The psychosocial burden of human papillomavirus related disease and screening interventions.

OBJECTIVES: (i) To assess the psychosocial burden of testing for human papillomavirus (HPV) related genital disease or of a HPV-related diagnosis; (ii) to compare an instrument specifically designed to measure HPV-related psychosocial burden with other generic quality of life (QoL) instruments. METHODS: A cross-sectional design. Researchers recruited women from outpatient clinics at a major tertiary women's hospital and a sexual health centre who completed surveys within 3 months of receiving RESULTS: 331 women, 18-45 years, who had experienced a normal cervical Papanicolaou (Pap) result, an abnormal Pap result, biopsy confirmed cervical intraepithelial neoplasia (CIN) or external genital warts (EGW). MAIN OUTCOME MEASURES: The HPV impact profile (HIP) designed to assess the psychosocial impact of HPV; two general health-related QoL surveys-the EuroQoL VAS and the Sheehan disability scale; and a HPV knowledge survey. RESULTS: Response rate was 78%. Significant psychosocial impacts were found for women screened for, or having a diagnosis of, HPV-related genital disease. The largest impact was in women with CIN 2/3 and EGW. This HPV-related psychosocial impact was most sensitively detected with the HIP. Relative to generic measures of QoL, the HIP provided insight into the full range of psychosocial impacts of HPV testing and diagnoses. CONCLUSIONS: Clinicians need to be aware of the potential psychosocial impact of testing for or diagnosing HPV-related genital disease, in particular CIN 2/3 and EGW. The HIP survey is a more sensitive measure of the psychosocial impact of HPV-related genital disease than generic QoL surveys.

Immunisation coverage among children born to HIV-infected women in Rakai district, Uganda: Effect of voluntary testing and counselling (VCT).

To evaluate the impact of maternal HIV-infection on routine childhood Immunisation coverage, we compared the Immunisation status of children born to HIV-infected and HIV-uninfected women in rural Uganda. The study population was 214 HIV(+) and 578 HIV(-) women with children aged 6 to 35 months previously enrolled in a community study to evaluate maternal and child health in Rakai District, Uganda. Sampling of subjects for interview was stratified by the use of voluntary counselling and testing (VCT) service so that the final sample was four groups: HIV + /VCT+ (n = 98); HIV + /VCT- (n = 116); HIV - /VCT+ (n= 348); HIV - /VCT- (n = 230). The main outcome measure was the percent of complete routine childhood Immunisations recommended by the WHO as assessed from Immunisation cards or maternal recall during household interviews. We found that Immunisation coverage in the overall sample was 26.1%. For all vaccines, children born to HIV-infected mothers had lower Immunisation coverage than children born to HIV-negative mothers (21.3 vs. 27.7%). There was a statistically significant interaction between maternal HIV-infection and maternal knowledge of HIV-infection (p = 0.034). The children of mothers who were HIV-infected and knew their serostatus (HIV + /VCT + ) had a more than two-fold odds of underImmunisation (OR = 2.21, 95% CI: 1.14, 4.29) compared to children of mothers who were HIV - /VCT-. We conclude that maternal HIV-infection was associated with childhood underImmunisation and this was mediated by a mother's knowledge of her HIV status. HIV VCT programmes should encourage HIV-infected mothers to complete childhood Immunisation. Improving access to Immunisation services could benefit vulnerable populations such as children born to HIV-infected mothers.

Measuring quality of life among HIV-infected women using a culturally adapted questionnaire in Rakai district, Uganda.

To examine self-reported quality of life and health status of HIV-infected women and a comparison sample of HIV-uninfected women in rural Uganda, we culturally adapted a Lugandan version of the Medical Outcomes Survey-HIV (MOS-HIV). We administered a cross-sectional survey among 803 women (239 HIV-positive and 564 HIV-negative) enrolled in a community study to evaluate maternal and child health in Rakai District, Uganda. The interview took 20 minutes and was generally well-accepted. Reliability coefficients were >0.70, except for role functioning, energy and cognitive function. MOS-HIV scores for HIV-positive women were correlated with increasing number of physical symptoms and higher HIV viral load. Compared to HIV-negative women, HIV-positive women reported lower scores than HIV-negative women for general health perceptions, physical functioning, pain, energy, role functioning, social functioning, mental health and overall quality of life (p all <0.01). Substantial impairment was noted among women reporting >/=4 symptoms. In summary, HIV-positive women reported significantly poorer functioning and well-being than HIV-negative women. We conclude that patient-reported measures of health status and related concepts may provide a feasible, reliable and valid method to assess the impact of HIV/AIDS and future therapeutic interventions to improve patient outcomes in rural Africa.

Safety and immunogenicity trial in adult volunteers of a human papillomavirus 16 L1 virus-like particle vaccine.

BACKGROUND: Studies in animal models have shown that systemic immunization with a papillomavirus virus-like particle (VLP) vaccine composed of L1, a major structural viral protein, can confer protection against subsequent experimental challenge with the homologous virus. Here we report results of a double-blind, placebo-controlled, dose-escalation trial to evaluate the safety and immunogenicity of a human papillomavirus (HPV) type 16 (HPV16) L1 VLP vaccine in healthy adults. METHODS: Volunteers were given intramuscular injections with placebo or with 10- or 50-microg doses of HPV16 L1 VLP vaccine given without adjuvant or with alum or MF59 as adjuvants at 0, 1, and 4 months. All vaccine recipients were monitored for clinical signs and symptoms for 7 days after each inoculation. Immune responses were measured by an HPV16 L1 VLP-based enzyme-linked immunosorbent assay (ELISA) and by an HPV16 pseudovirion neutralization assay. The antibody titers were given as the reciprocals of the highest dilution showing positive reactivity in each assay. All statistical tests were two-sided. RESULTS: The prevaccination geometric mean ELISA titer for six seropositive individuals was 202 (range, 40--640). All vaccine formulations were well tolerated, and all subjects receiving vaccine seroconverted. Serum antibody responses at 1 month after the third injection were dose dependent in recipients of vaccine without adjuvant or with MF59 but were similar at both doses when alum was the adjuvant. With the higher dose, the geometric means of serum ELISA antibody titers (95% confidence intervals) to purified VLP 1 month after the third injection were as follows: 10,240 (1499 to 69 938) without adjuvant, 10,240 (1114 to 94 145) with MF59, and 2190 (838 to 5723) with alum. Responses of subjects within each group were similar. Neutralizing and ELISA antibody titers were highly correlated (Spearman correlation =.85), confirming that ELISA titers are valid proxies for neutralizing antibodies. CONCLUSIONS: The HPV16 L1 VLP vaccine is well tolerated and is highly immunogenic even without adjuvant, with the majority of the recipients achieving serum antibody titers that were approximately 40-fold higher than what is observed in natural infection.

Suppression of HIV-1 reverse transcriptase activity by mycoplasma contamination of cell cultures.

The detection of HIV-1 in human peripheral blood lymphocytes is routinely carried out by cocultivation of test cells with normal peripheral blood mononuclear cells (PBMC). The presence of virus is evidenced by cytologic observation of syncytia or by detecting viral reverse transcriptase (RT) and/or p24 antigen in the culture supernatant fluid. Syncytia formation is almost always associated with the presence of virus as measured by RT, although many RT-positive cultures do not form syncytia. As part of a large screening program, we identified three cultures that showed syncytia but were RT negative. The basis for these discrepant observations was contamination of cultures with mycoplasma that interfered with the RT assay and thereby obscured virus detection. Treatment of cultures with BM-cycline removed mycoplasma contamination and restored RT activity. The present findings indicate the need for caution in the interpretation of negative RT results during HIV-1 isolation and especially in cultures that show evidence of syncytia formation.

Passive hemagglutination test for detection of antibodies to human immunodeficiency virus type 1 and comparison of the test with enzyme-linked immunosorbent assay and Western blot (immunoblot) analysis.

A passive hemagglutination test (PHA) was developed for detecting antibodies to human immunodeficiency virus type 1 (HIV-1) utilizing sheep erythrocytes cross-linked with purified envelope glycoprotein (gp160) of HIV-1. In an analysis of 216 human serum samples, 100% correlation was observed in 86 reactive and 124 nonreactive serum samples between PHA and commercial enzyme-linked immunosorbent assays and Western blot (immunoblot) analysis. Serum samples from gp160-immunized chimpanzees also reacted equally well in PHA. The test is simple, rapid, and inexpensive, thus providing an alternate, quick method of detecting HIV antibodies. These advantages and the thermal stability of the reagents that are used make this an attractive alternative for detecting prior exposure of individuals to HIV-1.