Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk (CHP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03386110|
Recruitment Status : Active, not recruiting
First Posted : December 29, 2017
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Risk Behavior Drug Use Sex, Anal||Behavioral: Couples Health Project (CHP) Behavioral: Education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk|
|Actual Study Start Date :||March 6, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||May 2022|
Experimental: Couples Health Project (CHP)
The CHP intervention is a three session intervention that occurs once a week for three weeks. The CHP intervention will be delivered by MI-trained mental health counselors. The CHP intervention is comprised of 3 sessions. 25 couples will be allocated to this arm.
Behavioral: Couples Health Project (CHP)
The CHP intervention focuses on addresses drug use and HIV transmission risk by enhancing dyadic communication skills and motivation to work towards shared health goals. The last session of the CHP intervention consists of a Couples HIV Testing and Counseling (CHTC) session.
Active Comparator: Education
The Education intervention is a attention-matched control three-session intervention that occurs once a week for three weeks. The education intervention will be delivered by trained health educators. The education intervention is comprised of 3 sessions. 25 couples will be allocated to this arm.
The Education intervention consists of a 3-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format with a male couple. Additionally, the last session of the education intervention consists of a Couples HIV Testing and Counseling (CHTC) session.
- Number of drug use instances [ Time Frame: 6 months ]Self-report
- Positive drug assays [ Time Frame: 6 months ]Drug test via fingernail assay
- Number of HIV transmission risk events [ Time Frame: 6 months ]Self-report of condomless anal sex (CAS)
- Positive sexually transmitted infection (STI) test [ Time Frame: 6 months ]STI test via urinalysis and rectal swab
- Communication skills [ Time Frame: 6 months ]Self-report
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03386110
|United States, New York|
|Center for HIV Educational Studies and Training|
|New York, New York, United States, 10018|
|Principal Investigator:||Tyrel J Starks, PhD||Hunter College of City University of New York|