Integration of Family Planning and HIV Services in Tanzania

HIV Infections Clinical Trial

Official title:

An Evaluation of Integration of Family Planning Into HIV/AIDS Care and Treatment Clinics in Tanzania

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00941876
• Other study ID #: 10121
• Status: Completed
• Phase: N/A
• First received: July 17, 2009
• Last updated: August 10, 2011
• Start date: August 2009
• Est. completion date: September 2010

Study information

• Verified date: August 2011
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 864
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infection
• HIV Infections
• Infection

Intervention

Behavioral:
• Facilitated Referral
Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.

Locations

Country	Name	City	State
Tanzania	Muhimbili University of Health and Allied Services	Dar es Salaam

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	Muhimbili University of Health and Allied Sciences

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of female CTC clients with unmet need for contraception		Before intervention begins (baseline) and 3 months after full implementation of intervention	No
Secondary	Proportion of female CTC clients screened on fertility intentions and unmet need for contraception		Three months after full implementation of intervention	No
Secondary	Proportion of female CTC clients provided counseling on contraception or safe pregnancy		Three months after full implementation of intervention	No
Secondary	Proportion of female CTC clients who received referral slip for FP services		Three months after full implementation of intervention	No
Secondary	Proportion of female CTC clients whose contraceptive use/fertility intentions are recorded on their patient record form		Three months after full implementation of intervention	No
Secondary	Proportion of female CTC clients who are accompanied to FP services		Three months after full implementation of intervention	No
Secondary	Proportion of female CTC clients who receive a FP method same-day or make an appointment for sterilization		Three months after full implementation of intervention	No
Secondary	Proportion of referrals to FP services that are tracked by the FP clinic		Three months after full implementation of intervention	No
Secondary	Incremental cost per clinic of adding facilitated referral process for FP to existing CTC services		First month of implementation	No
Secondary	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		Three months after full implementation of intervention	No