Targeted Screening of At-Risk Adults for Acute HIV-1 Infection (AHI)
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.
- What proportion of people presenting with these symptoms are HIV positive at the point of seeking urgent health care?
- 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?
- What is the best way (SMS, phone call or home visit) to remind people to come for the second test after two weeks?
- 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?
- Targeted screening for AHI among patients seeking health care for symptoms compatible with AHI or STD will identify AHI cases in more than 1% of those screened.
- 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).
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Targeted Screening of At-Risk Adults for Acute HIV-1 Infection|
- Difference in Number and proportion of adults responding to standard appointment versus intense follow up. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Number and proportion of adults diagnosed with AHI by p24 antigen testing alone [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- Proportion of patients diagnosed with AHI who successfully enroll in HIV-1 care [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
|Behavioral: intense follow up|
No Intervention: standard follow-up
2-week follow-up appointment with no reminders
Please refer to this study by its ClinicalTrials.gov identifier: NCT01876199
|Kilifi, Kenya, 80108|