Clinical trial NCT01904994: Link4Health: A Combination Strategy for Linkage and Retention, Swaziland
Official title: LINK4HEALTH: A Combination Approach to Linkage and Retention for HIV (Human Immunodeficiency Virus) Infected Individuals in Swaziland
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV (Human Immunodeficiency Virus)
Keywords: HIV (Human Immunodeficiency Virus)
ART (antiretroviral therapy)
financial incentive
linkage
retention
SMS (Short Message Service) appointment reminder
accelerated ART
CD4+ count
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Centers for Disease Control and Prevention
name: New York University
First posted: 2013-07-22
Enrollment: 2201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: one month after enrollment, 12 months after enrollment
Secondary outcomes:
measure: Proportion of participants successfully linked to care at designated study unit within 1 month of HIV diagnosis
timeFrame: 12 months after enrollment
measure: Proportion of participants retained in care at designated study unit 12 months after HIV diagnosis.
timeFrame: 12 months after enrollment
measure: Change in proportion of participants successfully linked to care at any HIV care clinic within one month of HIV diagnosis
timeFrame: one month after enrollment, 12 months after enrollment
measure: Median time from HIV testing to initial assessment of ART (antiretroviral) eligibility
timeFrame: 12-months after enrollment
measure: Median time from HIV testing to ART eligibility
timeFrame: 12 months after enrollment
measure: Proportion of participants who consistently engage in care (attend > 75% of scheduled appointments)
timeFrame: 12-months after enrollment
measure: Change in proportion of participants with new World Health Organization (WHO) Stage III/IV event or hospitalization
timeFrame: 1 month after enrollment,12 months after enrollment
measure: Median CD4+ (cluster difference 4) count and viral load 12 months after HIV diagnosis
timeFrame: 12 months after testing HIV-positive
measure: Change in Mortality rate
timeFrame: 1 month after enrollment, 12 months after enrollment
measure: Change in proportion of participants reporting interventions were received
timeFrame: 1 month after enrollment, 12 months after enrollment
measure: Proportion of participants reporting that interventions were highly acceptable
timeFrame: 12 months after enrollment
Other outcomes:
measure: 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
timeFrame: at enrollment, one month after enrollment, 12 months after enrollment
Locations:
city: Swaziland
country: Swaziland
facility: Bhalekane Clinic
city: Swaziland
country: Swaziland
facility: Dvokolwako
city: Swaziland
country: Swaziland
facility: Good Shepherd Hospital
city: Swaziland
country: Swaziland
facility: Hlatikhulu Hospital
city: Swaziland
country: Swaziland
facility: Horo
city: Swaziland
country: Swaziland
facility: Kamfishane
city: Swaziland
country: Swaziland
facility: Lamvelase
city: Swaziland
country: Swaziland
facility: Luyengo Clinic
city: Swaziland
country: Swaziland
facility: Mangweni Clinic
city: Swaziland
country: Swaziland
facility: Mankayane Hospital
city: Swaziland
country: Swaziland
facility: Mashobneni Clinic
city: Swaziland
country: Swaziland
facility: Mbabane Government Hospital
city: Swaziland
country: Swaziland
facility: Mkhuzweni Health Center
city: Swaziland
country: Swaziland
facility: Motshane
city: Swaziland
country: Swaziland
facility: Mpolenjeni Clinic
city: Swaziland
country: Swaziland
facility: Nhlangano Health Center
city: Swaziland
country: Swaziland
facility: Piggs Peak
city: Swaziland
country: Swaziland
facility: Raleigh Fitkin Memorial Hospital
city: Swaziland
country: Swaziland
facility: Siphofaneni Clinc
city: Swaziland
country: Swaziland
facility: Sithobeloa Rural Health Center
Study officials:
affiliation: ICAP Columbia University
name: Wafaa El-Sadr, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Swaziland MOH
name: Charles Azih, MD MPH
role: STUDY_DIRECTOR
affiliation: New York University
name: Scott Braithwaite, MD MSc
role: STUDY_DIRECTOR
affiliation: ICAP Columbia University
name: Batya Elul, PhD MD
role: STUDY_DIRECTOR
affiliation: Centers for Disease Control and Prevention
name: Peter Ehrenkranz, MD MPH
role: STUDY_DIRECTOR
affiliation: ICAP Columbia University
name: Matthew Lamb, PhD MPH
role: STUDY_DIRECTOR
affiliation: ICAP Columbia University
name: Margaret McNairy, MD MSc
role: STUDY_DIRECTOR
affiliation: Swaziland MOH
name: Phumzile Mndzebele
role: STUDY_DIRECTOR
affiliation: ICAP Swaziland
name: Ruben Sahabao, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.