Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk

NCT03386110 | Completed Results DMC

• 1 other identifier: R34DA043422
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This project tests the feasibility, acceptability, and preliminary efficacy of the Couples Health Project (CHP). CHP is a brief (3-session) couples-based Motivational Interviewing intervention which addresses drug use and sexual HIV transmission risk among partnered HIV negative YMSM (ages 18-29). The proposed project includes a randomized controlled trial (RCT) involving 50 couples who are randomized to complete either the CHP intervention or an attention-matched education control condition.

Conditions

Risk Behavior; Drug Use; Sex, Anal

Keywords

Couples; MSM; HIV; Drug Use

Outcome Measures

Primary Outcomes (2)

• Illicit Drug Use

  The self-reported number of illicit drug use instances (not including marijuana) in the past 30 days

  Baseline, 3-month follow-up; 6-month follow-up

• Number of HIV Transmission Risk Events

  The self-reported number of events of condomless anal sex (CAS) with casual partners in the past 30 days

  6 months

Secondary Outcomes (1)

• Marijuana Use

  6 months

Study Arms (2)

Couples Health Project (CHP)

EXPERIMENTAL

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)

Education

ACTIVE COMPARATOR

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.

Behavioral: Education

Interventions

Couples Health Project (CHP) BEHAVIORAL

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.

Couples Health Project (CHP)

Education BEHAVIORAL

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.

Education

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: Eligibility is based on self-identification of a male birth gender and current self-identification of a male gender identity of both parts of the couple.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• At least one member of the couple must be 18 to 29 years of age
• Both members assigned male gender at birth and currently identify as male
• At least one member of the couple reports an HIV-negative serostatus
• Couple has been together for at least 3 months
• The use of at least one of the following substances in the past 30 days (only one partner): marijuana, cocaine/crack, amphetamines, ecstasy, GHB, ketamine, nitrates, prescriptionn drug misuse
• At least one member of the couple, in the past 30 days, had condomless anal sex (CAS) with a casual partner and/or CAS with a non-monogamous or serodiscordant main partner.
• Both members must be able to communicate in English
• Both members must reside in the NYC metro area

You may not qualify if:

• Either member of the couple reports IPV, which is defined as serious physical or sexual violence that occurs outside the context of consensual bondage or sado-masochistic sexual play, which results in concerns of safety.
• Inconsistencies between information provided in the eligibility screener and the in-person meeting or any issues that might hinder participation. The couple may also be deemed ineligible if participant responses are sufficiently inconsistent to call into question the validity of their individual responses
• The couple reports a sero-concordant HIV-positive serostatus
• Unstable, serious psychiatric symptoms (assessed at Baseline)
• Currently suicidal/homicidal
• Evidence of gross cognitive impairment

Sponsors & Collaborators

• Hunter College of City University of New York: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Center for HIV Educational Studies and Training

New York, New York, 10018, United States

Location

Related Publications (3)

• Parsons JT, Lelutiu-Weinberger C, Botsko M, Golub SA. A randomized controlled trial utilizing motivational interviewing to reduce HIV risk and drug use in young gay and bisexual men. J Consult Clin Psychol. 2014 Feb;82(1):9-18. doi: 10.1037/a0035311. Epub 2013 Dec 23.

  PMID: 24364800 BACKGROUND

• Starks TJ, Adebayo T, Kyre KD, Millar BM, Stratton MJ Jr, Gandhi M, Ingersoll KS. Pilot Randomized Controlled Trial of Motivational Interviewing with Sexual Minority Male Couples to Reduce Drug Use and Sexual Risk: The Couples Health Project. AIDS Behav. 2022 Feb;26(2):310-327. doi: 10.1007/s10461-021-03384-9. Epub 2021 Jul 23.

  PMID: 34297275 DERIVED

• Starks TJ, Feldstein Ewing SW, Lovejoy T, Gurung S, Cain D, Fan CA, Naar S, Parsons JT. Adolescent Male Couples-Based HIV Testing Intervention (We Test): Protocol for a Type 1, Hybrid Implementation-Effectiveness Trial. JMIR Res Protoc. 2019 Jun 7;8(6):e11186. doi: 10.2196/11186.

  PMID: 31199341 DERIVED

MeSH Terms

Conditions

Risk-Taking; Sexual Behavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Limitations and Caveats

This was a pilot study with modest sample size intended to test preliminary efficacy and provide effect size estimates necessary to plan a larger trial. Results warrant replication in research with larger sample size. The sample was recruited from a large urban center and may not be representative of the wider U.S. population of partnered sexual minority men. Due to COVID, the collection of follow-up STI specimen data was curtailed, diminishing our ability to test associations with this outcome.

Results Point of Contact

• Title: Tyrel J. Starks
• Organization: Hunter College

tstarks@hunter.cuny.edu

212-206-7919

Study Officials

• Tyrel J Starks, PhD

  Hunter College of City University of New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychology

Study Record Dates

• First Submitted: December 21, 2017
• First Posted: December 29, 2017
• Study Start: March 6, 2018
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: August 19, 2021
• Results First Posted: August 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)