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

Primary Purpose

HIV, Sexually Transmitted Infections

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CNU Intervention

WP Intervention

About this trial

This is an interventional prevention trial for HIV focused on measuring HIV, sexually transmitted infection, STI, men who have sex with men, MSM, couples, African American, Black

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Columbia University School of Social Work

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CNU intervention

WP intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01394900

First Posted

July 13, 2011

Last Updated

April 4, 2022

Sponsor

Columbia University

Collaborators

National Institute on Drug Abuse (NIDA)

1. Study Identification

Unique Protocol Identification Number

NCT01394900

Brief Title

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

Acronym

CNU

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

July 2012 (undefined)

Primary Completion Date

December 31, 2016 (Actual)

Study Completion Date

April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Columbia University

Collaborators

National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV, Sexually Transmitted Infections

Keywords

HIV, sexually transmitted infection, STI, men who have sex with men, MSM, couples, African American, Black

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

424 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CNU intervention

Arm Type

Experimental

Arm Description

Arm Title

WP intervention

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

CNU Intervention

Other Intervention Name(s)

Connect 'n Unite (CNU) Intervention

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

WP Intervention

Other Intervention Name(s)

Wellness Promotion (WP) Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Difference in number of unprotected acts of anal intercourse between 2 groups

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Difference in incidence of sexually transmitted infections (STIs) between 2 groups

Description

To test whether participants assigned to CNU have lower cumulative incidence of STIs confirmed via biological assay compared to participants assigned to WP.

Time Frame

12 months

Title

Difference in number of illicit drug use between 2 groups

Description

To test whether participants assigned to CNU engage in less drug use compared to participants assigned to WP.

Time Frame

12 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elwin Wu, PhD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University School of Social Work

City

New York

State/Province

New York

ZIP/Postal Code

10027

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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