Integration of Family Planning and HIV Services in Tanzania

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

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections; HIV Infection
• Intervention / Treatment: Behavioral: Facilitated Referral

• Study Type: Interventional
• Enrollment (Actual): 864
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Dar es Salaam, Tanzania
    • Muhimbili University of Health and Allied Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of female CTC clients with unmet need for contraception	Before intervention begins (baseline) and 3 months after full implementation of intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of female CTC clients screened on fertility intentions and unmet need for contraception	Three months after full implementation of intervention
Proportion of female CTC clients provided counseling on contraception or safe pregnancy	Three months after full implementation of intervention
Proportion of female CTC clients who received referral slip for FP services	Three months after full implementation of intervention
Proportion of female CTC clients whose contraceptive use/fertility intentions are recorded on their patient record form	Three months after full implementation of intervention
Proportion of female CTC clients who are accompanied to FP services	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	Three months after full implementation of intervention
Proportion of referrals to FP services that are tracked by the FP clinic	Three months after full implementation of intervention
Incremental cost per clinic of adding facilitated referral process for FP to existing CTC services	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	Three months after full implementation of intervention

Collaborators and Investigators

• Sponsor: FHI 360
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): September 1, 2010

Study Registration Dates

• First Submitted: July 17, 2009
• First Submitted That Met QC Criteria: July 17, 2009
• First Posted (ESTIMATE): July 20, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): August 11, 2011
• Last Update Submitted That Met QC Criteria: August 10, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: ICH; PCR; HIV seronegativity; AIDS; DCF; ART; antiretroviral therapy; AE; acquired immunodeficiency syndrome; Hepatitis B surface antigen; data collection forms; FDA; IRB; Institutional Review Board; alanine aminotransferase; SAE; Western Blot; adverse event; polymerase chain reaction; GCP; aspartate aminotransferase; serious adverse event; ALT (SGPT); AST (SGOT); DMC; Data Monitoring Committee; (U.S.) Food and Drug Administration; Good Clinical Practice guidelines; HB sAg; International Conference of Harmonisation; IND; Investigational New Drug Application; IU; International units; mg; milligram(s); mm3; cubic millimeter(s); µg; microgram; ULN; upper limit of the normal range; WB; To inform the Ministry of Health strategy for integrating FP and HIV/AIDS Care and Treatment Services in Tanzania
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 10121 (DAIDS ES Registry Number)