Integrating Family Planning Services Into HIV Care and Treatment in Nyanza Province, Kenya
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01001507|
Recruitment Status : Completed
First Posted : October 26, 2009
Last Update Posted : December 9, 2013
|Condition or disease||Intervention/treatment||Phase|
|Unintended Pregnancy HIV Infections||Procedure: Integrated family planning/HIV care and treatment services||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5040 participants|
|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|
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
- 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 ]
- Pregnancy rate [ Time Frame: 1 year post integration/study initiation and 2 years post integration/site initiation ]
- Knowledge of contraceptive methods among HIV-positive women [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ]
- Knowledge of contraceptive methods among providers [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ]
- Acceptability of family planning services [ Time Frame: baseline (months 1-3); post-intervention (months 9-12) ]
- Feasibility of providing family planning services at HIV care and treatment centers [ Time Frame: months 9-12 ]
- Reproductive intentions of HIV-infected women receiving care and treatment [ Time Frame: months 1-3 ]
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
|Migori District Hospital|
|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|