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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
International AIDS Vaccine Initiative
KEMRI-Wellcome Trust Collaborative Research Program
University of Washington
Kenya Ministry of Health
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01876199
First received: June 10, 2013
Last updated: July 26, 2013
Last verified: July 2013

June 10, 2013
July 26, 2013
February 2013
July 2013   (final data collection date for primary outcome measure)
Difference in Number and proportion of adults responding to standard appointment versus intense follow up. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01876199 on ClinicalTrials.gov Archive Site
Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
  • Number and proportion of adults diagnosed with AHI by p24 antigen testing alone [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients diagnosed with AHI who successfully enroll in HIV-1 care [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
 
Targeted Screening of At-Risk Adults for Acute HIV-1 Infection
Targeted Screening of At-Risk Adults for Acute HIV-1 Infection

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?

Hypotheses

  1. Targeted screening for AHI among patients seeking health care for symptoms compatible with AHI or 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).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV
Behavioral: intense follow up
  • 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.
    Intervention: Behavioral: intense follow up
  • No Intervention: standard follow-up
    2-week follow-up appointment with no reminders
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
520
October 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 29 Years
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT01876199
SSC2359, 167-12
No
University of Oxford
University of Oxford
  • International AIDS Vaccine Initiative
  • KEMRI-Wellcome Trust Collaborative Research Program
  • University of Washington
  • Kenya Ministry of Health
Not Provided
University of Oxford
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP