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Integration of Family Planning and HIV Services in Tanzania

This study has been completed.
Sponsor:
Collaborator:
Muhimbili University of Health and Allied Sciences
Information provided by:
FHI 360
ClinicalTrials.gov Identifier:
NCT00941876
First received: July 17, 2009
Last updated: August 10, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
HIV Infection
HIV Infections
 Behavioral: Facilitated Referral

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by FHI 360:

Primary Outcome Measures:
  • Proportion of female CTC clients with unmet need for contraception [ Time Frame: Before intervention begins (baseline) and 3 months after full implementation of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of female CTC clients screened on fertility intentions and unmet need for contraception [ Time Frame: Three months after full implementation of intervention ] [ Designated as safety issue: No ]
  • Proportion of female CTC clients provided counseling on contraception or safe pregnancy [ Time Frame: Three months after full implementation of intervention ] [ Designated as safety issue: No ]
  • Proportion of female CTC clients who received referral slip for FP services [ Time Frame: Three months after full implementation of intervention ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of female CTC clients who are accompanied to FP services [ Time Frame: Three months after full implementation of intervention ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Proportion of referrals to FP services that are tracked by the FP clinic [ Time Frame: Three months after full implementation of intervention ] [ Designated as safety issue: No ]
  • Incremental cost per clinic of adding facilitated referral process for FP to existing CTC services [ Time Frame: First month of implementation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 864
Study Start Date: August 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Mackenzie Green, FHI
ClinicalTrials.gov Identifier: NCT00941876     History of Changes
Other Study ID Numbers: 10121
Study First Received: July 17, 2009
Last Updated: August 10, 2011
Health Authority: United States: Institutional Review Board

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:
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

ClinicalTrials.gov processed this record on February 28, 2013