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Outcomes of Differentiated Models of Antiretroviral Treatment (ART) Provision ([MMD])

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ClinicalTrials.gov Identifier: NCT03438370
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Collaborators:
Ministry of Health, Lesotho
United States Agency for International Development (USAID)
Elizabeth Glaser Pediatric AIDS Foundation
Lesotho Network of AIDS Services Organizations
National Drugs Service Organisation of Lesotho
Chemonics
Information provided by (Responsible Party):
Equip, Lesotho

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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Other: Three monthly ART supply at CAGs Other: Six monthly ART supply at outreaches Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster Randomized Trial comparing three different antiretroviral therapy (ART) dispensing strategies.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Outcomes of Differentiated Models of Antiretroviral Treatment (ART) Provision: Multi-Month Dispensing (MMD) of ART in Community ART Distribution for Stable HIV Infected Patients
Actual Study Start Date : August 7, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
No Intervention: Three monthly ART supply at facilities
Sites at which patients will be provided three monthly ART supply at health facilities.
Experimental: Three monthly ART supply at CAGs
Sites at which patients will be provided three monthly ART supply at Community ART Groups (CAGs).
Other: Three monthly ART supply at CAGs
Sites where three monthly ART supply will be provided at outreaches

Experimental: Six monthly ART supply at outreaches
Sites at which patients will be provided six monthly ART supply at Community distribution points or outreaches.
Other: Six monthly ART supply at outreaches
Sites where six monthly ART will supply will be provided at outreaches




Primary Outcome Measures :
  1. retention in care [ Time Frame: 12 months ]
    The proportion of patients remaining in care 12 months after study enrolment


Secondary Outcome Measures :
  1. Viral suppression [ Time Frame: 12 months ]
    The proportion of patients with virological suppression (<1000 copies/ml) 12 months after study enrolment

  2. Cost of providing ART [ Time Frame: 12 months ]
    The cost per patient of providing ART in each of the three arms (from a provider perspective)

  3. Cost of retaining a patient [ Time Frame: 12 months ]
    The provider cost per patient retained and provider cost per patient retained with virological suppression in each of the three arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03438370


Contacts
Contact: Iyiola Faturiyele, MBChB, MPH 00266 5939 9691 Iyiola.Faturiyele@equiphealth.org
Contact: Khotso Maile, MSc 00266 5709 9967 Kgotso.Maile@equiphealth.org

Locations
Lesotho
Ha Tlali Recruiting
Maseru, Lesotho, 100
Contact: Khotso Maile, MSc    +26657099967    Kgotso.Maile@equiphealth.org   
Contact: Masesi P Mngomezulu, BSc    +26650225467    Masesi.Mngomezulu@equiphealth.org   
Sponsors and Collaborators
Equip, Lesotho
Ministry of Health, Lesotho
United States Agency for International Development (USAID)
Elizabeth Glaser Pediatric AIDS Foundation
Lesotho Network of AIDS Services Organizations
National Drugs Service Organisation of Lesotho
Chemonics
Investigators
Principal Investigator: Iyiola Faturiyele, MBChB, MPH Member, Southern Africa HIV Clinician Society, Johannesburg, South Africa, 2010-present

Additional Information:
Publications of Results:
Cohen M, Chen Y, McCauley M, Gamble T, Hosseinipour M, Kumarasamy N, et al., editors. Final results of the HPTN 052 randomized controlled trial: antiretroviral therapy prevents HIV transmission. Journal of the International AIDS Society; 2015: INT AIDS SOCIETY AVENUE DE FRANCE 23, GENEVA, 1202, SWITZERLAND.

Other Publications:
WHO. HIV/AIDS: Fact sheet. 2016 [cited 2016 12/12/2016].
Joint United Nations Programme on HIV/AIDS. AIDS by numbers2016.
Government of Lesotho. National guidelines on the use of antiretroviral therapy for HIV prevention and treatment. In: MOH, editor.2014
MOH Lesotho. GLOBAL AIDS RESPONSE PROGRESS REPORT 2015. 2015 Reporting Period: January - December 2014.
Teck R. Reducing frequency of ARV pick-ups for HIV patients stabilised on ARV treatment 2015.
Lesotho Go. Lesotho CAG toolkit In: MOH, editor.2015.
Joint United Nations Programme on HIV/AIDS (UNAIDS). COMMUNITY-BASED ANTIRETROVIRAL THERAPY DELIVERY. EXPERIENCES OF MÉDECINS SANS FRONTIÈRES. 2015.
World Health Organization. Retention in HIV programmes: defining the challenges and identifying solutions: meeting report, 13-15 September 2011. 2012.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Equip, Lesotho
ClinicalTrials.gov Identifier: NCT03438370     History of Changes
Other Study ID Numbers: ID49-2017
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 19, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No