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PRS Efficacy Criteria for Best-Evidence (Tier I) Behavioral Interventions |
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Intervention Description
- Clear description of key aspects of the intervention
Quality–Study design
- Prospective study design
- Appropriate and concurrent comparison arm
- Random or minimally biased assignment of subjects to study arms
Quality–Study implementation and analysis
- At least a 3-month postintervention follow-up assessment for
each study arm (with recall referring to postintervention period
only)
- At least a 70% retention rate at a single follow-up assessment for
each study arm
- Comparison between intervention arm and an appropriate comparison arm
- Analysis of subjects in study arms as originally assigned
- Analysis of subjects regardless of the level of intervention exposure
- Use of appropriate cluster-level analyses if assigned to study arms by cluster or group
- Analysis must be based on postintervention levels or among pre-post changes in measures
- For pre-post changes used in analysis, measures must be identical, including identical recall period
- Analysis based on an
α =.05 (or more stringent) and a 2-sided test
- In nonrandomized assignment, either no statistical differences in baseline levels of the outcome exist or baseline differences are controlled for in the analysis
Strength of Evidence–Significant positive intervention effects
- Positive and statistically significant (p
≤ .05) intervention effect for ≥ 1 relevant outcome measure
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A positive intervention effect is defined as a greater reduction in HIV/STD incidence or risk behaviors or a greater increase in HIV protective behaviors in the intervention arm relative to the comparison arm.
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A relevant outcome is defined as a behavior (e.g., abstinence, mutual monogamy, number of sex partners, negotiating safer sex, condom use, injection drug use, HIV testing behaviors) that directly impacts HIV risk or
a biologic measure indicating HIV or STD infection (i.e., HIV or STD incidence)
Effect at the follow-up and based on the analyses that meet study implementation and analysis criteria
Strength of Evidence–Negative intervention effects
- No negative and statistically significant (p < .05) intervention effect for any relevant outcome (A negative intervention effect is defined as a greater increase in HIV/STD incidence or risk behaviors or a greater decrease in HIV protective behaviors in the intervention arm relative to the comparison arm.)
- No other statistically significant
harmful intervention effect
- For an intervention with a replication evaluation, no significant negative intervention effects in the replication study
Overall fatal flaw
- No evidence that any additional limitation was a fatal flaw
- A fatal flaw has occurred when the
limitation is thought to introduce
considerable bias, thus substantially
reducing the confidence of the findings
- Examples of fatal flaws include: small
sample size (<50 participants per study
arm); effects only found within a
potentially biased subset analyses;
substantial missing data
All criteria must be satisfied for an intervention to be considered as a best-evidence behavioral intervention
Source. Lyles et al. (2006) [14] and Lyles at al. (2007) [15].
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