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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00931216
• Other study ID #: KE.07.0055
• Status: Completed
• Phase: N/A
• First received: June 30, 2009
• Last updated: April 6, 2012
• Start date: June 2009
• Est. completion date: March 2012

Study information

• Verified date: April 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1172
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
Kenya	Migori District Hospital	Migori

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Centers for Disease Control and Prevention, Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vertical transmission of HIV		3 months postpartum	No
Secondary	Maternal HIV treatment outcomes		6 months, 1 year	No
Secondary	Provider job satisfaction		1 year	No
Secondary	Infant HIV testing uptake		3 months postpartum	No
Secondary	Patient enrollment, retention and adherence in HIV care and treatment		6 months, 1 year	No