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OpenTrials
Completed

NCT Number: NCT01876199

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 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).

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Key information

Conditions

HIV Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KEMRI Mtwapa

Kilifi, 80108, Kenya

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intense follow up

Behavioral

Primary outcomes

  1. Difference in Number and proportion of adults responding to standard appointment versus intense follow up.

    Time frame: 2 weeks

Secondary outcomes

  1. Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion.

    Time frame: 2 weeks

Other outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

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

Registry information

Acronym: AHI

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 12, 2013
Registry last updated
Aug 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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