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

Tracking Information
First Submitted Date ICMJE	October 22, 2009
First Posted Date ICMJE	October 26, 2009
Last Update Posted Date	December 9, 2013
Study Start Date ICMJE	September 2009
Actual Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 6, 2013)	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 ]
Original Primary Outcome Measures ICMJE; (submitted: October 23, 2009)	Contraceptive prevalence [ Time Frame: 1 year post integration/site initiation ]; Pregnancy rate [ Time Frame: 1 year post integration/study initiation ]
Change History	Complete list of historical versions of study NCT01001507 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: October 23, 2009)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Integrating Family Planning Services Into HIV Care and Treatment in Nyanza Province, Kenya
Official Title ICMJE	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
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.
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 Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
Condition ICMJE	Unintended Pregnancy; HIV Infections
Intervention ICMJE	Procedure: Integrated family planning/HIV care and treatment services; Family planning services will be provided during the patient's HIV care visit.
Study Arms	Experimental: Integrated HIV/FP services Family planning services are integrated into HIV care and treatment services at this facility. Intervention: Procedure: Integrated family planning/HIV care and treatment services; 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
Publications *	Cohen CR, Grossman D, Onono M, Blat C, Newmann SJ, Burger RL, Shade SB, Bett N, Bukusi EA. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya. PLoS One. 2017 Mar 22;12(3):e0172992. doi: 10.1371/journal.pone.0172992. eCollection 2017.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 23, 2009)	5040
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	October 2011
Actual Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 45 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Kenya
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01001507
Other Study ID Numbers ICMJE	TFR08-02986
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	University of California, San Francisco
Study Sponsor ICMJE	University of California, San Francisco
Collaborators ICMJE	Ibis Reproductive Health; Kenya Medical Research Institute; Tides; Bill and Melinda Gates Foundation
Investigators ICMJE	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
PRS Account	University of California, San Francisco
Verification Date	December 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP