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

NCT02572401 | Completed Results

• 2 other identifiers: 810971R01MD004075
• Study Type: interventional
• Target: 391
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus (HIV); Sexually Transmitted Disease (STD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Unprotected Intercourse

  Baseline, 6 months, 12 months post-intervention

• Multiple Partners

  Baseline, 6 months, 12 months post-intervention

• Insertive Anal Intercourse

  Baseline, 6 months, 12 months post-intervention

• Proportion Condom-protected Intercourse

  Baseline, 6 months, 12 months post-intervention

Study Arms (4)

HIV Risk Reduction Only

EXPERIMENTAL

STAND HIV Risk Reduction Intervention. Participants will not receive the Text Messaging Intervention.

Behavioral: STAND HIV Risk Reduction Intervention

No-Intervention No-Text Message Control

NO INTERVENTION

Participants do not receive the STAND HIV Risk Reduction Intervention or the Text Messaging Intervention.

HIV Risk Reduction and Text Messaging

EXPERIMENTAL

STAND HIV Risk Reduction Intervention and Text Messaging Intervention. Participants will receive the intervention and text messages.

Behavioral: STAND HIV Risk Reduction Intervention; Behavioral: Text Messaging Intervention

Text Messaging Only

EXPERIMENTAL

Text Messaging Intervention. Participants will receive the text messages but not the STAND HIV Risk Reduction Intervention.

Behavioral: Text Messaging Intervention

Interventions

STAND HIV Risk Reduction Intervention BEHAVIORAL

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.

Also known as: HIV Risk Reduction Intervention

HIV Risk Reduction Only; HIV Risk Reduction and Text Messaging

Text Messaging Intervention BEHAVIORAL

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.

HIV Risk Reduction and Text Messaging; Text Messaging Only

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; Sexual Behavior; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Limitations and Caveats

The outcome measures are self-reported; hence, they may be biased by socially desirable responding or problems of memory. The participants were not randomly selected; hence the findings may not generalize to the target population.

Results Point of Contact

• Title: Dr. John B. Jemmott III
• Organization: University of Pennsylvania

jjemmott@asc.upenn.edu

215-573-9366

Study Officials

• John B Jemmott III, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 8, 2015
• Study Start: October 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2015
• Last Updated: October 15, 2019
• Results First Posted: October 15, 2019

Record last verified: 2019-10

Locations

US (1)