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| Sponsor: | University of California, San Francisco |
|---|---|
| Collaborators: |
Ibis Reproductive Health Kenya Medical Research Institute Tides Foundation |
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01001507 |
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: | Health Services Research, Randomized, Open Label, Parallel Assignment |
| 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 |
| Estimated Enrollment: | 5040 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | February 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Family planning services will be provided during the patient's HIV care visit.
|
|
Standard (non-integrated) 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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For health facilities:
For participants:
Exclusion Criteria:
For health facilities
For participants:
Contacts and Locations| Contact: Craig Cohen, MD, MPH | 415.597.9192 | CCohen@globalhealth.ucsf.edu |
| Contact: Daniel Grossman, MD | 510.986.8941 | DGrossman@ibisreproductivehealth.org |
| Kenya | |
| Migori District Hospital | Recruiting |
| Migori, Kenya | |
| Contact: Maricianah Onono, MBChB +254 720 793 871 monono@kemri-ucsf.org | |
| Principal Investigator: Elizabeth Bukusi, MBChB, PhD | |
| Sub-Investigator: Maricianah Onono, MBChB | |
| 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 |
| Study Director: | Sara Newmann, MD, MPH | University of California, San Francisco |
More Information
| Responsible Party: | University of California, San Francisco ( Dr. Craig R. Cohen ) |
| Study ID Numbers: | TFR08-02986 |
| Study First Received: | October 22, 2009 |
| Last Updated: | November 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT01001507 History of Changes |
| Health Authority: | United States: Institutional Review Board; Kenya: Ethical Review Committee |
|
Family planning HIV Integrated services Unintended pregnancy Kenya |
|
Virus Diseases Sexually Transmitted Diseases, Viral RNA Virus Infections Slow Virus Diseases Immune System Diseases HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Lentivirus Infections Infection Retroviridae Infections Immunologic Deficiency Syndromes |
