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HIV (Human Immunodeficiency Virus)L4HNCT01904994

Link4Health: A Combination Strategy for Linkage and Retention, Swaziland

A study testing POC (point-of-care) CD4+ (cluster of differentiation 4) Count, Accelerated ART (antiretroviral therapy) Initiation and Basic Care and Prevention Package in people with HIV (Human Immunodeficiency Virus), run by Columbia University at 20 sites in Eswatini.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV (Human Immunodeficiency Virus)
What is being tested?
POC (point-of-care) CD4+ (cluster of differentiation 4) Count, Accelerated ART (antiretroviral therapy) Initiation and Basic Care and Prevention Package
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,201 participants
Where
20 sitesEswatini
Study dates
Aug 2013to 12 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • Testing HIV-positive at an HTC (HIV testing and counseling) site within a SU (study unit)
  • Willing to be referred to an HIV care clinic associated with the SU
  • Willing to provide locator information
  • Willing to adhere to study procedures, including a baseline interview, home-based interviews at 1 and 12 months after study enrollment; home-based CD4+ count assessment 12 months after enrollment, and abstraction of data from their medical records.
  • Able to provide informed consent

Who cannot join

  • Planning on leaving the community where they currently reside in the next 12 months for a period greater than 6 months
  • Enrolled in HIV (Human immunodeficiency virus) care in the past 6 months at any HIV care clinic
  • Currently on ART (antiretroviral therapy)
  • Initiated ART (for any duration) in the past 6 months at any HIV care clinic
  • Does not speak or understand English or si-Swati
  • Reports being currently pregnant at time of study enrollment

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

Eswatini20 sites

  • Bhalekane Clinic

    Swaziland

  • Dvokolwako

    Swaziland

  • Good Shepherd Hospital

    Swaziland

  • Hlatikhulu Hospital

    Swaziland

  • Horo

    Swaziland

  • Kamfishane

    Swaziland

  • Lamvelase

    Swaziland

  • Luyengo Clinic

    Swaziland

  • Mangweni Clinic

    Swaziland

  • Mankayane Hospital

    Swaziland

  • Mashobneni Clinic

    Swaziland

  • Mbabane Government Hospital

    Swaziland

  • Mkhuzweni Health Center

    Swaziland

  • Motshane

    Swaziland

  • Mpolenjeni Clinic

    Swaziland

  • Nhlangano Health Center

    Swaziland

  • Piggs Peak

    Swaziland

  • Raleigh Fitkin Memorial Hospital

    Swaziland

  • Siphofaneni Clinc

    Swaziland

  • Sithobeloa Rural Health Center

    Swaziland

Other trials in Eswatini

About this study

Official title: LINK4HEALTH: A Combination Approach to Linkage and Retention for HIV (Human Immunodeficiency Virus) Infected Individuals in Swaziland

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.

Read the detailed description

Linkage of patients from HIV testing to HIV care programs and their retention once enrolled in care are essential to HIV program effectiveness in terms of prevention of HIV;related morbidity and mortality and prevention of HIV transmission. Linkage and retention rates in HIV programs in sub-Saharan Africa (SSA) are suboptimal, with less than half of patients who test positive successfully linking and remaining in care at 1 year. This study is a two-arm cluster site;randomized trial to compare the effectiveness of a novel combination package of evidence;based interventions, the combination intervention strategy (CIS), compared to standard of care (SOC) on linkage and retention of HIV;positive patients from point of testing to retention in care. CIS will include 1) point of care CD4+ count assays at HIV testing sites; 2) accelerated antiretroviral therapy (ART) initiation for eligible patients; 3) provision of a basic care and prevention package (BCPP); 4) short message service (SMS) reminders for clinic appointments; and 5) financial incentives for linkage and retention. The primary aim is to evaluate the effectiveness of CIS as compared to SOC on the combined outcome of rapid linkage to HIV care within 1 month and retention in care at 12 months among adults testing positive for HIV. Secondary aims include evaluation of the effectiveness of CIS compared to SOC on each of linkage to HIV; retention in care; time to ART initiation; HIV disease progression and mortality; patient acceptability; association between baseline characteristics and outcomes, and comparison of cost effectiveness.

Being tested
POC (point-of-care) CD4+ (cluster of differentiation 4) Count, Accelerated ART (antiretroviral therapy) Initiation, Basic Care and Prevention Package, Cellular Appointment Reminders and Follow-Up, Financial Incentive
Keywords
HIV (Human Immunodeficiency Virus), ART (antiretroviral therapy), financial incentive, linkage, retention, SMS (Short Message Service) appointment reminder, accelerated ART, CD4+ count
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • POC (point-of-care) CD4+ (cluster of differentiation 4) CountProcedure or surgery

    Also called PIMA

    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.

  • Accelerated ART (antiretroviral therapy) InitiationProcedure or surgery

    Accelerated ART initiation for patients with POC CD4+ < 350 cells/uL (micro-liter) within 1 week from testing.

    2 counseling sessions (one at time of HTC and other at first HIV clinic visit), and collection of blood for other baseline lab tests, but initiation prior to return of results for patients who do not meet criteria for waiting

  • Basic Care and Prevention PackageBehavioural

    Also called BCPP

    Basic care and prevention package (BCPP) provided approximately every three months that includes: condoms; soap, pill box and pictorial education about use of materials and HIV, such as family testing tools and information. Information on BCPP contents and review the educational materials will be provided. An example of educational materials is a family-testing tool to encourage the participant to have all family members tested for HIV. All BCPP items will be replenished every 3 months for all participants, regardless of ART status, beginning at linkage to HIV care.

  • Cellular Appointment Reminders and Follow-UpBehavioural

    SMS (short messaging service) appointment reminders for follow-up appointments.

    Telephone call within 7 days of missed appointment for all patients.

  • Financial IncentiveOther

    Also called FI (Financial Incentive)

    Participants will receive a series of financial incentives to support linkage into care within 1 month and retention in care at 6 months and 12 months after testing HIV positive. The value of the financial incentive (FI) will be 80 Swaziland Rand, calculated based on the associated financial costs of traveling to clinic. These incentives will be distributed by through mobile airtime. Participants without mobile phones will be given an alternative incentive of equal value, such as a store voucher.

Study groups in NCT01904994
Study groupRoleWhat they receive
Standard of CareNo interventionParticipants will be managed per standard of care following prevailing Swaziland Ministry of Health guidelines.
Combined Intervention StrategyExperimentalPoint-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
Receives: Procedure: POC (point-of-care) CD4+ (cluster of differentiation 4) Count; Procedure: Accelerated ART (antiretroviral therapy) Initiation; Behavioral: Basic Care and Prevention Package; Behavioral: Cellular Appointment Reminders and Follow-Up; Other: Financial Incentive

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: one month after enrollment, 12 months after enrollment

Secondary outcomes (11)

  1. Proportion of participants successfully linked to care at designated study unit within 1 month of HIV diagnosis

    Linkage to care within 1 month of HIV testing (at any clinic within the assigned study unit).

    Measured: 12 months after enrollment

  2. Proportion of participants retained in care at designated study unit 12 months after HIV diagnosis.

    Retention in care 12 months after HIV testing, independent of linkage at 1 month (at any clinic within the assigned study unit).

    Measured: 12 months after enrollment

  3. Change in proportion of participants successfully linked to care at any HIV care clinic within one month of HIV diagnosis

    Proportion of participants successfully linked to care at any HIV care clinic within one month of HIV diagnosis

    Measured: one month after enrollment, 12 months after enrollment

  4. Median time from HIV testing to initial assessment of ART (antiretroviral) eligibility

    Time from linkage to ART eligibility assessment

    Measured: 12-months after enrollment

  5. Median time from HIV testing to ART eligibility

    Time from HIV testing to ART eligibility

    Measured: 12 months after enrollment

  6. Proportion of participants who consistently engage in care (attend > 75% of scheduled appointments)

    Proportion of participants who consistently engage in care, defined as attend > 75% of scheduled appointments

    Measured: 12-months after enrollment

  7. Change in proportion of participants with new World Health Organization (WHO) Stage III/IV event or hospitalization

    Proportion of participants with new WHO Stage III/IV event or hospitalization

    Measured: 1 month after enrollment,12 months after enrollment

  8. Median CD4+ (cluster difference 4) count and viral load 12 months after HIV diagnosis

    Median CD4+ cell count 12 months after HIV diagnosis, median viral load 12 months after HIV diagnosis

    Measured: 12 months after testing HIV-positive

  9. Change in Mortality rate

    Mortality rate 12 months after HIV diagnosis

    Measured: 1 month after enrollment, 12 months after enrollment

  10. Change in proportion of participants reporting interventions were received

    Proportion of participants, who are randomized to study units receiving CIS, reporting receipt of each intervention

    Measured: 1 month after enrollment, 12 months after enrollment

  11. Proportion of participants reporting that interventions were highly acceptable

    Proportion of participants, who are randomized to study units receiving CIS, reporting that interventions were highly acceptable

    Measured: 12 months after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionMay 2016
  4. Study completion12 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01904994
Sponsor's protocol ID
AAAL2708
Other IDs
5R01AI100059-02
Acronym
L4H
Status last verified
Oct 2021
First submitted
16 Jul 2013
Last updated
22 Oct 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • McNairy ML, Lamb MR, Gachuhi AB, Nuwagaba-Biribonwoha H, Burke S, Mazibuko S, Okello V, Ehrenkranz P, Sahabo R, El-Sadr WM. Effectiveness of a combination strategy for linkage and retention in adult HIV care in Swaziland: The Link4Health cluster randomized trial. PLoS Med. 2017 Nov 7;14(11):e1002420. doi: 10.1371/journal.pmed.1002420. eCollection 2017 Nov.

    PubMed 29112963

  • McNairy ML, Gachuhi AB, Lamb MR, Nuwagaba-Biribonwoha H, Burke S, Ehrenkranz P, Mazibuko S, Sahabo R, Philip NM, Okello V, El-Sadr WM. The Link4Health study to evaluate the effectiveness of a combination intervention strategy for linkage to and retention in HIV care in Swaziland: protocol for a cluster randomized trial. Implement Sci. 2015 Jul 19;10:101. doi: 10.1186/s13012-015-0291-4.

    PubMed 26189154

Questions about this trial

What is this clinical trial studying?

A study testing POC (point-of-care) CD4+ (cluster of differentiation 4) Count, Accelerated ART (antiretroviral therapy) Initiation and Basic Care and Prevention Package in people with HIV (Human Immunodeficiency Virus), run by Columbia University at 20 sites in Eswatini.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Eswatini. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: one month after enrollment, 12 months after enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01904994, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.

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