Outcomes of Differentiated Models of Antiretroviral Treatment (ART) Provision

NCT03438370 | Unknown DMC

• 1 other identifier: ID49-2017
• Study Type: interventional
• Target: 5,760
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evalulate the effectiveness and cost-effectiveness of three models of ART provision for stable ART patients. The objectives are to measure patient retention, virological suppression, provider and patient costs, cost-effectiveness, and patient acceptability amongst stable patients who receive ART at intervals of three and six months within community distribution models, and to compare these to patients who receive ART directly from the clinic at three month intervals. Methods A prospective, parallel, cluster-randomized non-inferiority trial with three study arms will be conducted. 30 Clusters (sites) will be randomized in strata according to geographic location (urban and rural) to the 3 study arms as follows:

• Control arm: sites at which patients will receive three monthly ART supply at the facility (arm 3MF).
• Intervention arm 1: sites at which patients will receive three monthly ART supply in CAGs (arm 3MC)
• Intervention arm 2: sites at which patients will receive six monthly ART supply in the community by a healthcare worker (arm 6MCD). The study population will consist of stable, HIV-infected adults who have received first-line ART for at least six months, who have a viral load \<1000 copies/ml at baseline, and who provide informed consent for inclusion in the study. An average of 192 participants from each study site will be included, with a total sample size of approximately 5760 participants. The primary outcome is retention in care defined as the proportion of patients remaining in care 12 months after study enrolment, with the hypothesis that patient retention within the intervention arms will be non-inferior compared to the control arm. Retention in care will also be compared between the three arms after 24 months. The secondary outcomes are:
• Viral suppression: defined as the proportion of patients with virological suppression (\<1000 copies/ml) 12 and 24 months after study enrolment;
• Cost of providing ART: defined as the cost per patient of providing ART in each of the three arms (from a provider perspective);
• Cost of retaining a patient: defined as the provider cost per patient retained and provider cost per patient retained with virological suppression in each of the three arms, and the incremental cost-effectiveness ratio for the comparative arms.

Conditions

HIV/AIDS

Outcome Measures

Primary Outcomes (1)

• retention in care

  The proportion of patients remaining in care 12 months after study enrolment

  12 months

Secondary Outcomes (3)

• Viral suppression

  12 months

• Cost of providing ART

  12 months

• Cost of retaining a patient

  12 months

Study Arms (3)

Three monthly ART supply at facilities

NO INTERVENTION

Sites at which patients will be provided three monthly ART supply at health facilities.

Three monthly ART supply at CAGs

EXPERIMENTAL

Sites at which patients will be provided three monthly ART supply at Community ART Groups (CAGs).

Other: Three monthly ART supply at CAGs

Six monthly ART supply at outreaches

EXPERIMENTAL

Sites at which patients will be provided six monthly ART supply at Community distribution points or outreaches.

Other: Six monthly ART supply at outreaches

Interventions

Three monthly ART supply at CAGs OTHER

Sites where three monthly ART supply will be provided at outreaches

Three monthly ART supply at CAGs

Six monthly ART supply at outreaches OTHER

Sites where six monthly ART will supply will be provided at outreaches

Six monthly ART supply at outreaches

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age and willing and able to provide written informed consent for participation in this study.
• Willing to participate in the multi-month dispensing model that the patient's study site has been randomized to.
• On ART ≥ 6 months with no periods of defaulting from ART since the last viral load result (ART default defined as missing 7 or more consecutive days of ART)
• On first-line ART regimen (substitutions within the first-line regimen prior to the last viral load test are permissible).
• No ARV drug substitutions since the last viral load result \< 1,000 copies per ml
• Plasma or dried-blood spot viral load \< 1,000 copies/ml in a patient who has been on first-line ART for at least 6 months, with viral load drawn within last 12 months of enrollment while patient is receiving ART

You may not qualify if:

• On second-line ART regimen.
• Patients with co-morbidities requiring facility visits more often than 6 monthly.
• ART substitutions since last VL test.
• Diagnosed with a WHO clinical stage 3 or 4 condition within the past 3 months.
• Pregnant or less than 12 months postpartum and breastfeeding mothers.
• Participating in another study that involves dispensing interval, adherence, or retention or involves receiving medications.

Sponsors & Collaborators

• Equip, Lesotho: lead
• Ministry of Health, Lesotho: collaborator
• United States Agency for International Development (USAID): collaborator
• Elizabeth Glaser Pediatric AIDS Foundation: collaborator
• Lesotho Network of AIDS Services Organizations: collaborator
• National Drugs Service Organisation of Lesotho: collaborator
• Chemonics: collaborator

Study Sites (1)

Ha Tlali

Maseru, 100, Lesotho

RECRUITING

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Related Links

• UNAIDS. Lesotho: HIV and AIDS estimates.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Iyiola Faturiyele, MBChB, MPH

  Member, Southern Africa HIV Clinician Society, Johannesburg, South Africa, 2010-present

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iyiola Faturiyele, MBChB, MPH

CONTACT

00266 5939 9691; Iyiola.Faturiyele@equiphealth.org

Khotso Maile, MSc

CONTACT

00266 5709 9967; Kgotso.Maile@equiphealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Randomized Trial comparing three different antiretroviral therapy (ART) dispensing strategies.

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: February 19, 2018
• Study Start: August 7, 2017
• Primary Completion: August 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 19, 2018

Record last verified: 2017-08

Locations

LE (1)