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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
HIV
Connect 'n Unite, Wellness Promotion
Columbia University School of Social Work
New York
New York
United States
10027
Recruiting
Columbia University
Published on BioPortfolio: 2014-08-27T04:00:28-0400
Wellness Initiative at New York University
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Nuclear Fusion
Thermonuclear reaction in which the nuclei of an element of low atomic weight unite under extremely high temperature and pressure to form a nucleus of a heavier atom.
National Institute Of Nursing Research (u.s.)
Component of the NATIONAL INSTITUTES OF HEALTH. It conducts and supports clinical and basic research to establish a scientific basis for the care of individuals across the life span, from the management of patients during illness and recovery to the reduction of risks for disease and disability; the promotion of healthy lifestyles; the promotion of quality of life in those with chronic illness; and the care for individuals at the end of life. It was established in 1986.
Fractures, Malunited
Union of the fragments of a fractured bone in a faulty or abnormal position. If two bones parallel to one another unite by osseous tissue, the result is a crossunion. (From Manual of Orthopaedic Terminology, 4th ed)
Healthy Lifestyle
A pattern of behavior involving LIFE STYLE choices which ensure optimum health. Examples are eating right; maintaining physical, emotional, and spiritual wellness, and taking preemptive steps against communicable diseases.
Capillaries
The minute vessels that connect the arterioles and venules.