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

Not Applicable

Completed

• Conditions: HIV
• Interventions: Behavioral: intense follow up

• Registration Number: NCT01876199
• Lead Sponsor: University of Oxford

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-06-10
• Study First Submitted QC: 2013-06-11
• Study First Posted: 2013-06-12
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-01
• Last Update Posted: 2014-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 522

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intense follow up	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.

Primary Outcome Measures

Name	Time	Method
Difference in Number and proportion of adults responding to standard appointment versus intense follow up.	2 weeks

Secondary Outcome Measures

Name	Time	Method
Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion.	2 weeks

Trial Locations

Locations (1)

KEMRI Mtwapa; 🇰🇪 Kilifi, Kenya