Trial record 1 of 1 for:    NCT00931216
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Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya

This study has been completed.
Sponsor:
Collaborators:
Kenya Medical Research Institute
Information provided by (Responsible Party):
Craig Cohen, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00931216
First received: June 30, 2009
Last updated: April 6, 2012
Last verified: April 2012

June 30, 2009
April 6, 2012
June 2009
March 2012   (final data collection date for primary outcome measure)
Vertical transmission of HIV [ Time Frame: 3 months postpartum ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00931216 on ClinicalTrials.gov Archive Site
  • Maternal HIV treatment outcomes [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]
  • Provider job satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Infant HIV testing uptake [ Time Frame: 3 months postpartum ] [ Designated as safety issue: No ]
  • Patient enrollment, retention and adherence in HIV care and treatment [ Time Frame: 6 months, 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya
Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya

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.

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).

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
HIV Infections
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.
  • 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.
    Intervention: Procedure: Integrated ANC, PMTCT, HIV services
  • 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.
Turan JM, Steinfeld RL, Onono M, Bukusi EA, Woods M, Shade SB, Washington S, Marima R, Penner J, Ackers ML, Mbori-Ngacha D, Cohen CR. The study of HIV and antenatal care integration in pregnancy in Kenya: design, methods, and baseline results of a cluster-randomized controlled trial. PLoS One. 2012;7(9):e44181. doi: 10.1371/journal.pone.0044181. Epub 2012 Sep 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1172
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT00931216
KE.07.0055
No
Craig Cohen, University of California, San Francisco
University of California, San Francisco
  • Centers for Disease Control and Prevention
  • Kenya Medical Research Institute
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
University of California, San Francisco
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP