NCT01001507

Brief Summary

This is a cluster randomized trial comparing the integration of family planning services into HIV care and treatment programs versus the standard referral for family planning services outside of HIV care and treatment programs within Suba, Kisumu East, Rongo and Migori districts in Nyanza province.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,040

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

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

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

December 9, 2013

Status Verified

December 1, 2013

Enrollment Period

2.1 years

First QC Date

October 22, 2009

Last Update Submit

December 6, 2013

Conditions

Unintended PregnancyHIV Infections

Keywords

Family planningHIVIntegrated servicesUnintended pregnancyKenya

Outcome Measures

Primary Outcomes (2)

  • Prevalence More Effective Contraception (defined as hormonal methods, intrauterine devices, and permanent methods)

    1 year post integration/site initiation and 2 years post integration/site initiation

  • Pregnancy rate

    1 year post integration/study initiation and 2 years post integration/site initiation

Secondary Outcomes (5)

  • Knowledge of contraceptive methods among HIV-positive women

    baseline (months 1-3); post-intervention (months 9-12)

  • Knowledge of contraceptive methods among providers

    baseline (months 1-3); post-intervention (months 9-12)

  • Acceptability of family planning services

    baseline (months 1-3); post-intervention (months 9-12)

  • Feasibility of providing family planning services at HIV care and treatment centers

    months 9-12

  • Reproductive intentions of HIV-infected women receiving care and treatment

    months 1-3

Study Arms (2)

Integrated HIV/FP services

EXPERIMENTAL

Family planning services are integrated into HIV care and treatment services at this facility.

Procedure: Integrated family planning/HIV care and treatment services

Standard (non-integrated), referral-based, services

NO INTERVENTION

Patients from the HIV care and treatment clinic will be referred for family planning services, and will not receive FP services by the HIV care provider

Interventions

Integrated family planning/HIV care and treatment servicesPROCEDURE

Family planning services will be provided during the patient's HIV care visit.

Integrated HIV/FP services

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • For health facilities:
  • Each site must be providing HIV care and treatment services
  • For participants:
  • Women aged 18-45, not pregnant, HIV+, receiving HIV care at that health facility
  • Men aged 18 and above, HIV+, receiving HIV care at that health facility

You may not qualify if:

  • For health facilities
  • If they are already providing integrated comprehensive HIV care and treatment that includes on-site family planning counseling and provision
  • For participants:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Migori District Hospital

Migori, Kenya

Location

Related Publications (1)

  • Cohen CR, Grossman D, Onono M, Blat C, Newmann SJ, Burger RL, Shade SB, Bett N, Bukusi EA. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya. PLoS One. 2017 Mar 22;12(3):e0172992. doi: 10.1371/journal.pone.0172992. eCollection 2017.

    PMID: 28328966DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Craig Cohen, MD, MPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Daniel Grossman, MD

    Ibis Reproductive Health

    PRINCIPAL INVESTIGATOR

  • Elizabeth Bukusi, MBChB, PhD

    Kenya Medical Research Institute

    PRINCIPAL INVESTIGATOR

  • Sara Newmann, MD, MPH

    University of California, San Francisco

    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
SPONSOR

Study Record Dates

First Submitted

October 22, 2009

First Posted

October 26, 2009

Study Start

September 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

December 9, 2013

Record last verified: 2013-12

Locations

KE(1)