Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Migori, Kenya
- Migori District Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Vertical transmission of HIV
Time Frame: 3 months postpartum
|
3 months postpartum
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Maternal HIV treatment outcomes
Time Frame: 6 months, 1 year
|
6 months, 1 year
|
|
Provider job satisfaction
Time Frame: 1 year
|
1 year
|
|
Infant HIV testing uptake
Time Frame: 3 months postpartum
|
3 months postpartum
|
|
Patient enrollment, retention and adherence in HIV care and treatment
Time Frame: 6 months, 1 year
|
6 months, 1 year
|
Collaborators and Investigators
Investigators
- Study Director: Janet M Turan, PhD, MPH, University of California, San Francisco
- Principal Investigator: Elizabeth A Bukusi, MBChB, PhD, Kenya Medical Research Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KE.07.0055
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.