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Integration of Family Planning and HIV Services in Tanzania

Primary Purpose

HIV Infection, HIV Infections

Status

Completed

Phase

Not Applicable

Locations

Tanzania

Study Type

Interventional

Intervention

Facilitated Referral

About this trial

This is an interventional health services research trial for HIV Infection focused on measuring 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), mm3, cubic millimeter(s), PCR, polymerase chain reaction, SAE, serious adverse event, µg, microgram, ULN, upper limit of the normal range, WB, Western Blot, To inform the Ministry of Health strategy for integrating FP and HIV/AIDS Care and Treatment Services in Tanzania, HIV seronegativity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Muhimbili University of Health and Allied Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A. Facilitated Referral

Arm Description

Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.

Outcomes

Primary Outcome Measures

Proportion of female CTC clients with unmet need for contraception

Secondary Outcome Measures

Proportion of female CTC clients screened on fertility intentions and unmet need for contraception

Proportion of female CTC clients provided counseling on contraception or safe pregnancy

Proportion of female CTC clients who received referral slip for FP services

Proportion of female CTC clients whose contraceptive use/fertility intentions are recorded on their patient record form

Proportion of female CTC clients who are accompanied to FP services

Proportion of female CTC clients who receive a FP method same-day or make an appointment for sterilization

Proportion of referrals to FP services that are tracked by the FP clinic

Incremental cost per clinic of adding facilitated referral process for FP to existing CTC services

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

Full Information

NCT ID

NCT00941876

First Posted

July 17, 2009

Last Updated

August 10, 2011

Sponsor

FHI 360

Collaborators

Muhimbili University of Health and Allied Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00941876

Brief Title

Integration of Family Planning and HIV Services in Tanzania

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

September 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

FHI 360

Collaborators

Muhimbili University of Health and Allied Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infection, HIV Infections

Keywords

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), mm3, cubic millimeter(s), PCR, polymerase chain reaction, SAE, serious adverse event, µg, microgram, ULN, upper limit of the normal range, WB, Western Blot, To inform the Ministry of Health strategy for integrating FP and HIV/AIDS Care and Treatment Services in Tanzania, HIV seronegativity

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

864 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A. Facilitated Referral

Arm Type

Experimental

Arm Description

Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.

Intervention Type

Behavioral

Intervention Name(s)

Facilitated Referral

Intervention Description

Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.

Primary Outcome Measure Information:

Title

Proportion of female CTC clients with unmet need for contraception

Time Frame

Before intervention begins (baseline) and 3 months after full implementation of intervention

Secondary Outcome Measure Information:

Title

Proportion of female CTC clients screened on fertility intentions and unmet need for contraception

Time Frame

Three months after full implementation of intervention

Title

Proportion of female CTC clients provided counseling on contraception or safe pregnancy

Time Frame

Three months after full implementation of intervention

Title

Proportion of female CTC clients who received referral slip for FP services

Time Frame

Three months after full implementation of intervention

Title

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

Title

Proportion of female CTC clients who are accompanied to FP services

Time Frame

Three months after full implementation of intervention

Title

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

Title

Proportion of referrals to FP services that are tracked by the FP clinic

Time Frame

Three months after full implementation of intervention

Title

Incremental cost per clinic of adding facilitated referral process for FP to existing CTC services

Time Frame

First month of implementation

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joy N Bumgartner, MSW, PhD

Organizational Affiliation

FHI 360

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thecla W Kohi, PhD

Organizational Affiliation

Muhimbili University of Health and Allied Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Muhimbili University of Health and Allied Services

City

Dar es Salaam

Country

Tanzania

12. IPD Sharing Statement

Learn more about this trial

Integration of Family Planning and HIV Services in Tanzania

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