The HVTN protocol 903 vaccine preparedness study: lessons learned in preparation for HIV vaccine efficacy trials

Successful recruitment and retention of HIV-uninfected at-risk participants are essential for HIV vaccine efficacy trials. A multicountry vaccine preparedness study was started in 2003 to assess enrollment and retention of HIV-negative high-risk participants and to assess their willingness to participate in future vaccine efficacy trials. HIV-negative high-risk adults were recruited in the Caribbean, in Southern Africa, and in Latin America, and were followed for 1 year. Participants included men who have sex with men, heterosexual men and women, and female sex workers. History of sexually transmitted infections and sexual risk behaviors were recorded with HIV testing at 0, 6, and 12 months, and willingness to participate in future vaccine trials was recorded at 0 and 12 months. Recruitment, retention, and willingness to participate in future trials were excellent at 3 of the 6 sites, with consistent declines in risk behaviors across cohorts over time. Although not powered to measure seroincidence, HIV seroincidence rates per 100 person-years (95% confidence interval [CI]) were as follows: 2.3 (95% CI: 0.3 to 8.2) in Botswana, 0.5 (95% CI: 0 to 2.9) in the Dominican Republic, and 3.1 (95% CI: 1.1 to 6.8) in Peru. The HIV Vaccine Trials Network 903 study helped to develop clinical trial site capacity, with a focus on recruitment and retention of high-risk women in the Americas, and improved network and site expertise about large-scale HIV vaccine efficacy trials.     

HIV-1 target cells in foreskins of African men with varying histories of sexually transmitted infections

Numerous epidemiologic studies have found significant associations between lack of circumcision and HIV-1 acquisition in men. To our knowledge, this is the first study of human foreskin tissue that examines biologic mechanisms that increase susceptibility of uncircumcised African men to HIV-1. Foreskin specimens from 20 men with and 19 men with no history of sexually transmitted infections were examined for HIV-1 target cells. Most Langerhans cells were found in the epithelium; most CD4+ T cells and macrophages were in the submucosa. There were no differences in HIV-1 target cells between men with and those without history of sexually transmitted infections. However Langerhans cells and macrophages were more abundant in the group with a history of infection. The densities and positions of HIV-1 target cells in the foreskin tissue of these Kenyan men indicate that the inner mucosal surface of the human foreskin contains cells that make it highly susceptible to HIV infection.     

HIV sexual risk behavior over 36 months of follow-up in the world's first HIV vaccine efficacy trial

Increased risk behavior among participants in HIV vaccine efficacy trials has been a concern. This study evaluated HIV sexual risk behavior among 5095 HIV-negative men who have sex with men (MSM) and 308 women enrolled in a randomized, double-blind, placebo-controlled efficacy trial of a bivalent rgp120 vaccine at 61 sites, primarily in North America. Sexual risk behavior data were collected at baseline and semiannually for 36 months. Overall, sexual risk behavior did not exceed baseline levels during the trial. Among MSM, younger age (< or =30 years), perceived assignment to vaccine, and nonblack race were associated with an increased probability of unprotected anal sex. Among women, unprotected vaginal sex initially decreased but was statistically equivalent to baseline by 24 months, whereas unprotected vaginal sex with HIV-infected partners decreased from baseline, where it remained throughout the trial. HIV sexual risk behavior did not increase among trial participants; however, it was substantial throughout the trial. Consistently high levels of risk behavior and the association of these behaviors to perceived assignment and demographic variables underscore the need for vigilant HIV risk reduction counseling, informed consent, and educational processes in the context of HIV vaccine efficacy trials.     

HIV-1 incidence among male workers at a sugar estate in rural Malawi

OBJECTIVES: To determine incidence of HIV and associated risk factors in two cohorts of men working at a sugar estate in rural Malawi. DESIGN: Prospective studies. METHODS: After counseling and obtaining informed consent, male workers were tested for HIV-1 and syphilis. Baseline HIV-seronegative men were enrolled in two follow-up studies in 1994 and 1998, and were retested for HIV and syphilis at 6-month follow-up visits. Demographic, behavioral, and medical history was collected at baseline. Cumulative HIV incidence based on Kaplan-Meier methods was estimated. HIV incidence was also estimated per 100 person-years (p-y). Crude and adjusted rate ratios for the association of risk factors with incident HIV infection were obtained using Cox proportional hazards models. RESULTS: HIV prevalence was 24.3% among 1692 men screened in 1994 and 21.0% among 1349 men screened in 1998 (p <.03). HIV incidence was extremely high during 1994 to 1995 (17.1% for that 1-year period). Incidence dramatically declined in 1996, averaging about 3.5% per year from 1996 through 1999. Among men enrolled in the 1998 cohort, HIV incidence during 1998 to 1999 was 3.8%. After controlling for potential confounders reactive syphilis was associated with a twofold risk of HIV acquisition in each cohort. CONCLUSIONS: Urgent preventive measures are needed to control the spread of HIV in this economically important occupational cohort. In addition to conventional educational messages to reduce risky sexual behavior, treatment of other sexually transmitted diseases should be considered.     

Behavioral and social issues among volunteers in a preventive HIV vaccine trial in Thailand

Behavioral and social issues were investigated in 363 phase I/II preventive HIV-1 vaccine trial volunteers in Thailand. These issues included risk behavior, HIV knowledge, distress, and social consequences of vaccine trial participation. Data were collected at baseline and at 4-, 8-, and 12-month follow-up visits. Volunteers reported relatively low levels of risk behaviors at baseline and at follow-up. Overtly negative reactions from family or friends were reported by 5.9%. No experiences of discrimination in employment, health care, or insurance were reported. Mean levels of distress were low throughout the trial, and HIV-related knowledge was high, although it was common to consider the possibility of HIV transmission through casual contact. Findings add to the evidence that preventive HIV vaccine trials are feasible in Thailand.     

Readiness for HIV vaccine trials: changes in willingness and knowledge among high-risk populations in the HIV network for prevention trials. The HIVNET Vaccine Preparedness Study Protocol Team

Longitudinal data were analyzed to determine changes in willingness to participate in HIV vaccine efficacy trials and knowledge of vaccine trial concepts among populations at high risk of HIV-1 infection. Gay men (MSM), male and female injection drug users, and non-injecting women at heterosexual risk were recruited (n = 4892). Follow-up visits occurred every 6 months up to 18 months. Willingness was significantly lower at follow-up visits compared with at baseline. Knowledge levels increased for all study populations. Problematic concepts were possible effects of the vaccine on the immune system and lack of knowledge about efficacy of a vaccine before the start of a trial. For concepts concerning safety, blinding, and guarantees of future participation in trials, MSM men had significant increases in knowledge, but little to no change occurred for the other populations. An increase in knowledge was associated with becoming not willing, particularly among MSM with low knowledge levels. At least half of high-risk participants were consistently willing to participate in future vaccine efficacy trials and with basic vaccine education, knowledge levels increased. Continued educational efforts at the community and individual level are needed to address certain vaccine trial concepts and to increase knowledge levels in all potential study populations.     

Opportunity for prevention of HIV and sexually transmitted infections in Kenyan youth: results of a population-based survey

BACKGROUND: Data from sentinel serosurveillance are useful to estimate HIV infection in populations but may not be representative of the general population. General population-based surveys attempt to avoid selection bias and are the most appropriate for tracking changes in exposure to risk of HIV infection over time and assessing changes in behavior following prevention campaigns. OBJECTIVES: To provide baseline data for targeted sexually transmitted infection (STI) and HIV infection prevention interventions by studying parameters of sexual behavior and knowledge of HIV infection and STIs, measuring health-seeking behavior related to STIs, and measuring gonorrhea, Chlamydia, syphilis, and HIV-1 prevalences. DESIGN: Population-based survey with stratified sampling by age group from randomly selected households in a suburb of Mombasa, Kenya. METHODS: A standard questionnaire was administered to 1497 consenting adults between the ages of 15 and 49 years who lived in randomly selected households. Urine and blood samples were obtained for the estimation of gonorrhea, chlamydial infection, syphilis, and HIV-1 infection prevalences. RESULTS: Sexual activity in the past 12 months was limited to one partner in all age groups for most sexually active men (68%) and women (88%). More men than women reported two or more partners in the past 12 months (23% vs. 5%, respectively). Almost one half of those persons in the 15- to 19-year-old age group (56% of boys and 48% of girls) were sexually active. Condom use was low with all sexual partners, more so for women than for men. Reported STI symptoms in the past 12 months were high for both men and women. Knowledge of STI symptoms and HIV infection was present but incomplete. Overall HIV seroprevalence was 10.8%, with significantly higher rates among women (13.7%) than among men (8.0%). HIV seroprevalence in the 15- to 19-year-old age group was 3.2%. Female gender, Protestant religion, Catholic religion, and being divorced, separated, and widowed were significantly associated with HIV seroprevalence. Prevalences of gonorrhea, chlamydial infection, and syphilis were 0.9%, 1.5%, and 1.3%, respectively. CONCLUSIONS: This study emphasizes the vulnerability of young adults, in particular young women, to HIV infection and the need for intensive interventions in this group. The low use of condoms, incomplete knowledge of HIV infection and STIs, the high number of reported STIs, and the relatively low HIV-1 seroprevalence among the 15- to 19-year-old group indicate a large need for intensive STI and HIV infection prevention programs, especially for the 15- to 19-year-old age group.     

Incidence of HIV infection in stable sexual partnerships: a retrospective cohort study of 1802 couples in Mwanza Region,Tanzania

OBJECTIVE: To describe the dynamics of HIV transmission in stable sexual partnerships in rural Tanzania. DESIGN: Retrospective cohort study nested within community-randomized trial to investigate the impact of a sexually transmitted disease treatment program. METHODS: A cohort of 1802 couples was followed up for 2 years, with the HIV status of each couple assessed at baseline and follow-up. RESULTS: At baseline, 96.7% of couples were concordant-negative, 0.9% were concordant-positive, 1.2% were discordant with the male partner being HIV-positive, and 1.2% were discordant with the female partner being HIV-positive. Individuals living with an HIV-positive partner were more likely to be HIV-positive at baseline (women: odds ratio [OR] = 75.7, 95% confidence interval [CI]: 33.4-172; men: OR = 62.4, CI: 28.5-137). Seroincidence rates in discordant couples were 10 per 100 person-years (py) and 5 per 100 py for women and men, respectively (rate ratio [RR] = 2.0, CI: 0.28-22.1). In concordant-negative couples, seroincidence rates were 0.17 per 100 py in women and 0.45 per 100 py in men (RR = 0.38, CI: 0.12-1.04). Individuals living in discordant couples were at a greatly increased risk of infection compared with individuals in concordant-negative couples (RR = 57.9, CI: 12.0-244 for women; RR = 11.0, CI: 1.2-47.5 for men). CONCLUSION: Men were more likely than women to introduce HIV infection in concordant-negative partnerships. In discordant couples, incidence in HIV-negative women was twice as high as in men. HIV-negative individuals in discordant partnerships are at high risk of infection, and preventive interventions targeted at such individuals are urgently needed.     

HIV vaccine trial participation among ethnic minority communities: barriers, motivators, and implications for recruitment

BACKGROUND: Underrepresentation of ethnic minority communities limits the generalizability of HIV vaccine trial results. We explored perceived barriers and motivators regarding HIV vaccine trial participation among low-socioeconomic ethnic minority respondents at risk for HIV. METHODS: Six focus group interviews were conducted using a semistructured interview guide. Participants (N = 58, mean age = 36 years, 37% female, and 56% Latino/a and 35% African American) were recruited using venue-based sampling in Los Angeles. Data were analyzed using narrative thematic analysis and Ethnograph qualitative software. RESULTS: Perceived barriers to HIV vaccine trial participation, in rank order, were (1) vaccine-induced HIV infection, (2) physical side effects, (3) uncertainty about vaccine efficacy, (4) uncertainty about other vaccine characteristics, (5) mistrust, (6) low perceived HIV risk, (7) study demands, (8) stigma, and (9) vaccine-induced HIV seropositivity. Motivators were (1) protection against HIV infection, (2) free insurance and/or medical care, (3) altruism, and (4) monetary incentives. CONCLUSIONS: Population-specific HIV vaccine trial recruitment and implementation strategies should address trial risks from a family perspective, cultural gender norms, mistrust, low perceived HIV risk, the importance of African-American and Latino/a community participation in HIV vaccine trials, and misconceptions about gaining protection against HIV infection. Increasing the cultural relevance of trial recruitment and implementation should facilitate the participation of Latinos/as and African Americans in HIV vaccine trials.     

Strategies for modifying sexual behavior for primary and secondary prevention of HIV disease

Sexual behavior change is needed for both the primary and secondary prevention of HIV disease. Remarkable progress has been made in modifying high-risk behaviors in selected populations (e.g., gay men living in the epicenters of the epidemic). However, many at-risk populations (e.g., gay men living outside these epicenters, homosexual men who are young or Black, ethnic minorities--especially women of childbearing age, and persons over age 50) have received relatively little research attention and may be at risk for further infection. A community-level approach to behavior change represents one kind of comprehensive strategy to achieve significant reduction in the spread of HIV. Effective approaches at this level require component interventions that are effective in changing behavior and acceptable to target populations. Also needed is an infrastructure to support behavioral change efforts. Lacking at present is a comprehensive and coordinated structure to conceptualize, stimulate, and support the continuum of behavioral research needed for the control of HIV and other sexually transmitted diseases.     

High HIV prevalence and risk behaviors in men who have sex with men in Chennai, India

OBJECTIVE: To estimate HIV and sexually transmitted disease (STD) prevalence and behavioral risk characteristics of men who have sex with men (MSM) in Chennai, India. METHODS: A cross-sectional population-based random sample survey was conducted in 2001. Randomly selected residents of 30 slums in Chennai were interviewed for behavioral risk factors through face-to-face interviews. Sera and urine were examined for syphilis, HIV-1, gonorrhea, and chlamydia. Logistic regression analyses were used to assess associations between MSM status and HIV infection and to identify risk characteristics of MSM. RESULTS: Of 774 men, 46 reported (5.9%) sex with other men. MSM were more likely to be seropositive for HIV (odds ratio [OR] = 8.57; 95% confidence interval [CI]: 1.83, 40.23) and were more likely to have a history of STD (OR = 2.66; 95% CI: 1.18, 6.02) than non-MSM. Men who used illicit drugs in past 3 months (adjusted odds ratio [AOR] = 4.01; 95% CI: 1.92, 8.41), ever exchanged money for sex (AOR = 3.93; 95% CI: 1.97, 7.84), or were ever tested for HIV (AOR = 3.72; 95% CI: 1.34, 10.34) were significantly more likely to report sex with men. CONCLUSIONS: MSM in Chennai slums are at high risk for HIV. HIV prevention strategies aimed at changing unsafe drug and sexual practices should target the general population of men, with specific attention to areas with high rates of MSM.     

Couples at risk: HIV-1 concordance and discordance among sexual partners receiving voluntary counseling and testing in Uganda

OBJECTIVE: To determine correlates of HIV-1 concordance for couples receiving voluntary HIV counseling and testing. DESIGN: Cross-sectional study of couples receiving voluntary HIV counseling and testing in Kampala, Uganda. METHODS: An interview and physical examination were conducted for 49 HIV-1-concordant (both partners infected with HIV) and 126 HIV-1-discordant (1 partner infected with HIV and 1 partner HIV negative) couples. Blood samples from all participants were tested for HIV-1 and syphilis serology. CD4 cell count and HIV load were characterized for all HIV-infected persons. Urine samples were tested for Neisseria gonorrhoeae and Chlamydia trachomatis using ligase chain reaction. Associations between couples' HIV status and key sociodemographic, behavioral, and biomedical factors were analyzed. RESULTS: Men in HIV-concordant couples were more likely than men in HIV-discordant couples to be living together with their sexual partner (odds ratio [OR], 11.3; 95% confidence interval [CI], 2.8-53.7; P=0.004), to be uncircumcised (OR, 4.5; 95% CI, 1.1-18.8; P=0.042), and to have higher HIV loads (OR for each log increase, 3.0; 95% CI, 2.0-4.7; P<0.001). Women in HIV-concordant couples were more likely than women in HIV-discordant couples to be living together with their sexual partner (OR, 19.0; 95% CI, 3.8-84.8), to have an uncircumcised male partner (OR, 6.5; 95% CI, 1.6-26.4), to have had a sexually transmitted disease in the 6 months before enrollment (OR, 1.9; 95% CI, 0.9-4.5), and to have higher HIV loads (OR for each log increase, 2.2; 95% CI, 1.5-3.2). CONCLUSIONS: Several behavioral and biologic risk factors were associated with HIV concordance for couples. Providing early sexually transmitted disease diagnosis and treatment, antiretroviral therapy, and specially designed counseling to HIV-discordant couples may help prevent HIV transmission in couples where being in a stable sexual relationship is a major risk factor for HIV infection.     

Heterosexually transmitted HIV infection among African Americans in North Carolina

CONTEXT: Rates of heterosexually transmitted HIV infection among African Americans in the southeastern United States greatly exceed those for whites. OBJECTIVE: Determine risk factors for heterosexually transmitted HIV infection among African Americans. METHODS: Population-based case-control study of black men and women, aged 18-61 years, reported to the North Carolina state health department with a recent diagnosis of heterosexually transmitted HIV infection and age- and gender-matched controls randomly selected from the state driver's license file. A lower-risk stratum of respondents was created to identify transmission risks among people who denied high-risk behaviors. RESULTS: Most case subjects reported annual household income < $16,000, history of sexually transmitted diseases, and high-risk behaviors, including crack cocaine use and sex partners who injected drugs or used crack cocaine. However, 27% of case subjects (and 69% of control subjects) denied high-risk sexual partners or behavior. Risk factors for HIV infection in this subset of participants were less than high school education (adjusted odds ratio [OR] 5.0; 95% CI: 2.2, 11.1), recent concern about having enough food for themselves or their family (OR 3.7; 1.5, 8.9), and having a sexual partner who was not monogamous during the relationship with the respondent (OR 2.9; 1.3, 6.4). CONCLUSION: Although most heterosexually transmitted HIV infection among African Americans in the South is associated with established high-risk characteristics, poverty may be an underlying determinant of these behaviors and a contributor to infection risk even in people who do not have high-risk behaviors.     

High prevalence of gonococcal and chlamydial infection in men who have sex with men with newly diagnosed HIV infection: an opportunity for same-day presumptive treatment

BACKGROUND: The increasing use of point-of-care HIV tests in sexually transmitted disease (STD) clinics allows for rapid identification of patients with newly diagnosed HIV infection who may also be at risk for more common sexually transmitted infections. Positive point-of-care HIV test results might be used to identify and provide presumptive treatment to patients who are likely to be coinfected with gonorrhea (GC) and chlamydia (CT). METHODS: Data from 6864 STD clinic visits by men who have sex with men (MSM) with no history of HIV infection and an HIV antibody test at that visit were analyzed. Results from rectal, pharyngeal, and urine nucleic acid amplification tests were used to calculate the prevalence of infection with GC and CT. RESULTS: MSM with newly diagnosed HIV infection were more likely than HIV-uninfected MSM to be infected with GC (25.9% [53 of 205] vs. 10.9% [728 of 6659]; P < 0.001) and CT (18.5% [38 of 205] vs. 7.8% [518 of 6659]; P < 0.001). CONCLUSIONS: GC and CT are common in MSM with newly diagnosed HIV infection at an STD clinic. In this population, a positive point-of-care HIV test result is a useful risk marker for untreated gonococcal and chlamydial infections and provides a justification for presumptive GC and CT treatment.     

HIV incidence among men diagnosed with early syphilis in Atlanta, San Francisco, and Los Angeles, 2004 to 2005

BACKGROUND: Syphilis outbreaks among men who have sex with men (MSM) in the United States have raised concerns about increased HIV transmission in this population. We sought to estimate HIV incidence among men diagnosed with primary or secondary (P&S) syphilis in sexually transmitted disease (STD) clinics in Atlanta, San Francisco, and Los Angeles. METHODS: We analyzed deidentified sociodemographic information from routine syphilis surveillance databases and matching remnant sera from consecutive male patients with P&S syphilis who were tested for syphilis at 3 public health laboratories during January 2004 through January 2006. Deidentified sera positive for Treponema pallidum by particle agglutination were screened for HIV-1 antibodies by enzyme immunoassay (EIA). Specimens that were confirmed HIV-positive by Western blot analysis were then tested for recent HIV infection using the less sensitive (LS) HIV-1 Vironostika EIA and BED HIV-specific IgG/total IgG assay. RESULTS: Of 357 men with P&S syphilis (98 in Atlanta, 151 in San Francisco, and 108 in Los Angeles), 32% had primary syphilis and 85% were MSM (12% no MSM risk and 3% no information). The median age was 36 years; 40% were white, 31% black, 20% Hispanic, and 8% other. Among men with P&S syphilis, 160 (45%) were HIV-positive, of whom 8 were classified as having acquired recent HIV infection by the LS-Vironostika EIA (all confirmed by BED) and had no history of antiretroviral use or HIV-positive results >6 months earlier. Seven of the 8 men with recent HIV infection were MSM. The estimated HIV incidence was 9.5% per year (95% confidence interval [CI]: 2.9 to 16.0) among all men and 10.5% per year (95% CI: 2.7 to 18.3) among MSM. CONCLUSIONS: We found high HIV incidence among a high-risk population of US men diagnosed with P&S syphilis in STD clinics in Atlanta, San Francisco, and Los Angeles. Intensive integrated HIV/STD prevention programs are needed for this population.     

Willingness to participate and enroll in a phase 3 preventive HIV-1 vaccine trial

OBJECTIVES: To assess the extent to which HIV-negative cohort study participants would be willing to participate (WTP) in future HIV vaccine trials, to explore enrollment into an ongoing phase 3 HIV vaccine trial, and to assess changing WTP in such trials over time. METHODS: The Vanguard Project is a prospective study of gay and bisexual men in the greater Vancouver region, British Columbia, Canada. Sociodemographic characteristics, sexual risk behavior, beliefs around HIV, and reasons for not participating in the AIDSVAX B/B trial were collected from self-administered questionnaires. Contingency table analysis compared subjects who were WTP with subjects who were not WTP. Logistic regression analyses identified possible predictors of WTP. A subset analysis was conducted to assess changes in WTP in 2001 versus 1997. RESULTS: Of 440 respondents, 214 (48.6%) were WTP, and 97 (22.0%) were not WTP. Those WTP were disadvantaged, sexually risky, and had a high-perceived HIV risk (all p <.05). Reasons for not participating in the AIDSVAX B/B trial included fear of health problems and having missed the deadline for enrollment (all p < 0.05). Multivariate analysis revealed that having had a regular sex partner (adjusted odds ratio, 0.48 [confidence interval, 0.25-0.92]) was a negative predictor whereas having a high-perceived HIV risk (adjusted odds ratio, 5.35 [confidence interval, 1.57-18.25]) was a positive predictor of WTP. Comparing WTP in 2001 with that in 1997, 24% of 100 participants who had been previously WTP were now not WTP. CONCLUSION: Improving community and participant knowledge about preventive HIV vaccine trials may help ensure informed consent. However, whether informing potential participants will reverse or contribute to the declining trend in WTP observed in this cohort warrants further investigation.     

Human immunodeficiency virus infection among patients attending clinics for sexually transmitted diseases

To assess the prevalence and associated risk factors for human immunodeficiency virus (HIV) infection in patients attending inner-city clinics for sexually transmitted diseases in Baltimore, we screened 4028 patients anonymously, of whom 209 (5.2 percent) were seropositive for HIV. HIV-seropositivity rates were higher among men (6.3 percent) than women (3.0 percent) (P less than 0.001) and among blacks (5.0 percent) than whites (1.2 percent) (P less than 0.02). Among men, but not women, HIV seroprevalence increased markedly and steadily up to the age of 40. In men, HIV seropositivity was independently associated with increased age, black race, a history of homosexual contact, and the use of parenteral drugs. In women, a history of parenteral drug use or of being a sexual partner of a bisexual man or parenteral drug user were independently predictive of HIV seropositivity. In men, HIV seropositivity was also associated with a history of syphilis or a reactive serologic test for syphilis, and in women, with a history of genital warts. Since these associations were independent of the type and number of reported sexual partners, they raise the possibility that sexually transmitted diseases that disrupt epithelial surfaces may be important in the transmissibility of HIV. In addition, on a self-administered questionnaire, one third of HIV-infected men and one half of infected women did not acknowledge previous high-risk behavior for HIV exposure. These data suggest that patients at clinics for sexually transmitted diseases represent a group at high risk for HIV infection, and that screening, counseling, and intensive education should be offered to all patients attending such clinics.     

Sexually transmitted infections among prostitutes in Bratislava, Slovakia

Sera from 18 prostitutes from Bratislava were examined for the presence of antibodies to several sexually transmitted pathogens, namely Herpes simplex virus 2 (HSV-2), Human immunodeficiency viruses 1 and 2 (HIV-1 and HIV-2), Hepatitis B and C viruses (HBV and HCV), Chlamydia trachomatis, and Treponema pallidum. Results of this screening indicated that 11 prostitutes (61%) carried 1 or more sexually transmitted infections. The most prevalent antibodies were directed against HSV-2 (9 cases, i.e. 50%), which represents the most common sexually transmitted infection agent.     

Changes in HIV-1 incidence in heroin users in Guangxi Province, China

Guangxi Province, China recently experienced an outbreak of HIV-1 infection among heroin users. We studied HIV-1 incidence rates and associated risk factors for HIV-1 infection among heroin users residing in Pingxiang City. A total of 318 heroin users were followed from February 1998 through January 1999 (median follow-up: 8.1 months). Of these, 130 were prospectively followed from January through September 1999 (median follow-up: 8.3 months). HIV-1 and hepatitis C virus (HCV) incidence rates for each period were calculated. A generalized estimating equation approach was implemented to identify independent risk factors associated with HIV-1 infection across both periods. Among 318 study participants, 97.2% were men. The median age was 22 years. Approximately 60% reported sharing needles. HIV-1 prevalence at baseline was 15.4%. During the first follow-up period, HIV-1 incidence was 2.38 per 100 person years (py), and HCV incidence was 26.8 per 100 py. During the second follow-up period, HIV-1 incidence was 6.86 per 100 py, and HCV incidence was 28.9 per 100 py. After controlling for age and other factors, HCV seropositivity, history of sexually transmitted diseases, and sharing needles were independently associated with HIV-1 infection. These data suggest that HIV-1 incidence was rising over time in Pingxiang City, Guangxi Province. The high incidence of HCV heightens the importance of enhanced prevention programs to reduce injection and needle sharing among heroin users.     

Randomized,controlled evaluation of a prototype informed consent process for HIV vaccine efficacy trials

Procedures must be developed to ensure that valid informed consent is obtained from participants in HIV vaccine efficacy trials. A prototype informed consent process was evaluated among 4,892 persons at high risk for HIV infection in the HIV Network for Prevention Trials Vaccine Preparedness Study (VPS), a prospective cohort study of HIV seroincidence in eight U.S. metropolitan areas. Twenty percent of VPS participants were selected at random to undergo the prototype informed consent process at VPS month 3. Participants' knowledge of 10 key HIV vaccine trial concepts and willingness to participate in HIV vaccine efficacy trials were assessed and compared at baseline and semiannually thereafter for 18 months. Knowledge of HIV vaccine trial concepts was low at baseline. Participation in the prototype process was associated with substantial and sustained increases in knowledge (relative risks for the 10 items, 1.04-2.26), which were of similar magnitude across HIV risk groups, race/ethnicity, and educational levels. It is recommended that the prototype informed consent process be adopted for future HIV vaccine efficacy trials as well as for clinical trials in other research areas.