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

• 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)

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.

• HIV
• Sexually Transmitted Infections

• Behavioral: Connect 'n Unite
  Couple-based behavioral HIV/STI preventive intervention
• Behavioral: Wellness Promotion
  Couple-based behavioral intervention to promote general health-promoting activities (e.g., exercise, nutrition, disease screening, stress reduction)

• Experimental: Connect 'n Unite
  7-session, manualized intervention
  Intervention: Behavioral: Connect 'n Unite
• Active Comparator: Wellness Program
  7-session intervention that will an attention control condition
  Intervention: Behavioral: Wellness Promotion

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