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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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infection HIV Infections | Behavioral: Facilitated Referral | Not Applicable |
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 |
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.
|
- Proportion of female CTC clients with unmet need for contraception [ Time Frame: Before intervention begins (baseline) and 3 months after full implementation of intervention ]
- 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 ]

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

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
Tanzania | |
Muhimbili University of Health and Allied Services | |
Dar es Salaam, Tanzania |
Principal Investigator: | Joy N Bumgartner, MSW, PhD | FHI 360 | |
Principal Investigator: | Thecla W Kohi, PhD | Muhimbili University of Health and Allied Services |
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 |