Trial record 1 of 1 for:    NCT01001507
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Integrating Family Planning Services Into HIV Care and Treatment in Nyanza Province, Kenya

This study has been completed.
Sponsor:
Collaborators:
Ibis Reproductive Health
Kenya Medical Research Institute
Tides
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01001507
First received: October 22, 2009
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Unintended Pregnancy
HIV Infections
Procedure: Integrated family planning/HIV care and treatment services

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Cluster Randomized Trial of Integration of Family Planning Services Into HIV Care and Treatment in Suba, Kisumu East, Rongo and Migori Districts of Nyanza Province

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Prevalence More Effective Contraception (defined as hormonal methods, intrauterine devices, and permanent methods) [ Time Frame: 1 year post integration/site initiation and 2 years post integration/site initiation ] [ Designated as safety issue: No ]
  • Pregnancy rate [ Time Frame: 1 year post integration/study initiation and 2 years post integration/site initiation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knowledge of contraceptive methods among HIV-positive women [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ] [ Designated as safety issue: No ]
  • Knowledge of contraceptive methods among providers [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ] [ Designated as safety issue: No ]
  • Acceptability of family planning services [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ] [ Designated as safety issue: No ]
  • Feasibility of providing family planning services at HIV care and treatment centers [ Time Frame: months 9-12 ] [ Designated as safety issue: No ]
  • Reproductive intentions of HIV-infected women receiving care and treatment [ Time Frame: months 1-3 ] [ Designated as safety issue: No ]

Enrollment: 5040
Study Start Date: September 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrated HIV/FP services
Family planning services are integrated into HIV care and treatment services at this facility.
Procedure: Integrated family planning/HIV care and treatment services
Family planning services will be provided during the patient's HIV care visit.
No Intervention: 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

For health facilities

  • If they do not meet the inclusion criteria listed above
  • If they are already providing integrated comprehensive HIV care and treatment that includes on-site family planning counseling and provision

For participants:

  • Participants are excluded if they do not meet the inclusion criteria listed above.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001507

Locations
Kenya
Migori District Hospital
Migori, Kenya
Sponsors and Collaborators
University of California, San Francisco
Ibis Reproductive Health
Kenya Medical Research Institute
Tides
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01001507     History of Changes
Other Study ID Numbers: TFR08-02986
Study First Received: October 22, 2009
Last Updated: December 6, 2013
Health Authority: United States: Institutional Review Board
Kenya: Ethical Review Committee

Keywords provided by University of California, San Francisco:
Family planning
HIV
Integrated services
Unintended pregnancy
Kenya

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 15, 2014