Adherence, MedicationPARTNERNCT03396367
Prevention and Risk: Treatment With a New Emphasis on Relationships
A study testing PARTNER and Education Intervention in people with Adherence, Medication and Risk Reduction, run by Hunter College of City University of New York at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 29 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adherence, Medication, Risk Reduction, Drug Use
- What is being tested?
- PARTNER and Education Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2018to 21 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter College- City University of New York
New York, New York, 10018
About this study
Official title: Intervention to Reduce Drug Use and HIV Incidence Among High PrEP Priority Partnered YMSM
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.
Read the 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.
- Conditions
- Adherence, Medication, Risk Reduction, Drug Use, Sex, Anal, HIV/AIDS
- Being tested
- PARTNER, Education Intervention
- Keywords
- Relationships, YMSM, HIV/AIDS, PrEP, Drug Use
- Medical subject headings
- Medication Adherence, Risk Reduction Behavior, Sexual Behavior, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PARTNERBehavioural
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 InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PARTNER Intervention | Experimental | 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. Receives: Behavioral: PARTNER |
| Education Intervention | Active comparator | This intervention is a four-session intervention that discussed drug use and its effect on physiological social functioning. Receives: Behavioral: Education Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illicit Drug Use Days
The self-reported number of illicit drug use days (not including marijuana) in the past 30 days
Measured: Baseline, 3-Month, 6-Month, 9-Month, 12-Month
Cannabis Use Days
The self-reported number of cannabis drug use days in the past 30 days
Measured: Baseline, 3-Month, 6-Month, 9-Month, 12-Month
Number (Proportion) of Participants Who Report Sexual HIV Transmission Risk With Casual Partners
The percentage of participants in each condition reporting sexual HIV transmission risk with a casual partner (any condomless sex with a casual partner in the absence of PrEP).
Measured: Baseline, 3-Month, 6-Month, 9-Month, 12-Month
The Number (Proportion) of Participants Reporting Pre-Exposure Prophylaxis (PrEP) Uptake
The percentage participants in each condition who report having a current PrEP prescription at the time of follow-up.
Measured: Baseline, 3-Month, 6-Month, 9-Month, 12-Month,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start14 Feb 2018
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adherence, MedicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Tyrel Starks, Hunter College of City University of New York
- Investigators
- Tyrel J Starks, PhD, Principal investigator, Hunter College of City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396367
- Sponsor's protocol ID
- R01DA045613
- Other IDs
- R01DA045613
- Acronym
- PARTNER
- Status last verified
- Oct 2025
- First submitted
- 4 Jan 2018
- Last updated
- 29 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 24364800Starks 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.
PubMed 31274114
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Reduce Drug Use and HIV Incidence Among High PrEP Priority Partnered YMSM
- ClinicalTrials.gov ID
- NCT03396367
- Acronym / sponsor ID
- PARTNER / R01DA045613
- Conditions
- Adherence, Medication, Risk Reduction, Drug Use, Sex, Anal, HIV/AIDS
- Keywords
- Relationships, YMSM, HIV/AIDS, PrEP, Drug Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 11 Jan 2018 (actual)
- Results
- Posted 29 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PARTNER Intervention | Experimental | Behavioral: PARTNERThis 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. |
| Education Intervention | Active comparator | Behavioral: Education InterventionThis intervention is a four-session intervention that discussed drug use and its effect on physiological social functioning. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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);
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PARTNERThe 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. | Behavioural | PARTNER Intervention |
| Education InterventionThe 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. | Behavioural | Education Intervention |
Primary outcome
Illicit Drug Use Days
Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month
The self-reported number of illicit drug use days (not including marijuana) in the past 30 days
Cannabis Use Days
Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month
The self-reported number of cannabis drug use days in the past 30 days
Number (Proportion) of Participants Who Report Sexual HIV Transmission Risk With Casual Partners
Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month
The percentage of participants in each condition reporting sexual HIV transmission risk with a casual partner (any condomless sex with a casual partner in the absence of PrEP).
The Number (Proportion) of Participants Reporting Pre-Exposure Prophylaxis (PrEP) Uptake
Time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month,
The percentage participants in each condition who report having a current PrEP prescription at the time of follow-up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24364800Parsons 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.
- Derived from this study: PubMed 31274114Starks 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyrel J Starks, PhD principal investigator
Hunter College of City University of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PARTNER and Education Intervention in people with Adherence, Medication and Risk Reduction, run by Hunter College of City University of New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Illicit Drug Use Days (time frame: Baseline, 3-Month, 6-Month, 9-Month, 12-Month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396367, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2025.