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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
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
FHI 360

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
HIV Infection HIV Infections Behavioral: Facilitated Referral Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 864 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: An Evaluation of Integration of Family Planning Into HIV/AIDS Care and Treatment Clinics in Tanzania
Study Start Date : August 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: A. Facilitated Referral
Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.
 Behavioral: Facilitated Referral
Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of female CTC clients with unmet need for contraception [ Time Frame: Before intervention begins (baseline) and 3 months after full implementation of intervention ]

Secondary Outcome Measures :
  1. Proportion of female CTC clients screened on fertility intentions and unmet need for contraception [ Time Frame: Three months after full implementation of intervention ]
  2. Proportion of female CTC clients provided counseling on contraception or safe pregnancy [ Time Frame: Three months after full implementation of intervention ]
  3. Proportion of female CTC clients who received referral slip for FP services [ Time Frame: Three months after full implementation of intervention ]
  4. 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 ]
  5. Proportion of female CTC clients who are accompanied to FP services [ Time Frame: Three months after full implementation of intervention ]
  6. 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 ]
  7. Proportion of referrals to FP services that are tracked by the FP clinic [ Time Frame: Three months after full implementation of intervention ]
  8. Incremental cost per clinic of adding facilitated referral process for FP to existing CTC services [ Time Frame: First month of implementation ]
  9. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female clients of Care & Treatment Clinics with CD4 counts >100, and are WHO Stage I - III. (CTC Clients)
  2. Care and Treatment providers who provide services to clients (CTC Providers)
  3. Care and Treatment supervisors who are the immediate in-charge supervisor for the CTC clinic. (CTC supervisor)
  4. Family Planning providers who provide services to clients. (FP providers)
  5. Family Planning supervisors who are the immediate in-charge supervisor for the FP clinic. (FP supervisor)
Contacts and Locations
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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): NCT00941876


Locations
Tanzania
Muhimbili University of Health and Allied Services
Dar es Salaam, Tanzania
Sponsors and Collaborators
FHI 360
Muhimbili University of Health and Allied Sciences
Investigators
Principal Investigator: Joy N Bumgartner, MSW, PhD FHI 360
Principal Investigator: Thecla W Kohi, PhD Muhimbili University of Health and Allied Services
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Mackenzie Green, FHI
ClinicalTrials.gov Identifier: NCT00941876     History of Changes
Other Study ID Numbers: 10121
First Posted: July 20, 2009    Key Record Dates
Last Update Posted: August 11, 2011
Last Verified: August 2011

Keywords provided by FHI 360:
AE
adverse event
AIDS
acquired immunodeficiency syndrome
ALT (SGPT)
alanine aminotransferase
ART
antiretroviral therapy
AST (SGOT)
aspartate aminotransferase
DCF
data collection forms
DMC
Data Monitoring Committee
FDA
 (U.S.) Food and Drug Administration
GCP
Good Clinical Practice guidelines
HB sAg
Hepatitis B surface antigen
ICH
International Conference of Harmonisation
IND
Investigational New Drug Application
IRB
Institutional Review Board
IU
International units
mg
milligram(s)

Additional relevant MeSH terms:
Infection
Communicable Diseases
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases