ClinicalTrials.gov
ClinicalTrials.gov Menu

Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00931216
Recruitment Status : Completed
First Posted : July 2, 2009
Last Update Posted : April 10, 2012
Sponsor:
Collaborators:
Centers for Disease Control and Prevention
Kenya Medical Research Institute
Information provided by (Responsible Party):
Craig Cohen, University of California, San Francisco

Study Description
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study seeks to determine the most effective way to reach and provide pregnant women with accessible, comprehensive, and high quality HIV care and treatment.

Condition or disease Intervention/treatment Phase
HIV Infections Procedure: Integrated ANC, PMTCT, HIV services Not Applicable

Detailed Description:

This study uses a prospective cluster randomized design. Twelve clinics similar in size, population, and services in Migori district, Kenya that provide ANC have been randomly assigned to receive "integrated ANC, PMTCT & HIV services" (intervention arm) or "non-integrated services" (control arm). At the intervention clinics, pregnant women will receive ANC, PMTCT and HIV care and treatment (including HAART if required) at the same clinic visit from the ANC provider. At the control clinics, women will receive antenatal care and PMTCT services with referral to the HIV care and treatment department located in the same facility. The control sites more closely resemble the current approach followed for care and treatment of HIV-infected pregnant women in Kenya. The content of ANC, PMTCT, and HIV care will be the same in the two study arms and will follow current Kenyan national guidelines. The only difference between the two arms will be the provider/location of HIV care and treatment.

Outcomes will be compared for HIV-positive pregnant women who attend intervention versus control facilities. In addition we will conduct qualitative research with health care providers at the study health facilities in order to learn provider perspectives on the two service models and to explore the effects of integration on provider job satisfaction (including work load).


Study Design
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya
Study Start Date : June 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Integrated ANC, PMTCT and HIV Services
HIV care and treatment services are integrated into antenatal care (ANC) services for women testing positive within the ANC at this facility.
 Procedure: Integrated ANC, PMTCT, HIV services
Of the 12 study clinics, 6 will be randomized to receive the intervention. At these 6 facilities, health care providers within the ANC department will be trained to also provide HIV/PMTCT care. Women testing positive within ANC clinics at integrated facilities will receive ANC, PMTCT and HIV services within the same visit/same service provider rather than being referred for HIV care and treatment.
No Intervention: Non-Integrated Services
Women testing positive in the ANC department are referred for care at the HIV clinic. HIV care and treatment services are not provided within the ANC at facilities randomized to this arm.


Outcome Measures
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Vertical transmission of HIV [ Time Frame: 3 months postpartum ]

Secondary Outcome Measures :
  1. Maternal HIV treatment outcomes [ Time Frame: 6 months, 1 year ]
  2. Provider job satisfaction [ Time Frame: 1 year ]
  3. Infant HIV testing uptake [ Time Frame: 3 months postpartum ]
  4. Patient enrollment, retention and adherence in HIV care and treatment [ Time Frame: 6 months, 1 year ]

Eligibility Criteria
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • FOR SITE INCLUSION:

    • Each site must provide ANC services
    • Each site must provide HIV testing services for pregnant women
    • Each site must have an average of at least 20 new ANC clients per month

  • FOR ENROLLMENT OF HIV-POSITIVE WOMEN:

    • All women testing HIV-positive at one of the 12 ANC clinics included in the study will be asked to participate in the study

  • FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:

    • Health care staff must work within the ANC clinic at selected facilities
    • Staff must be able to read and speak English well enough to complete the informed consent process, participate in a one-on-one in-depth interview in English and complete a brief self-administered questionnaire

Exclusion Criteria:

  • FOR SITE EXCLUSION:

    • If all of inclusion criteria are not met the site will be excluded
    • If site is already providing integrated ANC/HIV care services

  • FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:

    • If all of inclusion criteria are not met the site will be excluded
Contacts and Locations
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00931216


Locations
Kenya
Migori District Hospital
Migori, Kenya
Sponsors and Collaborators
University of California, San Francisco
Centers for Disease Control and Prevention
Kenya Medical Research Institute
Investigators
Principal Investigator: Craig R Cohen, MD, MPH University of California, San Francisco
Study Director: Janet M Turan, PhD, MPH University of California, San Francisco
Principal Investigator: Elizabeth A Bukusi, MBChB, PhD Kenya Medical Research Institute
More Information
Go to 
Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Craig Cohen, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00931216     History of Changes
Other Study ID Numbers: KE.07.0055
First Posted: July 2, 2009    Key Record Dates
Last Update Posted: April 10, 2012
Last Verified: April 2012

Keywords provided by Craig Cohen, University of California, San Francisco:
PMTCT
Vertical transmission of HIV
Pregnant women
 Infant HIV testing
Kenya
AIDS

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases