NCT01876199

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. 1.What proportion of people presenting with these symptoms are HIV positive at the point of seeking urgent health care?
  2. 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. 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. 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?
  5. 5.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.
  6. 6.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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
522

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 4, 2014

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

June 10, 2013

Last Update Submit

August 1, 2014

Conditions

HIV

Keywords

HIV-1acutediagnosispharmacieshealthcare facilities

Outcome Measures

Primary Outcomes (1)

  • Difference in Number and proportion of adults responding to standard appointment versus intense follow up.

    2 weeks

Secondary Outcomes (1)

  • Number and proportion of adults diagnosed with AHI by rapid antibody seroconversion.

    2 weeks

Other Outcomes (2)

  • Number and proportion of adults diagnosed with AHI by p24 antigen testing alone

    2 weeks

  • Proportion of patients diagnosed with AHI who successfully enroll in HIV-1 care

    3 months

Study Arms (2)

Intense follow up

EXPERIMENTAL

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

standard follow-up

NO INTERVENTION

2-week follow-up appointment with no reminders

Interventions

intense follow upBEHAVIORAL
Intense follow up

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KEMRI Mtwapa

Kilifi, 80108, Kenya

Location

Related Publications (1)

  • 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.

    PMID: 27077745DERIVED

Related Links

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2013

First Posted

June 12, 2013

Study Start

February 1, 2013

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

August 4, 2014

Record last verified: 2014-08

Locations

KE(1)