Challenges and processes of selecting outcome measures for the NIMH collaborative HIV/STD prevention trial

Carlos F. Caceres, David D. Celentano, Thomas J. Coates, Tyler D. Hartwell, Danuta Kasprzyk, Jeffrey A. Kelly, Andrei P. Kozlov, Willo Pequegnat, Mary Jane Rotheram-Borus, Suniti Solomon, Godfrey Woelk, Zunyou Wu

Research output: Contribution to journalReview articlepeer-review

11 Scopus citations


OBJECTIVE: To review the challenges of designing behavioral and biological outcome measures for the multinational NIMH Collaborative HIV/STD Prevention Trial and provide the rationale for selecting these measures. DESIGN: Although many different evidence-based prevention programmes have been developed, few have been evaluated in different countries, cultures, and populations. One issue in evaluating the generalized efficacy of any prevention approach is to identify a set of common outcome measures useful across diverse settings and peoples. The Trial is designed to evaluate whether the community popular opinion leader intervention can be adapted cross-nationally and cross-culturally for different populations and still retain its efficacy. METHODS: Literature reviews, investigator experience, ethnographic study, pilot studies, and epidemiological studies were used to select the endpoints for the Trial. RESULTS AND CONCLUSION: Both biological and behavioral data will be obtained at baseline and 12 and 24 months post-baseline. Communities that receive the intervention will be compared with matched control communities on two primary outcomes: (i) a change in self-reported unprotected sexual acts with non-spousal, non-live-in partners; and (ii) the incidence of sexually transmitted disease (STD), defined as a composite index of viral and bacterial STD.

Original languageEnglish (US)
Pages (from-to)S29-S36
Issue numberSUPPL. 2
StatePublished - Apr 2007


  • AIDS
  • Behavioral endpoints
  • Behavioral intervention
  • Biological endpoints
  • Community popular opinion leader
  • Developing nations
  • HIV
  • Outcome measures
  • Risk behavior

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology
  • Infectious Diseases


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