Integration of Family Planning and HIV Services in Tanzania

Tracking Information
First Submitted Date ICMJE	July 17, 2009
First Posted Date ICMJE	July 20, 2009
Last Update Posted Date	August 11, 2011
Study Start Date ICMJE	August 2009
Actual Primary Completion Date	September 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 17, 2009)	Proportion of female CTC clients with unmet need for contraception [ Time Frame: Before intervention begins (baseline) and 3 months after full implementation of intervention ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00941876 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 17, 2009)	Proportion of female CTC clients screened on fertility intentions and unmet need for contraception [ Time Frame: Three months after full implementation of intervention ]; Proportion of female CTC clients provided counseling on contraception or safe pregnancy [ Time Frame: Three months after full implementation of intervention ]; Proportion of female CTC clients who received referral slip for FP services [ Time Frame: Three months after full implementation of intervention ]; Proportion of female CTC clients whose contraceptive use/fertility intentions are recorded on their patient record form [ Time Frame: Three months after full implementation of intervention ]; Proportion of female CTC clients who are accompanied to FP services [ Time Frame: Three months after full implementation of intervention ]; Proportion of female CTC clients who receive a FP method same-day or make an appointment for sterilization [ Time Frame: Three months after full implementation of intervention ]; Proportion of referrals to FP services that are tracked by the FP clinic [ Time Frame: Three months after full implementation of intervention ]; Incremental cost per clinic of adding facilitated referral process for FP to existing CTC services [ Time Frame: First month of implementation ]; Descriptive data on the experiences and perception of CTC and FP providers and supervisors on how the facilitated referral for FP was feasible and effective within CTC services [ Time Frame: Three months after full implementation of intervention ]
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	Integration of Family Planning and HIV Services in Tanzania
Official Title ICMJE	An Evaluation of Integration of Family Planning Into HIV/AIDS Care and Treatment Clinics in Tanzania
Brief Summary	HIV positive women and couples have broad reproductive health needs that are not always met within HIV services. The integration of family planning (FP) services into Tanzania's HIV Care and Treatment Clinics (CTC) will address the fertility desires of CTC clients and ultimately result in the reduction of unintended pregnancies and HIV incidence. One strategy for integrating FP and CTC services is to use a "facilitated referral" model. Facilitated referrals are enhanced referrals for additional services that have been used in other settings and which are the preferred intervention strategy the Government of Tanzania would like to pilot test. This study will evaluate the feasibility, effectiveness, and costs of implementing a "facilitated referrals" intervention by examining FP use among female clients attending HIV/AIDS Care and Treatment Centers. This study will measure whether there is a reduction in unmet need for contraception among female CTC clients after the facilitated referral integration intervention has been implemented.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
Condition ICMJE	HIV Infection; HIV Infections
Intervention ICMJE	Behavioral: Facilitated Referral; Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.
Study Arms	Experimental: A. Facilitated Referral; Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.; Intervention: Behavioral: Facilitated Referral
Publications *	Not Provided
* 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: July 17, 2009)	864
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	September 2010
Actual Primary Completion Date	September 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: Female clients of Care & Treatment Clinics with CD4 counts >100, and are WHO Stage I - III. (CTC Clients); Care and Treatment providers who provide services to clients (CTC Providers); Care and Treatment supervisors who are the immediate in-charge supervisor for the CTC clinic. (CTC supervisor); Family Planning providers who provide services to clients. (FP providers); Family Planning supervisors who are the immediate in-charge supervisor for the FP clinic. (FP supervisor)
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	Tanzania
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00941876
Other Study ID Numbers ICMJE	10121
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Mackenzie Green, FHI
Study Sponsor ICMJE	FHI 360
Collaborators ICMJE	Muhimbili University of Health and Allied Sciences
Investigators ICMJE	Principal Investigator: Joy N Bumgartner, MSW, PhD FHI 360 Principal Investigator: Thecla W Kohi, PhD Muhimbili University of Health and Allied Services
PRS Account	FHI 360
Verification Date	August 2011
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP