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

This study has been completed.
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: August 1, 2014
Last verified: August 2014
  Purpose

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 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 Intervention
HIV
Behavioral: intense follow up

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Targeted Screening of At-Risk Adults for Acute HIV-1 Infection

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Difference in Number and proportion of adults responding to standard appointment versus intense follow up. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ]

Enrollment: 522
Study Start Date: February 2013
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01876199

Locations
Kenya
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:
No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01876199     History of Changes
Other Study ID Numbers: SSC2359, 167-12
Study First Received: June 10, 2013
Last Updated: August 1, 2014
Health Authority: Kenya: Ethical Review Committee

Keywords provided by University of Oxford:
HIV-1
acute
diagnosis
pharmacies
healthcare facilities

ClinicalTrials.gov processed this record on October 01, 2014