Unintended PregnancyNCT01001507
Integrating Family Planning Services Into HIV Care and Treatment in Nyanza Province, Kenya
A study testing Integrated family planning/HIV care and treatment services in people with Unintended Pregnancy and HIV Infections, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
This is a cluster randomized trial comparing the integration of family planning services into HIV care and treatment programs versus the standard referral for family planning services outside of HIV care and treatment programs within Suba, Kisumu East, Rongo and Migori districts in Nyanza province. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Unintended Pregnancy, HIV Infections
- What is being tested?
- Integrated family planning/HIV care and treatment services
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,040 participants
- Where
- 1 siteKenya
- Study dates
- Sep 2009to Oct 2011
- 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
- For health facilities:
- Each site must be providing HIV care and treatment services
- For participants:
- Women aged 18-45, not pregnant, HIV+, receiving HIV care at that health facility
- Men aged 18 and above, HIV+, receiving HIV care at that health facility
Who cannot join
- For health facilities
- If they do not meet the inclusion criteria listed above
- If they are already providing integrated comprehensive HIV care and treatment that includes on-site family planning counseling and provision
- For participants:
- Participants are excluded if they do not meet the inclusion criteria listed above.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Randomized Trial of Integration of Family Planning Services Into HIV Care and Treatment in Suba, Kisumu East, Rongo and Migori Districts of Nyanza Province
This is a cluster randomized trial comparing the integration of family planning services into HIV care and treatment programs versus the standard referral for family planning services outside of HIV care and treatment programs within Suba, Kisumu East, Rongo and Migori districts in Nyanza province.
Read the detailed description
The study will have three parts. During the first part (3 months), baseline data on contraceptive prevalence and unintended pregnancy will be collected at 18 PSCs that are supported by the FACES program in Suba, Kisumu East, Nyatike, Rongo and Migori Districts. Also during this first part, information about knowledge, attitudes and practices related to family planning will be obtained from patients and from clinicians at the sites. During the second part (3 months), an intervention consisting of integrating family planning services will be designed and implemented at twelve of the 18 FACES-supported PSCs. We aim to utilize a 2:1 integration:control model, with delayed integration so as to gradually expand the integration of FP and HIV services throughout the 18 sites, while maintaining the ability to test hypotheses on the effects of integration on health outcomes. After collecting the baseline data, we plan to stratify the clinics into two categories based on the overall patient volume and differences in the structure of family planning provision, i.e., whether or not there is a specific MCH division providing family planning at the site or not. Randomization of sites will then occur among clinics in each of these strata, with a ratio of two intervention sites (integrated model) to one control site (family planning provided in the standard manner at the site). During the third and last part (12 months), data on prevalence more effective contraception and unintended pregnancy will be collected from each of the 18 sites. At the end of part three, information about knowledge, attitudes and practices related to family planning again will be obtained from patients and from clinicians at the sites. In addition, we will administer questionnaires assessing the acceptability of family planning services to patients, and in addition clinic staff will be answer a questionnaire assessing the feasibility of providing integrated family planning services. After 12 months of data collection, the 6 control sites were integrated and data were collected for an additional 11 months from all 18 sites to assess the sustainability of the intervention under the Ministry of Health.
The study population will primarily consist of HIV-positive men and non-pregnant, HIV-positive women of reproductive age who obtain care at the FACES-supported PSCs in Suba, Kisumu East, Rongo and Migori Districts in Nyanza Province, Kenya. In addition, study subjects will also include clinic staff at the FACES centers included in the study.
- Conditions
- Unintended Pregnancy, HIV Infections
- Being tested
- Integrated family planning/HIV care and treatment services
- Keywords
- Family planning, HIV, Integrated services, Unintended pregnancy, Kenya
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated family planning/HIV care and treatment servicesProcedure or surgery
Family planning services will be provided during the patient's HIV care visit.
| Study group | Role | What they receive |
|---|---|---|
| Integrated HIV/FP services | Experimental | Family planning services are integrated into HIV care and treatment services at this facility. Receives: Procedure: Integrated family planning/HIV care and treatment services |
| Standard (non-integrated), referral-based, services | No intervention | Patients from the HIV care and treatment clinic will be referred for family planning services, and will not receive FP services by the HIV care provider |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence More Effective Contraception (defined as hormonal methods, intrauterine devices, and permanent methods)
Measured: 1 year post integration/site initiation and 2 years post integration/site initiation
Pregnancy rate
Measured: 1 year post integration/study initiation and 2 years post integration/site initiation
Secondary outcomes (5)
Knowledge of contraceptive methods among HIV-positive women
Measured: baseline (months 1-3); post-intervention (months 9-12)
Knowledge of contraceptive methods among providers
Measured: baseline (months 1-3); post-intervention (months 9-12)
Acceptability of family planning services
Measured: baseline (months 1-3); post-intervention (months 9-12)
Feasibility of providing family planning services at HIV care and treatment centers
Measured: months 9-12
Reproductive intentions of HIV-infected women receiving care and treatment
Measured: months 1-3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unintended PregnancyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,040 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Ibis Reproductive Health, Kenya Medical Research Institute, Tides, Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Craig Cohen, MD, MPH, Principal investigator, University of California, San FranciscoDaniel Grossman, MD, Principal investigator, Ibis Reproductive HealthElizabeth Bukusi, MBChB, PhD, Principal investigator, Kenya Medical Research InstituteSara Newmann, MD, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001507
- Sponsor's protocol ID
- TFR08-02986
- Status last verified
- Dec 2013
- First submitted
- 22 Oct 2009
- Last updated
- 9 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen CR, Grossman D, Onono M, Blat C, Newmann SJ, Burger RL, Shade SB, Bett N, Bukusi EA. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya. PLoS One. 2017 Mar 22;12(3):e0172992. doi: 10.1371/journal.pone.0172992. eCollection 2017.
PubMed 28328966
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Trial of Integration of Family Planning Services Into HIV Care and Treatment in Suba, Kisumu East, Rongo and Migori Districts of Nyanza Province
- ClinicalTrials.gov ID
- NCT01001507
- Acronym / sponsor ID
- TFR08-02986
- Conditions
- Unintended Pregnancy, HIV Infections
- Keywords
- Family planning, HIV, Integrated services, Unintended pregnancy, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,040 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Ibis Reproductive Health, Kenya Medical Research Institute, Tides, Bill and Melinda Gates Foundation
- Study start
- Sep 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 Oct 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.
This is a cluster randomized trial comparing the integration of family planning services into HIV care and treatment programs versus the standard referral for family planning services outside of HIV care and treatment programs within Suba, Kisumu East, Rongo and Migori districts in Nyanza province.
Detailed description
The study will have three parts. During the first part (3 months), baseline data on contraceptive prevalence and unintended pregnancy will be collected at 18 PSCs that are supported by the FACES program in Suba, Kisumu East, Nyatike, Rongo and Migori Districts. Also during this first part, information about knowledge, attitudes and practices related to family planning will be obtained from patients and from clinicians at the sites. During the second part (3 months), an intervention consisting of integrating family planning services will be designed and implemented at twelve of the 18 FACES-supported PSCs. We aim to utilize a 2:1 integration:control model, with delayed integration so as to gradually expand the integration of FP and HIV services throughout the 18 sites, while maintaining the ability to test hypotheses on the effects of integration on health outcomes. After collecting the baseline data, we plan to stratify the clinics into two categories based on the overall patient volume and differences in the structure of family planning provision, i.e., whether or not there is a specific MCH division providing family planning at the site or not. Randomization of sites will then occur among clinics in each of these strata, with a ratio of two intervention sites (integrated model) to one control site (family planning provided in the standard manner at the site). During the third and last part (12 months), data on prevalence more effective contraception and unintended pregnancy will be collected from each of the 18 sites. At the end of part three, information about knowledge, attitudes and practices related to family planning again will be obtained from patients and from clinicians at the sites. In addition, we will administer questionnaires assessing the acceptability of family planning services to patients, and in addition clinic staff will be answer a questionnaire assessing the feasibility of providing integrated family planning services. After 12 months of data collection, the 6 control sites were integrated and data were collected for an additional 11 months from all 18 sites to assess the sustainability of the intervention under the Ministry of Health.
The study population will primarily consist of HIV-positive men and non-pregnant, HIV-positive women of reproductive age who obtain care at the FACES-supported PSCs in Suba, Kisumu East, Rongo and Migori Districts in Nyanza Province, Kenya. In addition, study subjects will also include clinic staff at the FACES centers included in the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated HIV/FP services | Experimental | Procedure: Integrated family planning/HIV care and treatment servicesFamily planning services are integrated into HIV care and treatment services at this facility. |
| Standard (non-integrated), referral-based, services | No intervention | –Patients from the HIV care and treatment clinic will be referred for family planning services, and will not receive FP services by the HIV care provider |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Each site must be providing HIV care and treatment services
- Women aged 18-45, not pregnant, HIV+, receiving HIV care at that health facility
- Men aged 18 and above, HIV+, receiving HIV care at that health facility
Key exclusion criteria (5 listed)
- For health facilities
- If they do not meet the inclusion criteria listed above
- If they are already providing integrated comprehensive HIV care and treatment that includes on-site family planning counseling and provision
- Participants are excluded if they do not meet the inclusion criteria listed above.
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 |
|---|---|---|
| Integrated family planning/HIV care and treatment servicesFamily planning services will be provided during the patient's HIV care visit. | Procedure or surgery | Integrated HIV/FP services |
Primary outcome
Prevalence More Effective Contraception (defined as hormonal methods, intrauterine devices, and permanent methods)
Time frame: 1 year post integration/site initiation and 2 years post integration/site initiation
Pregnancy rate
Time frame: 1 year post integration/study initiation and 2 years post integration/site initiation
5 secondary outcomes
Knowledge of contraceptive methods among HIV-positive women
Time frame: baseline (months 1-3); post-intervention (months 9-12)
Knowledge of contraceptive methods among providers
Time frame: baseline (months 1-3); post-intervention (months 9-12)
Acceptability of family planning services
Time frame: baseline (months 1-3); post-intervention (months 9-12)
Feasibility of providing family planning services at HIV care and treatment centers
Time frame: months 9-12
Reproductive intentions of HIV-infected women receiving care and treatment
Time frame: months 1-3
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 9 Dec 2013.
- Derived from this study: PubMed 28328966Cohen CR, Grossman D, Onono M, Blat C, Newmann SJ, Burger RL, Shade SB, Bett N, Bukusi EA. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya. PLoS One. 2017 Mar 22;12(3):e0172992. doi: 10.1371/journal.pone.0172992. eCollection 2017.
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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.
Craig Cohen, MD, MPH principal investigator
University of California, San Francisco
Daniel Grossman, MD principal investigator
Ibis Reproductive Health
Elizabeth Bukusi, MBChB, PhD principal investigator
Kenya Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated family planning/HIV care and treatment services in people with Unintended Pregnancy and HIV Infections, run by University of California, San Francisco at 1 site in Kenya.
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 5 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 9 Dec 2013. 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 Kenya. 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?
Prevalence More Effective Contraception (defined as hormonal methods, intrauterine devices, and permanent methods) (time frame: 1 year post integration/site initiation and 2 years post integration/site initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01001507, which also lists 1 linked publication.
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 9 Dec 2013.