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

HIV Clinical Trial

— AHI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01876199
• Other study ID #: SSC2359
• Secondary ID: 167-12
• Status: Completed
• Phase: N/A
• First received: June 10, 2013
• Last updated: August 1, 2014
• Start date: February 2013
• Est. completion date: July 2013

Study information

• Verified date: August 2014
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 522
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 29 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV

Intervention

Behavioral:
• intense follow up

Locations

Country	Name	City	State
Kenya	KEMRI Mtwapa	Kilifi

Sponsors (5)

Lead Sponsor	Collaborator
University of Oxford	International AIDS Vaccine Initiative, KEMRI-Wellcome Trust Collaborative Research Program, Kenya Ministry of Health, University of Washington

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number and proportion of adults diagnosed with AHI by p24 antigen testing alone		2 weeks	No
Other	Proportion of patients diagnosed with AHI who successfully enroll in HIV-1 care		3 months	No
Primary	Difference in Number and proportion of adults responding to standard appointment versus intense follow up.		2 weeks	No
Secondary	Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion.		2 weeks	No

External Links

•   KEMRI Wellcome on SiteFinder
•   KEMRI Wellcome Trust Research Programme