Cynthia M. Lyles

Improving the Reporting Quality of Nonrandomized Evaluations of Behavioral and Public Health Interventions: The TREND Statement

Developing an evidence base for making public health decisions will require using data from evaluation studies with randomized and nonrandomized designs. Assessing individual studies and using studies in quantitative research syntheses require transparent reporting of the study, with sufficient detail and clarity to readily see differences and similarities among studies in the same area. The Consolidated Standards of Reporting Trials (CONSORT) statement provides guidelines for transparent reporting of randomized clinical trials. We present the initial version of the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement. These guidelines emphasize the reporting of theories used and descriptions of intervention and comparison conditions, research design, and methods of adjusting for possible biases in evaluation studies that use nonrandomized designs.

Do prevention interventions reduce HIV risk behaviours among people living with HIV: a meta-analytic review of controlled trials

Objective:To conduct a meta-analytic review of HIV interventions for people living with HIV (PLWH) to determine their overall efficacy in reducing HIV risk behaviours and identify intervention characteristics associated with efficacy. Methods:Comprehensive searches included electronic databases from 1988 to 2004, hand searches of journals, reference lists of articles, and contacts with researchers. Twelve trials met the stringent selection criteria: randomization or assignment with minimal bias, use of statistical analysis, and assessment of HIV-related behavioural or biologic outcomes at least 3 months after the intervention. Random-effects models were used to aggregate data. Results:Interventions significantly reduced unprotected sex [odds ratio (OR), 0.57; 95% confidence interval (CI) 0.40–0.82] and decreased acquisition of sexually transmitted diseases (OR, 0.20; 95% CI, 0.05–0.73). Non-significant intervention effects were observed for needle sharing (OR, 0.47, 95% CI, 0.13–1.71). As a whole, interventions with the following characteristics significantly reduced sexual risk behaviours: (1) based on behavioural theory; (2) designed to change specifically HIV transmission risk behaviours; (3) delivered by health-care providers or counsellors; (4) delivered to individuals; (5) delivered in an intensive manner; (6) delivered in settings where PLWH receive routine services or medical care; (7) provided skills building, or (8) addressed a myriad of issues related to mental health, medication adherence, and HIV risk behaviour. Conclusion:Interventions targeting PWLH are efficacious in reducing unprotected sex and acquisition of sexually transmitted diseases. Efficacious strategies identified in this review should be incorporated into community HIV prevention efforts and further evaluated for effectiveness.

Best-Evidence Interventions: Findings From a Systematic Review of HIV Behavioral Interventions for US Populations at High Risk, 2000-2004

OBJECTIVES The Centers for Disease Control and Preventions HIV/AIDS Prevention Research Synthesis Team conducted a systematic review of US-based HIV behavioral intervention research literature from 2000 through 2004 to identify interventions demonstrating best evidence of efficacy for reducing HIV risk. METHODS Standard systematic review methods were used. Each eligible study was reviewed on the basis of Prevention Research Synthesis Team efficacy criteria that focused on 3 domains: study design, implementation and analysis, and strength of evidence. RESULTS Eighteen interventions met the criteria for best evidence. Four targeted HIV-positive individuals. Of those targeting populations at risk for HIV, 4 targeted drug users, 6 targeted adults at risk because of heterosexual behaviors only, 2 targeted men who have sex with men, and 2 targeted youths at high risk. Eight interventions focused on women, and 13 had study samples with more than 50% minority participants. Significant intervention effects included increased condom use and reductions in unprotected sexual intercourse, number of sexual partners, injection drug use or needle sharing, and newly acquired sexually transmitted infections. CONCLUSIONS Most of the best-evidence interventions are directly applicable for populations in greatest need of effective prevention programs; however, important gaps still exist.

Sex differences in HIV-1 viral load and progression to AIDS

BACKGROUND Plasma HIV-1 RNA measurements are used for initiation of antiretroviral treatments. Whether the viral-load association with prognosis is similar in women and men is unknown. METHODS We studied 812 specimens from 650 injection-drug users (IDUs) participating in a continuous observational study of patients based in a community clinic. HIV-1 load was measured by branched-chain DNA on samples from 527 IDUs from the baseline visit, and by reverse-transcriptase PCR and quantitative microculture on samples from 285 IDUs at a follow-up visit 3 years later. FNDINGS: Women had lower median viral-load measurements than men by branched-chain DNA (3365 vs 8907 copies/mL; p=0.001), reverse-transcriptase PCR (45416 vs 93130 copies/mL; p=0.02), and quantitative microculture (5 vs 8 infectious units per million peripheral blood mononuclear cells; p=0.015). This association remained even after adjustment for CD4 cell count, race, and drug use within the previous 6 months. Time to AIDS was statistically similar for men and women in a univariate proportional-hazards model and in a model adjusting for CD4 cell count. Proportional-hazards models showed that women with the same viral load as men had a 1.6-fold higher risk of AIDS (95% CI 1.10-2.32); or, equivalently, that women with half the viral load of men had a similar time to AIDS as men. INTERPRETATION Although a biological mechanism remains unclear, these data suggest that current recommendations for HIV-1 viral-load thresholds to initiate antiretroviral therapy should be revised downwards for women.

A meta-analytic review of HIV behavioral interventions for reducing sexual risk behavior of men who have sex with men

This meta-analysis examines the efficacy of international HIV prevention interventions designed to reduce sexual risk behavior of men who have sex with men (MSM). We performed a comprehensive search of published and unpublished English-language reports of HIV prevention interventions that focus on MSM and evaluated changes in risky sexual behavior or biologic outcomes related to sexual risk. Data from 33 studies described in 65 reports were available as of July 2003. Studies with insufficient data to calculate effect sizes were excluded from the meta-analysis. Interventions were associated with a significant decrease in unprotected anal intercourse (odds ratio [OR] = 0.77, 95% confidence interval [CI]: 0.65-0.92) and number of sexual partners (OR = 0.85, 95% CI: 0.61-0.94) and with a significant increase in condom use during anal intercourse (OR = 1.61, 95% CI: 1.16-2.22). Interventions successful in reducing risky sexual behavior were based on theoretic models, included interpersonal skills training, incorporated several delivery methods, and were delivered over multiple sessions spanning a minimum of 3 weeks. Behavioral interventions provide an efficacious means of HIV prevention for MSM. To the extent that proven HIV prevention interventions for MSM can be successfully replicated in community settings and adapted and tailored to different situations, the effectiveness of current HIV prevention efforts can be increased.This article presents an analysis of the correlates of HIV status among samples of injection drug users (IDUs) in Lang Son Province, Vietnam (n = 348), and Ning Ming County, Guangxi Province, China (n = 294), who were interviewed and tested for HIV antibody just before the start of a peer-based HIV prevention intervention in this border region. Participants were largely male, in their 20s, and single. Logistic regression analysis suggests that among Chinese IDUs, border-related factors (eg, living closer to the border, buying drugs across the border more frequently) and younger age are the best predictors of HIV positivity. In Vietnam, HIV status seems to drive behavior (eg, some risk reduction practices are predictive of HIV positivity). These differing patterns may reflect the fact that the intertwined epidemics of heroin injection and HIV began earlier and HIV prevalence has reached significantly higher levels in Lang Son than across the border in Ning Ming. Although border-related factors emerge as predictors in Ning Ming, more IDUs in Lang Son are HIV-positive and may be reacting behaviorally to that status. Their greater likelihood of engaging in risk reduction measures may reflect some combination of a belief that risk reduction can slow disease progression and an altruistic desire to avoid infecting others.

Decreasing incidence of HIV and sexually transmitted diseases in young Thai men: Evidence for success of the HIV/AIDS control and prevention program

Objective:To determine whether HIV and sexually transmitted disease (STD) incidence rates among young men in northern Thailand have declined since the establishment of the ‘100% Condom Program’, and to prospectively document changes in the association between behavioral risk factors and incident HIV and STD infections. Setting:Thirteen military bases in northern Thailand. Methods:Serial prospective cohorts of 19–23-year-old male conscripts (n = 4086) inducted into military service from six northern Thai provinces between 1991 and 1993 were followed at 6-month intervals for incident HIV and STD through May 1995. HIV incidence was determined by serology, and incident STD were reported by conscripts as diagnosed by health-care providers. Results:HIV incidence declined from a rate of 2.48 per 100 person-years during 1991–1993 to 0.55 per 100 person-years during 1993–1995. STD incidence showed an even greater decline, with a 10-fold decrease from 1991–1993 to 1993–1995. Behavioral risk factors for incident STD infections included a history of prior STD and sex with girlfriends and sex workers. Inconsistent condom use remained a strong predictor of incident STD among brothel visitors. Other previously-reported risk factors in 1991–1993 such as illicit drug use, frequency and cost of brothel visits, and low socioeconomic status were not associated with incident STD or HIV in 1993–1995. Conclusions:Although several studies have recently reported decreased prevalence of HIV and STD infections in Thailand, these data demonstrate that a dramatic decrease in the incidence rates of STD, including HIV infection, has occurred among young men in military service in northern Thailand. The Thai AIDS prevention and control program might be implemented by other countries experiencing major epidemics of heterosexually transmitted HIV infections. Similar prevention programs targeted at other populations in Thailand and elsewhere in Asia are needed to decrease the spread of the HIV epidemic.

Sex Differences in Longitudinal Human Immunodeficiency Virus Type 1 RNA Levels among Seroconverters

Cross-sectional studies have demonstrated lower plasma human immunodeficiency virus type 1 (HIV-1) RNA virus levels (VLs) in women than in men, but it is unknown whether this sex difference is present at the time of seroconversion and throughout the course of infection. A nested case-control study was performed among HIV-1 seroconverters within a cohort of injection drug users. Plasma VL was determined longitudinally among both rapid progressors to AIDS (24 patients) and nonprogressors (47 controls). The initial median VL among female patients (n=10) was 14,918 copies/mL, compared with 148,354 copies/mL among male patients (n=14; P=.001); median plasma VL also tended to be lower among female (n=10) than among male controls (n=37; 11,917 vs. 61,311 copies/mL; P=.08). VL increased more rapidly over time in women than in men and subsequently converged in patients and controls, respectively. Understanding the mechanisms responsible for the sex difference in VL may provide insight into HIV-1 pathogenesis.

The Efficacy of Behavioral Interventions in Reducing HIV Risk Behaviors and Incident Sexually Transmitted Diseases in Heterosexual African Americans

Objective:To conduct a meta-analytic review of HIV interventions for heterosexual African Americans to determine the overall efficacy in reducing HIV-risk sex behaviors and incident sexually transmitted diseases and identify intervention characteristics associated with efficacy. Methods:Comprehensive searches included electronic databases from 1988 to 2005, handsearches of journals, reference lists of articles, and contacts with researchers. Thirty-eight randomized controlled trials met the selection criteria. Random-effects models were used to aggregate data. Results:Interventions significantly reduced unprotected sex (odds ratio = 0.75; 95% confidence interval = 0.67, 0.84; 35 trials; N = 14 682) and marginally significantly decreased incident sexually transmitted diseases (odds ratio = 0.88; 95% confidence interval = 0.72, 1.07; 10 trials; N = 10 944). Intervention characteristics associated with efficacy include cultural tailoring, aiming to influence social norms in promoting safe sex behavior, utilizing peer education, providing skills training on correct use of condoms and communication skills needed for negotiating safer sex, and multiple sessions and opportunities to practice learned skills. Conclusion:Interventions targeting heterosexual African Americans are efficacious in reducing HIV-risk sex behaviors. Efficacious intervention components identified in this study should be incorporated into the development of future interventions and further evaluated for effectiveness.

Needle-exchange attendance and health care utilization promote entry into detoxification.

This study was undertaken to identify factors associated with entry into detoxification among injection drug users (IDUs), and to assess the role of needle-exchange programs (NEPs) as a bridge to treatment. IDUs undergoing semiannual human immunodeficiency virus (HIV) tests and interviews were studied prospectively between 1994 and 1998, during which time an NEP was introduced in Baltimore. Logistic regression was used to identify independent predictors of entry into detoxification, stratifying by HIV serostatus. Of 1,490 IDUs, similar proportions of HIV-infected and uninfected IDUs entered detoxification (25% vs. 23%, respectively). After accounting for recent drug use, hospital admission was associated with four-fold increased odds of entering detoxification for HIV-seronegative subjects. Among HIV-infected subjects, hospital admission, outpatient medical care, and having health insurance independently increased the odds of entering detoxification. After accounting for these and other variables, needle-exchange attendance also was associated independently with entering detoxification for both HIV-infected (adjusted odds ratio [AOR]=3.2) and uninfected IDUs (AOR=1.4). However, among HIV-infected subjects, the increased odds of detoxification associated with needle exchange diminished significantly over time, concomitant with statewide reductions in detoxification admissions. These findings indicate that health care providers and NEPs represent an important bridge to drug abuse treatment for HIV-infected and uninfected IDUs. Creating and sustaining these linkages may facilitate entry into drug abuse treatment and serve the important public health goal of increasing the number of drug users in treatment.

Efficacy of Structural-Level Condom Distribution Interventions: A Meta-Analysis of U.S. and International Studies, 1998–2007

This systematic review examines the overall efficacy of U.S. and international-based structural-level condom distribution interventions (SLCDIs) on HIV risk behaviors and STIs and identifies factors associated with intervention efficacy. A comprehensive literature search of studies published from January 1988 through September 2007 yielded 21 relevant studies. Significant intervention effects were found for the following outcomes: condom use, condom acquisition/condom carrying, delayed sexual initiation among youth, and reduced incident STIs. The stratified analyses for condom use indicated that interventions were efficacious for various groups (e.g., youth, adults, males, commercial sex workers, clinic populations, and populations in areas with high STI incidence). Interventions increasing the availability of or accessibility to condoms or including additional individual, small-group or community-level components along with condom distribution were shown to be efficacious in increasing condom use behaviors. This review suggests that SLCDIs provide an efficacious means of HIV/STI prevention.