Acyclovir and transmission of HIV-1 from persons infected with HIV-1 and HSV-2.

BACKGROUND: Most persons who are infected with human immunodeficiency virus type 1 (HIV-1) are also infected with herpes simplex virus type 2 (HSV-2), which is frequently reactivated and is associated with increased plasma and genital levels of HIV-1. Therapy to suppress HSV-2 reduces the frequency of reactivation of HSV-2 as well as HIV-1 levels, suggesting that suppression of HSV-2 may reduce the risk of transmission of HIV-1. METHODS: We conducted a randomized, placebo-controlled trial of suppressive therapy for HSV-2 (acyclovir at a dose of 400 mg orally twice daily) in couples in which only one of the partners was seropositive for HIV-1 (CD4 count, > or = 250 cells per cubic millimeter) and that partner was also infected with HSV-2 and was not taking antiretroviral therapy at the time of enrollment. The primary end point was transmission of HIV-1 to the partner who was not initially infected with HIV-1; linkage of transmissions was assessed by means of genetic sequencing of viruses. RESULTS: A total of 3408 couples were enrolled at 14 sites in Africa. Of the partners who were infected with HIV-1, 68% were women, and the baseline median CD4 count was 462 cells per cubic millimeter. Of 132 HIV-1 seroconversions that occurred after randomization (an incidence of 2.7 per 100 person-years), 84 were linked within couples by viral sequencing: 41 in the acyclovir group and 43 in the placebo group (hazard ratio with acyclovir, 0.92, 95% confidence interval [CI], 0.60 to 1.41; P=0.69). Suppression with acyclovir reduced the mean plasma concentration of HIV-1 by 0.25 log(10) copies per milliliter (95% CI, 0.22 to 0.29; P<0.001) and the occurrence of HSV-2-positive genital ulcers by 73% (risk ratio, 0.27; 95% CI, 0.20 to 0.36; P<0.001). A total of 92% of the partners infected with HIV-1 and 84% of the partners not infected with HIV-1 remained in the study for 24 months. The level of adherence to the dispensed study drug was 96%. No serious adverse events related to acyclovir were observed. CONCLUSIONS: Daily acyclovir therapy did not reduce the risk of transmission of HIV-1, despite a reduction in plasma HIV-1 RNA of 0.25 log(10) copies per milliliter and a 73% reduction in the occurrence of genital ulcers due to HSV-2. (ClinicalTrials.gov number, NCT00194519.)

Excellent safety and tolerability of the human immunodeficiency virus type 1 pGA2/JS2 plasmid DNA priming vector vaccine in HIV type 1 uninfected adults.

A vaccine consisting of DNA priming followed by recombinant modified vaccinia Ankara (rMVA) boosting has achieved long-term control of a pathogenic challenge with a chimera of simian and human immunodeficiency viruses (SHIV-89.6P) in rhesus macaques. Based on these results, clade B HIV-1 DNA and rMVA immunogens have been developed for trials in humans. We conducted a first-time in humans phase I safety trial using the pGA2/JS2 (JS2) HIV-1 DNA priming vector expressing Gag, Pol, Env, Tat, Rev, and Vpu. Thirty HIV-uninfected adults were vaccinated with 0.3 or 3 mg of JS2 DNA, or a saline placebo, by intramuscular injection at months 0 and 2. Both doses of DNA were safe and well-tolerated with no differences between the control, 0.3 mg, or 3 mg groups (n = 6, 12, and 12, respectively) through 12 months of postvaccination follow- up. A chromium-release assay using fresh peripheral blood mononuclear cells (PBMCs) and a validated IFN-gamma ELISpot assay with frozen PBMCs failed to detect CD4(+) or CD8(+) HIV-1-specific T cell responses. HIV-specific neutralizing antibodies were also not detected. The vaccine is being further developed as a priming vector for a combined DNA plus rMVA prime/boost HIV vaccination regimen.

The ripple effect: why promoting female leadership in global health matters.

Leadership positions in global health are greatly skewed toward men; the imbalance is more pronounced in low- and middle-income countries (LMICs). The under-representation of women in leadership is a threat to gender equality, and also impacts the improvement of women's health outcomes globally. In this perspectives piece, we assert that the promotion and retention of women in global health leadership has a ripple effect that can achieve improvement in global health outcomes. We present pragmatic, actionable solutions to promote and retain female global health leaders in this field.

Les positions de dirigeant dans la santé du monde sont largement orientées vers les hommes et ce déséquilibre est encore plus prononcé dans les pays à revenu faible et moyen. La sous-représentation des femmes en termes de dirigeant menace l'égalité des genres et a également un impact sur l'amélioration de l'état de santé des femmes dans le monde. Dans cette perspective, nous affirmons que la promotion et la rétention des femmes au sein du leadership de la santé dans le monde a un effet d'entraînement qui peut aboutir à une amélioration de l'état de santé dans le monde. Nous présentons des solutions pragmatiques et réalisables pour promouvoir et retenir des leaders féminins en matière de santé dans le monde.

Los puestos directivos en materia de salud mundial se asignan de manera desproporcionada a los hombres; este desequilibrio es aun más notorio en los países de ingresos bajos y medianos. La subrepresentación de las mujeres en los cargos de responsabilidad pone en peligro la equidad entre los hombres y las mujeres y tiene además repercusiones en los resultados de salud de las mujeres en el mundo. En el presente artículo de opinión, se sostiene que promover a las mujeres a las funciones directivas relacionadas con la salud mundial y facilitar su permanencia en ellas genera una reacción en cadena que puede dar lugar a mejores resultados de salud a escala mundial. Se proponen soluciones viables y prácticas encaminadas a estimular la presencia de las mujeres en los cargos de responsabilidad en materia de salud mundial y a respaldar su permanencia en esta actividad.

Risk factors for repeatedly reactive HIV-1 EIA and indeterminate western blots. A population-based case-control study.

OBJECTIVE: Causes of indeterminate results of Western blot testing (IWB) for human immunodeficiency virus (HIV) type 1 include seroconversion, HIV-2 cross-reactivity, and autoimmune disease, but most IWB results remain unexplained. This case-control study assessed risk factors for IWB results, including early HIV infection, other retroviral infection, autoantibodies, and other medical conditions. DESIGN: Prospective study to determine HIV seroconversion rate, with a case-control design to assess other risk factors for IWB. Cases (persons with one or more repeatedly reactive HIV-1 enzyme immunoassay with IWB), their current sexual partners, and controls (persons with negative enzyme immunoassay and Western blot results) were recruited from blood banks, health department and prenatal clinics, and private providers in Washington and Oregon. RESULTS: Of 244 cases enrolled, 206 were followed up for 6 months or longer, and six (3.0%; 95% confidence interval [CI], 0.7% to 5.3%) with recent HIV risk behaviors seroconverted. The Western blot banding patterns differed among groups; cases usually had p17 or p24 bands, while controls and cases' sexual partners usually had polymerase bands. Conditional logistic regression indicated that independent risk factors for IWB among male cases and controls were a tetanus booster in the past 2 years (odds ratio, 3.2; 95% CI, 1.2 to 8.6) and sexual contact with a prostitute (odds ratio, 3.0; 95% CI, 1.0 to 9.5). Independent risk factors for women were parity (odds ratio, 1.2; 95% CI, 1.02 to 1.4) and autoantibodies, either rheumatoid factor or antinuclear antibodies (odds ratio, 2.3; 95% CI, 1.03 to 5.6). No cross-reactivity was detected with HIV-2, human T-lymphotrophic virus type 1, feline immunodeficiency or feline leukemia, or bovine immunodeficiency viruses. CONCLUSIONS: Evaluation of persons with reactive HIV-1 enzyme immunoassays and IWB should include an assessment of HIV risk and other possible risk factors, such as alloimmunization (ie, parity or recent immunization) or autoantibodies (ie, antinuclear antibodies and rheumatoid factor). The relationship of IWB among men who reported sex with prostitutes is intriguing and warrants further study.

Readiness of high-risk populations in the HIV Network for Prevention Trials to participate in HIV vaccine efficacy trials in the United States.

OBJECTIVE: To determine the willingness of populations at high risk of HIV-1 infection to participate in HIV vaccine efficacy trials, determine factors influencing decision-making, and evaluate knowledge levels of vaccine trial concepts. DESIGN: Cross-sectional study. METHODS: HIV-1-negative homosexual men, male and female injecting drug users and non-injecting women at heterosexual risk were recruited in eight cities in the United States (n=4892). RESULTS: A substantial proportion of the study population (77%) would definitely (27%) or probably (50%) be willing to participate in a randomized vaccine efficacy trial. Increased willingness was associated with high-risk behaviors, lower education level, being uninsured or covered by public insurance, and not having been in a previous vaccine preparedness study. Altruism and a desire for protection from the vaccine were major motivators for participation. Major concerns included positive HIV-1 antibody test due to vaccine, safety of the vaccine, and possible problems with insurance or foreign travel. Baseline knowledge of vaccine trial concepts was low. CONCLUSIONS: It is likely that high-risk volunteers will be willing to enroll in HIV vaccine efficacy trials. A variety of participant and community educational strategies are needed to address participant concerns, and to ensure understanding of key concepts prior to giving consent for participation.

Incidence of HIV and sexually transmitted diseases (STD) in a cohort of HIV-negative men who have sex with men (MSM).

OBJECTIVE: To determine the prevalence of sexually transmitted diseases (STD) and incidence of and risk factors for STD, including HIV-1, among a cohort of HIV-negative men who have sex with men (MSM). SETTING: Seattle, Washington, United States. PARTICIPANTS: Prospective cohort of 578 HIV-negative MSM in which risk factors for acquiring a STD over 12 months follow-up were evaluated using a cumulative incidence analysis. MAIN OUTCOME MEASURES: Baseline tests obtained were: herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) Western blots, hepatitis B, and syphilis serologies; anorectal and pharyngeal Neisseria gonorrhoeae (GC) cultures; first-catch urine for leukocyte esterase (LE) and Chlamydia trachomatis (CT) ligase chain reaction (LCR). Men with a positive urine LE had urethral GC cultures obtained. The following outcomes were measured over 12 months follow-up: incident symptomatic bacterial STD (urethritis, proctitis, epididymitis), HSV-1 and HSV-2 seroconversion, and HIV-1 seroconversion. The 31 incident cases of STD (men with bacterial STD) were compared with those 489 men without symptomatic bacterial STD or seroconversion to HSV-1, HSV-2 or HIV-1 infection. RESULTS: Bacterial STD were found in nine participants at enrollment; there were two cases of nonchlamydial urethritis, two cases of nonchlamydial epididymitis, and five cases of asymptomatic GC infection. At enrollment, HSV-2 antibodies were detected in 149 (26.0%) of 572 men and prior hepatitis B infection in 145 (34.8%) of 417 unvaccinated men. During the 1-year of follow-up, 31 men (5.7/100 person-years) had 34 episodes of a symptomatic bacterial STD syndrome (urethritis, epididymitis or proctitis). Urethritis was the most common STD syndrome, detected in 29 men, of whom 10 had GC and 19 had nongonococcal urethritis. In the 1-year of follow-up, five participants seroconverted to HIV-1 (1.3/100 person-years), four to HSV-2 (1.0/100 person-years), and seven to HSV-1 (4.3/100 person-years). Unprotected insertive anal sex [odds ratio (OR) 2.6; 95% confidence interval (CI) 1.2-5.6]; and nitrite inhalant ('poppers') use (OR, 2.3; 95% CI, 1.0-5.0) were independently associated with incident STD. CONCLUSIONS: STD and HIV infection continue to be acquired even in a city with an overall low bacterial STD prevalence and among educated MSM receiving regular HIV screening and risk-reduction. Urethritis was the most common STD detected, and public health messages aimed at MSM need to emphasize safe insertive as well as receptive sexual practices.

Cross-clade envelope glycoprotein 160-specific CD8+ cytotoxic T lymphocyte responses in early HIV type 1 clade B infection.

A major objective of current HIV-1 vaccination strategies is the induction of HIV-1-specific CD8+ MHC class I-restricted CTL responses, which are suggested to play a pivotal role in viral clearance and protection against HIV-1 disease progression. However, the marked genetic diversity of HIV-1 and existence of distinct viral subtypes or clades could potentially hinder the development of a universally efficacious HIV-1 vaccine. In this study we examined HIV-1 intraclade (B(LAI) versus B(MN)) Env gp160-specific CTL reactivity in recently HIV-1 clade B-infected individuals. We further evaluated the extent of interclade CTL cross-recognition of the divergent A and C Env gp160 subtypes, that are highly prevalent in the global pandemic. Freshly isolated PBMCs were stimulated in vitro with autologous PBMCs infected with recombinant vaccinia vectors expressing HIV-1 env, gag, pol, and nef genes derived from HIV-1 clade B. All 13 of the 19 HIV-1-seropositive subjects who elicited significant clade B Env gp160LAI CD8+ CTL responses also demonstrated comparable levels of CTL cross-reactivity against clade C92BR025 Env gp160. Nine of these individuals also showed extensive interclade CTL cross-recognition of clade A92UG037 Env gp160. Two HLA class I B7 donors had nondetectable intraclade CTL response against B Env gp160MN, while generating significant intraclade B(LAI) and interclade (A and C) Env gp160 CTL cross-reactivity. These observations serve to underscore the central importance of the HLA background of individuals in determining the pattern of immune reactivity to natural HIV-1 infection and presumably vaccines. Five donors studied also demonstrated broad CTL cross-reactivity against clade A92UG037 Gag p55, Pol, and/or Nef antigens. In conclusion, this present study indicates that there is a considerable degree of CD8+ CTL cross-recognition of the highly divergent HIV-1 Env gp160 subtypes during early phases of HIV-1 infection. Such findings suggest that HIV-1 vaccines based on a single clade that can induce extensive cross-clade immunity may demonstrate utility in diverse geographical regions.

Demographic rather than behavioral risk factors predict herpes simplex virus type 2 infection in sexually active adolescents.

BACKGROUND: Despite the high prevalence of herpes simplex virus type 2 (HSV-2) infection in adults and data indicating that many HSV-2 infections are acquired in late adolescence, the demographic and sexual behavior correlates of HSV-2 infection in high risk adolescents have not been extensively studied. METHODS: Using a cross-sectional design we evaluated serologic evidence of HSV-2 infection in 381 adolescents age 14 to 19 years at an urban sexually transmitted disease clinic and a community clinic. Study enrollment was offered to all patients participating in a project offering free hepatitis B vaccine. Participants were interviewed and blood was drawn for HSV Western blot. RESULTS: Twelve percent [95% confidence interval (CI), 8.6 to 15.1] of 379 adolescents in this study had antibodies to HSV-2. Only 22% of HSV-2-seropositive youth reported a history of herpes. Seropositivity for HSV-2 was significantly associated with African-American race (odds ratio, 2.3; 95% CI 1.1 to 4.8) and female gender (odds ratio, 6.0; 95% CI 2.3 to 15.9); 25% of the African-American girls were HSV-2-seropositive. Self-reported condom use, number of sexual partners in the prior 2 months and history of a sexually transmitted disease did not predict HSV-2 antibody status. CONCLUSIONS: HSV-2 infection among adolescents was prevalent, particularly among African-American girls, and correlated with demographic rather than behavioral variables. As in adults most HSV-2 infections were unrecognized. These data suggest that type-specific serologic testing for HSV-2 infection should be considered in sexually active adolescents. Prevention efforts should target children before initiation of sexual activity.

Global risk of sexually transmitted diseases.

Travelers returning from international destinations may have particular concerns regarding their risk of having acquired sexually transmitted diseases (STDs). The authors review diagnosis, treatment, and special considerations regarding viral, bacterial and protozoan STDs in the international traveler. Diseases that mimic STDs are presented. The authors also discuss the importance of preventative measures and pre-travel counseling.

Patterns of Medicaid eligibility: a sample of 408 Medi-Cal eligibles in San Francisco, California.

Medicaid expenditures per recipient have increased substantially in the past decade, even after controlling for medical care price inflation. In response to this Medicaid expenditure growth, various policies to encourage Medicaid enrollment in cost-effective health maintenance organizations (HMOs) are being considered, including guaranteed Medicaid eligibility for Medicaid eligibles enrolled in HMOs. This paper addresses several important questions about Medicaid eligibility that are essential to an analysis of guaranteed eligibility--the length of eligibility, turnover rates, and reasons individuals lose their Medicaid eligibility. We selected a stratified random sample of 408 eligibility case files for individuals eligible for Medicaid in San Francisco County during December 1977. Six aid categories are represented in this study: (1) Cash Grant AFDC; (2) Medically Needy Families; (3) Medically Needy Aged; (4) Medically Needy Disabled; (5) Medically indigent Adults; and (6) Medically indigent Children. We found that the majority of individuals remain eligible for Medicaid for long, uninterrupted spells, ranging from a median of 15 months (Medically Indigent Adults) to 40 months (Medically Needy Aged). A much smaller subset of eligible persons had relatively short spells and higher turnover; some of that turnover was due to failure to comply with income reporting requirements. We used data on length of eligibility to estimate the cost impact of 6 months' guaranteed eligibility (for months during which individuals would otherwise not have been eligible for Medicaid benefits). We also estimated the potential benefits (savings of HMOs relative to average fee-for-service expenditures) and the benefits of guaranteed eligibility appear to be greater than the costs.

Sensitivity and specificity of herpes simplex virus-2 serological assays among HIV-infected and uninfected urban Ugandans.

Herpes simplex virus type 2 (HSV-2) is a risk factor for HIV-1 infection. We characterized HSV-2 serology assay performance in HIV-positive and HIV-negative Africans. Serostatus for HSV-2 and HIV-1 was determined in 493 serum specimens stored from a community HSV-2 prevalence survey in Kampala, Uganda. HSV-2 serology by Focus HerpeSelect ELISA, Biokit HSV-2 rapid assay and Kalon HSV-2 was compared with HSV-2 Western blot (WB) according to HIV-1 serostatus. Sensitivity/specificity was: 99.5%/70.2% for Focus, 97.0%/86.4% for Biokit and 97.5%/96.2% for Kalon. Focus with Biokit confirmation improved sensitivity/specificity (99.4%/96.8%, respectively). Use of a higher Focus index value cut-off of 2.2 instead of 1.1 increased specificity from 70.2% to 92.4%. Kalon had higher specificity than Focus (P < 0.001). Of commercially available HSV-2 serological assays, Kalon alone, or Focus ELISA followed by Biokit confirmation perform best. Improved HSV-2 assays are needed for HSV-2 and HIV-1 public health activities in Africa.

HIV serodiscordant sex partners and the prevalence of human herpesvirus 8 infection among HIV negative men who have sex with men: baseline data from the EXPLORE Study.

OBJECTIVES: Human herpesvirus 8 (HHV-8) infection is common among men who have sex with men (MSM), especially those infected with HIV, and is frequently detected in saliva. We sought to determine whether oral or anogenital contact with HIV discordant, or unknown serostatus sexual partners is associated with HHV-8 seroprevalence among HIV negative MSM. METHODS: HIV negative MSM participating in a behavioural intervention trial for the prevention of HIV infection (the EXPLORE study) were recruited from the Seattle and Denver areas for participation in this cross sectional study. Participants completed detailed questionnaires regarding sexual behaviour, focusing on activities with possible exposure to the oropharynx. Serum samples from study enrollment were tested for the presence of HHV-8 antibodies using whole virus enzyme immunoassay and immunofluorescence assay to latent and lytic proteins. RESULTS: 198/819 MSM (24.3%) were HHV-8 antibody positive. Exposure to saliva with HIV positive and HIV unknown serostatus sex partners was reported by 83% and 90% of all men, respectively. In a multivariate model, reporting more than the median number of lifetime sex partners (OR 2.2, p = 0.03) or lifetime sex partners of unknown HIV status (OR 1.7, p = 0.03), and the performance of oro-anal sex ("rimming") on partners whose HIV status is unknown (OR 2.7, p = 0.04) were independently associated with HHV-8 infection. CONCLUSIONS: The oropharynx may be an important anatomical site in HHV-8 acquisition, and contact with HIV serodiscordant or unknown sex partners is associated with higher HHV-8 seroprevalence among HIV negative MSM.

High risk of human immunodeficiency virus in men who have sex with men with herpes simplex virus type 2 in the EXPLORE study.

The relation between herpes simplex virus type 2 (HSV-2) and human immunodeficiency virus (HIV) acquisition was evaluated among 4,295 high-risk, HIV-negative men who have sex with men in an intensive behavioral intervention (colloquially referred to as "EXPLORE") study in the United States from 1999 to 2003. Sexual behavior data were obtained by computer-assisted self-interview, and sera were collected semiannually for HIV and HSV-2 serology. HSV-2 infection was classified as "recent incident" (at the first HSV-2 seropositive visit), "remote incident" (within 24 months of the first positive visit), and "prevalent" (for visits >24 months after the first HSV-2 positive visit). Baseline HSV-2 prevalence was 20.3%. HSV-2 incidence was 1.9 (95% confidence interval (CI): 1.6, 2.2) per 100 person-years; significant risk factors were African-American race, unprotected receptive anal intercourse, an HIV-positive male sex partner, and six or more male partners in the prior 6 months. The behavioral intervention did not reduce HSV-2 acquisition (adjusted hazard ratio (HR) = 1.2, 95% CI: 0.9, 1.6). Overall HIV incidence was 1.9 (95% CI: 1.7, 2.2) per 100 person-years. HIV risk was elevated among men who have sex with men with recent incident HSV-2 (adjusted HR = 3.6, 95% CI: 1.7, 7.8), remote incident HSV-2 (adjusted HR = 1.7, 95% CI: 0.8, 3.3), and prevalent HSV-2 (adjusted HR = 1.5, 95% CI: 1.1, 2.1) infection compared with HSV-2 seronegative participants. HIV intervention strategies targeting HSV-2 prevention and suppression among men who have sex with men should be evaluated.

The clinical manifestations and treatment of sexually transmitted diseases in human immunodeficiency virus-positive men.

Sexually transmitted diseases (STDs) occur commonly in sexually active human immunodeficiency virus (HIV)-positive men. STDs may have atypical presentations, can cause significant morbidity in persons with HIV infection, and may increase the risk of HIV transmission. Thus, the appropriate diagnosis and treatment of STDs in this population are extremely important. The clinical manifestations and treatment of several common STDs in HIV-positive men are reviewed. Further research is needed to define effective management and screening strategies for STDs in men with HIV infection.

Herpes simplex virus type 1 as a cause of genital herpes: impact on surveillance and prevention.

This study compared characteristics of patients who had herpes simplex virus (HSV) type 1 with characteristics of patients who had HSV-2, by use of data from a cross-sectional analysis. Data were collected in an urban sexually transmitted diseases clinic from patients who had positive genital HSV cultures. Overall, 17.1% (95% confidence interval [CI], 14.9%-19.3%) of 1145 genital HSV isolates obtained during 1993-1997 were HSV-1. The proportion of HSV-1 among initial genital herpes infections was higher among men who had sex with men (46.9%) than among women (21.4%) and was lowest among heterosexual men (14.6%). White race (odds ratio [OR], 3.7; 95% CI, 2.3-5.9) and receptive oral sex in the preceding 2 months (OR, 2.8; 95% CI, 1.9-4.3) significantly increased the odds that initial infections were HSV-1 rather than HSV-2. Genital HSV-1 may often be acquired through contact with a partner's mouth. These data suggest that seroprevalence studies based solely on HSV-2 type-specific assays underestimate overall prevalence of genital HSV infection.

Possible potentiation of warfarin by fluconazole.

Fluconazole, a new triazole antifungal agent, interacts with a number of drugs. Only one study to date has examined the potentiation of warfarin's anticoagulant effect by fluconazole. To our knowledge, this is the first published case report of this interaction in the clinical setting. The patient had received a stable dosage regimen of warfarin for a number of months. Fluconazole 100 mg bid was added for a candidal wound infection. The prothrombin time increased from 19 to 65 seconds eight days later and the patient experienced a gastrointestinal bleeding episode. Fresh-frozen plasma was administered and warfarin was discontinued while the patient completed a planned 21-day course of fluconazole. The patient eventually resumed the original warfarin dosage with stable coagulation parameters. Until the influence of fluconazole on the anticoagulant effect of warfarin is studied in further detail, careful monitoring of coagulation parameters is recommended for all patients receiving the combination.

Selective screening for chlamydial infection in women: a comparison of three sets of criteria.

Selective screening has been associated with marked declines in the prevalence of chlamydial infection, the most common bacterial sexually transmitted disease (STD) in the United States. A comparison of the performance of different selective screening criteria in three groups of family planning and STD clinic clients shows that criteria recommended by the Centers for Disease Control and Prevention performed well overall, detecting 88-89% of infections by screening 58-74% of women. Criteria based on age alone performed best among low-risk clients with a low prevalence of chlamydial infection, particularly when all women younger than age 25 were screened (sensitivity, 84-92%); the age-based criteria still required screening only 59-71% of all women. Selective screening criteria should be based on age, risk profile and chlamydia prevalence in specific clinical settings, and should be reevaluated as chlamydia prevalence declines.

Rectal microbicides for U.S. gay men. Are clinical trials needed? Are they feasible? HIVNET Vaccine Preparedness Study Protocol Team.

BACKGROUND AND OBJECTIVES: Incomplete condom use during anal sex persists among gay men; microbicides may provide additional protection. Despite the absence of efficacy or safety data, many gay men use sexual lubricants containing nonoxynol-9 (N-9), a detergent-based spermicide under evaluation for efficacy as a vaginal microbicide. GOAL: Evaluate unprotected sex, lubricant use, and attitudes regarding possible participation in clinical trials of rectal microbicides among high-risk human immunodeficiency virus-(HIV) seronegative U.S. gay men in six cities. STUDY DESIGN: A total of 3,257 gay men were interviewed and responded to a self-administered questionnaire at enrollment into a longitudinal cohort study of HIV seroincidence. RESULTS: Among 2,216 men who practiced receptive anal intercourse in the previous 6 months, 438 (20%) reported they never used condoms. More than three fourths of 3,093 men who had anal sex used lubricants more than 80% of the time. 41% of whom actively sought N-9 containing products. About two thirds said they were definitely or probably willing to participate in rectal microbicide clinical trials. CONCLUSION: Condom use is imperfect among men who report anal sex. N-9 lubricants are popular. Most gay men in this cohort indicate willingness to participate in rectal microbicide studies.