Challenges and processes of selecting outcome measures for the NIMH Collaborative HIV/STD Prevention Trial.

Abstract

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. 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. Literature reviews, investigator experience, ethnographic study, pilot studies, and epidemiological studies were used to select the endpoints for the Trial. 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.