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
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Procedure: Integrated ANC, PMTCT, HIV services||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1172 participants|
|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|
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.
- Vertical transmission of HIV [ Time Frame: 3 months postpartum ]
- Maternal HIV treatment outcomes [ Time Frame: 6 months, 1 year ]
- Provider job satisfaction [ Time Frame: 1 year ]
- Infant HIV testing uptake [ Time Frame: 3 months postpartum ]
- Patient enrollment, retention and adherence in HIV care and treatment [ Time Frame: 6 months, 1 year ]
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
|Migori District Hospital|
|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|