Connect 'n Unite: Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM (CNU)
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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 |
- 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: | March 2012 |
| Estimated Primary Completion Date: | February 2015 (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 |
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| Contact: Elwin Wu, PhD | 212.851.2397 | ew157@columbia.edu |
| United States, New York | |
| Columbia University School of Social Work | Not yet recruiting |
| New York, New York, United States, 10027 | |
| Principal Investigator: Elwin Wu, PhD | |
| Principal Investigator: | Elwin Wu, PhD | Columbia University |
More Information
No publications provided
| Responsible Party: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT01394900 History of Changes |
| Other Study ID Numbers: | AAAI5452, 1R01DA030296-01A1 |
| Study First Received: | July 13, 2011 |
| Last Updated: | January 18, 2012 |
| 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 March 14, 2013
