Health departments with at least $1 million in annual cooperative agreement funding from CDC are to collect and report outcome data for either one outcome evaluation project or two outcome monitoring projects during the life of the cooperative agreement that ends December 31, 2003.

Health departments may choose whether to conduct an outcome evaluation or two outcome monitoring projects.

Chapter 6 of this volume contains information on outcome evaluation. In addition, Evaluating CDC-Funded Health Department HIV Prevention Programs, Volume 2, Supplemental Handbook contains chapters on outcome monitoring and outcome evaluation. Chapter 6, “Monitoring Outcomes of Health Education and Risk Reduction Individual - and Group - Level HIV Prevention Interventions” contains examples of outcome monitoring instruments and discussion of how to analyze outcome monitoring data. Chapter 7, “Evaluating Outcomes and Monitoring Impact of HIV Prevention Programs,” contains discussion of research design and methodology for outcome evaluation.

Outcome Evaluation

Outcome evaluation, also referred to as summative evaluation, assesses intervention efficacy or effectiveness in producing the desired cognitive, belief, skill, and behavioral outcomes within a target population. The fundamental assumption underlying an outcome evaluation is that the outcomes that are detected can be attributed to a specific set of activities – the components of the intervention. Outcome monitoring, unlike outcome evaluation, cannot attribute outcomes to the intervention under study.

The outcome evaluation should be carried out for a defined HIV prevention intervention or set of integrated interventions. The intervention should have sufficient evidence, justification, and maturity of development to warrant a rigorous evaluation. The evaluation design should be at least quasi-experimental, using a non-equivalent comparison group or multiple measurements before and after the intervention. When feasible, health departments may use an experimental design with random assignment of clients to treatment and control groups.

Any experimental-type design (e.g., assignment of clients to “treatment and “control” groups or comparison of outcomes between clients in “standard” and “enhanced” interventions) must undergo local Institutional Review Board (IRB) approval. No contact with “human subjects” in an experimental-type design may take place without local IRB approval.

The website http://www.hhs.gov/ohrp/assurances/assurances_index.html contains valuable information on IRBs and human subjects research.

What To Report To CDC

Reports to CDC on outcome monitoring projects (due in April 2003 and April 2004) should contain the following information:

• names and affiliations of evaluators conducting the outcome monitoring
• intervention type(s)
• intervention goals
• target population(s)
• evidence and justification for the intervention(s)

In addition, the report should include the following elements:

• copy of instruments/data collection tools
• methods of data collection and statistical analysis
• appropriate descriptive statistics, including client demographics
• summary of findings
• how results will be used for program improvement

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