HIVAHINCT01876199
Targeted Screening of At-Risk Adults for Acute HIV-1 Infection
A study testing intense follow up in people with HIV, run by University of Oxford at 1 site in Kenya.
Trial summary
In this research, the investigators want to see if early detection of HIV infection can be improved by testing young adults who seek urgent health care from pharmacies and healthcare facilities with symptoms similar to those people get with recent HIV infection. Specific objectives: 1. Read more about this study
- Who is it for?
- Ages 18 to 29 years
- Conditions the study is for
- HIV
- What is being tested?
- intense follow up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 1 siteKenya
- Study dates
- Feb 2013to 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 29 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- symptom score of 2 or more: Confirmed fever (≥37.5 °C axillary), reported diarrhoea, or evidence of STD (variable score=2); reported body pains, or report of more than one sexual partners in past 2 months (variable score=1)
- resident in Mtwapa or Shanzu or planning to stay in Mtwapa for approximately 4 weeks duration
- willing to give locator information (including mobile phone number)
- negative or unknown HIV status
Who cannot join
- patients not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
In this research, the investigators want to see if early detection of HIV infection can be improved by testing young adults who seek urgent health care from pharmacies and healthcare facilities with symptoms similar to those people get with recent HIV infection.
Specific objectives:
Read more
- What proportion of people presenting with these symptoms are HIV positive at the point of seeking urgent health care?
- What proportion of those who test negative or where the result is unclear (one rapid test positive and one negative) at first rapid HIV testing, will test positive two weeks later?
- What is the best way (SMS, phone call or home visit) to remind people to come for the second test after two weeks?
- Will young adults who seek urgent health care for fever, body pains, diarrhoea or an STD from pharmacies or health facilities find it acceptable to be invited for an HIV-1 test at the time of health care seeking?
Hypotheses
- Targeted screening for AHI among patients seeking health care for symptoms compatible with AHI or sexually transmitted disease (STD) will identify AHI cases in more than 1% of those screened.
- Intense follow-up of patients evaluated for AHI will improve rates of repeat HIV-1 testing 2-4 weeks after initial health-care seeking, relative to standard practice (i.e., recommendation to return for testing on a given date).
- Conditions
- HIV
- Being tested
- intense follow up
- Keywords
- HIV-1, acute, diagnosis, pharmacies, healthcare facilities
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intense follow upBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intense follow up | Experimental | 2-week follow up appointment with addition of a reminder mobile phone call or short text message (SMS) if possible, plus a home visit by a community counselor if the participant fails to present on the appointed date. Receives: Behavioral: intense follow up |
| standard follow-up | No intervention | 2-week follow-up appointment with no reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Number and proportion of adults responding to standard appointment versus intense follow up.
Measured: 2 weeks
Secondary outcomes (1)
Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study startFeb 2013
- 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 (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- None (open label)
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- International AIDS Vaccine Initiative, KEMRI-Wellcome Trust Collaborative Research Program, University of Washington, Kenya Ministry of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876199
- Sponsor's protocol ID
- SSC2359
- Other IDs
- 167-12
- Acronym
- AHI
- Status last verified
- Aug 2014
- First submitted
- 10 Jun 2013
- Last updated
- 4 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mugo PM, Wahome EW, Gichuru EN, Mwashigadi GM, Thiong'o AN, Prins HA, Rinke de Wit TF, Graham SM, Sanders EJ. Effect of Text Message, Phone Call, and In-Person Appointment Reminders on Uptake of Repeat HIV Testing among Outpatients Screened for Acute HIV Infection in Kenya: A Randomized Controlled Trial. PLoS One. 2016 Apr 14;11(4):e0153612. doi: 10.1371/journal.pone.0153612. eCollection 2016.
PubMed 27077745
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Screening of At-Risk Adults for Acute HIV-1 Infection
- ClinicalTrials.gov ID
- NCT01876199
- Acronym / sponsor ID
- AHI / SSC2359
- Conditions
- HIV
- Keywords
- HIV-1, acute, diagnosis, pharmacies, healthcare facilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- International AIDS Vaccine Initiative, KEMRI-Wellcome Trust Collaborative Research Program, University of Washington, Kenya Ministry of Health
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jun 2013 (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.
In this research, the investigators want to see if early detection of HIV infection can be improved by testing young adults who seek urgent health care from pharmacies and healthcare facilities with symptoms similar to those people get with recent HIV infection.
Specific objectives:
- What proportion of people presenting with these symptoms are HIV positive at the point of seeking urgent health care?
- What proportion of those who test negative or where the result is unclear (one rapid test positive and one negative) at first rapid HIV testing, will test positive two weeks later?
- What is the best way (SMS, phone call or home visit) to remind people to come for the second test after two weeks?
- Will young adults who seek urgent health care for fever, body pains, diarrhoea or an STD from pharmacies or health facilities find it acceptable to be invited for an HIV-1 test at the time of health care seeking?
Hypotheses
- Targeted screening for AHI among patients seeking health care for symptoms compatible with AHI or sexually transmitted disease (STD) will identify AHI cases in more than 1% of those screened.
- Intense follow-up of patients evaluated for AHI will improve rates of repeat HIV-1 testing 2-4 weeks after initial health-care seeking, relative to standard practice (i.e., recommendation to return for testing on a given date).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intense follow up | Experimental | Behavioral: intense follow up2-week follow up appointment with addition of a reminder mobile phone call or short text message (SMS) if possible, plus a home visit by a community counselor if the participant fails to present on the appointed date. |
| standard follow-up | No intervention | –2-week follow-up appointment with no reminders |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- symptom score of 2 or more: Confirmed fever (≥37.5 °C axillary), reported diarrhoea, or evidence of STD (variable score=2); reported body pains, or report of more than one sexual partners in past 2 months (variable score=1)
- resident in Mtwapa or Shanzu or planning to stay in Mtwapa for approximately 4 weeks duration
- willing to give locator information (including mobile phone number)
- negative or unknown HIV status
Key exclusion criteria (1 listed)
- patients not meeting inclusion criteria
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 |
|---|---|---|
| intense follow up | Behavioural | Intense follow up |
Primary outcome
Difference in Number and proportion of adults responding to standard appointment versus intense follow up.
Time frame: 2 weeks
1 secondary outcome
Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion.
Time frame: 2 weeks
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 4 Aug 2014.
- Derived from this study: PubMed 27077745Mugo PM, Wahome EW, Gichuru EN, Mwashigadi GM, Thiong'o AN, Prins HA, Rinke de Wit TF, Graham SM, Sanders EJ. Effect of Text Message, Phone Call, and In-Person Appointment Reminders on Uptake of Repeat HIV Testing among Outpatients Screened for Acute HIV Infection in Kenya: A Randomized Controlled Trial. PLoS One. 2016 Apr 14;11(4):e0153612. doi: 10.1371/journal.pone.0153612. eCollection 2016.
- KEMRI Wellcome Trust Research ProgrammeLink provided by the sponsor.
- KEMRI Wellcome on SiteFinderLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intense follow up in people with HIV, run by University of Oxford 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 4 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 4 Aug 2014. 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?
Difference in Number and proportion of adults responding to standard appointment versus intense follow up. (time frame: 2 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 NCT01876199, 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 4 Aug 2014.