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