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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01876199
Acronym
AHI
Enrollment
522
Registered
2013-06-12
Start date
2013-02-28
Completion date
2013-07-31
Last updated
2014-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV

Keywords

HIV-1, acute, diagnosis, pharmacies, healthcare facilities

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).

Interventions

BEHAVIORALintense follow up

Sponsors

International AIDS Vaccine Initiative
CollaboratorNETWORK
KEMRI-Wellcome Trust Collaborative Research Program
CollaboratorOTHER
University of Washington
CollaboratorOTHER
Kenya Ministry of Health
CollaboratorOTHER_GOV
University of Oxford
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Difference in Number and proportion of adults responding to standard appointment versus intense follow up.2 weeks

Secondary

MeasureTime frame
Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion.2 weeks

Other

MeasureTime frame
Number and proportion of adults diagnosed with AHI by p24 antigen testing alone2 weeks
Proportion of patients diagnosed with AHI who successfully enroll in HIV-1 care3 months

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026