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Targeted Screening of At-Risk Adults for Acute HIV-1 Infection (AHI)

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ClinicalTrials.gov Identifier: NCT01876199
Recruitment Status : Completed
First Posted : June 12, 2013
Last Update Posted : August 4, 2014
Information provided by (Responsible Party):

Study Description
Brief 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. What proportion of people presenting with these symptoms are HIV positive at the point of seeking urgent health care?
  2. 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?
  3. What is the best way (SMS, phone call or home visit) to remind people to come for the second test after two weeks?
  4. 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?


  1. 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.
  2. 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).

Condition or disease Intervention/treatment
HIV Behavioral: intense follow up

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 522 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Targeted Screening of At-Risk Adults for Acute HIV-1 Infection
Study Start Date : February 2013
Primary Completion Date : July 2013
Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intense follow up
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.
Behavioral: intense follow up
No Intervention: standard follow-up
2-week follow-up appointment with no reminders

Outcome Measures

Primary Outcome Measures :
  1. Difference in Number and proportion of adults responding to standard appointment versus intense follow up. [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion. [ Time Frame: 2 weeks ]

Other Outcome Measures:
  1. Number and proportion of adults diagnosed with AHI by p24 antigen testing alone [ Time Frame: 2 weeks ]
  2. Proportion of patients diagnosed with AHI who successfully enroll in HIV-1 care [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients not meeting inclusion criteria
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01876199

KEMRI Mtwapa
Kilifi, Kenya, 80108
Sponsors and Collaborators
University of Oxford
International AIDS Vaccine Initiative
KEMRI-Wellcome Trust Collaborative Research Program
University of Washington
Kenya Ministry of Health
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01876199     History of Changes
Other Study ID Numbers: SSC2359
167-12 ( Other Identifier: OXTREC )
First Posted: June 12, 2013    Key Record Dates
Last Update Posted: August 4, 2014
Last Verified: August 2014

Keywords provided by University of Oxford:
healthcare facilities