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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HIV, Sexually Transmitted Infections

Intervention / Treatment
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* Behavioral: CNU Intervention
* Behavioral: WP Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CNU intervention<br>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 | Behavioral: CNU Intervention<br>* 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.<br>* Other names: Connect 'n Unite (CNU) Intervention;|
| Active Comparator: WP intervention<br>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 general wellness promotion (WP) intervention | Behavioral: WP Intervention<br>* 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.<br>* Other names: Wellness Promotion (WP) Intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, sexually transmitted infection, STI, men who have sex with men, MSM, couples, African American, Black