Connect 'n Unite: Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM (CNU)
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|ClinicalTrials.gov Identifier: NCT01394900|
Recruitment Status : Active, not recruiting
First Posted : July 15, 2011
Last Update Posted : February 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Sexually Transmitted Infections||Behavioral: CNU Intervention Behavioral: WP Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||424 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||December 31, 2016|
|Estimated Study Completion Date :||April 30, 2017|
Experimental: CNU intervention
African American/Black men who have sex with men (MSM) in same sex intimate relationships in which at least one partner is illicitly using psychostimulants and/or psychoactive substances will receive 4 sessions of CNU intervention
Behavioral: CNU Intervention
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 Name: Connect 'n Unite (CNU) Intervention
Active Comparator: WP intervention
African American/Black men who have sex with men (MSM) in same sex intimate relationships in which at least one partner is illicitly using psychostimulants and/or psychoactive substances will receive 4 sessions of general wellness promotion (WP) intervention
Behavioral: WP Intervention
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 Name: Wellness Promotion (WP) Intervention
- 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.
- 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.
- 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.
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): NCT01394900
|United States, New York|
|Columbia University School of Social Work|
|New York, New York, United States, 10027|
|Principal Investigator:||Elwin Wu, PhD||Columbia University|