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Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk

Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03386110
Acronym
CHP
Enrollment
100
Registered
2017-12-29
Start date
2018-03-06
Completion date
2020-09-14
Last updated
2021-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Use, Risk Behavior, Sex, Anal

Keywords

Couples, MSM, HIV, Drug Use

Brief 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). 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.

Interventions

BEHAVIORALCouples 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.

BEHAVIORALEducation

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 29 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Illicit Drug UseBaseline, 3-month follow-up; 6-month follow-upThe self-reported number of illicit drug use instances (not including marijuana) in the past 30 days
Number of HIV Transmission Risk Events6 monthsThe self-reported number of events of condomless anal sex (CAS) with casual partners in the past 30 days

Secondary

MeasureTime frameDescription
Marijuana Use6 monthsThe self-reported number of marijuana drug use instances in the past 30 days

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Couples Health Project (CHP)
Participants who received the intervention condition, CHP
56
Education
Participants who received the attention-matched Education control
44
Total100

Baseline characteristics

CharacteristicCouples Health Project (CHP)EducationTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
56 Participants44 Participants100 Participants
Age, Continuous28.7 years
STANDARD_DEVIATION 6.17
28.05 years
STANDARD_DEVIATION 6.1
28.41 years
STANDARD_DEVIATION 6.12
HIV Status
HIV-negative
51 Participants39 Participants90 Participants
HIV Status
HIV-positive
5 Participants5 Participants10 Participants
Race/Ethnicity, Customized
Race & Ethnicity
Black/African American
5 Participants6 Participants11 Participants
Race/Ethnicity, Customized
Race & Ethnicity
Latino
11 Participants11 Participants22 Participants
Race/Ethnicity, Customized
Race & Ethnicity
Other
7 Participants2 Participants9 Participants
Race/Ethnicity, Customized
Race & Ethnicity
White/European
33 Participants25 Participants58 Participants
Region of Enrollment
United States
56 participants44 participants100 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
56 Participants44 Participants100 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 560 / 44
other
Total, other adverse events
0 / 560 / 44
serious
Total, serious adverse events
0 / 560 / 44

Outcome results

Primary

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

Population: Intent-to-treat population (assigned to either the CHP intervention or Education Control)

ArmMeasureGroupValue (MEAN)Dispersion
Couples Health Project (CHP)Illicit Drug UseUse at 3-month follow-up3.13 Days (in the past 30 days)Standard Deviation 8.41
Couples Health Project (CHP)Illicit Drug UseUse at 6-month follow-up1.17 Days (in the past 30 days)Standard Deviation 3.79
Couples Health Project (CHP)Illicit Drug UseUse at Baseline3.36 Days (in the past 30 days)Standard Deviation 8.46
EducationIllicit Drug UseUse at Baseline0.84 Days (in the past 30 days)Standard Deviation 2.34
EducationIllicit Drug UseUse at 3-month follow-up0.73 Days (in the past 30 days)Standard Deviation 1.37
EducationIllicit Drug UseUse at 6-month follow-up0.58 Days (in the past 30 days)Standard Deviation 1.24
Comparison: Multi-level models tested whether treatment condition predicted outcome at 3-month follow-up, and controlled for the nesting of participants within couples.p-value: 0.0895% CI: [-0.15, 2.54]Mixed Models Analysis
Comparison: Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.p-value: 0.2595% CI: [-0.49, 1.89]Mixed Models Analysis
Comparison: Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 3-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples.p-value: 0.00795% CI: [0.49, 3.09]Mixed Models Analysis
Comparison: Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 6-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples.p-value: 0.7195% CI: [-2.26, 1.53]Mixed Models Analysis
Primary

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

Population: Intent-to-treat population (assigned to either the CHP intervention or Education Control)

ArmMeasureGroupValue (MEAN)Dispersion
Couples Health Project (CHP)Number of HIV Transmission Risk EventsEvents at Baseline1.68 Events in the past 30 daysStandard Deviation 2.78
Couples Health Project (CHP)Number of HIV Transmission Risk EventsEvents at 3-month follow-up2.13 Events in the past 30 daysStandard Deviation 3.61
Couples Health Project (CHP)Number of HIV Transmission Risk EventsEvents at 6-month follow-up0.88 Events in the past 30 daysStandard Deviation 1.66
EducationNumber of HIV Transmission Risk EventsEvents at Baseline1.68 Events in the past 30 daysStandard Deviation 2.34
EducationNumber of HIV Transmission Risk EventsEvents at 3-month follow-up1.49 Events in the past 30 daysStandard Deviation 3.7
EducationNumber of HIV Transmission Risk EventsEvents at 6-month follow-up1.05 Events in the past 30 daysStandard Deviation 1.82
Comparison: Multi-level models tested whether treatment condition predicted outcome at 3-months, and controlled for the nesting of participants within couples.p-value: 0.3695% CI: [-0.65, 1.37]Mixed Models Analysis
Comparison: Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.p-value: 0.6395% CI: [-1.15, 0.78]Mixed Models Analysis
Comparison: Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 3-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples.p-value: 0.4295% CI: [-1.85, 0.77]Mixed Models Analysis
Comparison: Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment at 6-months was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples.p-value: 0.0295% CI: [-3.14, -0.27]Mixed Models Analysis
Secondary

Marijuana Use

The self-reported number of marijuana drug use instances in the past 30 days

Time frame: 6 months

Population: Intent-to-treat population (assigned to either the CHP intervention or Education Control)

ArmMeasureGroupValue (MEAN)Dispersion
Couples Health Project (CHP)Marijuana UseUse at Baseline9.61 days out of 30Standard Deviation 11.93
Couples Health Project (CHP)Marijuana UseUse at 3-month follow-up9.62 days out of 30Standard Deviation 11.83
Couples Health Project (CHP)Marijuana UseUse at 6-month follow-up10.00 days out of 30Standard Deviation 12.43
EducationMarijuana UseUse at Baseline7.02 days out of 30Standard Deviation 10.24
EducationMarijuana UseUse at 3-month follow-up5.95 days out of 30Standard Deviation 10.24
EducationMarijuana UseUse at 6-month follow-up7.89 days out of 30Standard Deviation 11.75
Comparison: Multi-level models tested whether treatment condition predicted outcome at 3-months, and controlled for the nesting of participants within couples.p-value: 0.1595% CI: [-0.18, 1.44]Mixed Models Analysis
Comparison: Multi-level models tested whether treatment condition predicted outcome at 6-months, and controlled for the nesting of participants within couples.p-value: 0.595% CI: [-0.44, 0.92]Mixed Models Analysis
Comparison: Moderation analysis in 3-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples.p-value: 0.9195% CI: [-0.34, 0.31]Mixed Models Analysis
Comparison: Moderation analysis in 6-month follow-up data.~The hypothesis that baseline frequency may moderate the effects of treatment was evaluated using models incorporating participants' baseline report of the outcome (actor) as well as their partners' report (partner) at Level 1. Interactions among actor and partner baseline scores and treatment condition were also included at Level 1. Additionally, the model controlled for the nesting of participants within couples.p-value: 0.1195% CI: [-0.07, 0.75]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026