Biomedical subjects

J M Douglas

Publications and source records attributed to J M Douglas.

At least 37 records · Page 2Linked to original sources

PubMed2000

Circumcision and STD in the United States: cross sectional and cohort analyses.

BACKGROUND: Male circumcision status has been shown to be associated with sexually transmitted disease (STD) acquisition in some, but not all, studies. Most studies have been cross sectional. OBJECTIVES: We examined the association between circumcision status and the prevalence and incidence of gonorrhoea, chlamydia, and syphilis. METHODS: We analysed cross sectional and cohort study data from a multicentre controlled trial in the United States. Between July 1993 and September 1996, 2021 men visiting public inner city STD clinics in the United States were examined by a clinician at enrolment and 1456 were examined at follow up visits 6 and 12 months later. At each visit, men had laboratory tests for gonorrhoea, chlamydia, and syphilis and were examined for circumcision status. We used multiple logistic regression to compare STD risk among circumcised and uncircumcised men adjusted for potentially confounding factors. RESULTS: Uncircumcised men were significantly more likely than circumcised men to have gonorrhoea in the multivariate analyses, adjusted for age, race, and site, in both the cross sectional (odds ratio (OR), 1.3; 95% confidence interval (CI), 0.9 to 1.7) and in the cohort analysis (OR, 1.6; 95% CI, 1.0 to 2.6). There was no association between lack of circumcision and chlamydia in either the cross sectional (OR, 1.0; 95% CI 0.7-1.4) or the cohort analysis (OR, 0.9; 95% CI 0.5-1.5). The magnitude of association between lack of circumcision and syphilis was similar in the cross sectional (OR, 1.4; 95% CI 0.6 to 3.3) and cohort analysis (OR, 1.5; 95% CI 0.4 to 6.1). CONCLUSION: Uncircumcised men in the United States may be at increased risk for gonorrhoea and syphilis, but chlamydia risk appears similar in circumcised and uncircumcised men. Our results suggest that risk estimates from cross sectional studies would be similar to cohort findings.

Adult↗

PubMed2000

The prevalence of genital human papillomavirus infections in abused and nonabused preadolescent girls.

OBJECTIVE: To compare the prevalence of genital human papillomavirus (HPV) infections in sexually abused and nonabused preadolescent girls and assess the feasibility of conducting a longitudinal study of the natural history of HPV infection in this population. METHOD: Consecutively referred, 5- to 12-year-old girls who were evaluated for sexual abuse by a Child Advocacy and Protection Team were invited to participate in the study. During a standard forensic medical examination, 2 specimens for HPV testing were obtained (one by rubbing a Dacron swab over the perineum and the other by lavaging the vagina with phosphate-buffered saline). The specimens were evaluated for HPV DNA by polymerase chain reaction using MY09/11 consensus primers and high-risk (16,18,31,33,35,39,45,51,52, 56,58) and low-risk (6,11,42,43,44) types were detected with a solution hybridization assay, the SHARP Signal System (Digene Diagnostics). The genital area was examined for warts and subclinical, colposcopic evidence of HPV. Participants were invited to return for longitudinal evaluation at 4-month intervals for 2 years. RESULTS: Sexual abuse was confirmed in 29 (72.5%) of the 40 study participants, suspected in 2 (5%), and ruled out in 9 (22.5%). None of the girls had genital warts or abnormal colposcopic findings. HPV DNA was detected in 5 (16%) of the 31 girls with confirmed or suspected sexual abuse (1 with high-risk and 4 with low-risk types) and none of the nonabused girls (Fisher's exact test). Girls who tested positive and negative for HPV did not differ significantly in age or type of abuse. Despite close telephone follow-up and numerous attempts to schedule appointments, none of the participants returned for follow-up. CONCLUSIONS: Genital HPV infection is more common among sexually abused than nonsexually abused girls, with the majority of infections not clinically apparent. Because it is so difficult to study the natural history of these infections in abused children, it may be necessary to draw inferences about the long-term sequelae of pediatric HPV infections from longitudinal studies of girls who voluntarily initiate sexual activity soon after menarche.

Child↗

PubMed1999

Recombinant glycoprotein vaccine for the prevention of genital HSV-2 infection: two randomized controlled trials. Chiron HSV Vaccine Study Group.

CONTEXT: In the last 3 decades, herpes simplex virus type 2 (HSV-2) infection seroprevalence and neonatal herpes have increased substantially. An effective vaccine for the prevention of genital herpes could help control this epidemic. OBJECTIVE: To evaluate the efficacy of a vaccine for prevention of HSV-2 infection. DESIGN: Two randomized, double-blind, placebo-controlled multicenter trials of a recombinant subunit vaccine containing 30 microg each of 2 major HSV-2 surface glycoproteins (gB2 and gD2) against which neutralizing antibodies are directed, administered at months 0, 1, and 6. Control subjects were given a citrate buffer vehicle. Participants were followed up for 1 year after the third immunization. SETTING AND PARTICIPANTS: We enrolled 2393 persons from December 10, 1993, to April 4, 1995, who were HSV-2 and human immunodeficiency virus seronegative. One trial with 18 centers enrolled 531 HSV-2-seronegative partners of HSV-2-infected persons; the other, with 22 centers, enrolled 1862 persons attending sexually transmitted disease clinics. A total of 2268 (94.8%) met inclusion criteria and were included in the analysis with 1135 randomized to placebo and 2012 to vaccine. MAIN OUTCOME MEASURE: Time to acquisition of HSV-2 infection, defined by seroconversion or isolation of HSV-2 in culture during the study period by randomization group. RESULTS: Time-to-event curves indicated a 50% lower acquisition rate among vaccine vs placebo recipients during the initial 5 months of the trial; however, overall vaccine efficacy was 9% (95% confidence interval, -29% to 36%). Acquisition rates of HSV-2 were 4.6 and 4.2 per 100 patient-years in the placebo and vaccine recipients, respectively (P =.58). Follow-up of vaccine recipients acquiring HSV-2 infection showed vaccination had no significant influence on duration of clinical first genital HSV-2 episodes (vaccine, median of 7.1 days; placebo, 6.5 days; P>.10) or subsequent frequency of reactivation (median monthly recurrence rate with vaccine, 0.2; with placebo, 0.3; P>.10). The vaccine induced high levels of HSV-2-specific neutralizing antibodies in vaccinated persons who did and did not develop genital herpes. CONCLUSIONS: Efficient and sustained protection from sexual acquisition of HSV-2 infection will require more than high titers of specific neutralizing antibodies. Protection against sexually transmitted viruses involving exposure over a prolonged period will require a higher degree of vaccine efficacy than that achieved in this study.

Adolescent↗

PubMed1999

Correlates of condom failure in a sexually active cohort of men who have sex with men.

Condom failure (slippage or breakage) has been shown to be associated with HIV seroconversion among men who have sex with men (MSM), but predictors of failure have been poorly elucidated. Of 2592 HIV-seronegative MSM participants in the HIV Network for Prevention Trials (HIVNET) multisite Vaccine Preparedness Study who reported condom use for anal sex in the 6 months before enrollment, condom failure was reported by 16.6%, with failure rates of 2.1/100 episodes of condom usage (2.5 failures/100 episodes for receptive anal sex and 1.9/100 episodes for insertive anal sex). In separate multivariate models evaluating predictors of condom failure reported by the insertive and receptive partners, more frequent condom use was associated with a decreased per-condom failure rate and amphetamine and heavy alcohol use with increased rates in both models. Being employed, having private medical insurance, and using lubricants for >80% of anal sex acts were significantly associated with decreased failure rates in the insertive model. Safer sex counseling should particularly target men of lower socioeconomic status, promote proper and consistent use of condoms with appropriate lubricants, and address the impact of drug use, especially amphetamines and alcohol, on condom failure.

Adult↗

PubMed1999

Feasibility and suitability of targeting young gay men for HIV vaccine efficacy trials.

We evaluated factors affecting the feasibility of including young high-risk HIV-negative gay and bisexual men in preventive HIV vaccine trials using data from the U.S. Centers for Disease Control and Prevention Collaborative HIV Seroincidence Study. Of 2189 men enrolled in this study, 17% were <25 years of age. HIV seroincidence was 4.2/100 person-years (95% confidence interval [CI], 2.6-7.0) in young men compared with 2.0/100 person-years (95% CI, 1.4-2.6) for older men. Compared with men 25 and older, young men were more likely to report several high-risk behaviors, to perceive themselves to be at risk for HIV infection, and to report that their risk behavior might be increased by participation in an HIV vaccine trial. The majority of both young men (69%) and older men (74%) expressed willingness in participate in HIV vaccine trials. Young men were less likely to answer questions about vaccine concepts correctly and were more likely to be lost to follow-up. Young gay and bisexual men are important candidates for future HIV vaccine trials, but they may need targeted approaches to recruitment, retention, education about trial concepts prior to enrollment, and behavioral interventions during the trial.

AIDS Vaccines↗

PubMed1999

Genital warts and their treatment.

Genital warts are manifestations of a common viral sexually transmitted disease (STD) that are often diagnosed and treated with a variety of clinical specialties. Unlike for other STDs, there is a general lack of a well-established treatment algorithm for the management of external genital warts. This, coupled with a wide variety of treatments and clinical settings, makes the development of a simple algorithm virtually impossible. In this review what is known and not known about current treatments and case management will be discussed.

Condylomata Acuminata↗

PubMed1999

Use of reality "female condoms" for anal sex by US men who have sex with men. HIVNET Vaccine Preparedness Study Protocol Team.

OBJECTIVES: This study assessed use of Reality "female condoms" for anal sex by HIV-seronegative men who have sex with men and are at high risk for HIV infection. METHODS: Self-administered questionnaires were completed by 2277 participants in a 6-city prospective cohort study. RESULTS: Of the 1084 (48%) men who had heard of using the female condom for anal sex, 145 (13%) reported using it in the prior 6 months. Users were at greater risk than nonusers: 47 receptive and 35 insertive users reported problems, including bleeding by the receptive partner (4). CONCLUSIONS: Redesign of the female condom could increase acceptability and use by men who have sex with men and could address possible safety concerns.

Adult↗

PubMed1998

Efficacy of risk-reduction counseling to prevent human immunodeficiency virus and sexually transmitted diseases: a randomized controlled trial. Project RESPECT Study Group.

CONTEXT: The efficacy of counseling to prevent infection with the human immunodeficiency virus (HIV) and other sexually transmitted diseases (STDs) has not been definitively shown. OBJECTIVE: To compare the effects of 2 interactive HIV/STD counseling interventions with didactic prevention messages typical of current practice. DESIGN: Multicenter randomized controlled trial (Project RESPECT), with participants assigned to 1 of 3 individual face-to-face interventions. SETTING: Five public STD clinics (Baltimore, Md; Denver, Colo; Long Beach, Calif; Newark, NJ; and San Francisco, Calif) between July 1993 and September 1996. PARTICIPANTS: A total of 5758 heterosexual, HIV-negative patients aged 14 years or older who came for STD examinations. INTERVENTIONS: Arm 1 received enhanced counseling, 4 interactive theory-based sessions. Arm 2 received brief counseling, 2 interactive risk-reduction sessions. Arms 3 and 4 each received 2 brief didactic messages typical of current care. Arms 1, 2, and 3 were actively followed up after enrollment with questionnaires at 3, 6, 9, and 12 months and STD tests at 6 and 12 months. An intent-to-treat analysis was used to compare interventions. MAIN OUTCOME MEASURES: Self-reported condom use and new diagnoses of STDs (gonorrhea, chlamydia, syphilis, HIV) defined by laboratory tests. RESULTS: At the 3- and 6-month follow-up visits, self-reported 100% condom use was higher (P<.05) in both the enhanced counseling and brief counseling arms compared with participants in the didactic messages arm. Through the 6-month interval, 30% fewer participants had new STDs in both the enhanced counseling (7.2%; P= .002) and brief counseling (7.3%; P= .005) arms compared with those in the didactic messages arm (10.4%). Through the 12-month study, 20% fewer participants in each counseling intervention had new STDs compared with those in the didactic messages arm (P = .008). Consistently at each of the 5 study sites, STD incidence was lower in the counseling intervention arms than in the didactic messages intervention arm. Reduction of STD was similar for men and women and greater for adolescents and persons with an STD diagnosed at enrollment. CONCLUSIONS: Short counseling interventions using personalized risk reduction plans can increase condom use and prevent new STDs. Effective counseling can be conducted even in busy public clinics.

Adolescent↗

PubMed1998

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.

AIDS Vaccines↗

PubMed1998

A randomized, placebo-controlled comparison of oral valacyclovir and acyclovir in immunocompetent patients with recurrent genital herpes infections. The Valaciclovir International Study Group.

OBJECTIVE: To compare valacyclovir hydrochloride with acyclovir in the treatment of recurrent genital herpes infection. DESIGN: A multicenter, double-blind, placebo-controlled, randomized, parallel-design study. SETTING: University clinics (dermatology, gynecology, and infectious diseases) and private practices. PATIENTS: One thousand two hundred patients with recurrent genital herpes simplex infections. INTERVENTIONS: Patients self-initiated oral therapy with 1000 mg of valacyclovir hydrochloride twice daily, 200 mg of acyclovir 5 times daily, or placebo for 5 days. MAIN OUTCOME MEASURES: Resolution of all signs and symptoms of recurrent genital herpes infection. RESULTS: Both drugs were significantly more effective than placebo in speeding resolution of herpetic episodes (median duration, 4.8, 4.8, and 5.9 days, respectively); the hazards ratios for valacyclovir and acyclovir vs placebo were 1.66 (95% confidence interval [CI], 1.38-2.01) and 1.71 (95% CI, 1.41-2.06) (both P < .001). Similarly, valacyclovir and acyclovir significantly hastened lesion healing (hazards ratios vs placebo were 1.88 [95% CI, 1.53-2.32] and 1.90 [95% CI, 1.55-2.34], respectively; P < .001). Pain duration was shorter in valacyclovir- and acyclovir-treated patients (median, 2 vs 3 days). Viral shedding stopped 2.55 times faster in patients treated with valacyclovir and 2.24 times faster in patients treated with acyclovir than in patients treated with placebo. Aborted episodes, in which lesions did not progress beyond the macule or papule stage, tended to occur in more patients treated with valacyclovir (25.9%) or acyclovir (24.8%) than in patients treated with placebo (19.8%). Valacyclovir and acyclovir did not differ significantly with regard to their respective effects on any of the above efficacy parameters. The nature, severity, and frequency of adverse events did not differ among the 3 treatment groups. CONCLUSIONS: Twice-daily valacyclovir was as effective and well tolerated in the treatment of recurrent genital herpes simplex virus infection as 5-times-daily acyclovir. Therefore, valacyclovir could prove a useful alternative to acyclovir when convenience of dosing or compliance issues are the prime considerations in treatment.

Acyclovir↗

PubMed1998

Treatment of genital warts with an immune-response modifier (imiquimod).

BACKGROUND: Genital warts are a common sexually transmitted disease caused by human papillomavirus. Imiquimod is a novel immune-response modifier capable of inducing a variety of cytokines, including interferon alfa, tumor necrosis factor-alpha, as well as interleukins 1, 6, and 8. In animal models imiquimod has demonstrated antiviral, antitumor, and adjuvant activity. In vitro, imiquimod has no antiviral or antitumor activity. OBJECTIVE: Our purpose was to determine the safety and efficacy of topical imiquimod for the treatment of external genital warts. METHODS: This prospective double-blind, placebo-controlled, parallel design clinical trial was performed in three outpatient centers, a public health clinic, a university-based clinic, and a private practice. One hundred eight patients with external genital warts (predominantly white men) were entered into the trial. Fifty-one patients were randomly selected to receive 5% imiquimod cream; 57 patients were randomly chosen to receive placebo cream. Study medication was applied three times weekly for up to 8 weeks. Patients whose warts cleared completely were observed for up to 10 weeks to determine recurrence rates. RESULTS: In the intent-to-treat analysis, the warts of 37% (19 of 51) of the imiquimod-treated patients and 0% (0 of 57) of the placebo group cleared completely (p < 0.001). In addition, many patients experienced a partial response. A reduction in baseline wart area of 80% or more was observed in 62% of imiquimod-treated patients (28 of 45) and 4% of the placebo group (2 of 50) (p < 0.001); a 50% reduction or more in wart area was noted in 76% of imiquimod-treated patients (34 of 45) and 8% of placebo recipients (4 of 50) (p < 0.001). Of imiquimod-treated patients whose warts cleared completely and who finished the 10-week follow-up period, 19% (3 of 16) experienced recurrences of warts. Imiquimod-treated patients experienced a significantly greater number of local inflammatory reactions than the placebo group. Symptoms and signs associated with the local inflammatory reactions included itching (54.2%), erythema (33.3%), burning (31.3%), irritation (16.7%), tenderness (12.5%), ulceration (10.4%), erosion (10.4%), and pain (8.3%). There were no differences in systemic reactions or laboratory abnormalities between treatment groups. CONCLUSION: Topical 5% imiquimod cream appears to have a significant therapeutic effect in the treatment of external genital warts.

Adjuvants, Immunologic↗

PubMed1998

Educational outcome for secondary and postsecondary students following traumatic brain injury.

During the 12 month period of January-December 1991, 75 admissions were made to the Head Injury Unit at Bethesda Hospital, Melbourne, Australia. Approximately 26% (20) of these admissions were either secondary or postsecondary students. Thirteen of the 20 students were interviewed by telephone at approximately 3 years postinjury and demographic and medical information were obtained from their medical files. Outcome was documented in three areas: educational, medical and psychosocial status. At 3 years postinjury, 11 subjects (85%) had either completed a course or were still studying. The average time for students to return to study was approximately 11 months postinjury. The students reported a number of changes including: enrollment in different courses, a reduction in course load to part-time study, altered educational and vocational goals and an increased need to utilize study skill strategies, individual tuition and special consideration. In addition, students reported changes to their relationships with peers and their involvement in extracurricular activities. It is apparent from these results that a number of factors need to be considered when a student is planning to return to study following TBI and that a range of support services may be required. Future studies are needed to examine the factors which impede or enhance a student's progress following TBI.

Adolescent↗

PubMed1998

Patterns of general health care and STD services use among high-risk youth in Denver participating in community-based urine chlamydia screening.

BACKGROUND: In the United States, youth are at highest risk for STDs, and innovative programs have been called for to increase their access to essential STD-related services. To guide the development of such programs, locally relevant information is needed on current use of general health care and STD services in this population. GOAL: To study access to and use of general health care and STD services in a purposive sample of high-risk youth in inner-city Denver. STUDY DESIGN: An interview-based survey conducted as part of a community program for urine chlamydia screening targeting black and Hispanic youth 13 years to 25 years. RESULTS: Of 221 sexually experienced youth in the survey, 72% had accessed general health services in the past year and 39% reported an STD evaluation at any time in the past. Community and school clinics were reported by 50% as a source for general health care and by 62% as a source for STD services. STD clinics were reported by only 14% as a source for STD services. Routine checkups were the most important reasons to seek general health care, yet of those who went for a routine checkup, only 34% reported an STD evaluation. Although few barriers appeared to exist in accessing general health care, anticipated anxiety about procedures and results formed the major barrier to accessing STD services. CONCLUSIONS: Use of general health services was common in this population of high-risk adolescents; however, the provision of STD services as part of general health care visits appeared to be low. On the basis of these findings, a comprehensive STD prevention strategy may be envisioned, which would include provider interventions to increase the provision of STD prevention services in general health care settings; community interventions to enhance access to general health care and STD services; and community-based screening programs for those not able or willing to seek clinic-based services.

Adolescent↗

PubMed1998

Pap smear screening in an urban STD clinic. Yield of screening and predictors of abnormalities.

BACKGROUND: Pap smear screening studies in STD clinics have reported high rates of squamous intraepithelial lesions (SIL); however, there are limited data on levels of unsatisfactory smears of characteristics associated with cytologic abnormalities. GOAL: To assess the yield to Pap smear screening in an STD clinic and to evaluate the rates of and risk factors for atypia, low-grade SIL (LSIL), and high-grade SIL (HSIL). STUDY DESIGN: A chart review of the clinic records of women undergoing Pap smear screening between 1991 and 1994 was conducted. Results were assessed from two different screening protocols, the first using a Dacron swab to obtain the endocervical sample and the second using a cytobrush. RESULTS: Of 2034 Pap smears, 1313 (64.6%) were negative, 202 (9.9%) were unsatisfactory, 257 (12.6%) were atypical, 211 (10.4%) had LSIL, and 51 (2.5%) had HSIL. With the change to the cytobrush protocol, the rate of unsatisfactory smears decreased from 14.4% to 3% (p < 0.001), atypia increased from 10% to 16.7% (p < 0.001), and HSIL rose from 1.7% to 3.7% (p < 0.001). By multivariate analysis, atypia was associated with genital warts (odds ratio (OR) 1.53, 95% confidence interval (CI): 1.16-2.02); LSIL with younger age (p < 0.001, for trend), black race (OR 1.51, 95% CI: 1.08-2.10), genital warts (OR 1.81, 95% CI: 1.33-2.47), and an abnormal appearance of the cervix on examination (OR 2.49, 95% CI: 1.85-3.35); and HSIL with a previous abnormal Pap smear (OR 2.48, 95% CI: 1.08-2.10). Overall, abnormality rates were significantly higher in adolescents (35.5%) than older women (21.7%) (p < 0.01). CONCLUSIONS: Obtaining satisfactory Pap smears among women undergoing screening in an STD clinic is feasible and cytologic abnormalities are common. These results continue to support the need for Pap smear screening in STD clinics, but the high rates in adolescents, a group in whom the natural history of cytologic abnormalities has not been well-defined, raise questions about the need to develop age-appropriate screening and management strategies.

Adolescent↗

PubMed1998

Imiquimod, a patient-applied immune-response modifier for treatment of external genital warts.

Genital human papillomavirus infection is one of the most common sexually transmitted diseases. Imiquimod is a new agent, an immune-response modifier, that has been demonstrated to have potent in vivo antiviral and antitumor effects in animal models. The present prospective, multicenter, double-blind, randomized, vehicle-controlled trial evaluated the efficacy and safety of daily patient-applied imiquimod for up to 16 weeks for the treatment of external genital warts. Wart recurrence was investigated during a 12-week treatment-free follow-up period. In the intent-to-treat analysis, baseline warts cleared from 49 of 94 (52%) patients treated with 5% imiquimod cream, 13 of 90 (14%) patients treated with 1% imiquimod cream, and 3 of 95 (4%) vehicle-treated patients; the differences between the groups treated with vehicle and imiquimod were significant (P < 0.0001). For subjects who completed the follow-up period, recurrence rates after a complete response were 19% (9 of 48 patients) in the 5% imiquimod cream group, 17% (2 of 12) in the 1% imiquimod cream group, and 0% (0 of 3) in the vehicle-treated group. There were no systemic reactions, although local skin reactions (generally of mild or moderate severity) were common, particularly in the 5% imiquimod cream group. Local reactions caused two patients to discontinue treatment. The most frequently reported local skin reactions were erythema, excoriation or flaking, and erosion. Patient-applied 5% imiquimod cream is effective for the treatment of external genital warts and has a favorable safety profile.

Administration, Topical↗

PubMed1997

Assessment of the changing willingness to participate in phase III HIV vaccine trials among men who have sex with men.

This paper describes the willingness of 1267 men who have sex with men (MSM) enrolled in a prospective HIV vaccine preparedness study from Chicago, Denver, and San Francisco to enroll in HIV vaccine efficacy trials. Respondents were interviewed at baseline and followed-up at 6, 12, and 18 months. At each visit respondents were tested for HIV antibodies using enzyme-linked immunosorbent assay (ELISA) testing with Western blot confirmation. Over 18 months, the annualized HIV seroincidence of this cohort was 2.4%. At baseline, 37% of the men reported that they would be "definitely" willing to participate in an HIV vaccine efficacy trial; however, this dropped to 21% at 12 months and remained stable at 18 months. Greater willingness to participate (WTP) was related to lower education, engaging in HIV risk behavior, living in Denver, white ethnicity, and older age. Changing WTP suggests that the decision to participate in HIV vaccine efficacy trials may be complex and dynamic and take an extended time. These data underscore the importance of informed consent and raise questions regarding the influence of decision-making processes on HIV vaccine efficacy trial design, compliance, and validity.

AIDS Vaccines↗

PubMed1997

Insurance type and satisfaction with medical care among HIV-infected men.

Patient satisfaction is a valuable indicator of the quality of medical care. We assessed the impact of type of health insurance on satisfaction with seven aspects of medical care among 593 HIV-infected men without AIDS, drawn from three sites in San Francisco, California and Denver, Colorado. After adjustment for site of medical care, patient age, race, income, education, and CD4 lymphocyte count, there were few differences in satisfaction between men with fee-for-service and those with managed care insurance. Men with fee-for-service insurance were significantly more satisfied with their interpersonal relations with their clinicians (p = 0.01) but less satisfied with their finances (p = 0.0001) than persons with managed care. Uninsured men were significantly less satisfied with several aspects of care than insured persons. There were no significant differences in satisfaction between men with managed care and those with public insurance. HIV-infected persons who have a choice of insurance should carefully weigh their options, recognizing the implicit trade-offs between types of insurance. Those who choose fee-for-service insurance can expect to be more satisfied with interpersonal relations with their medical providers but less satisfied with financial aspects of their plans. Efforts to address the low satisfaction of uninsured persons are needed.

Adult↗

PubMed1997

Results of valve replacement with mechanical and biological prostheses in chronic renal dialysis patients.

BACKGROUND: Whether biological or mechanical valves should be used in patients on chronic dialysis therapy remains to be clearly defined. METHODS: A retrospective review was performed on 19 consecutive patients from our institution with end-stage renal disease on chronic peritoneal or hemodialysis undergoing aortic (n = 12), mitral (n = 5), or aortic-mitral (n = 2) valve replacement. RESULTS: The 9 biological and 10 mechanical valve patients had similar ages (56.5 versus 56.6 years) and cardiovascular risk factors. The overall estimated Kaplan-Meier survival was 60% +/- 12% at 12 months and 42% +/- 14% at 60 months. Mechanical valve patients had a significantly higher rate of postoperative cerebrovascular accidents or bleeding complications (10/10 versus 0/9; chi 2 = 17.0; p < 0.001). No subsequent reoperations were required for biological valve failure at a mean follow-up of 32 +/- 53 months. CONCLUSIONS: These results demonstrate that in patients with end-stage renal disease, use of mechanical valves is associated with significant risk of complications, whereas biological valve failure from prosthetic dysfunction is unusual. Overall survival is poor in both groups of patients. Therefore, preference should be given to biological valve instead of mechanical valve prostheses in patients on chronic renal dialysis.

Aged↗