An interventional study of Couples Health Project (CHP) and Education in Risk Behavior, Drug Use and Sex, Anal, sponsored by Hunter College of City University of New York. Completed at 1 site in United States. Open to male participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-19.
Sponsored by Hunter College of City University of New York · Not applicable, Interventional, and Prevention
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.
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.
136 studies on the registry are indexed under Risk-Taking; 18 are open to participants now.
This study's enrollment of 100 is below the median of 255 across 117 interventional studies indexed under Risk-Taking.
Browse Risk-Taking studies →Hunter College of City University of New York is the lead sponsor of 36 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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.
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.
Illicit Drug Use
The self-reported number of illicit drug use instances (not including marijuana) in the past 30 days
Time frame: 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
Time frame: 6 months
Marijuana Use
The self-reported number of marijuana drug use instances in the past 30 days
Time frame: 6 months
We used an index participant approach to recruit couples. Online recruitment included advertisements on websites and geosocial networking apps for gay, bisexual, trans, and queer people seeking out sexual partners. Also, staff attended bars, nightclubs, and other social events for these populations in the NYC metro area to screen. Through June 2019, eligible index participants were contacted by phone to complete a study specific screener. This was converted to an online survey in July 2019.
| Milestone | Couples Health Project (CHP) | Education |
|---|---|---|
| Started | 56 | 44 |
| Completed | 41 | 38 |
| Not completed | 15 | 6 |
The self-reported number of illicit drug use instances (not including marijuana) in the past 30 days
| Days (in the past 30 days) | Couples Health Project (CHP) | Education |
|---|---|---|
| Use at Baseline | 3.36 ± 8.46 | 0.84 ± 2.34 |
| Use at 3-month follow-up | 3.13 ± 8.41 | 0.73 ± 1.37 |
| Use at 6-month follow-up | 1.17 ± 3.79 | 0.58 ± 1.24 |
The self-reported number of events of condomless anal sex (CAS) with casual partners in the past 30 days
| Events in the past 30 days | Couples Health Project (CHP) | Education |
|---|---|---|
| Events at Baseline | 1.68 ± 2.78 | 1.68 ± 2.34 |
| Events at 3-month follow-up | 2.13 ± 3.61 | 1.49 ± 3.70 |
| Events at 6-month follow-up | 0.88 ± 1.66 | 1.05 ± 1.82 |
The self-reported number of marijuana drug use instances in the past 30 days
| days out of 30 | Couples Health Project (CHP) | Education |
|---|---|---|
| Use at Baseline | 9.61 ± 11.93 | 7.02 ± 10.24 |
| Use at 3-month follow-up | 9.62 ± 11.83 | 5.95 ± 10.24 |
| Use at 6-month follow-up | 10.00 ± 12.43 | 7.89 ± 11.75 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Couples Health Project (CHP) | 0/56 (0%) | 0/56 (0%) | 0/56 (0%) |
| Education | 0/44 (0%) | 0/44 (0%) | 0/44 (0%) |
| Age, Categorical(Participants) | Couples Health Project (CHP) | Education | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 56 | 44 | 100 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Couples Health Project (CHP) | Education | Total |
|---|---|---|---|
| Mean | 28.7 ± 6.17 | 28.05 ± 6.10 | 28.41 ± 6.12 |
| Sex: Female, Male(Participants) | Couples Health Project (CHP) | Education | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 56 | 44 | 100 |
| Race/Ethnicity, Customized(Participants) | Couples Health Project (CHP) | Education | Total |
|---|---|---|---|
| Race & Ethnicity — White/European | 33 | 25 | 58 |
| Race & Ethnicity — Black/African American | 5 | 6 | 11 |
| Race & Ethnicity — Latino | 11 | 11 | 22 |
| Race & Ethnicity — Other | 7 | 2 | 9 |
| Region of Enrollment(participants) | Couples Health Project (CHP) | Education | Total |
|---|---|---|---|
| United States | 56 | 44 | 100 |
| HIV Status(Participants) | Couples Health Project (CHP) | Education | Total |
|---|---|---|---|
| HIV-negative | 51 | 39 | 90 |
| HIV-positive | 5 | 5 | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Ran from Mar 2018 to primary completion in Sep 2020, 30 months.
Results were first posted in Aug 2021, 11 months after primary completion.
Of 65 non-industry interventional studies with no phase under Risk-Taking, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 48. This study's 30 months is close to that.
Counting every sponsor, half of 68 studies reached it within 28 months; a quarter within 7 and three quarters within 49.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Hunter College of City University of New York