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

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ClinicalTrials.gov Identifier: NCT02572401
Recruitment Status : Completed
First Posted : October 8, 2015
Last Update Posted : October 8, 2015
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
University of Pennsylvania

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

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus (HIV) Sexually Transmitted Disease (STD) Behavioral: STAND HIV Risk Reduction Intervention Behavioral: Text Messaging Intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 391 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Reducing the Risk of HIV/STD Infection Among African American Men
Study Start Date : October 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIV Risk Reduction Only
STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.
Behavioral: STAND HIV Risk Reduction Intervention
STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-minute sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
Other Name: HIV Risk Reduction Intervention

No Intervention: No-Intervention No-Text Message Control
Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.
Experimental: HIV Risk Reduction and Text Messaging
STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.
Behavioral: STAND HIV Risk Reduction Intervention
STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-minute sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
Other Name: HIV Risk Reduction Intervention

Behavioral: Text Messaging Intervention
Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex.

Experimental: Text Messaging Only
Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.
Behavioral: Text Messaging Intervention
Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex.




Primary Outcome Measures :
  1. Consistent (100%) condom use [ Time Frame: up to 12 months post-intervention ]
    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.


Secondary Outcome Measures :
  1. Unprotected intercourse [ Time Frame: up to 12 months post-intervention ]
    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.

  2. Multiple partners [ Time Frame: up to 12 months post-intervention ]
    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.

  3. Insertive anal intercourse [ Time Frame: up to 12 months post-intervention ]
    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.

  4. Proportion condom-protected intercourse [ Time Frame: up to 12 months post-intervention ]
    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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572401


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: John B Jemmott III, PhD University of Pennsylvania

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02572401     History of Changes
Other Study ID Numbers: 810971
R01MD004075 ( U.S. NIH Grant/Contract )
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: October 8, 2015
Last Verified: September 2015
Keywords provided by University of Pennsylvania:
Human immunodeficiency virus
Sexually transmitted disease
Behavioral intervention
Randomized controlled trial
Text messages
Social cognitive theory
Theory of planned behavior
Sexual behavior
African Americans
Men
Additional relevant MeSH terms:
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Sexually Transmitted Diseases
Immune System Diseases
Virus Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Genital Diseases, Male
Genital Diseases, Female
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Infection