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

Study Overview
=================
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: 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? Hypotheses 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. 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).

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

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Behavioral: intense follow up


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intense follow up<br>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<br> <br> |
| No Intervention: standard follow-up<br>2-week follow-up appointment with no reminders | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Number and proportion of adults responding to standard appointment versus intense follow up. |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion. |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-1, acute, diagnosis, pharmacies, healthcare facilities