Brief Summary

Despite increased HIV (Human Immunodeficiency Virus) infection testing in Africa, many patients never enroll in subsequent HIV care after testing or remain in care after an initial enrollment. This study's aim is to improve linkage to HIV care and retention in HIV care through the use of feasible, evidence-based, and practical interventions. The study takes place in Swaziland, the country with the highest HIV prevalence (24%) in sub-Saharan Africa. The study will randomize groups of HIV testing sites and affiliated clinics to either standard of care or a combined intervention strategy (CIS) which consists of point-of care CD4 (cluster differentiation 4 (CD4)) testing at time of HIV testing, fast-track HIV medications for those who are eligible for treatment,mobile phone appointment reminders, care bags filled with health prevention materials, and financial incentives. The study outcomes are linkage to and retention in care as well as cost effectiveness, feasibility of interventions, and patient acceptability of interventions.

Trial Health

On Track

Trial Health Score

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

Enrollment

2,201

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Aug 2013

Longer than P75 for not_applicable

Geographic Reach

1 country

20 active sites

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

8.2 years study duration

First Submitted

Initial submission to the registry

July 16, 2013

Completed

6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2013

Completed

10 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed

5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2021

Completed

Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

2.8 years

First QC Date

July 16, 2013

Last Update Submit

October 20, 2021

Conditions

HIV (Human Immunodeficiency Virus)

Keywords

HIV (Human Immunodeficiency Virus)ART (antiretroviral therapy)financial incentivelinkageretentionSMS (Short Message Service) appointment reminderaccelerated ARTCD4+ count

Outcome Measures

Primary Outcomes (1)

Change in proportion of participants who both link to care at assigned study unit within 1 month and are retained in care at the designated study unit 12 months after HIV (Human Immunodeficiency Virus) diagnosis
Combined outcome of linkage to HIV care within 1 month after testing HIV positive and retention in care 12 months after testing. Participants are considered to achieve this outcome if they successfully link to the HIV clinic at their study unit (SU) within 1 month of testing HIV positive and are retained in care at the HIV clinic at their SU 12 months after testing HIV positive, as measured from medical records.
one month after enrollment, 12 months after enrollment

Secondary Outcomes (11)

Proportion of participants successfully linked to care at designated study unit within 1 month of HIV diagnosis
12 months after enrollment
Proportion of participants retained in care at designated study unit 12 months after HIV diagnosis.
12 months after enrollment
Change in proportion of participants successfully linked to care at any HIV care clinic within one month of HIV diagnosis
one month after enrollment, 12 months after enrollment
Median time from HIV testing to initial assessment of ART (antiretroviral) eligibility
12-months after enrollment
Median time from HIV testing to ART eligibility
12 months after enrollment
+6 more secondary outcomes

Other Outcomes (1)

Change in adjusted risk ratio comparing proportion of participants who both link to care at assigned study unit within one month and are retained in care at designated study unit twelve months after HIV diagnosis
at enrollment, one month after enrollment, 12 months after enrollment

Study Arms (2)

Standard of Care

NO INTERVENTION

Participants will be managed per standard of care following prevailing Swaziland Ministry of Health guidelines.

Combined Intervention Strategy

EXPERIMENTAL

Point-of-care (POC) CD4+ (cluster of differentiation 4) Count Accelerated ART initiation for ART eligible participants Basic care and prevention package Cellular Appointment Reminders and Follow-Up Financial Incentives

Procedure: POC (point-of-care) CD4+ (cluster of differentiation 4) CountProcedure: Accelerated ART (antiretroviral therapy) InitiationBehavioral: Basic Care and Prevention PackageBehavioral: Cellular Appointment Reminders and Follow-UpOther: Financial Incentive

Interventions

POC (point-of-care) CD4+ (cluster of differentiation 4) CountPROCEDURE

Each HIV testing and counseling (HTC) site will be equipped with POC CD4+ testing using PIMA™ Analyser (Inverness), test strips, and reagents. Study staff will obtain 25 microliters of blood via finger prick and process the POC (point-of-care) CD4+ (cluster of differentiation 4) Count' test immediately following the baseline interview. Test results will be recorded on study forms including a referral form that has multiple copies, one copy to be given to the participant, the second sent to the affiliated HIV (Human immunodeficiency virus)care clinic in the study unit, and the third kept by study staff in a locked cabinet with other confidential material. All participants, regardless of the CD4+ result, will be encouraged to enroll in HIV care as soon as they can.

Also known as: PIMA