Yale University

Prevention with Newly HIV+ Men: A Pilot Intervention-Supplement to P30MH66294-05

Principle Investigator(s):

Funder: Office of AIDS Research
Project period: 09/15/2006 - 06/30/2008
Grant Type: Center Grant

Abstract Text:

The purpose of this proposal is to conduct a pilot intervention trial of a Brief Risk Reduction (BRR) intervention among newly diagnosed HIV+ men who have sex with men (MSM), conducted in community partnership with the Callen Lorde Community Health Center in New York City.  The aims of the study include:

  1. Conduct of the planned 3-session individual intervention with up to 60 recently diagnosed (within 90 days of test result) HIV+ MSM, randomly assigned to the experimental condition or to the comprehensive standard of care comparison condition, with the following goals: (1) determination of appropriateness of planned intervention, with refinement and tailoring of intervention components; (2) feasibility of recruiting participants within 90 days of HIV+ diagnosis, as planned, as well as whether this is an optimal time period; (3) conduct of pre-, post (3-mo)-intervention, and follow-up (6-mo)  assessments, to determine preliminary effect of the intervention on HIV sexual transmission risk behavior and provide data for sample size calculation; and, (4) documentation that human subjects issues regarding the impact of disclosure, HIPAA regulations, and potential of harm to others due to continued transmission risk behavior can be adequately addressed;
  2. Assessment of recent infection using STARHS, to estimate the proportion of newly diagnosed MSM who are recently infected, so to develop the appropriate tailoring and integration of medical implications of recent infection into the intervention protocol; and
  3. Review of medical records at Callen Lorde to ascertain the number of newly diagnosed MSM who remain in care at Callen Lorde over a minimum of 12-months, in order to document the collaborative research team’s ability to retain the enrolled study sample in a full scale efficacy trial.