How Many Sexual Partners of an Individual Need to Be Evaluated to Capture HIV/STI Risk Behavior in a Study?

Investigators conducting HIV studies ask participants multiple questions about sexual risk behaviors with their partners to ensure that they can describe the level of HIV risky sexual behavior. The assessment should be as short as possible because of the expense of collecting the data, the burden to the research subject, and ethical concerns. This study used data from the NIMH Collaborative HIV/STD Prevention Trial to answer the question about how many non-spousal/non live-in partners a research participant needs to be asked about to capture sufficient sexual risk behavior (not using a condom with a non-spousal/non live-in partner in the last 3 months). The data provided evidence that 95 % of the sexual risk behavior was captured by asking about two partners while 98 % was captured by three partners. As research funds become increasingly limited, it is important to design as parsimonious and robust a study as possible.

Mediation Analysis of the Efficacy of the Eban HIV/STD Risk-Reduction Intervention for African American HIV Serodiscordant Couples.

Targeting couples is a promising behavioral HIV risk-reduction strategy, but the mechanisms underlying the effects of such interventions are unknown. We report secondary analyses testing whether Social-Cognitive-Theory variables mediated the Eban HIV-risk-reduction intervention's effects on condom-use outcomes. In a multisite randomized controlled trial conducted in four US cities, 535 African American HIV-serodiscordant couples were randomized to the Eban HIV risk-reduction intervention or attention-matched control intervention. Outcomes were proportion condom-protected sex, consistent condom use, and frequency of unprotected sex measured pre-, immediately post-, and 6 and 12 months post-intervention. Potential mediators included Social-Cognitive-Theory variables: outcome expectancies and self-efficacy. Mediation analyses using the product-of-coefficients approach in a generalized-estimating-equations framework revealed that condom-use outcome expectancy, partner-reaction outcome expectancy, intention, self-efficacy, and safer-sex communication improved post-intervention and mediated intervention-induced improvements in condom-use outcomes. These findings underscore the importance of targeting outcome expectancies, self-efficacy, and safer-sex communication in couples-level HIV risk-reduction interventions.

Caregiver behavior change for child survival and development in low- and middle-income countries: an examination of the evidence.

In June of 2012, representatives from more than 80 countries promulgated a Child Survival Call to Action, which called for reducing child mortality to 20 or fewer child deaths per 1,000 live births in every country by 2035. To address the problem of ending preventable child deaths, the U.S. Agency for International Development and the United Nations Children's Fund convened, on June 3-4, 2013, an Evidence Summit on Enhancing Child Survival and Development in Lower- and Middle-Income Countries by Achieving Population-Level Behavior Change. Six evidence review teams were established on different topics related to child survival and healthy development to identify the relevant evidence-based interventions and to prepare reports. This article was developed by the evidence review team responsible for identifying the research literature on caregiver change for child survival and development. This article is organized into childhood developmental periods and cross-cutting issues that affect child survival and healthy early development across all these periods. On the basis of this review, the authors present evidence-based recommendations for programs focused on caregivers to increase child survival and promote healthy development. Last, promising directions for future research to change caregivers' behaviors are given.

The utility of a composite biological endpoint in HIV/STI prevention trials.

A human immunodeficiency virus (HIV) as a biological endpoint in HIV prevention trials may not be feasible, so investigators have used surrogate biological outcomes. In a multisite trial, the epidemiology of STIs may be different across sites and preclude using one STI as the outcome. This study explored using a composite STI outcome to address that problem. The combined biological endpoint was the incidence of any of six new STIs (chlamydia, gonorrhea, trichomonas (women only), syphilis, herpes simplex virus type 2 infection and HIV) during a 24-month follow up period. We investigated how a composite STI outcome would perform compared to single and dual STI outcomes under various conditions. We simulated outcomes for four populations that represented a wide range of sex and age distributions, and STI prevalences. The simulations demonstrated that a combined biologic outcome was superior to single and dual STI outcomes in assessing intervention effects in 82 % of the cases. A composite biological outcome was effective in detecting intervention effects and might allow more investigations to incorporate multiple biological outcomes in the assessment of behavioral intervention trials for HIV prevention.

Statistical challenges in studying complex and changing families.

This paper describes challenges of studying complex and changing families and provides suggestions for methods of analyses to study these family systems. Five common problems that NIMH-funded investigators have encountered in analyzing family based studies are addressed and analytic solutions for addressing these problems are illustrated using data from Family HIV/AIDS projects. The problems discussed in the paper are (1) differences in subgroup responses to interventions; (2) longitudinal changes in family relationships and covariates that vary by group in nested designs; (3) dealing with missing data over time from attrition and planned missing data due to death; (4) dealing with multiple reports from different family members; and (5) developing concordance measures among family members. The use of multi-level and growth curve modeling techniques to address these problems is illustrated with some of the studies.

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.

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.

Effects of behavioral intervention on substance use among people living with HIV: the Healthy Living Project randomized controlled study.

AIM: Reductions in substance use were examined in response to an intensive intervention with people living with human immunodeficiency virus (HIV) (PLH). DESIGN, SETTING AND PARTICIPANTS: A randomized controlled trial was conducted with 936 PLH who had recently engaged in unprotected sexual risk acts recruited from four US cities: Milwaukee, San Francisco, New York and Los Angeles. Substance use was assessed as the number of days of use of 19 substances recently (over the last 90 days), evaluated at 5-month intervals over 25 months. INTERVENTION: A 15-session case management intervention was delivered to PLH in the intervention condition; the control condition received usual care. MEASUREMENTS: An intention-to-treat analysis was conducted examining reductions on multiple indices of recent substance use calculated as the number of days of use. FINDINGS: Reductions in recent substance use were significantly greater for intervention PLH compared to control PLH: alcohol and/or marijuana use, any substance use, hard drug use and a weighted index adjusting for seriousness of the drug. While the intervention-related reductions in substance use were larger among women than men, men also reduced their use. Compared to controls, gay and heterosexual men in the intervention reduced significantly their use of alcohol and marijuana, any substance, stimulants and the drug severity-weighted frequency of use index. Gay men also reduced their hard drug use significantly in the intervention compared to the control condition. CONCLUSIONS: A case management intervention model, delivered individually, is likely to result in significant and sustained reductions in substance use among PLH.

Intervention to influence behaviors linked to risk of chronic diseases: a multisite randomized controlled trial with African-American HIV-serodiscordant heterosexual couples.

BACKGROUND: The high morbidity and mortality in African Americans associated with behavior-linked chronic diseases are well documented. METHODS: We tested the efficacy of an intervention to increase multiple health-related behaviors in African Americans. In a multisite cluster-randomized controlled trial, groups of African American human immunodeficiency virus (HIV)-serodiscordant heterosexual couples in Atlanta (Georgia), Los Angeles (California), New York (New York), and Philadelphia (Pennsylvania) were allocated to an individual-focused health promotion that addressed multiple health-related behaviors or to a couple-focused HIV/sexually transmitted disease (STD) risk reduction intervention. Primary outcomes were adherence to fruit and vegetable consumption and physical activity guidelines assessed preintervention, immediately postintervention, and 6 and 12 months postintervention. Secondary outcomes included fatty food consumption, prostate and breast cancer screening, and alcohol use. Generalized estimating equations tested the efficacy of the health promotion intervention over the postintervention assessments. RESULTS: Health promotion intervention participants were more likely to report consuming 5 or more servings of fruits and vegetables daily (rate ratio [RR], 1.38; 95% confidence interval [CI], 1.18 to 1.62) and adhering to physical activity guidelines (1.39; 1.22 to 1.59) compared with HIV/STD intervention participants. In the health promotion intervention compared with the HIV/STD intervention, participants consumed fatty foods less frequently (mean difference, -0.18; 95% CI, -0.30 to -0.07), more men received prostate cancer screening (RR, 1.51; 95% CI, 1.21 to 1.88), and more women received a mammogram (RR, 1.26; 95% CI, 1.06 to 1.50). Alcohol use did not differ between the intervention groups. CONCLUSION: This trial demonstrates the efficacy of interventions targeting multiple health-related behaviors in African American HIV-seropositive and HIV-seronegative men and women. Trial Registration clinicaltrials.gov Identifier: NCT00644163.

Prevalence of Sexually Transmitted Diseases and Risk Behaviors from the NIMH Collaborative HIV/STD Prevention Trial.

This cross-sectional study describes the baseline prevalence and correlates of common bacterial and viral sexually transmitted diseases (STDs) and risk behaviors among individuals at high risk for HIV recruited in five low- and middle-income countries. Correlations of risk behaviors and demographic factors with prevalent STDs and the association of STDs with HIV prevalence are examined. Between 2,212 and 5,543 participants were recruited in each of five countries (China, India, Peru, Russia, and Zimbabwe). Standard protocols were used to collect behavioral risk information and biological samples for STD testing. Risk factors for HIV/STD prevalence were evaluated using logistic regression models. STD prevalence was significantly higher for women than men in all countries, and the most prevalent STD was Herpes simplex virus-type 2 (HSV-2). HIV prevalence was generally low (below 5%) except in Zimbabwe (30% among women, 11.7% among men). Prevalence of bacterial STDs was generally low (below 5% for gonorrhea and under 7% for syphilis in all sites), with the exception of syphilis among female sex workers in India. Behavioral and demographic risks for STDs varied widely across the five study sites. Common risks for STDs included female gender, increasing number of recent sex partners, and in some sites, older age, particularly for chronic STDs (i.e., HSV-2 and HIV). Prevalence of HIV was not associated with STDs except in Zimbabwe, which showed a modest correlation between HIV and HSV-2 prevalence (Pearson coefficient = .55). These findings underscore the heterogeneity of global STD and HIV epidemics and suggest that local, focused interventions are needed to achieve significant declines in these infections.

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 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 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.

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.

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.

Psychological distress, substance use, and adjustment among parents living with HIV.

BACKGROUND: Being a parent, especially a custodial parent, living with HIV was anticipated to increase psychological distress and challenges to self-care. METHODS: Mental health symptoms, substance use, and health care utilization were assessed among 3818 HIV-infected adults, including custodial parents, noncustodial parents, and nonparents, in 4 AIDS epicenters. RESULTS: Custodial parents demonstrated significantly poorer medication adherence and attendance at medical appointments but were similar to nonparents and noncustodial parents in mental health symptoms and treatment utilization for mental health and substance use problems. Noncustodial parents demonstrated the highest levels of recent substance use and substance abuse treatment. Other markers of risk, such as African American ethnicity, lack of current employment income, and injection drug use moderated many of the apparent psychosocial disadvantages exhibited by parents. CONCLUSIONS: Interventions specific to the psychosocial stressors facing families living with HIV are needed.