Integration of Family Planning and HIV Services in Tanzania
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ClinicalTrials.gov Identifier: NCT00941876 |
Recruitment Status
:
Completed
First Posted
: July 20, 2009
Last Update Posted
: August 11, 2011
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Sponsor:
FHI 360
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
FHI 360
Tracking Information | |||||||
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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 |
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 |
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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 |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Facilitated Referral
Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC. |
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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 |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
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:
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Sex/Gender |
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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 |
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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 |