Prevention and Risk: Treatment With a New Emphasis on Relationships

HIV/AIDS Clinical Trial

— PARTNER  

Official title:

Intervention to Reduce Drug Use and HIV Incidence Among High PrEP Priority Partnered YMSM

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396367
• Other study ID #: R01DA045613
• Secondary ID: R01DA045613
• Status: Completed
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: February 28, 2024

Study information

• Verified date: April 2024
• Source: Hunter College of City University of New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 29 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Adherence, Medication
• Drug Use
• HIV Infections
• HIV/AIDS
• Risk Reduction
• Sex, Anal

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center for HIV Educational Studies and Training; Hunter College	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hunter College of City University of New York	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of drug use instances	Self Report	12 Months
Primary	Positive drug assays	Drug test via fingernail assay	12 Months
Primary	Pre-Exposure Prophylaxis (PrEP) uptake	Self Report	12 Month
Primary	Pre-Exposure Prophylaxis (PrEP) adherence	Dried blood spot (DBS) via Western Blot analysis	12 Months
Primary	Number of HIV transmission risk events	Self-report of condomless anal sex (CAS)	12 Months
Primary	Positive sexually transmitted infection (STI) test	STI test via urinalysis and rectal swab	12 Months
Secondary	Pre-Exposure Prophylaxis (PrEP) adherence	Via fingernail assay	12 Months
Secondary	Effectiveness of intervention implementation	Qualitative analysis of intervention feedback interviews	12 Months