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

• ClinicalTrials.gov Identifier: NCT03386110
• Recruitment Status: Completed
• First Posted: December 29, 2017
• Results First Posted: August 19, 2021
• Last Update Posted: August 19, 2021
• Sponsor: Hunter College of City University of New York
• Collaborator: National Institute on Drug Abuse (NIDA)
• Information provided by (Responsible Party): Tyrel Starks, Hunter College of City University of New York

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Risk Behavior; Drug Use; Sex, Anal	Behavioral: Couples Health Project (CHP); Behavioral: Education	Not Applicable

Detailed Description:

This study aims to evaluate a couples-based intervention with an integrated focus on drug use and HIV prevention, including uptake of and adherence to PrEP. The investigators will recruit a sample of 50 couples (n = 100 individuals)

Recruitment occurs using a mix of in-person and Internet recruitment. Outreach workers will visit bars and events in the New York City area to recruit participants. Also, information on our project will be posted on social media sites (e.g.,Facebook, Grindr, Scruff). Interested individuals will complete a brief online screener to assess eligibility.

A telephone screener will be conducted with participants who are preliminarily eligible based upon online screener responses. Participants who are eligible based upon telephone screening responses will be sent two emails. The first contains a link for them to access the baseline online survey. The second email is for them to forward to their partner. It provides information which introduces the study to the recruited partner and a link to the baseline survey online. If participants indicate intimate partner violence (IPV) on the online baseline survey, participants will be rendered ineligible. Only the participant that indicated experiencing IPV will be given a list of local referrals to access IPV-related services.

An in-person baseline assessment appointment will be scheduled after both participants have completed the online survey. If participants come to the research site alone, they will need to reschedule the appointment when both partners can attend.

The in-person baseline assessment appointment consists of four components; written consenting, a computer-assisted self interview (CASI), a timeline follow back interview, and biological testing.

Written consent is obtained with each participant individually in separate rooms. Participants additionally complete a computer-assisted self interview (CASI) independently. After this, participants will independently complete a TFLB.

TLFB is a semi-structured interview to collect retrospective event-level data on drug use, sexual behavior and PrEP adherence (for those on PrEP) in the past 30 days. Participants complete the survey and TLFB independently in a different room, without their partner.

The final part of the in-person baseline assessment consists of biological testing for STI (gonorrhea & chlamydia via urinalysis and rectal swabs), drug testing via 5-panel fingernail drug assay via finger or toe nail clippings. Drugs tested are 5 major drugs: Amphetamines, Cannabinoids, Cocaine, Opiates, and Phencyclidine (PCP).

After the baseline assessment, participants will be randomized to receive their first CHP or Education session, of which the first session will occur immediately following their baseline assessment. The study will employ a stratified randomization procedure using an algorithm via Qualtrics. Couples will be randomized using three couple-level criteria. Couples will be randomized based on relationship length difference (less than 2 years versus 2 or more), age difference (less than 3 years versus 3 or more), and racial difference (both white versus all others combinations). Each of the intervention arms consists of 3 sessions that occur once a week for three consecutive weeks.

For Session 3 of the experimental and control conditions, participants complete a Couples HIV Testing and Counseling (CHTC) session that involves a rapid HIV testing for couples. HIV testing is done via the Alere Determine HIV-1/2 Ag/Ab Combo blood test. The couple undergo HIV testing together and receive the results together.

All participants complete a 1-month, 3-month, and 6-month follow ups. Follow-up appointments are scheduled with each participant independently (not as a couple). For the 1 month follow up (post baseline assessment), participants will complete an online survey at home for which participants are instructed to take this survey independent from their partner. At the 3 month follow up (post baseline assessment), participants complete a survey with a TLFB and Fingernail specimen collection for drug use at the research office. At the 6 month follow up (post baseline assessment), participants complete a survey with a TLFB and biological specimen collection to test drug use via fingernail sample and Gonorrhea & Chlamydia for STI testing (Urinalysis and Rectal swabs) at the research offices.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk
• Actual Study Start Date: March 6, 2018
• Actual Primary Completion Date: September 14, 2020
• Actual Study Completion Date: September 14, 2020

Arms and Interventions

Arm	Intervention/treatment
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.	Behavioral: Education; 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.

Outcome Measures

Primary Outcome Measures :

1. Illicit Drug Use [ Time Frame: Baseline, 3-month follow-up; 6-month follow-up ]
   The self-reported number of illicit drug use instances (not including marijuana) in the past 30 days
2. Number of HIV Transmission Risk Events [ Time Frame: 6 months ]
   The self-reported number of events of condomless anal sex (CAS) with casual partners in the past 30 days

Secondary Outcome Measures :

1. Marijuana Use [ Time Frame: 6 months ]
   The self-reported number of marijuana drug use instances in the past 30 days

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 29 Years (Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: 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.
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

United States, New York

Center for HIV Educational Studies and Training

New York, New York, United States, 10018

Sponsors and Collaborators

Hunter College of City University of New York

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Tyrel J Starks, PhD; Hunter College of City University of New York

  Study Documents (Full-Text)

Documents provided by Tyrel Starks, Hunter College of City University of New York:

Study Protocol  [PDF] May 15, 2019

Statistical Analysis Plan  [PDF] June 1, 2021

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Tyrel Starks, Associate Professor of Psychology, Hunter College of City University of New York
• ClinicalTrials.gov Identifier: NCT03386110
• Other Study ID Numbers: R34DA043422 ( U.S. NIH Grant/Contract ); R34DA043422 ( U.S. NIH Grant/Contract )
• First Posted: December 29, 2017
• Results First Posted: August 19, 2021
• Last Update Posted: August 19, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: A databank may be used to share data consistent with the NIH resource sharing agreement. The requester will contact the PI of the study and the PI will contact the CUNY Office for Research Compliance per university guidelines for data sharing.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tyrel Starks, Hunter College of City University of New York:

Couples; MSM; HIV; Drug Use