Willo Pequegnat

Alternatives to the randomized controlled trial

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.

Evaluating AIDS prevention interventions using behavioral and biological outcome measures.

Objective: To begin a dialogue on the role of behavioral and biological outcome measures in evaluating the effectiveness of behavior change interventions to reduce the risk of transmitting and acquiring HIV and other sexually transmitted diseases (STDs). Methods: A selective review of the literature was undertaken to identify issues and problems associated with the use of behavioral and biological outcome measures. In particular, the article considers the validity of self‐reports and the theoretical relationships between behavioral and biological measures. Results: Available data suggest that when proper care is taken, behavioral self‐reports are valid. Similarly, sensitive and specific diagnostic tests are available, particularly for bacterial STDs. However, even when diagnostic tests and behavioral self‐reports provide valid data, one should not expect a simple relationship between behavioral and biological measures. Conclusion: 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.

From child sexual abuse to adult sexual risk: Trauma, revictimization, and intervention.

From Child Sexual Abuse to Adult Sexual Risk: An Introduction to the Issues Childhood Sexual Abuse and Adult Sexual Relationships: Review and Perspective Childhood Sexual Abuse and Adult Sexual Revictimization Sexual Abuse of Girls and HIV Infection Among Women: Are They Related? Sexual Abuse of Boys: Short- and Long-Term Associations and Implications for HIV Prevention Cognitive and Attitudinal Paths From Childhood Trauma to Adult HIV Risk The Link Between Childhood Sexual Abuse and Risky Sexual Behavior: The Role of Dissociative Tendencies, Information-Processing Effects, and Consensual Sex Decision Mechanisms Toward a Social-Narrative Model of Revictimization Childhood Sexual Abuse and Alcohol Use Among Women: Setting the Stage for Risky Sexual Behavior Translating Traumatic Experiences into Language: Implications for Childhood Abuse and Long-Term Health Integrating HIV/AIDS Prevention Activities into Psychotherapy for Sexual Abuse Survivors Child Sexual Abuse and HIV: An Integrative Risk-Reduction Approach Trauma-Focused Versus Present-Focused Models of Group Therapy for Women Sexually Abused in Childhood Sexual Assault Revictimization: Toward Effective Risk Reduction Programs Child Sexual Abuse and Adult Sexual Risk: Where Do We Go From Here?

Conducting internet-based HIV/STD prevention survey research: Considerations in design and evaluation

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.

Effects of a behavioral intervention to reduce risk of transmission among people living with HIV: The Healthy Living Project randomized controlled study

Context:The US Centers for Disease Control and Prevention (CDC) strongly recommend comprehensive risk counceling and services for people living with HIV (PLH); yet, there are no evidence-based counseling protocols. Objective:To examine the effect of a 15-session, individually delivered, cognitive behavioral intervention on a diverse sample of PLH at risk of transmitting to others. Design:This was a multisite, 2-group, randomized, controlled trial. Participants:Nine hundred thirty-six HIV-infected participants considered to be at risk of transmitting HIV of 3818 persons screened were randomized into the trial. Participants were recruited in Los Angeles, Milwaukee, New York, and San Francisco. Intervention:Fifteen 90-minute individually delivered intervention sessions were divided into 3 modules: stress, coping, and adjustment; safer behaviors; and health behaviors. The control group received no intervention until the trial was completed. Both groups completed follow-up assessments at 5, 10, 15, 20, and 25 months after randomization. Main Outcome Measure:Transmission risk, as measured by the number of unprotected sexual risk acts with persons of HIV-negative or unknown status, was the main outcome measure. Results:Overall, a significance difference in mean transmission risk acts was shown between the intervention and control arms over 5 to 25 months (χ2 = 16.0, degrees of freedom = 5; P = 0.007). The greatest reduction occurred at the 20-month follow-up, with a 36% reduction in the intervention group compared with the control group. Conclusion:Cognitive behavioral intervention programs can effectively reduce the potential of HIV transmission to others among PLH who report significant transmission risk behavior.

National Institute of Mental Health Multisite Eban HIV/STD Prevention Intervention for African American HIV Serodiscordant Couples: A Cluster Randomized Trial

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 others 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 seroconversion 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. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00644163.

The incidence and correlates of symptomatic and asymptomatic Chlamydia trachomatis and Neisseria gonorrhoeae infections in selected populations in five countries.

Background: Asymptomatic Chlamydia trachomatis (chlamydia) and Neisseria gonorrhoeae (gonorrhea) infections pose diagnostic and control problems in developing countries. Methods: Participants in China, India, Peru, Russia, and Zimbabwe were screened for C. trachomatis and N. gonorrhoeae infections and symptoms. Results: A total of 18,014 participants were evaluated at baseline, 15,054 at 12 months, and 14,243 at 24 months. The incidence of chlamydia in men was 2.0 per 100 person years both from baseline to 12 months and from 12 to 24 months, and in women, 4.6 from baseline to 12 months and 3.6 from 12 to 24 months; a range of 31.2% to 100% reported no symptoms across the 5 countries. The incidence of gonorrhea in men was 0.3 per 100 person years both from baseline to 12 months and from 12 to 24 months, and in women, 1.4 from baseline to 12 months and 1.1 from 12 to 24 months; a range of 66.7% to 100% reported no symptoms. Being female, aged 18 to 24 years, and having more than 1 partner were associated with both the infections. In addition, being divorced, separated, or widowed was associated with gonorrhea. Being male, having 6+ years of education, and reporting only 1 partner were associated with having no symptoms among those infected with chlamydia. No variables correlated with asymptomatic gonorrhea among those infected. Conclusion: A high prevalence and incidence of asymptomatic sexually transmitted infections was identified among men and women in a wide variety of settings. More effective programs are needed to identify and treat chlamydia and gonorrhea infections, especially among women, young adults, those with multiple partners, those repeatedly infected, and particularly those at risk without symptoms. The risk of transmission from persons with no symptoms requires further study.

Measurement of the Role of Families in Prevention and Adaptation to HIV/AIDS

HIV is a family disease. Family research in HIV is challenging because of complexities of family measurement, the range of family constellations across cultures, and the issues specific to HIV-affected families. A Consortium of NIMH-funded investigators is conducting HIV research on families—defined as networks of mutual commitments. A procedure for identifying the “family” is proposed. This article reviews assessment strategies from two research traditions, both of which have been greatly concerned with social context: family assessment tradition—family membership, parenting, and interactional dynamics; HIV/AIDS research tradition—HIV-relevant constructs generalized to minority families. Initially, a systematic procedure for defining family membership is provided. Constructs and measures derived from the family assessment tradition are described, including self-report and observational procedures. Constructs and measures of relevance to family research that originated in the HIV/AIDS research tradition are described: HIV knowledge, stigma, disclosure, and social support. Constructs presented derive from the Consortiums research on the role of families in prevention and adaptation to HIV/AIDS. Most of the research conducted by the Consortium has taken place with inner-city, minority, heterosexual families. By informing the selection of constructs and measures relevant to investigating the role of families in HIV prevention, and adaptation to living with HIV/AIDS, it is the Consortiums intention to enhance the quality and quantity of research at the intersection of families and HIV/AIDS.

Relationships over Time between Mental Health Symptoms and Transmission Risk Among Persons Living with HIV

Relationships between mental health symptoms (anxiety and depression) or a positive state of mind and behavior associated with HIV transmission (substance use and risky sexual behavior) were explored in a longitudinal study of persons living with HIV (PLH; N = 936) who were participants in a transmission-prevention trial. Bivariate longitudinal regressions were used to estimate the correlations between mental health symptoms and HIV-related transmission acts for 3 time frames: at the baseline interview, over 25 months, and from assessment to assessment. At baseline, mental health symptoms were associated with transmission acts. Elevated levels of mental health symptoms at baseline were associated with decreasing alcohol or marijuana use over 25 months. Over 25 months, an increasingly positive state of mind was associated with decreasing alcohol or marijuana use; an increasingly positive state of mind in the immediate intervention condition and increasing depressive symptoms in the lagged condition were related to increasing risky sexual behavior. Our findings suggest that mental health symptoms precede a decrease in substance use and challenge self-medication theories. Changes in mental health symptoms and sexual behavior occur more in tandem.

A cost-effectiveness analysis of interventions to increase repeat testing in patients treated for gonorrhea or chlamydia at public sexually transmitted disease clinics.

Background: Persons who have been infected with chlamydia or gonorrhea (CT/GC) are at elevated risk for reinfection. The cost-effectiveness of interventions designed to encourage public sexually transmitted disease (STD) clinic patients to return for rescreening has not been well-evaluated. Goal: The goal of this study was to conduct a program- and societal-perspective cost-effectiveness analysis of five interventions designed to encourage public STD clinic patients infected with CT/GC to return for rescreening 3 months after initial treatment. Study: Researchers at two STD clinics collected cost data for the five interventions. These were combined with study data on return rates and CT/GC positivity rates among returning patients to compare the cost-effectiveness of the interventions. Results: The cost per patient counseled with a brief recommendation to return, followed by a telephone reminder after 3 months, was higher than two interventions: a brief recommendation to return with no reminder and a