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

University of Oxford

Status: Completed

Conditions: HIV

Treatments: Behavioral: intense follow up

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01876199

167-12 (Other Identifier)

SSC2359

Details and patient eligibility

About

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).

Enrollment: 522 patients

Sex: All

Ages: 18 to 29 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

522 participants in 2 patient groups

Intense follow up

Experimental group

Description:

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.

Treatment:

Behavioral: intense follow up

standard follow-up

No Intervention group

Description:

2-week follow-up appointment with no reminders