded as not practicing consistent condom use. Separate binary variables reflect consistent condom use with steady partners and casual partners analyzed as a repeated outcome. | Baseline, 6 months, 12 months post-intervention | |
Secondary | Unprotected Intercourse | A binary variable indicating whether the participants reported having intercourse in the past 90 days without using a condom. It was constructed by subtracting the sum of the condom-protected intercourse acts from the total number of intercourse acts in the past 90 days. If the difference was one or greater the participant was coded as having unprotected intercourse; if the difference was zero or if the person reported no intercourse in the past 90 days, the person was coded as not having unprotected intercourse. Calculated separately for steady partners and casual partners and analyzed as a repeated outcome. | Baseline, 6 months, 12 months post-intervention | |
Secondary | Multiple Partners | Participants whose number of intercourse partners in the past 90 days was 2 or greater are coded as having multiple partners, and those who reported having 0 or 1 intercourse partners in the past 90 days are coded as not having multiple partners. | Baseline, 6 months, 12 months post-intervention | |
Secondary | Insertive Anal Intercourse | A binary variable indicating whether the participant reported having insertive anal intercourse in the past 90 days. Measured separately for steady partners and casual partners and analyzed as a repeated outcome. | Baseline, 6 months, 12 months post-intervention | |
Secondary | Proportion Condom-protected Intercourse | The denominator is the number intercourse acts in the past 90 days and the numerator is the number of condom-protected intercourse acts in the past 90 days. Calculated separately for steady partners and casual partners and analyzed as a repeated outcome. | Baseline, 6 months, 12 months post-intervention |
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