Outcomes of Differentiated Models of Antiretroviral Treatment (ART) Provision

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

Interventions

OTHER

Three monthly ART supply at CAGs

Sites where three monthly ART supply will be provided at outreaches

OTHER

Six monthly ART supply at outreaches

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

Sponsors & Collaborators

• Ministry of Health, Lesotho

  collaborator OTHER_GOV

• United States Agency for International Development (USAID)

  collaborator FED

• Elizabeth Glaser Pediatric AIDS Foundation

  collaborator OTHER

• Lesotho Network of AIDS Services Organizations

  collaborator UNKNOWN

• National Drugs Service Organisation of Lesotho

  collaborator UNKNOWN

• Chemonics

  collaborator UNKNOWN

• Equip, Lesotho

  lead OTHER

Principal Investigators

• Iyiola Faturiyele, MBChB, MPH · Member, Southern Africa HIV Clinician Society, Johannesburg, South Africa, 2010-present

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-08-07

Primary Completion

2019-08-31

Completion

2019-09-30

Countries

• Lesotho

Study Locations