Clinical trial NCT01876199: Targeted Screening of At-Risk Adults for Acute HIV-1 Infection
Official title: Targeted Screening of At-Risk Adults for Acute HIV-1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV-1
acute
diagnosis
pharmacies
healthcare facilities
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: International AIDS Vaccine Initiative
name: KEMRI-Wellcome Trust Collaborative Research Program
name: University of Washington
name: Kenya Ministry of Health
First posted: 2013-06-12
Enrollment: 522
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


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

Primary outcomes:
measure: Difference in Number and proportion of adults responding to standard appointment versus intense follow up.
timeFrame: 2 weeks
Secondary outcomes:
measure: Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion.
timeFrame: 2 weeks
Other outcomes:
measure: Number and proportion of adults diagnosed with AHI by p24 antigen testing alone
timeFrame: 2 weeks
measure: Proportion of patients diagnosed with AHI who successfully enroll in HIV-1 care
timeFrame: 3 months
Locations:
city: Kilifi
country: Kenya
facility: KEMRI Mtwapa
Study officials:
References:
citation: Mugo PM, Wahome EW, Gichuru EN, Mwashigadi GM, Thiong'o AN, Prins HA, Rinke de Wit TF, Graham SM, Sanders EJ. Effect of Text Message, Phone Call, and In-Person Appointment Reminders on Uptake of Repeat HIV Testing among Outpatients Screened for Acute HIV Infection in Kenya: A Randomized Controlled Trial. PLoS One. 2016 Apr 14;11(4):e0153612. doi: 10.1371/journal.pone.0153612. eCollection 2016.