HIV Infections Clinical Trial
Official title:
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).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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