Outcomes of Differentiated Models of Antiretroviral Treatment (ART) Provision ([MMD])
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03438370|
Recruitment Status : Recruiting
First Posted : February 19, 2018
Last Update Posted : February 19, 2018
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.
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|
|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|
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
- retention in care [ Time Frame: 12 months ]The proportion of patients remaining in care 12 months after study enrolment
- Viral suppression [ Time Frame: 12 months ]The proportion of patients with virological suppression (<1000 copies/ml) 12 months after study enrolment
- 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)
- 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
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
|Contact: Iyiola Faturiyele, MBChB, MPH||00266 5939 9691||Iyiola.Faturiyele@equiphealth.org|
|Contact: Khotso Maile, MSc||00266 5709 9967||Kgotso.Maile@equiphealth.org|
|Maseru, Lesotho, 100|
|Contact: Khotso Maile, MSc +26657099967 Kgotso.Maile@equiphealth.org|
|Contact: Masesi P Mngomezulu, BSc +26650225467 Masesi.Mngomezulu@equiphealth.org|
|Principal Investigator:||Iyiola Faturiyele, MBChB, MPH||Member, Southern Africa HIV Clinician Society, Johannesburg, South Africa, 2010-present|