Integration of Family Planning and HIV Services in Tanzania - Full Text View

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:

MedlinePlus related topics: Birth Control HIV/AIDS

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 (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


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

ClinicalTrials.gov processed this record on September 28, 2016