Feasibility of voluntary counselling and testing services for HIV among pregnant women presenting in labour in Pune, India.

Factors affecting the eligibility and acceptability of voluntary counselling and rapid HIV testing (VCT) were examined among pregnant women presenting in labour in Pune, India. Of the 6702 total women appearing at the delivery room from April 2001 to March 2002, 4638 (69%) were admitted for normal delivery. The remaining women presented with obstetrical complications, delivered immediately or were detected to be in false labour. Overall, 2818 (61%) of the admitted women had been previously tested for HIV during their pregnancy. If previously seen in the hospital's affiliated antenatal clinic, the likelihood of being previously tested was 89%, in contrast to 27% of women having prenatal care elsewhere. Of the admitted women, 3436 (74.3%) were assessed for their eligibility for rapid HIV VCT in the delivery room. Only 1322 (38%) of these women were found to be in early labour and without severe pain or complications, and therefore eligible for rapid HIV screening in the delivery room (DR). Of those 1322 eligible women, only 582 (44%) consented and were tested for HIV, of whom nine (1.6%) were found to be HIV-infected. Of the 1674 women arriving in the DR with no evidence of previous HIV testing, through this DR screening programme, we identified four women with HIV who could now benefit from treatment with ART. Given the high rates of HIV testing in the antenatal clinic at this site and the challenges inherent to conducting DR screening, alternatives such as post-partum testing should be considered to help reduce maternal to infant transmission in this population.

Profile of bone marrow examination in HIV/AIDS patients to detect opportunistic infections, especially tuberculosis.

Morphological evaluation of 140 bone marrow aspirations received in haematopathology laboratory with serologically established HIV infection, along with other relevant special haematological tests, was done during 1st Jan 1999 - 31st Dec 2002 at state government run tertiary care General Hospital in Maharashtra state, India. Out of 140 cases: 118 (84.28%) patients had anaemia, 25 (17.86%) had leukopenia, while 13 (9.28%) were thrombocytopenic. Dyserythropoiesis was present in 18 (12.86%) cases, dysmyelopoiesis 37 (26.43%) and micromegakaryocytes were noted in 44 (31.43%) cases. Haemophagocytosis was evident in 8 (5.71%) cases. Plasmacytosis encountered in 120 (85.71%) cases was a common feature. Based on clinical profile and results of other investigations 56 (40%) patients were clinically diagnosed to be of Mycobacterium tuberculosis (TB). Of these, 18 (12.86%) bone marrow aspirates were positive for AFB, Mycobacterium tuberculosis. In 4 cases cryptococci were demonstrated (Mucicarmine stain). There was one case each of Histoplasma capsulatum and leishmaniasis. One patient showed dense parasitemia with Plasmodium falciparum. One patient had immunoblastic lymphoma and showed bone marrow infiltration. Findings in this study strongly indicate that in HIV/AIDS, AFB stain should be done on each marrow aspirate to rule out tuberculosis in countries like India; where TB and AIDS are marching together.

A comparative clinical study to assess safety and reactogenicity of a DTwP-HepB+Hib vaccine.

Hepatitis B and Haemophilus influenzae type b (Hib) infections are major public health problems in developing countries, including India. Hence, combination vaccines containing DTwP, recombinant hepatitis B and Hib conjugate vaccines have been developed. Here, we report a Phase IV study which assessed safety and reactogenicity of a new DTwP-HepB+Hib vaccine. Three doses of DTwP-HepB+Hib vaccine (Pentavac, Serum Institute of India Ltd) or Tritanrix-HB+Hib (GlaxoSmithKline Beecham) were administered to infants at 6, 10 and 14 weeks of age in 2:1 ratio. The subjects were followed till one month after the third dose for safety assessment. Adverse events were captured in structured diaries and physical examinations were performed on each visit. The study was conducted in 1510 infants. Both vaccines caused injection site local and systemic reactions and the incidence was similar in both the groups. The incidence of local solicited reactions was: tenderness 35.9 %-33.6 %; redness 18.1 %-17.2 %; swelling 23.7 %-22.4 %; induration 12.8 % -13.7 %. The percentage of systemic solicited reactions were: diarrhea 2.2 %-2.2 %; drowsiness 3.3 %-3.4 %; fever 14.0 %-11.2 %; irritability 28.1 %-25.4 %; loss of appetite 6.6 %-5.6 %; persistent crying 17.7 %-15.7 %; vomiting 3.5 %-3.0 %. No serious adverse event was caused by the vaccines. The new DTwP-HepB+Hib combination vaccine showed similar safety profile to that of an imported vaccine in Indian infants.

Optimizing the HIV/AIDS informed consent process in India.

BACKGROUND: While the basic ethical issues regarding consent may be universal to all countries, the consent procedures required by international review boards which include detailed scientific and legal information, may not be optimal when administered within certain populations. The time and the technicalities of the process itself intimidate individuals in societies where literacy and awareness about medical and legal rights is low. METHODS: In this study, we examined pregnant women's understanding of group education and counseling (GEC) about HIV/AIDS provided within an antenatal clinic in Maharashtra, India. We then enhanced the GEC process with the use of culturally appropriate visual aids and assessed the subsequent changes in women's understanding of informed consent issues. RESULTS: We found the use of visual aids during group counseling sessions increased women's overall understanding of key issues regarding informed consent from 38% to 72%. Moreover, if these same visuals were reinforced during individual counseling, improvements in women's overall comprehension rose to 96%. CONCLUSIONS: This study demonstrates that complex constructs such as informed consent can be conveyed in populations with little education and within busy government hospital settings, and that the standard model may not be sufficient to ensure true informed consent.

Awareness of HIV/AIDS and household environment of pregnant women in Pune, India.

Our objective was to determine the level of HIV/AIDS knowledge of pregnant women in India. In a sub-sample of these women, we documented the extent to which they experienced adverse social and physical difficulties within their home. The study was performed at an urban antenatal hospital clinic in Maharastra, India. From April to September 2001, structured interviews were conducted on 707 randomly selected antenatal clinic patients related to HIV/AIDS knowledge. Of these, 283 were further interviewed to document any social or physical difficulties they experienced. Over 75% of women displayed knowledge of primary transmission routes. Nearly 70% of women demonstrated knowledge of maternal to child transmission, however, only 8% knew of any methods of prevention. TV and written material were more strongly related to knowledge than access to radio messages or conversations with individuals. Thirty per cent of the women experienced physical or mental abuse or their spouse's alcohol and/or drug problems. Women reporting such abuse were more than twice as likely to have adequate HIV/AIDS knowledge compared with women reporting no such abuse. We found no relationship between reported household abuse and educational level of woman, husband, occupation of either partner, language or religion. We found no relationship between HIV status and knowledge of HIV and no relationship between HIV status and risk of abuse in the household. However, the total number of HIV patients in our sample was very small.

Sensitivity and specificity of rapid HIV testing of pregnant women in India.

OBJECTIVE: Efforts to prevent HIV transmission from mother to infants in settings like India may benefit from the availability of reliable methods for rapid and simple HIV screening. Data from India on the reliability of rapid HIV test kits are limited and there are no data on the use of rapid HIV tests for screening of pregnant women. METHODS: Pregnant women attending an antenatal clinic and delivery room in Pune agreed to participate in an evaluation of five rapid HIV tests, including (a) a saliva brush test (Oraquick HIV-1/2, Orasure Technologies Inc.), (b) a rapid plasma test (Oraquick HIV-1/2) and (c) three rapid finger prick tests (Oraquick HIV-1/2; HIV-1/2 Determine, Abbott; NEVA HIV-1/2 Cadila). Results of the rapid tests were compared with three commercial plasma enzyme immunoassay (EIA) tests (Innotest HIV AB EIA, Lab systems/ELISCAN HIV AB EIA, UBI HIV Ab EIA). RESULTS: Between September 2000 and October 1, 2001, 1258 pregnant women were screened for HIV using these rapid tests. Forty-four (3.49%) of the specimens were HIV-antibody-positive by at least two plasma EIA tests. All of the rapid HIV tests demonstrated excellent specificity (96-100%). The sensitivity of the rapid tests ranged from 75-94%. The combined sensitivity and specificity of a two-step algorithm for rapid HIV testing was excellent for a number of combinations of the five rapid finger stick tests. CONCLUSION: In this relatively low HIV prevalence population of pregnant women in India, the sensitivity of the rapid HIV tests varied, when compared to a dual EIA algorithm. In general, the specificity of all the rapid tests was excellent, with very few false positive HIV tests. Based upon these data, two different rapid HIV tests for screening pregnant women in India would be highly sensitive, with excellent specificity to reliably prevent inappropriate use of antiretroviral therapy for prevention of vertical HIV transmission.

Fetal hydantoin syndrome with rheumatic valvular heart disease.

Research has shown that anticonvulsants are teratogens and pose a risk for fetal malformations. Though Fetal Hydantoin Syndrome (FHS) was first reported by Langhman and others, wide phenotypic variability of this syndrome has lead many clinicians to question its very existence. We report a twelve year old girl with FHS with rheumatic valvular heart disease.

A randomised multicentre study to compare the safety and efficacy of albendazole and metronidazole in the treatment of giardiasis in children.

A randomised control multicentre study to compare the safety and efficacy of albendazole and metronidazole in the treatment of giardiasis in children is reported. One hundred and fifty children of either sex (age range: 2-10 years) were randomised to receive either a single dose of 400 mg of albendazole suspension, or 22.5 mg/kg/day of metronidazole in 3 divided doses for 5 consecutive days. At the end of therapy, majority of children in both treatment groups were symptom free. Two days after completion of therapy, 97% of children in both treatment groups were giardia free in the stools. Side effects were noted in 3 children in the albendazole group, and in 20 children in the metronidazole group. We conclude that albendazole suspension is as effective as metronidazole in the treatment of giardial infection in children. It is safe and has fewer side effects as compared to metronidazole.

Experience with a measles vaccine manufactured in India.

Five hundred and twenty seven children between 7 months and 2 years of age were vaccinated with measles vaccine manufactured by the Serum Institute of India. The sero-conversion rate in children who had no antibodies previous to vaccination was 98.4% as tested in HI. Ninety per cent of children who had pre-vaccination measles antibodies showed a two-fold or more rise in HI antibodies. The side reactions of the vaccine were negligible.

Efficacy of two dose measles vaccination in a community setting.

OBJECTIVE: To compare the efficacy of two dose and single dose measles vaccination in a community setting. DESIGN: Two community ICDS blocks with populations of 8990 and 8550 children below 12 years of age were selected. Block A had 1560 children between 9 mo to 1 year of age and Block B had 1380 children between the age of 9 mo to 1 year. METHODS: All eligible children between 9 mo to 1 year of age were given measles vaccination in October 1994. Only the children in Group A were given a second dose of measles (as MMR) in April 1995; six months after the first dose. A survey was undertaken from January 1996 to April 1996 to clinically evaluate the number of cases of measles in both these blocks. RESULTS: In Block A 3 children developed measles, whereas in Block B, there were 16 cases of measles (p < 0.01). All other parameters in both groups, e.g., cold chain maintenance were similar. CONCLUSION: This study supports the superiority of two dose measles vaccination given at an interval of 6 months over a single dose measles in a community setting.

Immunogenicity study of Haemophilus influenzae type B conjugate vaccine in Indian infants.

OBJECTIVE: To assess the immunogenicity in Indian infants to Haemophilus influenzae b oligosaccharide conjugate vaccine (HbOC). DESIGN: Prospective multicenter study. SETTING: Pediatric Out Patient Department of general hospitals in Pune and Mumbai. SUBJECTS: 124 full term healthy infants brought for routine DPT/OPV immunization. METHODS: Infants were administered 3 doses of 0.5 ml of HbOC, on the same day as their DPT/OPV immunization, injected intramuscularly on the limb opposite to that where DPT vaccine was administered. Data on local reactions and general symptoms was collected for three days after every dose. The children had their blood collected for assay of anti PRP (polyribosil ribitol phosphate) antibody titers, along with the first injection and one month after the third injection. One hundred and three infants completed the study protocol with two blood collections. RESULTS: The initial geometric mean titers (GMT) of 0.124 mcg/ml rose by 37 times to 4.552 mcg/ml. Ninety eight children (95.1%) had a final titer of > or = 0.15 mcg/ml, the minimum level associated with protection, and 77 children (74.8%) had a final level of > or = 1.0 mcg/ml, a level associated with long term protection. CONCLUSION: HbOC is immunogenic in Indian infants when used as per the locally recommended DPT/OPV immunization schedule.

Serum amino acids and genesis of protein energy malnutrition.

Twenty four patients of classical marasmus and kwashiorkor along with equal number of healthy controls were selected for the study. Their serum amino acid patterns analysis revealed a mean ratio of glutamate to alanine in fasting samples of normal individuals to be 0.33, while it as 9.3 in kwashiorkor and 1.6 in marasmus. This differences in controls, kwashiorkor and marasmus was statistically significant. This observation may explain evolution of marasmus and kwashiorkor in children with similar diets. On the basis of the present observation it is postulated that in kwashiorkor, the conversion of pyruvate to alanine in presence of glutamate, an aminogroup donor does not proceed normally, resulting in accumulation of glutamate and low alanine. Thus the development of marasmus and kwashiorkor may not be related to dietary inadequacy alone but also to the transaminase function. This could be genetic in origin.

Immunogenicity and reactogenicity of indigenously produced MMR vaccine.

OBJECTIVES: To study immunogenicity and reactogenicity of indigenously produced MMR vaccine and to assess the booster effect of MMR immunization on measles seroconversion. DESIGN: A longitudinal follow up. SETTING: Hospital based and home follow up, as required. SUBJECTS: 89 children already immunized for measles, between 15 to 24 months of age for immunogenic evaluation and 866 subjects for the reactogenic component. METHODS: Prevaccination and postvaccination samples collected one and four weeks after vaccination were studied by ELISA for IgG and IgM antibodies against the three diseases. A clinical follow up of immunized children was done at 3 days, 7 days, 6 weeks and 6 months after immunization. RESULTS: IgG positivity 4 weeks after immunization rose from 75% to 100% for measles, from 12% to 92% for mumps, and from 13% to 99% for rubella. Only mild side effects including pain and swelling in 37 (4.3%) cases, mild fever in 51 (5.9%) cases, cough in 40 (4.6%) cases and a transient rash in 7 (0.8%) cases were observed. CONCLUSIONS: The indigenously manufactured MMR vaccine has an excellent immunogenicity and low reactogenicity with a booster effect for measles seroconversion in children already immunized for this disease.

Reactogenecity of indigenously produced measles vaccine.

OBJECTIVE: To assess the safety and reactogenecity of indigenously produced measles vaccine derived from EZ strain. DESIGN: A longitudinal clinical follow up after vaccination. SETTING: Hospital based and home follow up, as required. SUBJECTS: 12,470 children, 9 to 15 months old, immunized with measles vaccine of EZ strain, in accordance with the National Immunization Schedule, at five centers. METHODS: A clinical follow up of children at 1 day, 1 week, 2 weeks, 3 weeks and 6 weeks after measles vaccination. A detailed clinical neurological examination in children showing side effects. RESULTS: Mild side effects were documented in 31%. Of these, 90% were seen in the first two weeks, out of which two thirds were seen during the first week. Commonest side effects were coryza (10%), fever (9.8%), cough (3.2%) and diarrhea (3.2%). Convulsions, with no later sequelae were documented in 2 cases only. CONCLUSIONS: Measles vaccine manufactured in India, using EZ strain is a safe vaccine. It has a level of reactogenecity including neurological aspects, lower than that reported in India with the Schwarz strain vaccine.