Risk BehaviorCHPNCT03386110
Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk
A study testing Couples Health Project (CHP) and Education in people with Risk Behavior and Drug Use, run by Hunter College of City University of New York at 1 site in United States.
Trial 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). 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
- Risk Behavior, Drug Use, Sex, Anal
- What is being tested?
- Couples Health Project (CHP) and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 14 Sep 2020
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for HIV Educational Studies and Training
New York, New York, 10018
About this study
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.
Read the 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.
- Conditions
- Risk Behavior, Drug Use, Sex, Anal
- Being tested
- Couples Health Project (CHP), Education
- Keywords
- Couples, MSM, HIV, Drug Use
- Medical subject headings
- Risk-Taking, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples Health Project (CHP)Behavioural
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.
EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Illicit Drug Use
The self-reported number of illicit drug use instances (not including marijuana) in the past 30 days
Measured: 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
Measured: 6 months
Secondary outcomes (1)
Marijuana Use
The self-reported number of marijuana drug use instances in the past 30 days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start6 Mar 2018
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
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 (3)Papers the sponsor has linked to this study.
- Other trials for Risk BehaviorStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 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
- NCT03386110
- Sponsor's protocol ID
- R34DA043422
- Other IDs
- R34DA043422
- Acronym
- CHP
- Status last verified
- Jul 2021
- First submitted
- 21 Dec 2017
- Last updated
- 19 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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, 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.
PubMed 34297275Starks 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.
PubMed 31199341
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk
- ClinicalTrials.gov ID
- NCT03386110
- Acronym / sponsor ID
- CHP / R34DA043422
- Conditions
- Risk Behavior, Drug Use, Sex, Anal
- Keywords
- Couples, MSM, HIV, Drug Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Posted 19 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Couples Health Project (CHP) | Experimental | Behavioral: 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. |
| Education | Active comparator | Behavioral: EducationThe 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| 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. | Behavioural | Couples Health Project (CHP) |
| EducationThe 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. | Behavioural | Education |
Primary outcome
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
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
1 secondary outcome
Marijuana Use
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
- 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 34297275Starks 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.
- Derived from this study: PubMed 31199341Starks 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.
- Individual participant dataSharing planned: No. 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.
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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 Couples Health Project (CHP) and Education in people with Risk Behavior and Drug Use, 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 6 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 19 Aug 2021. 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 19 Aug 2021). 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 (time frame: Baseline, 3-month follow-up; 6-month follow-up). The study lists 2 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 NCT03386110, which also lists 3 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 19 Aug 2021.