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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

522 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-07-31

Brief Summary

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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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Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

intense follow up

Intervention Type BEHAVIORAL

standard follow-up

2-week follow-up appointment with no reminders

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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intense follow up

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No