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Integrating Family Planning Services Into HIV Care and Treatment in Nyanza Province, Kenya

NCT ID: NCT01001507

Last Updated: 2013-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5040 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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The study will have three parts. During the first part (3 months), baseline data on contraceptive prevalence and unintended pregnancy will be collected at 18 PSCs that are supported by the FACES program in Suba, Kisumu East, Nyatike, Rongo and Migori Districts. Also during this first part, information about knowledge, attitudes and practices related to family planning will be obtained from patients and from clinicians at the sites. During the second part (3 months), an intervention consisting of integrating family planning services will be designed and implemented at twelve of the 18 FACES-supported PSCs. We aim to utilize a 2:1 integration:control model, with delayed integration so as to gradually expand the integration of FP and HIV services throughout the 18 sites, while maintaining the ability to test hypotheses on the effects of integration on health outcomes. After collecting the baseline data, we plan to stratify the clinics into two categories based on the overall patient volume and differences in the structure of family planning provision, i.e., whether or not there is a specific MCH division providing family planning at the site or not. Randomization of sites will then occur among clinics in each of these strata, with a ratio of two intervention sites (integrated model) to one control site (family planning provided in the standard manner at the site). During the third and last part (12 months), data on prevalence more effective contraception and unintended pregnancy will be collected from each of the 18 sites. At the end of part three, information about knowledge, attitudes and practices related to family planning again will be obtained from patients and from clinicians at the sites. In addition, we will administer questionnaires assessing the acceptability of family planning services to patients, and in addition clinic staff will be answer a questionnaire assessing the feasibility of providing integrated family planning services. After 12 months of data collection, the 6 control sites were integrated and data were collected for an additional 11 months from all 18 sites to assess the sustainability of the intervention under the Ministry of Health.

The study population will primarily consist of HIV-positive men and non-pregnant, HIV-positive women of reproductive age who obtain care at the FACES-supported PSCs in Suba, Kisumu East, Rongo and Migori Districts in Nyanza Province, Kenya. In addition, study subjects will also include clinic staff at the FACES centers included in the study.

Conditions

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Unintended Pregnancy HIV Infections

Keywords

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Family planning HIV Integrated services Unintended pregnancy Kenya

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Integrated HIV/FP services

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

Group Type EXPERIMENTAL

Integrated family planning/HIV care and treatment services

Intervention Type PROCEDURE

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

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

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Integrated family planning/HIV care and treatment services

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

* If they are already providing integrated comprehensive HIV care and treatment that includes on-site family planning counseling and provision

For participants:

Exclusion Criteria

For health facilities
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ibis Reproductive Health

OTHER

Sponsor Role collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role collaborator

Tides

OTHER

Sponsor Role collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Craig Cohen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Daniel Grossman, MD

Role: PRINCIPAL_INVESTIGATOR

Ibis Reproductive Health

Elizabeth Bukusi, MBChB, PhD

Role: PRINCIPAL_INVESTIGATOR

Kenya Medical Research Institute

Sara Newmann, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Migori District Hospital

Migori, , Kenya

Site Status

Countries

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Kenya

References

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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.

Reference Type DERIVED
PMID: 28328966 (View on PubMed)

Other Identifiers

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TFR08-02986

Identifier Type: -

Identifier Source: org_study_id