Integrating Family Planning Services Into HIV Care and Treatment in Nyanza Province, Kenya
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.
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, 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 (9 months), data on contraceptive prevalence 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 female 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.
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
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Conditions
Unintended Pregnancy
Intervention
Integrated family planning/HIV care and treatment services
Location
Migori District Hospital
Migori
Kenya
Status
Recruiting
Source
University of California, San Francisco
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01001507
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Family Planning Services
Health care programs or services designed to assist individuals in the planning of family size. Various methods of CONTRACEPTION can be used to control the number and timing of childbirths.
Pregnancy, Unplanned
Unintended accidental pregnancy, including pregnancy resulting from failed contraceptive measures.
Delivery Of Health Care, Integrated
A health care system which combines physicians, hospitals, and other medical services with a health plan to provide the complete spectrum of medical care for its customers. In a fully integrated system, the three key elements - physicians, hospital, and health plan membership - are in balance in terms of matching medical resources with the needs of purchasers and patients. (Coddington et al., Integrated Health Care: Reorganizing the Physician, Hospital and Health Plan Relationship, 1994, p7)
Primary Health Care
Care which provides integrated, accessible health care services by clinicians who are accountable for addressing a large majority of personal health care needs, developing a sustained partnership with patients, and practicing in the context of family and community. (JAMA 1995;273(3):192)
Case Management
A traditional term for all the activities which a physician or other health care professional normally performs to insure the coordination of the medical services required by a patient. It also, when used in connection with managed care, covers all the activities of evaluating the patient, planning treatment, referral, and follow-up so that care is continuous and comprehensive and payment for the care is obtained. (From Slee & Slee, Health Care Terms, 2nd ed)
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