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

HIV Clinical Trial

— CNU  

Official title:

Couples-Based HIV/STI Prevention for Drug-Involved, Black MSM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394900
• Other study ID #: AAAI5452
• Secondary ID: 1R01DA030296-01A
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: August 2, 2019

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study has the following primary aims: (1) to test whether participants assigned to CNU (a 7-session, manualized intervention entitled "Connect 'n Unite") engage in lower HIV/STI behavioral risk compared to participants assigned to WP (a wellness promotion attention control condition); (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.

Description:

This study addresses the overrepresentation of the African American/Black community among those living with HIV/AIDS in the U.S. as well as men who have sex with men (MSM), the transmission category that accounts for the majority of HIV infections. In the absence of a vaccine or cure for HIV infection, behavioral risk reduction represents the best public health tool for prevention of HIV transmission. The proposed randomized clinical trial will rigorously test an innovative, couples-based intervention targeting the intersection of stimulant use and sexual risk behavior among racial/ethnic and sexual minorities, with the ultimate goal providing an evidence-based intervention that can be delivered in drug treatment and other service settings to reduce the spread of HIV among stimulant-using, African American/Black MSM.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: August 2, 2019
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 illicit use of psychostimulant and/or psychoactive drugs 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

Related Conditions & MeSH terms

• HIV
• Sexually Transmitted Diseases
• Sexually Transmitted Infections

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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University School of Social Work	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in number of unprotected acts of anal intercourse between 2 groups	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.	12 months
Secondary	Difference in incidence of sexually transmitted infections (STIs) between 2 groups	To test whether participants assigned to CNU have lower cumulative incidence of STIs confirmed via biological assay compared to participants assigned to WP.	12 months
Secondary	Difference in number of illicit drug use between 2 groups	To test whether participants assigned to CNU engage in less drug use compared to participants assigned to WP.	12 months