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

NCT ID: NCT00931216

Last Updated: 2012-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-03-31

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.

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).

Conditions

HIV Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Integrated ANC, PMTCT, HIV services

Intervention Type: PROCEDURE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• If site is already providing integrated ANC/HIV care services
• FOR HEALTH PROVIDER INCLUSION IN INTERVIEWS:

Exclusion Criteria

• FOR SITE EXCLUSION:

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Craig Cohen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig R Cohen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Janet M Turan, PhD, MPH

Role: STUDY_DIRECTOR

University of California, San Francisco

Elizabeth A Bukusi, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

Kenya Medical Research Institute

Locations

Migori District Hospital

Migori, , Kenya

Countries

Kenya

References

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.

Reference Type: DERIVED

PMID: 22970177 (View on PubMed)

Other Identifiers

KE.07.0055

Identifier Type: -

Identifier Source: org_study_id