October 2, 2013
Promoting Action Towards Health, or PATH, is a five-year study conducted by researchers at Columbia University and Yale University. PATH's goal is to develop effective counseling for men who have sex with men (MSM) and have been recently diagnosed with HIV. PATH is designed to promote positive health behaviors, reduce HIV risk and increase self-awareness. Here, the co-principal investigators of the study explain the study's significance, how it works, and how providers can get their eligible clients involved.
Can you describe the PATH study?
Promoting Action Towards Health (PATH) is a brief health-enhancement intervention for newly HIV-diagnosed men who have sex with men (MSM). The PATH study is a randomized controlled research trial to test the clinical efficacy of the PATH intervention. Our goal is to recruit and enroll 440 newly (within the previous three months) HIV-diagnosed MSM and randomly assign participants to receive one of two interventions, either PATH or Personalized Cognitive Counseling (PCC). Currently, the study is in its second year and we have enrolled nearly 15% of our enrollment goal.
In order to participate in the study, men must have been diagnosed within the last three months, be between the ages of 18 and 64, be a man who has sex with men, and be proficient in English. Participants see HIV counselors at one of two community health clinics between one and five times, depending on the intervention to which they are assigned. They also meet with PATH study staff for five visits to take a computerized survey. These surveys occur when participants enroll in the study and then at 3, 6, 9, and 12 months thereafter. Regardless of their intervention assignment, participants are enrolled in the study for approximately one year.
In order to be enrolled in the study, men must be receiving HIV care at the clinic/provider of their choosing. The interventions are delivered by HIV counselors at one of two NYC-based community health clinics, but participants do not need to seek care at those locations. If participants choose to leave care during the course of the study, they are still eligible to participate.
Participants are eligible to receive up to $225 over the course of the study.
What is significant about the PATH study?
The PATH study aims to establish a new, effective individual-level health promotion intervention. PATH takes a holistic approach for newly HIV-diagnosed men. There are many potential challenges that exist once a client learns of their diagnosis, particularly in the first three months. Some of these challenges are depression, sexual safety, and disclosure. These can lead to low adherence to medication and care, high viral load, and reduced T-cell count. PATH takes on these challenges to empower each participant to make healthy choices and establish a foundation to maintain their adherence to medication and retention in care.
What has the PATH study set out to assess, or prove?
The PATH study is testing the efficacy of the PATH health promotion intervention. The hypotheses are that participants in the PATH intervention will: (1) achieve greater suppression of HIV viral load; (2) achieve greater uptake of care and adherence to treatment; and (3) engage in less sexual risk behavior, across the study duration.
How long has the study been going on? Can you comment about how it's going so far, some men's responses to the intervention, etc.?
PATH is an intervention that originates from the previous Positive Choices (PC) study. Through PC, our team demonstrated the potential efficacy of using a brief risk-reduction intervention for reducing sexual risk behaviors and increasing uptake of health care services among newly HIV-diagnosed MSM.
PC was developed in collaboration with community partners to respond to increasing numbers of new HIV diagnoses observed at community health centers. The intervention was well received and both participants and counselors suggested adding more sessions to address emotional distress and engagement in care. The PATH intervention was developed through these suggestions, adding stress management components and three additional sessions to create a more comprehensive health promotion package.
The PATH study is a five-year study and we are currently in our second year. Our participants have been very positive in response to the PATH study, and to both study interventions. They enjoy their one-on-one time with HIV counselors and the connection they make in their sessions. The HIV counselors working on the study are also enjoying the interventions and connecting with the participants.
How were study sites chosen? What are the similarities and differences between the Callen-Lorde and Harlem United cohorts?
Callen-Lorde Community Health Center provides health care and related services targeted to the lesbian, gay, bisexual, and transgender communities in New York City. The Positive Choices study, the precursor to the PATH study, was conducted in collaboration with Callen-Lorde to recruit and enroll participants and to deliver the intervention. As the PATH study expanded from the previous Positive Choices study, the team sought out Harlem United, a community-based organization that offers medical, social and supportive services, as a collaborator. Harlem United serves racially/ethnically diverse communities in northern Manhattan, and, as a collaborator on PATH, expands the reach of the study.
Callen-Lorde and Harlem United were both chosen because of their excellent history and reputation in testing, care and treatment for clients with HIV/AIDS and other related medical and social issues. Although participants do not have to be enrolled in care at either of these locations, the study sites provide excellent HIV counselors to deliver the intervention and are available for referrals to services should the participants need them.
What's the "control" group for the study?
The control group for the study is the PCC intervention. Often in research studies, the control group is given either no counseling or standard-of-care treatment. We felt a responsibility to provide the control group in this study with better than standard-of-care treatment. PCC is a proven effective intervention, as noted by the U.S. Centers for Disease Control and Prevention. It is an individual-level, single-session counseling intervention designed to reduce unprotected anal intercourse among MSM who are repeat testers for HIV. For the purposes of this intervention, we have modified the intervention for MSM who are recently diagnosed with HIV.
Is this study enrolling now?
This study is currently enrolling participants. The eligibility criteria for the PATH study are as follows:
Is there someplace someone who's not in New York City could go to find out about entering studies like this one?
People who are interested in participating in PATH can go to the PATH study website for more information or can contact the PATH study team at (212) 271-7203 or firstname.lastname@example.org. For additional studies run by this affiliated research group, please visit SPHERE Lab's website for more information.
If you do not live in New York City, ClinicalTrials.gov is a great resource for looking up research studies across the United States.
What message would you like to send to a newly diagnosed gay/bisexual/SGL man/MSM regarding dealing with their diagnosis?
Although there can be many challenges dealing with a new diagnosis, it is important for you to be engaged into care and understand all your medical needs. Knowledge is power! Learn all the resources that are available for you throughout your community, such as PATH. For more information, visit our PATH website.
Patrick A. Wilson, Ph.D., and Nathan Hansen, Ph.D., are co-principal investigators of the PATH Study.
Olivia Ford is the executive editor for TheBody.com and TheBodyPRO.com.