Clinical trial NCT00941876: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Muhimbili University of Health and Allied Sciences
First posted: 2009-07-20
Enrollment: 864
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of female CTC clients with unmet need for contraception
timeFrame: Before intervention begins (baseline) and 3 months after full implementation of intervention
Secondary outcomes:
measure: Proportion of female CTC clients screened on fertility intentions and unmet need for contraception
timeFrame: Three months after full implementation of intervention
measure: Proportion of female CTC clients provided counseling on contraception or safe pregnancy
timeFrame: Three months after full implementation of intervention
measure: Proportion of female CTC clients who received referral slip for FP services
timeFrame: Three months after full implementation of intervention
measure: Proportion of female CTC clients whose contraceptive use/fertility intentions are recorded on their patient record form
timeFrame: Three months after full implementation of intervention
measure: Proportion of female CTC clients who are accompanied to FP services
timeFrame: Three months after full implementation of intervention
measure: Proportion of female CTC clients who receive a FP method same-day or make an appointment for sterilization
timeFrame: Three months after full implementation of intervention
measure: Proportion of referrals to FP services that are tracked by the FP clinic
timeFrame: Three months after full implementation of intervention
measure: Incremental cost per clinic of adding facilitated referral process for FP to existing CTC services
timeFrame: First month of implementation
measure: 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
timeFrame: Three months after full implementation of intervention
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Services
Study officials:
affiliation: FHI 360
name: Joy N Bumgartner, MSW, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Muhimbili University of Health and Allied Sciences
name: Thecla W Kohi, PhD
role: PRINCIPAL_INVESTIGATOR
References: