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Completed

NCT Number: NCT01394900

Connect 'n Unite: Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM

The study has the following primary aims: (1) to test whether participants assigned to CNU (a 7-session, manualized intervention entitled "Connect 'n Unite") engage in lower HIV/STI behavioral risk compared to participants assigned to WP (a wellness promotion attention control condition); (2) to test whether participants assigned to CNU have lower cumulative incidence of STIs-chlamydia and gonorrhea-confirmed via biological assay compared to participants assigned to WP; and (3) to test whether participants assigned to CNU engage in less drug use compared to participants assigned to WP.

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Key information

Conditions

HIV Behavior Communicable Diseases Disease Attributes Genital Diseases Homosexuality Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexual Behavior Sexuality Sexually Transmitted Diseases Sexually Transmitted Infections Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University School of Social Work

New York, 10027, United States

About this study

This study addresses the overrepresentation of the African American/Black community among those living with HIV/AIDS in the U.S. as well as men who have sex with men (MSM), the transmission category that accounts for the majority of HIV infections. In the absence of a vaccine or cure for HIV infection, behavioral risk reduction represents the best public health tool for prevention of HIV transmission. The proposed randomized clinical trial will rigorously test an innovative, couples-based intervention targeting the intersection of stimulant use and sexual risk behavior among racial/ethnic and sexual minorities, with the ultimate goal providing an evidence-based intervention that can be delivered in drug treatment and other service settings to reduce the spread of HIV among stimulant-using, African American/Black MSM.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male
  • At least 18 years old
  • Report having a "primary/main male partner" operationalized as a male with whom he has had an ongoing sexual relationship over the prior 6 months and has an emotional bond with more than any person
  • Self-identify as African American and/or Black, or identify having a main partner who self-identifies in this manner
  • Report using a illicit use of psychostimulant and/or psychoactive drugs in the past 90 days (or has a main male partner who meets this criterion)
  • Report having unprotected anal sex with a man who is a non-main partner in the past 90 days (or has a main male partner who meets this criterion)
  • Identify each other as their main partner

Exclusion criteria

  • Either partner reports the occurrence of ≥1 incident of severe intimate partner violence (IPV) within the relationship in the past year as assessed using the Revised Conflict Tactics Scales
  • Either partner has a language or cognitive impairment that prevents comprehension of study procedures as assessed during informed consent
  • Either partner reports being currently involved (i.e., has not completed the final follow-up assessment) in an HIV prevention research study

Treatment and study plan

CNU Intervention

Behavioral

Notions that strengthen the closeness with one's partner, connect with similar couples, and visibly strengthen a community as key to combating dynamics that cause poor communication, isolation, fragmentation of the Black MSM community.

Other names: Connect 'n Unite (CNU) Intervention

WP Intervention

Behavioral

Attention control condition - WP focuses on nutrition, fitness, healthcare, and stress management. Given the prevalence of health problems among the target population, WP emphasizes adherence to medical guidance and medication regimens.

Other names: Wellness Promotion (WP) Intervention

Primary outcomes

  1. Difference in number of unprotected acts of anal intercourse between 2 groups

    Time frame: 12 months

    To test whether participants assigned to the CNU intervention engage in lower HIV/STI behavioral risk compared to participants assigned to the WP attention control condition using the following primary outcome - number of unprotected acts of anal intercourse.

Secondary outcomes

  1. Difference in incidence of sexually transmitted infections (STIs) between 2 groups

    Time frame: 12 months

    To test whether participants assigned to CNU have lower cumulative incidence of STIs confirmed via biological assay compared to participants assigned to WP.

  2. Difference in number of illicit drug use between 2 groups

    Time frame: 12 months

    To test whether participants assigned to CNU engage in less drug use compared to participants assigned to WP.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM

Acronym: CNU

Important dates

Study start
2012
Primary completion
2016
Study completion
2019
First posted
Jul 15, 2011
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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