Male PartnerNCT01620073
Home-Based Versus Partner-Friendly Clinic Testing to Enhance Male Partner HIV-1 Testing During Pregnancy
A study testing HIV counseling and testing in people with Male Partner and HIV Counseling and Testing, run by University of Washington at 2 sites in Kenya.
Trial summary
The investigators hypothesize that home based HIV counseling and testing can increase male partner uptake of HIV testing during pregnancy. The investigators study aims through a randomized clinical trial to determine whether a home-based model (HBM) versus a partner-friendly clinic model (PFM) can increase male uptake… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Male Partner, HIV Counseling and Testing, Home Based
- What is being tested?
- HIV counseling and testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 2 sitesKenya
- Study dates
- Jul 2012to Jul 2013
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women and their male partners
Who cannot join
- Non-pregnant, minors, inability to live in study area for 6 weeks
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Ahero Sub-District Hospital, Nyando, Kenya
Kisumu, Nyanza, 254
Ahero Sub-District Hospital
Kisumu, Nyanza, 254
About this study
Official title: Home-Based Versus Partner-Friendly Clinic Testing to Enhance Male Partner HIV-1 Testing During Pregnancy: A Randomized Clinical Trial
The investigators hypothesize that home based HIV counseling and testing can increase male partner uptake of HIV testing during pregnancy.
The investigators study aims through a randomized clinical trial to determine whether a home-based model (HBM) versus a partner-friendly clinic model (PFM) can increase male uptake of HIV counseling and testing during pregnancy.
- Conditions
- Male Partner, HIV Counseling and Testing, Home Based, Pregnancy
- Being tested
- HIV counseling and testing
- Keywords
- Male partner, HIV counseling and testing, Home based, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV counseling and testingOther
Male partner HIV counseling and testing
| Study group | Role | What they receive |
|---|---|---|
| Partner friendly arm | Other | Proportion of males counseled and tested using routine standards of prenatal care Receives: Other: HIV counseling and testing |
| Home based arm | Experimental | Proportion of male partners accepting HIV counseling and testing following home visits for couple HIV counseling and testing during pregnancy Receives: Other: HIV counseling and testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Male Partners Counseled and Tested for HIV During Pregnancy
To determine male partner acceptability of counseling and testing within a six week period following the counseling and testing of the pregnant woman.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Male PartnerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfred Osoti MBChB MMed, University of Washington
- Investigators
- Alfred O Osoti, MBChB MMed, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620073
- Sponsor's protocol ID
- 42561
- Status last verified
- Aug 2013
- First submitted
- 12 Jun 2012
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Osoti AO, John-Stewart G, Kiarie JN, Barbra R, Kinuthia J, Krakowiak D, Farquhar C. Home-based HIV testing for men preferred over clinic-based testing by pregnant women and their male partners, a nested cross-sectional study. BMC Infect Dis. 2015 Jul 30;15:298. doi: 10.1186/s12879-015-1053-2.
PubMed 26223540Osoti AO, John-Stewart G, Kiarie J, Richardson B, Kinuthia J, Krakowiak D, Farquhar C. Home visits during pregnancy enhance male partner HIV counselling and testing in Kenya: a randomized clinical trial. AIDS. 2014 Jan 2;28(1):95-103. doi: 10.1097/QAD.0000000000000023.
PubMed 23942059
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Based Versus Partner-Friendly Clinic Testing to Enhance Male Partner HIV-1 Testing During Pregnancy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01620073
- Acronym / sponsor ID
- 42561
- Conditions
- Male Partner, HIV Counseling and Testing, Home Based, Pregnancy
- Keywords
- Male partner, HIV counseling and testing, Home based, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Jun 2012 (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.
The investigators hypothesize that home based HIV counseling and testing can increase male partner uptake of HIV testing during pregnancy.
The investigators study aims through a randomized clinical trial to determine whether a home-based model (HBM) versus a partner-friendly clinic model (PFM) can increase male uptake of HIV counseling and testing during pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partner friendly arm | Other | Other: HIV counseling and testingProportion of males counseled and tested using routine standards of prenatal care |
| Home based arm | Experimental | Other: HIV counseling and testingProportion of male partners accepting HIV counseling and testing following home visits for couple HIV counseling and testing during pregnancy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women and their male partners
Key exclusion criteria (1 listed)
- Non-pregnant, minors, inability to live in study area for 6 weeks
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 |
|---|---|---|
| HIV counseling and testingMale partner HIV counseling and testing | Other | Home based arm, Partner friendly arm |
Primary outcome
Number of Male Partners Counseled and Tested for HIV During Pregnancy
Time frame: 6 weeks
To determine male partner acceptability of counseling and testing within a six week period following the counseling and testing of the pregnant woman.
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 28 Aug 2013.
- Derived from this study: PubMed 26223540Osoti AO, John-Stewart G, Kiarie JN, Barbra R, Kinuthia J, Krakowiak D, Farquhar C. Home-based HIV testing for men preferred over clinic-based testing by pregnant women and their male partners, a nested cross-sectional study. BMC Infect Dis. 2015 Jul 30;15:298. doi: 10.1186/s12879-015-1053-2.
- Derived from this study: PubMed 23942059Osoti AO, John-Stewart G, Kiarie J, Richardson B, Kinuthia J, Krakowiak D, Farquhar C. Home visits during pregnancy enhance male partner HIV counselling and testing in Kenya: a randomized clinical trial. AIDS. 2014 Jan 2;28(1):95-103. doi: 10.1097/QAD.0000000000000023.
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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.
Alfred O Osoti, MBChB MMed principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV counseling and testing in people with Male Partner and HIV Counseling and Testing, run by University of Washington at 2 sites 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 1 inclusion and 1 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 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of Male Partners Counseled and Tested for HIV During Pregnancy (time frame: 6 weeks). 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 NCT01620073, which also lists 2 linked publications.
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 28 Aug 2013.