Public health researchers are addressing new research questions (e.g., effects of environmental tobacco smoke, Hurricane Katrina) for which the randomized controlled trial (RCT) may not be a feasible option. Drawing on the potential outcomes framework (Rubin Causal Model) and Campbellian perspectives, we consider alternative research designs that permit relatively strong causal inferences. In randomized encouragement designs, participants are randomly invited to participate in one of the treatment conditions, but are allowed to decide whether to receive treatment. In quantitative assignment designs, treatment is assigned on the basis of a quantitative measure (e.g., need, merit, risk). In observational studies, treatment assignment is unknown and presumed to be nonrandom. Major threats to the validity of each design and statistical strategies for mitigating those threats are presented.

The aim of this paper is to advance rigorous Internet-based HIV/STD Prevention quantitative research by providing guidance to fellow researchers, faculty supervising graduates, human subjects' committees, and review groups about some of the most common and challenging questions about Internet-based HIV prevention quantitative research. The authors represent several research groups who have gained experience conducting some of the first Internet-based HIV/STD prevention quantitative surveys in the US and elsewhere. Sixteen questions specific to Internet-based HIV prevention survey research are identified. To aid rigorous development and review of applications, these questions are organized around six common criteria used in federal review groups in the US: significance, innovation, approach (broken down further by research design, formative development, procedures, sampling considerations, and data collection); investigator, environment and human subjects' issues. Strategies promoting minority participant recruitment, minimizing attrition, validating participants, and compensating participants are discussed. Throughout, the implications on budget and realistic timetabling are identified.

Background Human immunodeficiency virus (HIV) has disproportionately affected African Americans. Couple-level interventions may be a promising intervention strategy. Methods To determine if a behavioral intervention can reduce HIV/sexually transmitted disease (STD) risk behaviors among African American HIV serodiscordant couples, a cluster randomized controlled trial (Eban) was conducted in Atlanta, Georgia; Los Angeles, California; New York, New York; and Philadelphia, Pennsylvania; with African American HIV serodiscordant heterosexual couples who were eligible if both partners were at least 18 years old and reported unprotected intercourse in the previous 90 days and awareness of each other's serostatus. One thousand seventy participants were enrolled (mean age, 43 years; 40% of male participants were HIV positive). Couples were randomized to 1 of 2 interventions: couple-focused Eban HIV/STD risk-reduction intervention or attention-matched individual-focused health promotion comparison. The primary outcomes were the proportion of condom-protected intercourse acts and cumulative incidence of STDs (chlamydia, gonorrhea, or trichomonas). Data were collected preintervention and postintervention, and at 6- and 12-month follow-ups. Results Data were analyzed for 535 randomized couples: 260 in the intervention group and 275 in the comparison group; 81.9% were retained at the 12-month follow-up. Generalized estimating equation analyses revealed that the proportion of condom-protected intercourse acts was larger among couples in the intervention group (0.77) than in the comparison group (0.47; risk ratio, 1.24; 95% confidence interval [CI], 1.09 to 1.41; P=.006) when adjusted for the baseline criterion measure. The adjusted percentage of couples using condoms consistently was higher in the intervention group (63%) than in the comparison group (48%; risk ratio, 1.45; 95% CI, 1.24 to 1.70; P<.001). The adjusted mean number of (log)unprotected intercourse acts was lower in the intervention group than in the comparison group (mean difference, –1.52; 95% CI, –2.07 to –0.98; P<.001). The cumulative STD incidence over the 12-month follow-up did not differ between couples in the intervention and comparison groups. The overall HIV sero-conversion at the 12-month follow-up was 5 (2 in the intervention group, 3 in the comparison group) of 535 individuals, which translates to 935 per 100 000 population. Conclusion To our knowledge, this is the first randomized controlled intervention trial to report significant reductions in HIV/STD risk behaviors among African American HIV serodiscordant couples.

Background-Asymptomatic Chlamydia trachomatis (chlamydia) and Neisseria gonorrhoeae

Both behavioral and biological measures are important outcomes for studying the efficacy and effectiveness of behavior-change interventions. However, one measure cannot substitute for or validate the other, and neither serves as a true surrogate for HIV prevalence or incidence. Therefore, it is important to better understand the relationship among STDs, HIV, and self-reported condom use. To do this, it will first be necessary to assess correct as well as consistent condom use.

This article presents an extended (7-9 hours) and a brief (1-2 hours) battery designed to evaluate early cognitive changes associated with seropositive, asymptomatic persons. The battery was recommended by an NIMH Workgroup which was guided by 10 principles in its development. The domains assessed by the battery are: (1) Indicators of Premorbid Intelligence; (2) Attention; (3) Speed of Processing; (4) Memory; (5) Abstraction; (6) Language; (7) Visuoperception; (8) Constructional Abilities; (9) Motor Abilities; and (10) Psychiatric Assessment. Although the battery assesses a wide range of psychological functioning, specific emphasis has been placed on divided and sustained attention as well as speed of processing and retrieval from working and long-term memory. Descriptions of both the traditional clinical tests and tasks used in cognitive psychology are provided. Although the Workgroup strongly recommends the use of the extended battery in order to ensure the most sensitivity, it recognizes that there may be situations in which this is not possible. In order to increase the likelihood that neuropsychological tests will identify neurologically affected CDC Stage II and III seropositive individuals, the Workshop recommends that each patient's protocol be rated by two trained neuropsychologists using the same clinical criteria. The Workgroup also recommends that a concerted effort be made to incorporate data from the extended and the brief batteries in some central data bank.

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A case management intervention model, delivered individually, is likely to result in significant and sustained reductions in substance use among PLH.