HIV InfectionNCT00941876
Integration of Family Planning and HIV Services in Tanzania
A study testing Facilitated Referral in people with HIV Infection and HIV Infections, run by FHI 360 at 1 site in Tanzania.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- HIV Infection, HIV Infections
- What is being tested?
- Facilitated Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 864 participants
- Where
- 1 siteTanzania
- Study dates
- Aug 2009to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health and Allied Services
Dar es Salaam
About this study
Official title: 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.
- Conditions
- HIV Infection, HIV Infections
- Being tested
- Facilitated Referral
- 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
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facilitated ReferralBehavioural
Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.
| Study group | Role | What they receive |
|---|---|---|
| A. Facilitated Referral | Experimental | Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC. Receives: Behavioral: Facilitated Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of female CTC clients with unmet need for contraception
Measured: Before intervention begins (baseline) and 3 months after full implementation of intervention
Secondary outcomes (9)
Proportion of female CTC clients screened on fertility intentions and unmet need for contraception
Measured: Three months after full implementation of intervention
Proportion of female CTC clients provided counseling on contraception or safe pregnancy
Measured: Three months after full implementation of intervention
Proportion of female CTC clients who received referral slip for FP services
Measured: Three months after full implementation of intervention
Proportion of female CTC clients whose contraceptive use/fertility intentions are recorded on their patient record form
Measured: Three months after full implementation of intervention
Proportion of female CTC clients who are accompanied to FP services
Measured: 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
Measured: Three months after full implementation of intervention
Proportion of referrals to FP services that are tracked by the FP clinic
Measured: Three months after full implementation of intervention
Incremental cost per clinic of adding facilitated referral process for FP to existing CTC services
Measured: 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
Measured: Three months after full implementation of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 864 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Investigators
- Joy N Bumgartner, MSW, PhD, Principal investigator, FHI 360Thecla W Kohi, PhD, Principal investigator, Muhimbili University of Health and Allied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941876
- Sponsor's protocol ID
- 10121
- Status last verified
- Aug 2011
- First submitted
- 17 Jul 2009
- Last updated
- 11 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Integration of Family Planning Into HIV/AIDS Care and Treatment Clinics in Tanzania
- ClinicalTrials.gov ID
- NCT00941876
- Acronym / sponsor ID
- 10121
- Conditions
- HIV Infection, HIV Infections
- Keywords
- AE, adverse event, AIDS, acquired immunodeficiency syndrome, ALT (SGPT), alanine aminotransferase, ART, antiretroviral therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 864 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- Aug 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 20 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A. Facilitated Referral | Experimental | Behavioral: Facilitated ReferralSeven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Facilitated ReferralSeven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC. | Behavioural | A. Facilitated Referral |
Primary outcome
Proportion of female CTC clients with unmet need for contraception
Time frame: Before intervention begins (baseline) and 3 months after full implementation of intervention
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy N Bumgartner, MSW, PhD principal investigator
FHI 360
Thecla W Kohi, PhD principal investigator
Muhimbili University of Health and Allied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facilitated Referral in people with HIV Infection and HIV Infections, run by FHI 360 at 1 site in Tanzania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of female CTC clients with unmet need for contraception (time frame: Before intervention begins (baseline) and 3 months after full implementation of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.