Interventions to Decrease the Risk of Mother-to-Child Transmission of HIV in India

NCT00341796 | Completed

• 2 other identifiers: 99990221402-CH-N214
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study, conducted in Tamil Nadu, India, was initiated in response to the developing epidemic of HIV/AIDS 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

Conditions

HIV-1

Keywords

AIDS; HIV; Perinatal; Transmission; Antiretroviral; Outcomes

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage I:
• Registration in the Antenatal Clinics, Namakkal District Hospital or Rasipuram Government Hospital.
• Stage II:
• Registration in the Antenatal Clinics, Namakkal District Hospital or Rasipuram Government Hospital.
• Receipt of voluntary HIV counseling.
• Signed informed consent for HIV testing.
• Completion of HIV testing.
• Confirmation of HIV infection (documented by ELISA and Western Blot reports) if rapid test result is positive.
• Receipt of results of HIV testing.
• Age 18 years or more.
• Residence in Namakkal District, Tamil Nadu.
• Confirmation of pregnancy based upon history (last menstrual period) and/or physical examination (documented by a physician's statement in the medical record) and/or ultrasound.
• Willingness and intent to be followed at the antenatal clinic or by home visits for 1year after delivery.
• Signed informed consent by the HIV-infected woman for maternal and infant enrollment into prospective cohort study before onset of labor.
• Enrollment in the prospective cohort study between 24 and 32 weeks.

You may not qualify if:

• Stage II
• Clinical - Diagnosis of pre-eclampsia.
• Clinical - severe congenital malformations or other condition(s) not compatible with life; Documented or suspected serious infectious, cardiac, respiratory, or metabolic illness, or other immediate life threatening condition making the infant unable to tolerate oral medication beginning the first 24 hours of life.
• Laboratory - Hemoglobin of less than 13 grams per deciliter.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Study Sites (1)

National Institute of Child Health and Human Development (NICHD)

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Nduati R, John G, Mbori-Ngacha D, Richardson B, Overbaugh J, Mwatha A, Ndinya-Achola J, Bwayo J, Onyango FE, Hughes J, Kreiss J. Effect of breastfeeding and formula feeding on transmission of HIV-1: a randomized clinical trial. JAMA. 2000 Mar 1;283(9):1167-74. doi: 10.1001/jama.283.9.1167.

  PMID: 10703779 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: June 19, 2006
• First Posted: June 21, 2006
• Study Start: June 1, 2002
• Study Completion: August 1, 2006
• Last Updated: March 4, 2008

Record last verified: 2006-08

Locations

US (1)