Trial record 16 of 28 for:    " July 06, 2011":" August 05, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Columbia University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Elwin Wu, Columbia University
ClinicalTrials.gov Identifier:
NCT01394900
First received: July 13, 2011
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

This study rigorously tests the efficacy of a couples-based HIV and sexually transmitted infection (HIV/STI) preventive intervention for African American/Black men who have sex with men (MSM) in same sex intimate relationships in which at least one partner is using stimulants (herein referred to as "stimulant-using, Black MSM couples"). This study is a logical progression from the investigative team's CDC-funded pilot study that successfully pilot tested a couples-based intervention originally for heterosexual couples ("Connect") adapted for a new target population of methamphetamine-using, Black MSM couples. That pilot study culminated with a manualized, 7-session intervention entitled "Connect 'n Unite" (CNU—pronounced "seein' you"—for short) as a candidate couples-based HIV preventive intervention for stimulant-using, Black MSM couples. This study is a randomized clinical trial with 240 stimulant-using, Black MSM couples to test the impact of CNU versus a wellness promotion (WP) attention control condition on behavioral and biologically assayed outcomes over a 12-month follow-up period. The study has the following primary aims: (1) to test whether participants assigned to CNU engage in lower HIV/STI behavioral risk compared to participants assigned to WP; (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.


Condition Intervention
HIV
Sexually Transmitted Infections
Behavioral: Connect 'n Unite
Behavioral: Wellness Promotion

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Sexually transmitted infection (STI) incidence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Cumulative incidence of chlamydia and gonorrhea detected by biological assay

  • Sexual HIV risk behavior [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of acts of unprotected anal intercourse; Proportion of acts of anal intercourse that are condom-protected; Number of sexual partners

  • Illicit drug use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Frequency of illicit drug use (self-reported); Number of types of illicit drugs used (self-reported)


Estimated Enrollment: 480
Study Start Date: July 2012
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Connect 'n Unite
7-session, manualized intervention
Behavioral: Connect 'n Unite
Couple-based behavioral HIV/STI preventive intervention
Active Comparator: Wellness Program
7-session intervention that will an attention control condition
Behavioral: Wellness Promotion
Couple-based behavioral intervention to promote general health-promoting activities (e.g., exercise, nutrition, disease screening, stress reduction)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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 stimulant—operationally defined as cocaine, crack, or a methamphetamine-group substance—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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394900

Contacts
Contact: Elwin Wu, PhD 212.851.2397 ew157@columbia.edu

Locations
United States, New York
Columbia University School of Social Work Recruiting
New York, New York, United States, 10027
Contact: Elwin Wu, PhD       ew157@columbia.edu   
Principal Investigator: Elwin Wu, PhD         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Elwin Wu, PhD Columbia University
  More Information

No publications provided

Responsible Party: Elwin Wu, Associate Professor of Social Work, Columbia University
ClinicalTrials.gov Identifier: NCT01394900     History of Changes
Other Study ID Numbers: AAAI5452, 1R01DA030296-01A1
Study First Received: July 13, 2011
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
HIV
sexually transmitted infection
STI
men who have sex with men
MSM
couples
African American
Black

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 31, 2014