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

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ClinicalTrials.gov Identifier: NCT01001507
Recruitment Status : Completed
First Posted : October 26, 2009
Last Update Posted : December 9, 2013
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Unintended Pregnancy HIV Infections Procedure: Integrated family planning/HIV care and treatment services Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5040 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Pregnancy rate [ Time Frame: 1 year post integration/study initiation and 2 years post integration/site initiation ]

Secondary Outcome Measures :
  1. Knowledge of contraceptive methods among HIV-positive women [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ]
  2. Knowledge of contraceptive methods among providers [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ]
  3. Acceptability of family planning services [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ]
  4. Feasibility of providing family planning services at HIV care and treatment centers [ Time Frame: months 9-12 ]
  5. Reproductive intentions of HIV-infected women receiving care and treatment [ Time Frame: months 1-3 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001507


Locations
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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
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01001507    
Other Study ID Numbers: TFR08-02986
First Posted: October 26, 2009    Key Record Dates
Last Update Posted: December 9, 2013
Last Verified: December 2013
Keywords provided by University of California, San Francisco:
Family planning
HIV
Integrated services
Unintended pregnancy
Kenya
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
 Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases