Being Responsible for Ourselves HIV Risk Reduction for Black MSM

NCT02561286 | Completed

• 2 other identifiers: 806708R01MH079736
• Study Type: interventional
• Target: 595
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of HIV/AIDS among African American men who have sex with men (MSM) is alarming, and the public health response to this urgent situation has been hampered by a lack of sexual risk reduction interventions with solid evidence of efficacy in this population. Accordingly, the broad, long-term objective of the proposed research is to identify interventions to reduce the risk of sexually transmitted infection (STI) among African American MSM. This application seeks funds to develop and test the efficacy of a theory-based, contextually appropriate behavioral intervention to reduce sexual risk behavior among African American MSM. Intervention development will be guided by social cognitive theory, the theory of planned behavior, qualitative information from focus groups, and findings from a longitudinal survey of men from the study population. A one-on-one intervention will be utilized to address the specific prevention needs of each man and to allay participants' concerns about revealing their sexual involvement with men by virtue of participating in a group or workshop intervention. The study will utilize a randomized controlled trial design, with baseline, immediate post intervention, and 6 and 12 months post intervention assessments. The participants will be African American MSM who will be randomized to a one-on-one sexual risk reduction intervention or a one-on-one health promotion intervention that will serve as the control condition. The primary outcome is consistent condom use during anal and vaginal intercourse. The study will test whether the intervention increases the consistent use of condoms during anal intercourse, the primary outcome, whether it decreases other sexual risk behaviors, and whether social cognitive theory variables mediate the effects of the intervention on consistent condom use. This study will provide an urgently needed intervention to reduce the risk of HIV and other STIs in one of the highest risk populations in the United States.

Conditions

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

Keywords

Human immunodeficiency virus; Sexually transmitted disease; Men who have sex with men; African Americans; Behavioral intervention; Randomized controlled trial; Sexual behavior; Mediation analysis; Social cognitive theory; Theory of planned behavior

Outcome Measures

Primary Outcomes (1)

• Consistent (100%) condom use during anal and vaginal intercourse in the past 3 months

  Men who reported at least one intercourse act and whose number of reported protected acts equaled their number of acts were coded as practicing consistent condom use. Men who reported at least one intercourse act and whose reported number of protected acts was less than their number of acts were coded as not practicing consistent condom use.

  6 and 12 months post-intervention

Secondary Outcomes (5)

• Receptive anal intercourse in the past 3 months

  6 and 12 months post-intervention

• Insertive anal intercourse in the past 3 months

  6 and 12 months post-intervention

• Proportion condom-protected intercourse in the past 3 months

  6 and 12 months post-intervention

• Multiple sexual partners in the past 3 months

  6 and 12 months post-intervention

• Unprotected intercourse in the past 3 months

  6 and 12 months post-intervention

Study Arms (2)

HIV risk reduction

EXPERIMENTAL

BRO HIV Risk Reduction Intervention

Behavioral: BRO HIV Risk Reduction Intervention

Health promotion control

ACTIVE COMPARATOR

Health Promotion Intervention

Behavioral: Health Promotion Intervention

Interventions

BRO HIV Risk Reduction Intervention BEHAVIORAL

BRO HIV Risk Reduction Intervention was designed to strengthen outcome expectancies supporting condom use and other sexual risk reduction strategies and skill and self-efficacy to use condoms and reduce sexual risk behaviors. It consisted of three 90-min one-on-one individual sessions implemented during 3 consecutive weeks by specially trained facilitators using standardized intervention manuals. Sessions 1 and 2 included take-home assignments that the participants reviewed at the subsequent session. The delivery of the intervention was tailored to the information that the participants provided during the sessions, including the context in which behaviors occurred and participants' motivation for the behaviors.

Also known as: HIV Risk Reduction Intervention

HIV risk reduction

Health Promotion Intervention BEHAVIORAL

Health Promotion Intervention was designed to provide a control for "Hawthorne effects," reducing the likelihood that the HIV/STI risk-reduction intervention's effects could be attributed to non-specific features, including special attention. It focused on increasing physical activity and fruit-and-vegetable consumption and decreasing fat consumption to reduce the risk of chronic diseases, including heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among African Americans It also consisted of three 90-min one-on-one individual sessions implemented during 3 consecutive weeks by specially trained facilitators using standardized intervention manuals.

Also known as: Attention Control Intervention, BRO Health Promotion Intervention, Health Promotion Control

Health promotion control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Self-identified as black or African American
• Born a male
• Reported having anal intercourse with a man in the previous 90 days.

You may not qualify if:

• Reported having anal intercourse with only one main male partner in the past 90 days
• Participated in an HIV/STI risk-reduction intervention in the past 12 months

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

• Stevens R, Bernadini S, Jemmott JB. Social environment and sexual risk-taking among gay and transgender African American youth. Cult Health Sex. 2013;15(10):1148-61. doi: 10.1080/13691058.2013.809608. Epub 2013 Jul 26.

  PMID: 23889233 BACKGROUND

• O'Leary A, Jemmott JB 3rd, Stevens R, Rutledge SE, Icard LD. Optimism and education buffer the effects of syndemic conditions on HIV status among African American men who have sex with men. AIDS Behav. 2014 Nov;18(11):2080-8. doi: 10.1007/s10461-014-0708-0.

  PMID: 24705710 BACKGROUND

• Jemmott JB 3rd, Jemmott LS, O'Leary A, Icard LD, Rutledge SE, Stevens R, Hsu J, Stephens AJ. On the Efficacy and Mediation of a One-on-One HIV Risk-Reduction Intervention for African American Men Who Have Sex with Men: A Randomized Controlled Trial. AIDS Behav. 2015 Jul;19(7):1247-62. doi: 10.1007/s10461-014-0961-2.

  PMID: 25449552 RESULT

• Zhang J, Jemmott JB 3rd, O'Leary A, Stevens R, Jemmott LS, Icard LD, Hsu J, Rutledge SE. Efficacy and Mediation of a Theory-Based Physical Activity Intervention for African American Men Who Have Sex with Men: A Randomized Controlled Trial. Ann Behav Med. 2017 Feb;51(1):106-116. doi: 10.1007/s12160-016-9832-6.

  PMID: 27658914 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases; Homosexuality; Sexual Behavior

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; Sexuality; Behavior

Study Officials

• John B Jemmott III, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: September 28, 2015
• Study Start: April 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 29, 2015

Record last verified: 2015-09

Locations

US (1)