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Completed

NCT Number: NCT01904994

Link4Health: A Combination Strategy for Linkage and Retention, 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.

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Key information

Conditions

HIV (Human Immunodeficiency Virus) Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bhalekane Clinic, Swaziland, Eswatini

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Procedure

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.

Other names: PIMA

Accelerated ART (antiretroviral therapy) Initiation

Procedure

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 Package

Behavioral

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.

Other names: BCPP

Cellular Appointment Reminders and Follow-Up

Behavioral

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

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

Financial Incentive

Other

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.

Other names: FI (Financial Incentive)

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

    Time frame: one month after enrollment, 12 months after enrollment

    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.

Secondary outcomes

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

    Time frame: 12 months after enrollment

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

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

    Time frame: 12 months after enrollment

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

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

    Time frame: one month after enrollment, 12 months after enrollment

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

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

    Time frame: 12-months after enrollment

    Time from linkage to ART eligibility assessment

  5. Median time from HIV testing to ART eligibility

    Time frame: 12 months after enrollment

    Time from HIV testing to ART eligibility

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

    Time frame: 12-months after enrollment

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

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

    Time frame: 1 month after enrollment,12 months after enrollment

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

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

    Time frame: 12 months after testing HIV-positive

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

  9. Change in Mortality rate

    Time frame: 1 month after enrollment, 12 months after enrollment

    Mortality rate 12 months after HIV diagnosis

  10. Change in proportion of participants reporting interventions were received

    Time frame: 1 month after enrollment, 12 months after enrollment

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

  11. Proportion of participants reporting that interventions were highly acceptable

    Time frame: 12 months after enrollment

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

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

    Time frame: at enrollment, one month after enrollment, 12 months after enrollment

    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, by strata of age, sex, and other socio-demographic variables

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Centers for Disease Control and Prevention
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Institutes of Health (NIH)
  • New York University

Registry information

Official study title

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

Acronym: L4H

Important dates

Study start
2013
Primary completion
2016
Study completion
2021
First posted
Jul 22, 2013
Registry last updated
Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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