Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341796
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2006-06-19
Brief Title:
Interventions to Decrease the Risk of Mother-to-Child Transmission of HIV in India
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Prospective Cohort Study of the Seroprevalence of and Interventions to Decrease the Risk of Mother-to-Child Transmission of Human Immunodeficiency Virus Type 1 HIV in Tamil Nadu India
Status:
COMPLETED
Status Verified Date:
2006-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study conducted in Tamil Nadu India was initiated in response to the developing epidemic of HIVAIDS in India It is divided into two stages as follows
Stage I
All women registered in the pregnancy clinics at the Namakkal District Hospital or the Rasipuram Government Hospital in the state of Tamil Nadu in India will be offered participation in an educational session on HIV infection and transmission It will include a pre-educational assessment of knowledge attitudes and beliefs and a post-educational assessment of knowledge about HIV infection and transmission All women at the clinic regardless of whether or not they participate in the educational and assessment sessions will be offered HIV counseling and testing The objectives of this stage of the study are to
Assess the acceptance of education about HIV infection and transmission among pregnant women at the participating sites and their knowledge attitudes and beliefs about HIV
Assess the acceptance of voluntary counseling and HIV testing among pregnant women at these sites
Determine the prevalence of infection among women who accept HIV testing at these sites
Stage II
Pregnant HIV-infected women at the pregnancy clinics at the Namakkal District Hospital or the Rasipuram Government Hospital who are 18 years of age or older will be offered enrollment in Stage II of this study Participants will be followed during their pregnancy and until their baby is a year old The baby will be a part of the study from birth to one year of age After delivery both the mother and baby will be followed with regularly scheduled visits that include a physical examination and blood test
Treatment with the anti-AIDS drug zidovudine will be offered for both the mother and child For the study protocol the mother will receive the drug starting the 28th week of pregnancy and continuing through labor and delivery The infants will start drug treatment within the first 24 hours of life and continue for 6 weeks Women who do not choose to take zidovudine according to this schedule will be offered standard treatment with a shorter course of drug beginning with the 36th week of pregnancy and no preventative treatment for their infants All women will be offered education and counseling about the risks and benefits of breastfeeding and the risk of HIV transmission through breastfeeding The objectives of this stage of the study are to
Assess the safety and tolerability of zidovudine given according to this protocol
Assess the acceptance of and adherence to the zidovudine regimen in the protocol
Assess the acceptance of education and counseling about breastfeeding
Determine the mother-to-child HIV transmission rates in this study
Determine the rates of illness and death through 12 months after delivery
Determine risk factors for mother-to-child transmission of HIV
Stage I
All women registered in the pregnancy clinics at the Namakkal District Hospital or the Rasipuram Government Hospital in the state of Tamil Nadu in India will be offered participation in an educational session on HIV infection and transmission It will include a pre-educational assessment of knowledge attitudes and beliefs and a post-educational assessment of knowledge about HIV infection and transmission All women at the clinic regardless of whether or not they participate in the educational and assessment sessions will be offered HIV counseling and testing The objectives of this stage of the study are to
Assess the acceptance of education about HIV infection and transmission among pregnant women at the participating sites and their knowledge attitudes and beliefs about HIV
Assess the acceptance of voluntary counseling and HIV testing among pregnant women at these sites
Determine the prevalence of infection among women who accept HIV testing at these sites
Stage II
Pregnant HIV-infected women at the pregnancy clinics at the Namakkal District Hospital or the Rasipuram Government Hospital who are 18 years of age or older will be offered enrollment in Stage II of this study Participants will be followed during their pregnancy and until their baby is a year old The baby will be a part of the study from birth to one year of age After delivery both the mother and baby will be followed with regularly scheduled visits that include a physical examination and blood test
Treatment with the anti-AIDS drug zidovudine will be offered for both the mother and child For the study protocol the mother will receive the drug starting the 28th week of pregnancy and continuing through labor and delivery The infants will start drug treatment within the first 24 hours of life and continue for 6 weeks Women who do not choose to take zidovudine according to this schedule will be offered standard treatment with a shorter course of drug beginning with the 36th week of pregnancy and no preventative treatment for their infants All women will be offered education and counseling about the risks and benefits of breastfeeding and the risk of HIV transmission through breastfeeding The objectives of this stage of the study are to
Assess the safety and tolerability of zidovudine given according to this protocol
Assess the acceptance of and adherence to the zidovudine regimen in the protocol
Assess the acceptance of education and counseling about breastfeeding
Determine the mother-to-child HIV transmission rates in this study
Determine the rates of illness and death through 12 months after delivery
Determine risk factors for mother-to-child transmission of HIV
Detailed Description:
This study is divided into two stages In Stage I all women registered in the antenatal clinics at the Namakkal District Hospital or at the Rasipuram Government Hospital in the state of Tamil Nadu in India will be offered the opportunity to participate in an educational session on HIV infection and transmission With informed consent a systematic sample of the population will be asked to participate in a pre-educational session assessment of knowledge attitudes and beliefs and in a post-educational assessment of knowledge regarding HIV infection and transmission All women will be offered voluntary HIV counseling and testing irrespective of participation in the education session those who refuse to participate although education offered and in the pre- and post-educational assessments those among the systematic sample who do not provide signed informed consent The objectives of Stage I are 1 to assess the acceptance of education regarding HIV infection and transmission among antenatal women at the participating clinical sites and among a systematic sample of those offered such education to assess knowledge attitudes and beliefs as well as changes in knowledge 2 to assess the acceptance of voluntary counseling and HIV testing among antenatal women at the participating clinical sites and 3 to describe the HIV seroprevalence among antenatal women at the participating clinical sites who accept HIV testing The main outcomes of interest are the proportions of women in the antenatal clinics who agree to undergo HIV testing and of these the proportion who are seropositive for HIV
HIV seropositive women will be offered enrollment in Stage II a prospective cohort study All women enrolled in the prospective cohort study will be offered education and counseling regarding infant feeding ie the risks and benefits of breastfeeding factors which are likely to increase the risk of transmission through breastfeeding and the potential advantages and disadvantages of early weaning from breastmilk and replacement feeding
Women enrolled in the prospective cohort study at Rasipuram Government Hospital who meet eligibility criteria will be offered Protocol ZDVNVP zidovudine prophylaxis beginning at 28 weeks gestation or as soon as possible thereafter up to 36 weeks gestation if late presentation for antenatal care or other reasons preclude initiation at 28 weeks and continuing through labor until delivery and one dose of nevirapine at the onset of labor or as soon as possible thereafter Their infants will receive zidovudine beginning within the first 24 hours of life and continuing through the end of the sixth week of life and one dose of nevirapine within 24 hours after birth Those women who decline protocol ZDVNVP or who enroll after 32 weeks gestation can receive the standard of care the two dose nevirapine regimen Women enrolled at Namakkal District Hospital could receive the two-dose nevirapine regimen
The primary objectives of Stage II are 1 to assess the safety and tolerability of protocol ZDVNVP 2 to assess the acceptance of and adherence to protocol ZDVNVP 3 to assess the acceptance of education and counseling regarding infant feeding and 4 to describe the mother-to-child transmission rates among HIV-infected women and their infants enrolled in the prospective cohort study The secondary objectives of Stage II are 1 to describe morbidity and mortality rates through 12 months after deliverybirth and 2 to describe risk factors for mother-to-child transmission of HIV among HIV-infected women and their infants enrolled in the prospective cohort study The primary outcomes of interest are the safety and tolerability of protocol ZDVNVP the proportion of HIV-infected women who agree to receive protocol ZDVNVP the mother-to-child HIV transmission rate overall as well as according to receipt of protocol ZDVNVP and infant feeding modality and risk factors for transmission
HIV seropositive women will be offered enrollment in Stage II a prospective cohort study All women enrolled in the prospective cohort study will be offered education and counseling regarding infant feeding ie the risks and benefits of breastfeeding factors which are likely to increase the risk of transmission through breastfeeding and the potential advantages and disadvantages of early weaning from breastmilk and replacement feeding
Women enrolled in the prospective cohort study at Rasipuram Government Hospital who meet eligibility criteria will be offered Protocol ZDVNVP zidovudine prophylaxis beginning at 28 weeks gestation or as soon as possible thereafter up to 36 weeks gestation if late presentation for antenatal care or other reasons preclude initiation at 28 weeks and continuing through labor until delivery and one dose of nevirapine at the onset of labor or as soon as possible thereafter Their infants will receive zidovudine beginning within the first 24 hours of life and continuing through the end of the sixth week of life and one dose of nevirapine within 24 hours after birth Those women who decline protocol ZDVNVP or who enroll after 32 weeks gestation can receive the standard of care the two dose nevirapine regimen Women enrolled at Namakkal District Hospital could receive the two-dose nevirapine regimen
The primary objectives of Stage II are 1 to assess the safety and tolerability of protocol ZDVNVP 2 to assess the acceptance of and adherence to protocol ZDVNVP 3 to assess the acceptance of education and counseling regarding infant feeding and 4 to describe the mother-to-child transmission rates among HIV-infected women and their infants enrolled in the prospective cohort study The secondary objectives of Stage II are 1 to describe morbidity and mortality rates through 12 months after deliverybirth and 2 to describe risk factors for mother-to-child transmission of HIV among HIV-infected women and their infants enrolled in the prospective cohort study The primary outcomes of interest are the safety and tolerability of protocol ZDVNVP the proportion of HIV-infected women who agree to receive protocol ZDVNVP the mother-to-child HIV transmission rate overall as well as according to receipt of protocol ZDVNVP and infant feeding modality and risk factors for transmission
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-CH-N214 | None | None | None |