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

August 1, 2014 updated by: University of Oxford

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

522

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Kilifi, Kenya, 80108
        • KEMRI Mtwapa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in Number and proportion of adults responding to standard appointment versus intense follow up.
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion.
Time Frame: 2 weeks
2 weeks

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

University of Washington
KEMRI-Wellcome Trust Collaborative Research Program
International AIDS Vaccine Initiative
Kenya Ministry of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (Estimate)

June 12, 2013

Study Record Updates

Last Update Posted (Estimate)

August 4, 2014

Last Update Submitted That Met QC Criteria

August 1, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSC2359
  • 167-12 (Other Identifier: OXTREC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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