Enhancing Partner Services Among Men Who Have Sex With Men Living With HIV
Condition: Contact Tracing
Study type: Interventional

Summary: 
      Individuals will participate in a pilot randomized controlled trial (RCT) that implements and
      evaluates the feasibility, acceptability, and effectiveness of crowdsourced partner services
      (PS) or conventional PS among Chinese men who have sex with men (MSM) living with HIV.

      The pilot RCT will include 120 newly identified MSM HIV cases who were born biologically
      male, aged 18 years old or older, newly identified as HIV positive, had oral or anal sex with
      a man, had at least one sexual partner in the previous 6 months and live in Guangzhou.
      Participants will undergo a series of computer-based interviews (baseline and 2 months after
      enrollment) and will be randomly assigned into two groups in 2:1 ratio (intervention:
      control) and receive crowdsourced PS and conventional PS, respectively.
    

Detailed description: 
      This is a pilot RCT, and the primary outcomes of this study are: 1) to test the feasibility
      and acceptability of the crowdsourced intervention, and 2) to pilot the preliminary impact of
      crowdsourced PS intervention in promoting HIV testing among partners of the newly identified
      HIV cases. In addition, this pilot RCT aimed to collect preliminary data for the designing of
      a full RCT, which aimed to measure the efficacy of the crowdsourced PS intervention in
      promoting PS. Thus, the sample size of this study is not designed and will be not powered
      enough to test the difference between the two arms. However, with a sample size of 120 (80
      for intervention arm and 40 for the control arm, respectively), this pilot study would be
      able to observe the differences between the two arms and collect preliminary data for
      adequate sample size calculation of a full RCT. With a sample size of 120 (ratio of 2:1),
      alpha=0.05, power=0.80, and the partner return rate in the conventional PS arm is 30% (around
      31% in 2016 in Guangzhou), the minimal detectable effect size would be 26.7% for this pilot
      study.

      Data analyses: For the primary outcomes of feasibility and acceptability of the intervention:
      this will be analyzed through descriptive analysis to assess the feedback on the feasibility
      and acceptability of the crowdsourced PS intervention at baseline and the follow-up survey.
      For the primary outcome of the proportion of partners returning for HIV testing within 2
      months of the index participant's enrolment in the study, log-binomial regression
      (generalized linear model with binomial distribution and log link) will be used to calculate
      95% confidence intervals for the proportion of notifiable partners visiting by arm. Risk
      differences and risk ratios will also be calculated in these models. As this study is a pilot
      RCT, adjustment for covariates is not necessary and will not be conducted in the primary
      analysis. In secondary analyses, pre-specified potential confounding variables will be
      adjusted that might bias the estimate if not accounted for (e.g. index age, index marital
      status). If a partner reports more than one index referred him, he will be counted as a
      returning partner for each identified index.

      Subgroup analyses will be performed by partner sex, partner type (e.g. main male partner vs.
      casual male partner) and sexual orientation. Time to presentation will also be assessed among
      all notifiable partners using Cox proportional hazards with a robust variance estimator. In
      the time-to-event analyses, censoring will occur at the end of 2-months. Note that for the
      primary outcome, the assumption is that any partner without an identifiable record at the
      community center or in the centralized electronic medical record (EMR) did not present for
      HIV testing. Therefore, this study assumes no missing outcome data. Sensitivity analyses will
      be conducted using alternative definitions of presentation for testing, including using the
      self-reported data from index cases and partners. For count variables expressed as the mean
      number of partners, the investigators will use either Poisson regression or negative binomial
      regression if overdispersion is identified.
    

Intervention name(s): Crowdsourced partner services intervention
Intervention type(s): Combination Product
Intervention description(s): The intervention includes the provision of provider referral and dual referral services, crowdsourced materials such as postcards and an HTML aiming to promote PS, as well as free take-home HIV self-testing kits.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 120 newly identified MSM HIV cases will be randomly assigned into two groups in 2:1 ratio (intervention: control) and receive crowdsourced PS and conventional PS, respectively.
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Partner notification services; Crowdsourcing; MSM; HIV