Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk
Condition: Risk Behavior; Drug Use; Sex, Anal
Study type: Interventional

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.
    

Intervention name(s): Couples Health Project (CHP); Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Couples; MSM; HIV; Drug Use