Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya - Full Text View

Purpose

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.

Condition	Intervention
HIV Infections	Procedure: Integrated ANC, PMTCT, HIV services


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Integration of HIV Care and Treatment Into Antenatal Care in Migori District, Kenya

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Vertical transmission of HIV [ Time Frame: 3 months postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]


Enrollment:	1172
Study Start Date:	June 2009
Study Completion Date:	March 2012
Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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).

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00931216

Locations


Kenya
Migori District Hospital
Migori, Kenya

Sponsors and Collaborators

University of California, San Francisco

Centers for Disease Control and Prevention

Kenya Medical Research Institute

Investigators


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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Craig Cohen, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00931216 History of Changes
Other Study ID Numbers:	KE.07.0055
Study First Received:	June 30, 2009
Last Updated:	April 6, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:


PMTCT Vertical transmission of HIV Pregnant women	Infant HIV testing Kenya AIDS

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2016