NCT00931216

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,172

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

April 10, 2012

Status Verified

April 1, 2012

Enrollment Period

2.8 years

First QC Date

June 30, 2009

Last Update Submit

April 6, 2012

Conditions

HIV Infections

Keywords

PMTCTVertical transmission of HIVPregnant womenInfant HIV testingKenyaAIDS

Outcome Measures

Primary Outcomes (1)

  • Vertical transmission of HIV

    3 months postpartum

Secondary Outcomes (4)

  • Maternal HIV treatment outcomes

    6 months, 1 year

  • Provider job satisfaction

    1 year

  • Infant HIV testing uptake

    3 months postpartum

  • Patient enrollment, retention and adherence in HIV care and treatment

    6 months, 1 year

Study Arms (2)

Integrated ANC, PMTCT and HIV Services

EXPERIMENTAL

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

Non-Integrated Services

NO INTERVENTION

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.

Interventions

Integrated ANC, PMTCT, HIV servicesPROCEDURE

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.

Integrated ANC, PMTCT and HIV Services

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • If site is already providing integrated ANC/HIV care services

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Migori District Hospital

Migori, Kenya

Location

Related Publications (1)

  • 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.

    PMID: 22970177DERIVED

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Officials

  • Craig R Cohen, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Janet M Turan, PhD, MPH

    University of California, San Francisco

    STUDY DIRECTOR

  • Elizabeth A Bukusi, MBChB, PhD

    Kenya Medical Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

June 1, 2009

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

April 10, 2012

Record last verified: 2012-04

Locations

KE(1)