Prevention and Risk: Treatment With a New Emphasis on Relationships (PARTNER)

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ClinicalTrials.gov Identifier: NCT03396367

Recruitment Status : Recruiting

First Posted : January 11, 2018

Last Update Posted : November 17, 2020

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Sponsor:

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 research examines the efficacy of an individually-delivered intervention tailored for YMSM in relationships. The intervention - termed PARTNER - utilizes a brief (4 session) motivational interviewing format to target Pre-Exposure Prophylaxis (PrEP) uptake/adherence, HIV transmission risk behavior, and associated drug use.

Condition or disease	Intervention/treatment	Phase
Adherence, Medication Risk Reduction Drug Use Sex, Anal HIV/AIDS	Behavioral: PARTNER Behavioral: Education Intervention	Not Applicable

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Detailed Description:

This study aims to evaluate a individual-focused 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 240 partnered 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 an email. The email contains a link for them to access the baseline online survey. 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.

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

Written consent is obtained prior to the start of any in-person baseline activity. Participants additionally complete a computer-assisted self interview (CASI). 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.

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). HIV testing will consist of a finder prick test using the Alere Determine HIV-1/2 Ag/Ab Combo test. Participants indicating current PrEP use will receive an HIV test via blood draw for a laboratory immunoassay. Participants indicating current PrEP give an additional blood sample and fingernail sample to examine PrEP adherence using a dried blood spot for western blot analysis and fingernail assay.

After the baseline assessment, participants will be randomized to receive their first PARTNER or Education session, of which will occur immediately following their baseline assessment.

The study will employ a stratified randomization procedure using an algorithm via Qualtrics. Participants will be randomized using three couple-level criteria as reported by the participant. Participants 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), racial difference (both white versus all others combinations), PrEP use (Participant reports current PrEP use versus does not report current use).

Each of the intervention arms consists of 4 sessions that occur once a week for four consecutive weeks.

All participants complete a 3-month, 6-month, 9-month, and 12-month follow ups. At the 3 month follow up (post baseline assessment), participants complete a survey with a TLFB, fingernail specimen collection for drug use. For participants indicating current PrEP use, participants and give blood for a dried blood spot analysis and an additional fingernail sample to test for PrEP uptake/adherence.

At the 6 month follow up month follow up (post baseline assessment), participants complete a survey with a TLFB, fingernail specimen collection for drug use, biological testing for STI (gonorrhea & chlamydia via urinalysis and rectal swabs) and HIV testing using the Alere Determine HIV-1/2 Ag/Ab Combo test. Participants indicating current PrEP use will receive an HIV test via blood draw for a laboratory immunoassay Also, for participants indicating current PrEP use, participants and give blood for a dried blood spot analysis and an additional fingernail sample to test for PrEP uptake/adherence.

At the 9 month follow up (post baseline assessment), participants complete a survey with a TLFB, fingernail specimen collection for drug use. For participants indicating current PrEP use, participants and give blood for a dried blood spot analysis and an additional fingernail sample to test for PrEP uptake/adherence.

At final assessment (12 month follow up post baseline assessment), participants complete a survey with a TLFB, fingernail specimen collection for drug use, biological testing for STI (gonorrhea & chlamydia via urinalysis and rectal swabs) and HIV testing using the Alere Determine HIV-1/2 Ag/Ab Combo test. Participants indicating current PrEP use will receive an HIV test via blood draw for a laboratory immunoassay Also, for participants indicating current PrEP use, participants and give blood for a dried blood spot analysis and an additional fingernail sample to test for PrEP uptake/adherence.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	240 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Intervention to Reduce Drug Use and HIV Incidence Among High PrEP Priority Partnered YMSM
Actual Study Start Date :	February 14, 2018
Estimated Primary Completion Date :	January 2023
Estimated Study Completion Date :	January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Medicines

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: PARTNER Intervention This intervention is a four-session intervention designed to increase PrEP uptake, increase PrEP adherence, and reduce drug use and HIV transmission risk behaviors of individuals in relationships.	Behavioral: PARTNER The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.
Active Comparator: Education Intervention This intervention is a four-session intervention that discussed drug use and its effect on physiological social functioning.	Behavioral: Education Intervention The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.

Outcome Measures

Primary Outcome Measures :

Number of drug use instances [ Time Frame: 12 Months ]
Self Report
Positive drug assays [ Time Frame: 12 Months ]
Drug test via fingernail assay
Pre-Exposure Prophylaxis (PrEP) uptake [ Time Frame: 12 Month ]
Self Report
Pre-Exposure Prophylaxis (PrEP) adherence [ Time Frame: 12 Months ]
Dried blood spot (DBS) via Western Blot analysis
Number of HIV transmission risk events [ Time Frame: 12 Months ]
Self-report of condomless anal sex (CAS)
Positive sexually transmitted infection (STI) test [ Time Frame: 12 Months ]
STI test via urinalysis and rectal swab

Secondary Outcome Measures :

Pre-Exposure Prophylaxis (PrEP) adherence [ Time Frame: 12 Months ]
Via fingernail assay
Effectiveness of intervention implementation [ Time Frame: 12 Months ]
Qualitative analysis of intervention feedback interviews

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 29 Years (Adult)
Sexes Eligible for Study:	Male
Gender Based Eligibility:	Yes
Gender Eligibility Description:	Both gender at birth and current self-identified gender must be male.
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18 to 29 years of age (inclusive);
Main partner must be aged 18 or older.
Must be in a main partner relationship with another male (duration ≥ 1 months);
HIV-negative serostatus (confirmed by rapid test);
Recent (past 30 day) use of at least one of the substances identified as most commonly used by YMSM (marijuana, cocaine, methamphetamine, heroin or other opiates, MDMA, psychedelics, GHB, and/or ketamine);
Sexual behavior meeting CDC criteria for PrEP candidacy (TRB with a casual partner in the past 30 days or TRB with a non-monogamous or serodiscordant main partner).
Participants must reside in the NYC metro area
Ability to communicate in English

Exclusion Criteria:

Unstable, serious psychiatric symptoms (assessed by the Psychotic Disorder subsection of the Structured Clinical Interview for DSM-IV);
Current suicidal/homicidal ideation;
Evidence of gross cognitive impairment (a score of <24 on the mini-mental state examination)
A history of severe physical or sexual Intimate Partner Violence (IPV) victimization in the current relationship in which participants report not currently feeling "safe" in their relationship and/or coerced to participate in the study.

Contacts and Locations

Information from the National Library of Medicine

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): NCT03396367

Contacts

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Contact: Tyrel J Starks, PhD	212-206-7919 ext 934	tstarks@hunter.cuny.edu
Contact: Rodrigo Valles, PhD	212-206-7919 ext 925	rvalles@chestnyc.org

Locations

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United States, New York
Center for HIV Educational Studies and Training; Hunter College	Recruiting
New York, New York, United States, 10018
Contact: Rodrigo Valles, PhD 212-206-7919 ext 925 rvalles@chestnyc.org
Principal Investigator: Tyrel J Starks, PhD
Sub-Investigator: Jeffrey T Parsons, PhD

Sponsors and Collaborators

Hunter College of City University of New York

National Institute on Drug Abuse (NIDA)

Investigators

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

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, Robles G, Pawson M, Jimenez RH, Gandhi M, Parsons JT, Millar BM. Motivational Interviewing to Reduce Drug Use and HIV Incidence Among Young Men Who Have Sex With Men in Relationships and Are High Priority for Pre-Exposure Prophylaxis (Project PARTNER): Randomized Controlled Trial Protocol. JMIR Res Protoc. 2019 Jul 4;8(7):e13015. doi: 10.2196/13015.

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Responsible Party:	Tyrel Starks, Associate Professor of Psychology, Hunter College of City University of New York
ClinicalTrials.gov Identifier:	NCT03396367
Other Study ID Numbers:	R01DA045613 ( U.S. NIH Grant/Contract ) R01DA045613 ( U.S. NIH Grant/Contract )
First Posted:	January 11, 2018 Key Record Dates
Last Update Posted:	November 17, 2020
Last Verified:	November 2020

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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:


Relationships YMSM HIV/AIDS PrEP Drug Use

Additional relevant MeSH terms:

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Acquired Immunodeficiency Syndrome HIV Infections Blood-Borne Infections Communicable Diseases Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases	Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Slow Virus Diseases Immunologic Deficiency Syndromes Immune System Diseases

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